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González-Muñoza C, Gely C, Gordillo J, Calafat M, Bertoletti F, Cañete F, Mañosa M, López-Faba A, Torres P, Domènech E, Garcia-Planella E. Perception of the impact of intravenous biological treatment on the work and professional environment in patients with inflammatory bowel disease. GASTROENTEROLOGIA Y HEPATOLOGIA 2024; 47:502193. [PMID: 38723767 DOI: 10.1016/j.gastrohep.2024.502193] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/29/2024] [Revised: 04/08/2024] [Accepted: 04/12/2024] [Indexed: 06/02/2024]
Abstract
INTRODUCTION In the treatment of inflammatory bowel disease (IBD), we have biologic therapies administered intravenously and subcutaneously. Recently, some drugs can be administered by either of these routes. The real impact that intravenous administration has on the perception of the disease and the personal and work life of the patient is unknown. METHODS All IBD patients receiving intravenous infliximab treatment for at least 6 months were anonymously invited to participate. They were provided with a specific structured questionnaire with visual analogue scales (0-10) at two reference centers in the Barcelona area. RESULTS A total of 90 patients with a median age of 45 years (36-56) and a median infliximab treatment duration of 48 months (24-84) were included. The visit and therapy with infliximab in the day hospital were globally well evaluated (9, IQR 7-10). 78% of patients combined day hospital stays with other activities (26% employment). The personal impact was generally low (4, IQR 0-5.8), but the patient's job was threatened in 43% of patients on intensified treatment. CONCLUSIONS The intravenous administration of biologic drugs on an outpatient basis is highly satisfactory among IBD patients. The impact on the work sphere appears to be more pronounced than on the personal sphere, an aspect that should be considered in shared decision-making with the patient.
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Affiliation(s)
| | - Cristina Gely
- Servicio de Patología Digestiva, Hospital Santa Creu i Sant Pau, Barcelona, España
| | - Jordi Gordillo
- Servicio de Patología Digestiva, Hospital Santa Creu i Sant Pau, Barcelona, España
| | - Margalida Calafat
- Servicio de Aparato Digestivo, Hospital Universitari Germans Trias i Pujol, Barcelona, España; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), España
| | - Federico Bertoletti
- Servicio de Patología Digestiva, Hospital Santa Creu i Sant Pau, Barcelona, España
| | - Fiorella Cañete
- Servicio de Aparato Digestivo, Hospital Universitari Germans Trias i Pujol, Barcelona, España; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), España
| | - Míriam Mañosa
- Servicio de Aparato Digestivo, Hospital Universitari Germans Trias i Pujol, Barcelona, España; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), España
| | - Alberto López-Faba
- Servicio de Patología Digestiva, Hospital Santa Creu i Sant Pau, Barcelona, España
| | - Paola Torres
- Servicio de Aparato Digestivo, Hospital Universitari Germans Trias i Pujol, Barcelona, España
| | - Eugeni Domènech
- Servicio de Aparato Digestivo, Hospital Universitari Germans Trias i Pujol, Barcelona, España; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), España; Departamento de Medicina, Universitat Autònoma de Barcelona, Barcelona, España
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Sequier L, Caron B, Danese S, Peyrin-Biroulet L. Clinical experience of using biosimilars in Crohn's disease and their effectiveness. Expert Opin Biol Ther 2024; 24:1145-1169. [PMID: 39269146 DOI: 10.1080/14712598.2024.2401616] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/23/2024] [Accepted: 09/03/2024] [Indexed: 09/15/2024]
Abstract
INTRODUCTION The approval of biosimilars in the management of inflammatory bowel diseases (IBDs) has offered an answer to a growing concern about healthcare costs, and availability of treatments. Several studies have been conducted to demonstrate proof of biosimilars effectiveness as treatment in Crohn's disease (CD). AREAS COVERED Since 2013, the European Medicines Agency has approved five biosimilars for infliximab and eight for adalimumab. Initial data leading to approval were extrapolated from studies conducted in patients with rheumatological or dermatological diseases, but recent studies filled the gap of clinical data among patients with IBD. In this review, 75 studies were included, with data from a total of 20 707 patients with CD. Clinical data on biosimilars in the treatment of CD show equivalence in terms of efficacy, either as induction or maintenance of treatment and regardless of previous exposure to originator or other biosimilar. EXPERT OPINION Since biosimilar market entry, utilization of infliximab increased by 89.9% and by 22.4% for adalimumab in European countries. With a 10-year insight since the first approval of biosimilar in Europe, biosimilars prescriptions should be implemented in routine clinical practice given the efficacy and safety profile.
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Affiliation(s)
- Léa Sequier
- Department of Gastroenterology and Hepatology, Nîmes University Hospital, Carémeau Hospital, Nîmes, France
- Department of Gastroenterology and Hepatology A, Saint-Éloi Hospital, Montpellier, France
| | - Bénédicte Caron
- Department of Gastroenterology, Nancy University Hospital, Vandœuvre-lès-Nancy, France
- INSERM, NGERE, University of Lorraine, Nancy, France
- INFINY Institute, Nancy University Hospital, Vandœuvre-lès-Nancy, France
- FHU-CURE, Nancy University Hospital, Vandœuvre-lès-Nancy, France
| | - Silvio Danese
- Department of Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele, Milan, Italy
- Department of Immunology, Transplantation and Infectious Disease, Università Vita-Salute San Raffaele, Milan, Italy
| | - Laurent Peyrin-Biroulet
- Department of Gastroenterology, Nancy University Hospital, Vandœuvre-lès-Nancy, France
- INSERM, NGERE, University of Lorraine, Nancy, France
- INFINY Institute, Nancy University Hospital, Vandœuvre-lès-Nancy, France
- FHU-CURE, Nancy University Hospital, Vandœuvre-lès-Nancy, France
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Little RD, McKenzie J, Srinivasan A, Hilley P, Gilmore RB, Chee D, Sandhu M, Saitta D, Chow E, Thin L, Walker GJ, Moore GT, Lynch K, Andrews J, An YK, Bryant RV, Connor SJ, Garg M, Wright EK, Hold G, Segal JP, Boussioutas A, De Cruz P, Ward MG, Sparrow MP. Switching from Dose-Intensified intravenous to SubCutaneoUS infliximab in Inflammatory Bowel Disease (DISCUS-IBD): protocol for a multicentre randomised controlled trial. BMJ Open 2024; 14:e081787. [PMID: 39032928 PMCID: PMC11261670 DOI: 10.1136/bmjopen-2023-081787] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/06/2023] [Accepted: 05/24/2024] [Indexed: 07/23/2024] Open
Abstract
INTRODUCTION A substantial proportion of patients with inflammatory bowel disease (IBD) on intravenous infliximab require dose intensification. Accessing additional intravenous infliximab is labour-intensive and expensive, depending on insurance and pharmaceutical reimbursement. Observational data suggest that subcutaneous infliximab may offer a convenient and safe alternative to maintain disease remission in patients requiring dose-intensified infliximab. A prospective, controlled trial is required to confirm that subcutaneous infliximab is as effective as dose-intensified intravenous infliximab, to identify predictors of disease flare and to establish the role of subcutaneous infliximab therapeutic drug monitoring. METHODS AND ANALYSIS The DISCUS-IBD trial is an investigator-initiated, prospective, multicentre, randomised, open-label non-inferiority study comparing the rate of disease flares in participants randomised to continue dose-intensified intravenous infliximab to those switched to subcutaneous infliximab after 48 weeks. Participants are adult patients with IBD in sustained corticosteroid-free remission on any regimen of dose-intensified infliximab up to a maximum of 10 mg/kg 4-weekly intravenously. Participants allocated to intravenous infliximab will continue infliximab at the same dose-intensified regimen they were receiving at study enrolment. Subcutaneous infliximab dosing will be stratified by prior intravenous infliximab dosing. Clinical (Harvey-Bradshaw Index, partial Mayo score), biochemical (C reactive protein, faecal calprotectin), pharmacokinetic (drug-level±antidrug antibodies) and qualitative data are collected 12-weekly until study conclusion at week 48. 13 sites across Australia will participate in recruitment to reach a calculated sample size of 120 participants. ETHICS AND DISSEMINATION Multisite ethics approval was obtained from the Health District Human Research Ethics Committee (HREC) at The Alfred Hospital under a National Mutual Acceptance (NMA) agreement (HREC/90559/Alfred-2022; Local Reference: Project 618/22, version 1.6, 2 March 2023). Findings will be reported at national and international gastroenterology meetings and published in peer-reviewed journals. DISCUS-IBD was prospectively registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR) prior to commencing recruitment. TRIAL REGISTRATION NUMBER ACTRN12622001458729.
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Affiliation(s)
- Robert D Little
- Department of Gastroenterology, Alfred Hospital, Melbourne, Victoria, Australia
- Monash University, Faculty of Medicine Nursing and Health Sciences, Clayton, Victoria, Australia
| | - Jo McKenzie
- Department of Gastroenterology, Alfred Hospital, Melbourne, Victoria, Australia
| | - Ashish Srinivasan
- Department of Gastroenterology, Austin Health, Melbourne, Victoria, Australia
- Faculty of Medicine, Dentistry & Health Sciences, The University of Melbourne Melbourne Medical School, Melbourne, Victoria, Australia
| | - Patrick Hilley
- Department of Gastroenterology, Austin Health, Melbourne, Victoria, Australia
| | - Robert B Gilmore
- Department of Gastroenterology, Mater Hospital Brisbane, Brisbane, Queensland, Australia
- Mater Research Institute-UQ, South Brisbane, Queensland, Australia
| | - Desmond Chee
- Gastroenterology Department, Monash Health, Melbourne, Victoria, Australia
| | - Manjeet Sandhu
- Gastroenterology Department, Monash Health, Melbourne, Victoria, Australia
| | - Daniel Saitta
- Department of Gastroenterology, Western Health, Melbourne, Victoria, Australia
| | - Elizabeth Chow
- Faculty of Medicine, Dentistry & Health Sciences, The University of Melbourne Melbourne Medical School, Melbourne, Victoria, Australia
- Department of Gastroenterology, Western Health, Melbourne, Victoria, Australia
| | - Lena Thin
- Department of Gastroenterology, Fiona Stanley Hospital, Perth, Western Australia, Australia
- Department of Internal Medicine, The University of Western Australia Faculty of Medicine Dentistry and Health Sciences, Perth, Western Australia, Australia
| | - Gareth J Walker
- Department of Gastroenterology and Hepatology, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia
- Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia
| | - Gregory T Moore
- Monash University, Faculty of Medicine Nursing and Health Sciences, Clayton, Victoria, Australia
- Gastroenterology Department, Monash Health, Melbourne, Victoria, Australia
| | - Kate Lynch
- Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, South Australia, Australia
- School of Medicine, The University of Adelaide Faculty of Health and Medical Sciences, Adelaide, South Australia, Australia
| | - Jane Andrews
- Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, South Australia, Australia
- School of Medicine, The University of Adelaide Faculty of Health and Medical Sciences, Adelaide, South Australia, Australia
| | - Yoon K An
- Department of Gastroenterology, Mater Hospital Brisbane, Brisbane, Queensland, Australia
- Mater Research Institute-UQ, South Brisbane, Queensland, Australia
| | - Robert V Bryant
- School of Medicine, The University of Adelaide Faculty of Health and Medical Sciences, Adelaide, South Australia, Australia
- Department of Gastroenterology and Hepatology, The Queen Elizabeth Hospital, Woodville South, South Australia, Australia
| | - Susan J Connor
- Department of Gastroenterology, Liverpool Hospital, Sydney, New South Wales, Australia
- South West Sydney Clinical Campuses, University of New South Wales Medicine & Health, Sydney, New South Wales, Australia
| | - Mayur Garg
- Faculty of Medicine, Dentistry & Health Sciences, The University of Melbourne Melbourne Medical School, Melbourne, Victoria, Australia
- Department of Gastroenterology, Northern Health, Melbourne, Victoria, Australia
| | - Emily K Wright
- Faculty of Medicine, Dentistry & Health Sciences, The University of Melbourne Melbourne Medical School, Melbourne, Victoria, Australia
- Department of Gastroenterology, St Vincent's Hospital, Melbourne, Victoria, Australia
| | - Georgina Hold
- Microbiome Research Centre, University of New South Wales, Sydney, New South Wales, Australia
| | - Jonathan P Segal
- Faculty of Medicine, Dentistry & Health Sciences, The University of Melbourne Melbourne Medical School, Melbourne, Victoria, Australia
- Department of Gastroenterology, The Royal Melbourne Hospital, Melbourne, Victoria, Australia
| | - Alex Boussioutas
- Department of Gastroenterology, Alfred Hospital, Melbourne, Victoria, Australia
- Monash University, Faculty of Medicine Nursing and Health Sciences, Clayton, Victoria, Australia
| | - Peter De Cruz
- Department of Gastroenterology, Austin Health, Melbourne, Victoria, Australia
- Faculty of Medicine, Dentistry & Health Sciences, The University of Melbourne Melbourne Medical School, Melbourne, Victoria, Australia
| | - Mark G Ward
- Department of Gastroenterology, Alfred Hospital, Melbourne, Victoria, Australia
- Monash University, Faculty of Medicine Nursing and Health Sciences, Clayton, Victoria, Australia
| | - Miles P Sparrow
- Department of Gastroenterology, Alfred Hospital, Melbourne, Victoria, Australia
- Monash University, Faculty of Medicine Nursing and Health Sciences, Clayton, Victoria, Australia
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Kumar A, Smith PJ. Horizon scanning: new and future therapies in the management of inflammatory bowel disease. EGASTROENTEROLOGY 2023; 1:e100012. [PMID: 39944001 PMCID: PMC11731077 DOI: 10.1136/egastro-2023-100012] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/27/2023] [Accepted: 09/15/2023] [Indexed: 01/02/2025]
Abstract
The current mainstay treatment modalities for inflammatory bowel disease (IBD) include immunomodulators (methotrexate and thiopurines), biologics (antitumour necrosis factor alpha (TNF-α) being the most commonly used) and other monoclonal antibodies such as the anti-integrins and anti-interleukins (IL-12/23). While ideally treatment should be initiated early in the disease process to avoid relapses and complications, the major recurring issue continues to be primary and secondary loss of response, with often 'diminishing returns' in terms of efficacy for the next line of therapies prescribed for patients with IBD. Additional concerns include the long-term risk factors such as malignancy and susceptibility to infections. Recently, there has been an influx of new and emerging medications entering the market that are showing promising efficacy results in patients with moderate-to-severe disease who have previously failed to respond to multiple drugs. This review will focus on these novel and emerging therapies-in essence, 'horizon scanning'-which includes the antiadhesion agents, cytokine inhibitors, Janus kinase inhibitors, phosphodiesterase inhibitors, sphingosine-1 phosphate receptor modulators and MicroRNA-124 (miR-124) upregulators.
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Affiliation(s)
- Aditi Kumar
- Department of Gastroenterology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
| | - Philip J Smith
- Department of Gastroenterology, Royal Liverpool Hospital, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK
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Targownik LE, Bollegala N, Huang VW, Windsor JW, Kuenzig ME, Benchimol EI, Kaplan GG, Murthy SK, Bitton A, Bernstein CN, Jones JL, Lee K, Peña-Sánchez JN, Rohatinsky N, Ghandeharian S, Davis T, Weinstein J, Im JHB, Jannati N, Khan R, Matthews P, Jones May T, Tabatabavakili S, Jogendran R, Hazan E, Browne M, Meka S, Vukovic S, Jogendran M, Hu M, Osei JA, Wang GY, Sheekha TA, Dahlwi G, Goddard Q, Gorospe J, Nisbett C, Gertsman S, Sousa J, Morganstein T, Stocks T, Weber A, Seow CH. The 2023 Impact of Inflammatory Bowel Disease in Canada: The Influence of Sex and Gender on Canadians Living With Inflammatory Bowel Disease. J Can Assoc Gastroenterol 2023; 6:S55-S63. [PMID: 37674498 PMCID: PMC10478807 DOI: 10.1093/jcag/gwad011] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 09/08/2023] Open
Abstract
Sex (the physical and physiologic effects resulting from having specific combinations of sex chromosomes) and gender (sex-associated behaviours, expectations, identities, and roles) significantly affect the course of inflammatory bowel disease (IBD) and the experience of living with IBD. Sex-influenced physiologic states, like puberty, the menstrual cycle, pregnancy, and andropause/menopause may also impact and be impacted by IBD. While neither Crohn's disease nor ulcerative colitis is commonly considered sex-determined illnesses, the relative incidence of Crohn's disease and ulcerative colitis between males and females varies over the life cycle. In terms of gender, women tend to use healthcare resources at slightly higher rates than men and are more likely to have fragmented care. Women are more commonly prescribed opioid medications and are less likely than men to undergo colectomy. Women tend to report lower quality of life and have higher indirect costs due to higher rates of disability. Women are also more likely to take on caregiver roles for children with IBD. Women with IBD are more commonly burdened with adverse mental health concerns and having poor mental health has a more profound impact on women than men. Pregnant people with active IBD have higher rates of adverse outcomes in pregnancy, made worse in regions with poor access to IBD specialist care. The majority of individuals with IBD in Canada do not have access to a pregnancy-in-IBD specialist; access to this type of care has been shown to allay fears and increase knowledge among pregnant people with IBD.
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Affiliation(s)
- Laura E Targownik
- Division of Gastroenterology and Hepatology, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada
| | - Natasha Bollegala
- Department of Gastroenterology, Women’s College Hospital, Toronto, Ontario, Canada
| | - Vivian W Huang
- Division of Gastroenterology and Hepatology, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada
- Department of Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
| | - Joseph W Windsor
- Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
| | - M Ellen Kuenzig
- SickKids Inflammatory Bowel Disease Centre, Division of Gastroenterology, Hepatology, and Nutrition, The Hospital for Sick Children, Toronto, Ontario, Canada
- Child Health Evaluative Sciences, SickKids Research Institute, The Hospital for Sick Children, Toronto, Ontario, Canada
| | - Eric I Benchimol
- SickKids Inflammatory Bowel Disease Centre, Division of Gastroenterology, Hepatology, and Nutrition, The Hospital for Sick Children, Toronto, Ontario, Canada
- Child Health Evaluative Sciences, SickKids Research Institute, The Hospital for Sick Children, Toronto, Ontario, Canada
- ICES, Toronto, Ontario, Canada
- Department of Paediatrics, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
- Institute of Health Policy, Management, and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada
| | - Gilaad G Kaplan
- Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
| | - Sanjay K Murthy
- Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
- The Ottawa Hospital IBD Centre, Ottawa, Ontario, Canada
| | - Alain Bitton
- Division of Gastroenterology and Hepatology, McGill University Health Centre IBD Centre, McGill University, Montréal, Quebec, Canada
| | - Charles N Bernstein
- Department of Internal Medicine, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada
- University of Manitoba IBD Clinical and Research Centre, Winnipeg, Manitoba, Canada
| | - Jennifer L Jones
- Departments of Medicine, Clinical Health, and Epidemiology, Dalhousie University, Halifax, Nova Scotia, Canada
| | - Kate Lee
- Crohn’s and Colitis Canada, Toronto, Ontario, Canada
| | - Juan-Nicolás Peña-Sánchez
- Department of Community Health and Epidemiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada
| | - Noelle Rohatinsky
- College of Nursing, University of Saskatchewan, Saskatoon, Saskatchewan, Canada
| | | | - Tal Davis
- SickKids Inflammatory Bowel Disease Centre, Division of Gastroenterology, Hepatology, and Nutrition, The Hospital for Sick Children, Toronto, Ontario, Canada
- Child Health Evaluative Sciences, SickKids Research Institute, The Hospital for Sick Children, Toronto, Ontario, Canada
| | - Jake Weinstein
- SickKids Inflammatory Bowel Disease Centre, Division of Gastroenterology, Hepatology, and Nutrition, The Hospital for Sick Children, Toronto, Ontario, Canada
- Child Health Evaluative Sciences, SickKids Research Institute, The Hospital for Sick Children, Toronto, Ontario, Canada
| | - James H B Im
- SickKids Inflammatory Bowel Disease Centre, Division of Gastroenterology, Hepatology, and Nutrition, The Hospital for Sick Children, Toronto, Ontario, Canada
- Child Health Evaluative Sciences, SickKids Research Institute, The Hospital for Sick Children, Toronto, Ontario, Canada
| | - Nazanin Jannati
- Department of Community Health and Epidemiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada
| | - Rabia Khan
- SickKids Inflammatory Bowel Disease Centre, Division of Gastroenterology, Hepatology, and Nutrition, The Hospital for Sick Children, Toronto, Ontario, Canada
- Child Health Evaluative Sciences, SickKids Research Institute, The Hospital for Sick Children, Toronto, Ontario, Canada
- ICES, Toronto, Ontario, Canada
| | | | - Tyrel Jones May
- Division of Gastroenterology and Hepatology, University Health Network, University of Toronto, Toronto, Ontario, Canada
| | - Sahar Tabatabavakili
- Department of Gastroenterology, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
| | - Rohit Jogendran
- Department of Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
| | - Elias Hazan
- Department of Internal Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
| | - Mira Browne
- SickKids Inflammatory Bowel Disease Centre, Division of Gastroenterology, Hepatology, and Nutrition, The Hospital for Sick Children, Toronto, Ontario, Canada
- Child Health Evaluative Sciences, SickKids Research Institute, The Hospital for Sick Children, Toronto, Ontario, Canada
| | - Saketh Meka
- Department of Internal Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
| | - Sonya Vukovic
- Department of Internal Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
| | - Manisha Jogendran
- Department of Medicine, Queen’s University, Kingston, Ontario, Canada
| | - Malini Hu
- Department of Gastroenterology, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
| | - Jessica Amankwah Osei
- Department of Community Health and Epidemiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada
| | - Grace Y Wang
- Department of Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
| | - Tasbeen Akhtar Sheekha
- Department of Community Health and Epidemiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada
| | - Ghaida Dahlwi
- Division of Gastroenterology, Hepatology, and Nutrition, The Hospital for Sick Children, University of Toronto, Toronto, Canada
- Department of Pediatrics, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia
| | - Quinn Goddard
- Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
| | - Julia Gorospe
- Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
| | - Cyanne Nisbett
- Faculty of Law, University of Victoria, Victoria, British Colombia, Canada
- School of Criminology, Simon Fraser University, Burnaby, British Colombia, Canada
| | - Shira Gertsman
- Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada
| | - James Sousa
- Crohn’s and Colitis Canada, Toronto, Ontario, Canada
| | - Taylor Morganstein
- Faculty of Medicine and Health Sciences, McGill University, Montreal, Quebec, Canada
| | - Taylor Stocks
- Crohn’s and Colitis Canada, Toronto, Ontario, Canada
| | - Ann Weber
- Department of Obstetrics and Gynecology, Memorial University of Newfoundland, St. John’s, Newfoundland, Canada
| | - Cynthia H Seow
- Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
- Department of Neuroscience, McGill University, Montreal, Quebec, Canada
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Kim ES, Kang B. Infliximab vs adalimumab: Points to consider when selecting anti-tumor necrosis factor agents in pediatric patients with Crohn’s disease. World J Gastroenterol 2023; 29:2784-2797. [PMID: 37274072 PMCID: PMC10237103 DOI: 10.3748/wjg.v29.i18.2784] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/28/2022] [Revised: 03/20/2023] [Accepted: 04/17/2023] [Indexed: 05/11/2023] Open
Abstract
Biologic agents with various mechanisms against Crohn’s disease (CD) have been released and are widely used in clinical practice. However, two anti-tumor necrosis factor (TNF) agents, infliximab (IFX) and adalimumab (ADL), are the only biologic agents approved by the Food and Drug Administration for pediatric CD currently. Therefore, in pediatric CD, the choice of biologic agents should be made more carefully to achieve the therapeutic goal. There are currently no head-to-head trials of biologic agents in pediatric or adult CD. There is a lack of accumulated data for pediatric CD, which requires the extrapolation of adult data for the positioning of biologics in pediatric CD. From a pharmacokinetic point of view, IFX is more advantageous than ADL when the inflammatory burden is high, and ADL is expected to be advantageous over IFX in sustaining remission in the maintenance phase. Additionally, we reviewed the safety profile, immunogenicity, preference, and compliance between IFX and ADL and provide practical insights into the choice of anti-TNF therapy in pediatric CD. Careful evaluation of clinical indications and disease behavior is essential when prescribing anti-TNF agents. In addition, factors such as the efficacy of induction and maintenance of remission, safety profile, immunogenicity, patient preference, and compliance play an important role in evaluating and selecting treatment options.
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Affiliation(s)
- Eun Sil Kim
- Department of Pediatrics, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul 03181, South Korea
| | - Ben Kang
- Department of Pediatrics, School of Medicine, Kyungpook National University, Daegu 41944, South Korea
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Advancing Biologic Therapy for Refractory Autoimmune Hepatitis. Dig Dis Sci 2022; 67:4979-5005. [PMID: 35147819 DOI: 10.1007/s10620-021-07378-4] [Citation(s) in RCA: 6] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/27/2021] [Accepted: 12/27/2021] [Indexed: 01/05/2023]
Abstract
Biologic agents may satisfy an unmet clinical need for treatment of refractory autoimmune hepatitis. The goals of this review are to present the types and results of biologic therapy for refractory autoimmune hepatitis, indicate opportunities to improve and expand biologic treatment, and encourage comparative clinical trials. English abstracts were identified in PubMed by multiple search terms. Full-length articles were selected for review, and secondary and tertiary bibliographies were developed. Rituximab (monoclonal antibodies against CD20 on B cells), infliximab (monoclonal antibodies against tumor necrosis factor-alpha), low-dose recombinant interleukin 2 (regulatory T cell promoter), and belimumab (monoclonal antibodies against B cell activating factor) have induced laboratory improvement in small cohorts with refractory autoimmune hepatitis. Ianalumab (monoclonal antibodies against the receptor for B cell activating factor) is in clinical trial. These agents target critical pathogenic pathways, but they may also have serious side effects. Blockade of the B cell activating factor or its receptors may disrupt pivotal B and T cell responses, and recombinant interleukin 2 complexed with certain interleukin 2 antibodies may selectively expand the regulatory T cell population. A proliferation-inducing ligand that enhances T cell proliferation and survival is an unevaluated, potentially pivotal, therapeutic target. Fully human antibodies, expanded target options, improved targeting precision, more effective delivery systems, and biosimilar agents promise to improve efficacy, safety, and accessibility. In conclusion, biologic agents target key pathogenic pathways in autoimmune hepatitis, and early experiences in refractory disease encourage clarification of the preferred target, rigorous clinical trial, and comparative evaluations.
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Brunet-Houdard S, Monmousseau F, Berthon G, Des Garets V, Laharie D, Picon L, Fotsing G, Gargot D, Charpentier C, Buisson A, Trang-Poisson C, Dib N, Rusch E, Aubourg A. How are patients' preferences for anti-TNF influenced by quality of life? A discrete choice experiment in Crohn's disease patients. Scand J Gastroenterol 2022; 57:1312-1320. [PMID: 35722732 DOI: 10.1080/00365521.2022.2085057] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
BACKGROUND AND OBJECTIVE Anti-TNFs have been shown to significantly improve the health-related quality of life (HRQoL) in Crohn's disease (CD) patients. The purpose of this study was to investigate to what extend the patients' preferences for these intravenous (IV) and subcutaneous (SC) treatments differ based on respondents' quality of life. An online discrete choice experiment (DCE) was conducted to understand patient trade-offs in treatment choice. METHODS Fifty-seven Crohn's disease anti-TNF naïve patients were asked to choose between two different scenarios, considering the following attributes: mode of administration (MODE), total availability for injection (TIME), speed of onset (DELAY), risk of anti-TNF administration despite a contraindication (RISK) and total monthly out-of-pocket expenses (COST). At the same time, patients completed the IBDQ-32 questionnaire. Conditional logit models without and with interaction terms were estimated to evaluate attribute weights. RESULTS Patients preferred to self-administer SC anti-TNF rather than have a primary care nurse do it, whereas the preference for IV route was negative. After adding interaction terms however, the IV route became preferred for patients with impaired HRQoL, this preference having decreased as HRQoL increased. Surprisingly, patients with impaired HRQoL were less willing to spend more time on treatment, and this effect diminished as HRQoL (overall and in each dimension) became higher. CONCLUSIONS HRQoL level changed patients' preferences for the anti-TNF treatment. The results suggest the need to optimise the management of IV infusions in the hospital and reinforce the importance of patient-reported outcome measures (PROMS) as a common practice to improve shared medical decision making.
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Affiliation(s)
- Solène Brunet-Houdard
- Health Economic Evaluation Unit, University Hospital of Tours, Tours, France.,EA7505 Education, Ethics, Health Research Unit, University of Tours, Tours, France
| | - Fanny Monmousseau
- Health Economic Evaluation Unit, University Hospital of Tours, Tours, France.,EA7505 Education, Ethics, Health Research Unit, University of Tours, Tours, France
| | - Geoffrey Berthon
- Health Economic Evaluation Unit, University Hospital of Tours, Tours, France
| | - Véronique Des Garets
- EA6296 VALLOREM Loire Valley Management Research Unit, Loire Valley University Management School, University of Tours, Tours, France
| | - David Laharie
- Department of Gastroenterology, University Hospital of Bordeaux, Pessac, France
| | - Laurence Picon
- Department of Gastroenterology, University Hospital of Tours, Chambray-lès-Tours, France
| | - Ginette Fotsing
- Department of Gastroenterology, University Hospital of Poitiers, Poitiers, France
| | - Dany Gargot
- Department of Gastroenterology, Hospital of Blois, Blois, France
| | - Cloé Charpentier
- Department of Gastroenterology, University Hospital of Rouen, Rouen, France
| | - Anthony Buisson
- Department of Gastroenterology, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France
| | | | - Nina Dib
- Department of Gastroenterology, University Hospital of Angers, Angers, France
| | - Emmanuel Rusch
- Health Economic Evaluation Unit, University Hospital of Tours, Tours, France.,EA7505 Education, Ethics, Health Research Unit, University of Tours, Tours, France
| | - Alexandre Aubourg
- Department of Gastroenterology, University Hospital of Tours, Chambray-lès-Tours, France
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9
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Schoefs E, Vermeire S, Ferrante M, Sabino J, Lambrechts T, Avedano L, Haaf I, De Rocchis MS, Broggi A, Sajak-Szczerba M, Saldaña R, Janssens R, Huys I. What are the unmet needs and most relevant treatment outcomes according to patients with inflammatory bowel disease? A qualitative patient preference study. J Crohns Colitis 2022; 17:379-388. [PMID: 36165579 PMCID: PMC10069611 DOI: 10.1093/ecco-jcc/jjac145] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/18/2022] [Indexed: 01/09/2023]
Abstract
BACKGROUND AND AIMS As more therapeutic options with their own characteristics become available for inflammatory bowel disease (IBD), drug development and individual treatment decision-making needs to be tailored towards patients' preferences and needs. This study aimed to understand patient preferences among IBD patients, and their most important treatment outcomes and unmet needs. METHODS This qualitative study consisted of 1) a scoping literature review, 2) two focus group discussions (FGDs) with IBD patients (n=11) using the nominal group technique, and 3) two expert panel discussions. RESULTS IBD patients discussed a multitude of unmet needs regarding their symptoms, side-effects, psychological and social issues for which they would welcome improved outcomes. Particularly, IBD patients elaborated on the uncertainties and fears they experienced regarding the possible need for surgery or an ostomy, the effectiveness and onset of action of their medication, and its long-term effects. Furthermore, participants extensively discussed the mental impact of IBD and their need for more psychological guidance, support, and improved information and communication with healthcare workers regarding their disease and emotional well-being. The following five characteristics were identified during the attribute grading as most important: prevent surgery, long-term clinical remission, improved quality of life (QoL), occurrence of urgency, and improved labor rate. CONCLUSIONS This study suggests that IBD drug development and treatment decision-making needs to improve IBD symptoms and adverse events that significantly impact IBD patients' QoL. Furthermore, this study underscores patients need for a shared decision-making process where their desired treatment outcomes and uncertainties are explicitly discussed and considered.
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Affiliation(s)
- Elise Schoefs
- Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
| | - Séverine Vermeire
- Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.,Department of Chronic Diseases, Metabolism and Aging, KU Leuven, Leuven, Belgium
| | - Marc Ferrante
- Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.,Department of Chronic Diseases, Metabolism and Aging, KU Leuven, Leuven, Belgium
| | - João Sabino
- Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.,Department of Chronic Diseases, Metabolism and Aging, KU Leuven, Leuven, Belgium
| | - Tessy Lambrechts
- Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium
| | - Luisa Avedano
- European Federation of Crohn's & Ulcerative Colitis Associations (EFCCA), Brussels, Belgium
| | - Isabella Haaf
- European Federation of Crohn's & Ulcerative Colitis Associations (EFCCA), Brussels, Belgium
| | | | - Andrea Broggi
- European Federation of Crohn's & Ulcerative Colitis Associations (EFCCA), Brussels, Belgium
| | | | - Roberto Saldaña
- European Federation of Crohn's & Ulcerative Colitis Associations (EFCCA), Madrid, Spain
| | - Rosanne Janssens
- Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
| | - Isabelle Huys
- Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
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10
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Volkers A, Straatmijer T, Duijvestein M, Sales A, Levran A, van Schaik F, Maljaars J, Gecse K, Ponsioen C, Grootjans J, Hanzel J, Tack G, Jansen J, Hoentjen F, de Boer N, van der Marel S, Dijkstra G, Oldenburg B, Löwenberg M, van der Meulen A, D′Haens G. Real-world experience of switching from intravenous to subcutaneous vedolizumab maintenance treatment for inflammatory bowel diseases. Aliment Pharmacol Ther 2022; 56:1044-1054. [PMID: 35869807 PMCID: PMC9540102 DOI: 10.1111/apt.17153] [Citation(s) in RCA: 26] [Impact Index Per Article: 8.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/26/2022] [Revised: 05/16/2022] [Accepted: 07/07/2022] [Indexed: 12/19/2022]
Abstract
BACKGROUND Subcutaneous (SC) vedolizumab is effective in inflammatory bowel diseases (IBD) when administered after induction with two infusions. AIM To assess the effectiveness, safety and pharmacokinetics of a switch from intravenous (IV) to SC maintenance vedolizumab in patients with IBD METHODS: In this prospective cohort study, patients with IBD who had ≥4 months IV vedolizumab were switched to SC vedolizumab. We studied the time to discontinuation of SC vedolizumab, adverse events (AEs), changes in clinical and biochemical outcomes and vedolizumab concentrations at baseline, and weeks 12 and 24. RESULTS We included 82 patients with Crohn's disease (CD) and 53 with ulcerative colitis (UC). Eleven (13.4%) patients with CD and five (9.4%) with UC discontinued SC vedolizumab after a median of 18 (IQR 8-22) and 6 weeks (IQR 5-10), respectively. Four patients with CD switched to a different drug due to loss of response, nine switched back to IV vedolizumab due to adverse events, and three due to needle fear. Common AEs were injection site reactions (n = 15) and headache (n = 6). Median clinical and biochemical disease activity remained stable after the switch. Median serum vedolizumab concentrations increased from 19 μg/ml at the time of the switch to 31 μg/ml 12 weeks after the switch (p < 0.005). CONCLUSIONS Switching from IV to SC vedolizumab maintenance treatment is effective in patients with CD or UC. However, 9% of patients were switched back to IV vedolizumab due to adverse events or fear of needles.
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Affiliation(s)
- Adriaan Volkers
- Department of Gastroenterology and HepatologyAmsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research InstituteAmsterdam UMC, University of AmsterdamAmsterdamThe Netherlands
| | - Tessa Straatmijer
- Department of Gastroenterology and HepatologyAmsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research InstituteAmsterdam UMC, University of AmsterdamAmsterdamThe Netherlands,Department of Gastroenterology and HepatologyLeiden University Medical CentreLeidenThe Netherlands
| | - Marjolijn Duijvestein
- Department of GastroenterologyRadboud University Medical CenterNijmegenThe Netherlands
| | - Amber Sales
- Department of Gastroenterology and HepatologyAmsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research InstituteAmsterdam UMC, University of AmsterdamAmsterdamThe Netherlands
| | - Amit Levran
- Department of Gastroenterology and HepatologyAmsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research InstituteAmsterdam UMC, University of AmsterdamAmsterdamThe Netherlands
| | | | - Jeroen Maljaars
- Department of Gastroenterology and HepatologyLeiden University Medical CentreLeidenThe Netherlands
| | - Krisztina Gecse
- Department of Gastroenterology and HepatologyAmsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research InstituteAmsterdam UMC, University of AmsterdamAmsterdamThe Netherlands
| | - Cyriel Ponsioen
- Department of Gastroenterology and HepatologyAmsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research InstituteAmsterdam UMC, University of AmsterdamAmsterdamThe Netherlands
| | - Joep Grootjans
- Department of Gastroenterology and HepatologyAmsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research InstituteAmsterdam UMC, University of AmsterdamAmsterdamThe Netherlands
| | - Jurij Hanzel
- Department of Gastroenterology, UMC Ljubljana, Faculty of MedicineUniversity of LjubljanaLjubljanaSlovenia
| | - Greetje Tack
- Medical centre LeeuwardenLeeuwardenThe Netherlands
| | | | - Frank Hoentjen
- Department of GastroenterologyRadboud University Medical CenterNijmegenThe Netherlands,Division of Gastroenterology, Department of MedicineUniversity of AlbertaEdmontonCanada
| | - Nanne de Boer
- Department of Gastroenterology and HepatologyAmsterdam Gastroenterology Endocrinology Metabolism Research InstituteAmsterdam University Medical Centre, Vrije Universiteit AmsterdamAmsterdamThe Netherlands
| | | | - Gerard Dijkstra
- University Medical Centre GroningenUniversity of GroningenGroningenThe Netherlands
| | - Bas Oldenburg
- University Medical Centre UtrechtUtrechtThe Netherlands
| | - Mark Löwenberg
- Department of Gastroenterology and HepatologyAmsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research InstituteAmsterdam UMC, University of AmsterdamAmsterdamThe Netherlands
| | - Andrea van der Meulen
- Department of Gastroenterology and HepatologyLeiden University Medical CentreLeidenThe Netherlands
| | - Geert D′Haens
- Department of Gastroenterology and HepatologyAmsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research InstituteAmsterdam UMC, University of AmsterdamAmsterdamThe Netherlands
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11
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Fierens L, Liefferinckx C, Hoefkens E, Lobatòn T, Dreesen E, Sabino J, Ferrante M. Introduction of Subcutaneous Infliximab CT-P13 and Vedolizumab in Clinical Practice: A Multi-Stakeholder Position Statement Highlighting the Need for Post-Marketing Studies. J Crohns Colitis 2022; 16:1059-1069. [PMID: 35078228 DOI: 10.1093/ecco-jcc/jjac009] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/31/2021] [Revised: 11/17/2021] [Accepted: 01/24/2022] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIMS Although subcutaneous formulations of infliximab CT-P13 and vedolizumab are registered for treating moderate-to-severe inflammatory bowel disease [IBD], many questions on their use remain unanswered. We set up a multi-stakeholder initiative resulting in a position statement. METHODS Based on publicly available data, statements on subcutaneous infliximab and vedolizumab were developed and reviewed by 45 Belgian IBD physicians in a three-round modified Delphi process. During a consensus meeting, input from 16 IBD patients, nine IBD nurses and two clinical pharmacologists was provided and statements were further discussed, modified and scored. Statements achieving agreement by at least 70% of the IBD physicians were accepted. RESULTS The Delphi process resulted in 79 agreed statements. In patients initiating intravenous therapy, IBD physicians would only consider switching to subcutaneous formulations in patients achieving both clinical and biological response [for Crohn's disease] or both clinical and endoscopic response [for ulcerative colitis]. For patients under maintenance therapy, switching to subcutaneous formulations was only considered in those achieving both clinical and endoscopic response while receiving standard dosing of infliximab or vedolizumab. While awaiting more scientific data, IBD physicians should consider weekly subcutaneous injections or switching back to an intravenous formulation in case of loss of response. Finally, switching to a subcutaneous formulation should always be a shared decision. CONCLUSIONS All stakeholders welcomed subcutaneous infliximab and vedolizumab. However, more scientific data are needed to select the right patients and timing for switching to these newer formulations, and to explore the optimal strategy in case of loss of response.
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Affiliation(s)
- Liselotte Fierens
- KU Leuven, Department of Chronic Diseases, Metabolism and Ageing (CHROMETA), Leuven, Belgium
| | | | - Eveline Hoefkens
- Imelda General Hospital, Department of Gastroenterology, Bonheiden, Belgium
| | - Triana Lobatòn
- University Hospital Ghent, Department of Gastroenterology, Ghent, Belgium
- Ghent University, Department of Internal Medicine and Pediatrics, Ghent, Belgium
| | - Erwin Dreesen
- KU Leuven, Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium
| | - João Sabino
- KU Leuven, Department of Chronic Diseases, Metabolism and Ageing (CHROMETA), Leuven, Belgium
- University Hospitals Leuven, Department of Gastroenterology and Hepatology, Leuven, Belgium
| | - Marc Ferrante
- KU Leuven, Department of Chronic Diseases, Metabolism and Ageing (CHROMETA), Leuven, Belgium
- University Hospitals Leuven, Department of Gastroenterology and Hepatology, Leuven, Belgium
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12
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Ventress E, Young D, Rahmany S, Harris C, Bettey M, Smith T, Moyses H, Lech M, Gwiggner M, Felwick R, Cummings JRF. Transitioning from Intravenous to Subcutaneous Vedolizumab in Patients with Inflammatory Bowel Disease [TRAVELESS]. J Crohns Colitis 2022; 16:911-921. [PMID: 34935945 PMCID: PMC9383144 DOI: 10.1093/ecco-jcc/jjab224] [Citation(s) in RCA: 26] [Impact Index Per Article: 8.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/05/2021] [Revised: 11/17/2021] [Accepted: 12/20/2021] [Indexed: 02/07/2023]
Abstract
BACKGROUND AND AIMS Subcutaneous [SC] vedolizumab presents the opportunity for inflammatory bowel disease [IBD] patients to manage their treatment at home. There are currently no data on the process of transitioning patients established on intravenous [IV] to SC vedolizumab as part of routine clinical care. The aim of this programme is to evaluate the clinical and biochemical outcomes of switching a cohort of IBD patients established on IV vedolizumab to SC, at 12 weeks following the transition. METHODS In all, 178 adult patients were offered the opportunity to transition to SC vedolizumab. Patients who agreed were reviewed prior to switching and at Week 12 [W12] after their first SC dose. Evaluation outcomes included disease activity scores, the IBD-Control Patient-Reported Outcome Measures [PROMs], and faecal calprotectin [FCP]. Reasons for patients declining or accepting transitioning, pharmacokinetics, adverse drug reactions, and risk factors for a poor outcome in SARS-CoV-2 infection were also assessed. RESULTS A total of 124 patients agreed to transition, of whom 106 patients had been on IV vedolizumab for at least 4 months. There were no statistically significant differences in disease activity scores or IBD-Control PROMs between baseline and W12. A statistically significant increase in FCP was observed [31 µg/g vs. 47 µg/g; p = 0.008], although this was unlikely to be clinically relevant. The most common adverse drug reaction reported was injection site reactions [15%]. Based on this cohort of patients, an expected reduction of £572,000 per annum is likely to be achieved. CONCLUSIONS Transitioning patients established on IV vedolizumab to SC appears to be safe and effective, with high patient satisfaction and multiple benefits for the health service.
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Affiliation(s)
- Esther Ventress
- Pharmacy Department, University Hospital Southampton NHS Foundation Trust [UHS], Southampton, UK
| | - David Young
- Pharmacy Department, University Hospital Southampton NHS Foundation Trust [UHS], Southampton, UK
- Faculty of Medicine, University of Southampton, Southampton, UK
| | - Sohail Rahmany
- Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK
| | - Clare Harris
- Faculty of Medicine, University of Southampton, Southampton, UK
| | - Marion Bettey
- Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK
| | - Trevor Smith
- Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK
| | - Helen Moyses
- NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK
| | - Magdalena Lech
- Faculty of Medicine, University of Southampton, Southampton, UK
| | - Markus Gwiggner
- Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK
| | - Richard Felwick
- Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK
| | - J R Fraser Cummings
- Faculty of Medicine, University of Southampton, Southampton, UK
- Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK
- NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK
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13
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Buisson A, Serrero M, Orsat L, Nancey S, Rivière P, Altwegg R, Peyrin-Biroulet L, Nachury M, Hébuterne X, Gilletta C, Flamant M, Viennot S, Bouguen G, Amiot A, Mathieu S, Vuitton L, Plastaras L, Bourreille A, Caillo L, Goutorbe F, Pineton De Chambrun G, Attar A, Roblin X, Pereira B, Fumery M. Comparative Acceptability of Therapeutic Maintenance Regimens in Patients With Inflammatory Bowel Disease: Results From the Nationwide ACCEPT2 Study. Inflamm Bowel Dis 2022; 29:579-588. [PMID: 35815744 DOI: 10.1093/ibd/izac119] [Citation(s) in RCA: 16] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/11/2022] [Indexed: 12/15/2022]
Abstract
BACKGROUND Owing to growing number of therapeutic options with similar efficacy and safety, we compared the acceptability of therapeutic maintenance regimens in inflammatory bowel disease (IBD). METHODS From a nationwide study (24 public or private centers), IBD patients were consecutively included for 6 weeks. A dedicated questionnaire including acceptability numerical scales (ANS) ranging from 0 to 10 (highest acceptability) was administered to both patients and related physicians. RESULTS Among 1850 included patients (65.9% with Crohn's disease), the ANS were 8.68 ± 2.52 for oral route (first choice in 65.8%), 7.67 ± 2.94 for subcutaneous injections (first choice in 21.4%), and 6.79 ± 3.31 for intravenous infusions (first choice in 12.8%; P < .001 for each comparison). In biologic-naïve patients (n = 315), the most accepted maintenance regimens were oral intake once (ANS = 8.8 ± 2.2) or twice (ANS = 6.9 ± 3.4) daily and subcutaneous injections every 12 or 8 weeks (ANS = 7.9 ± 3.0 and ANS = 7.2 ± 3.2, respectively). Among 342 patients with prior exposure to subcutaneous biologics, the preferred regimens were subcutaneous injections (≥2 week-intervals; ANS between 9.1 ± 2.3 and 8.1 ± 2.7) and oral intake once daily (ANS = 7.7 ± 3.2); although it was subcutaneous injections every 12 or 8 weeks (ANS = 8.4 ± 3.0 and ANS = 8.1 ± 3.0, respectively) and oral intake once daily (ANS = 7.6 ± 3.1) in case of prior exposure to intravenous biologics (n = 1181). The impact of usual therapeutic escalation or de-escalation was mild (effect size <0.5). From patients' acceptability perspective, superiority and noninferiority cutoff values should be 15% and 5%, respectively. CONCLUSIONS Although oral intake is overall preferred, acceptability is highly impacted by the rhythm of administration and prior medication exposures. However, SC treatment with long intervals between 2 injections (≥8 weeks) and oral intake once daily seems to be the most accepted modalities.
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Affiliation(s)
- Anthony Buisson
- Université Clermont Auvergne, Inserm, Centre Hospitalier Universitaire Clermont-Ferrand, 3iHP, Service d'Hépato-Gastro Entérologie, Clermont-Ferrand, France.,Université Clermont Auvergne, Inserm, M2iSH, USC-INRA, Clermont-Ferrand, France
| | - Mélanie Serrero
- Department of Gastroenterology, University Hospital of Marseille Nord, Aix-Marseille, Marseille University, Marseille, France
| | - Laurie Orsat
- Université Clermont Auvergne, Inserm, Centre Hospitalier Universitaire Clermont-Ferrand, 3iHP, Service d'Hépato-Gastro Entérologie, Clermont-Ferrand, France
| | - Stéphane Nancey
- French Institute of Health and Medical Research U1111-CIRI, Department of Gastroenterology, Lyon-Sud University Hospital, Hospices Civils de Lyon, Pierre Bénite, France
| | - Pauline Rivière
- Service d'Hépato-gastroentérologie et oncologie digestive, Hôpital Haut-Lévêque, Centre Hospitalier Universitaire de Bordeaux, Université de Bordeaux, Bordeaux, France
| | - Romain Altwegg
- Department of Hepatogastroenterology, Centre Hospitalier Universitaire St Eloi Montpellier, Montpellier, France
| | - Laurent Peyrin-Biroulet
- French Institute of Health and Medical Research Nutrition-Genetics and Exposure to Environmental Risks U1256, Department of Gastroenterology, University Hospital of Nancy, University of Lorraine, Vandœuvre-lès-Nancy, France
| | - Maria Nachury
- Université Lille, Inserm, Centre Hospitalier Universitaire Lille, U1286-INFINITE-Institute for Translational Research in Inflammation, F-59000 Lille, France
| | - Xavier Hébuterne
- Gastroenterology and Clinical Nutrition, Centre Hospitalier Universitaire Nice and University Côte d'Azur, Nice, France
| | | | | | | | - Guillaume Bouguen
- Centre Hospitalier Universitaire Rennes, Univ Rennes, INSERM, CIC1414, Institut NUMECAN (Nutrition Metabolism and Cancer), Rennes, France
| | - Aurélien Amiot
- EC2M3-EA7375, Department of Gastroenterology, Groupe Hospitalier Henri Mondor-Albert Chennevier, Assistance Publique-Hôpitaux de Paris, University of Paris Est Créteil, Créteil, France
| | | | - Lucine Vuitton
- Centre Hospitalier Universitaire Besançon, Besançon, France
| | | | | | - Ludovic Caillo
- Service d'hépato-gastro-entérologie, Centre Hospitalier Universitaire Nimes, Univ Montpellier, Nimes, France
| | - Félix Goutorbe
- Department of Gastroenterology, Hospital of Bayonne, Bayonne, France
| | | | - Alain Attar
- Private practice, Clinique Monceau, Paris, France
| | - Xavier Roblin
- Centre Hospitalier Universitaire Saint-Etienne, Saint-Etienne, France
| | - Bruno Pereira
- Université Clermont Auvergne, Centre Hospitalier Universitaire Clermont-Ferrand, DRCI, Unité de Biostatistiques, Clermont-Ferrand, France
| | - Mathurin Fumery
- Centre Hospitalier Universitaire Amiens, Université de Picardie Jules Verne, Unité Peritox, Amiens, France
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14
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Schreiber S, Ben-Horin S, Alten R, Westhovens R, Peyrin-Biroulet L, Danese S, Hibi T, Takeuchi K, Magro F, An Y, Kim DH, Yoon S, Reinisch W. Perspectives on Subcutaneous Infliximab for Rheumatic Diseases and Inflammatory Bowel Disease: Before, During, and After the COVID-19 Era. Adv Ther 2022. [DOI: 10.1007/s12325-021-01990-6
expr 982114691 + 941296860] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 03/16/2023]
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15
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Re-Routing Infliximab Therapy: Subcutaneous Infliximab Opens a Path Towards Greater Convenience and Clinical Benefit. Clin Drug Investig 2022; 42:477-489. [PMID: 35657560 DOI: 10.1007/s40261-022-01162-6] [Citation(s) in RCA: 14] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 05/01/2022] [Indexed: 11/03/2022]
Abstract
Subcutaneous infliximab recently received approval for the treatment of various immune-mediated inflammatory diseases in Europe, following pivotal clinical trials in patients with rheumatoid arthritis and inflammatory bowel disease. Subcutaneous infliximab demonstrated an improved pharmacokinetic profile compared with intravenous infliximab: the more stable exposure and increased systemic drug concentrations mean it has been cited as a biobetter. Alongside the pharmacokinetic advantages, potential benefits for efficacy, immunogenicity, and health-related quality-of-life outcomes have been suggested with subcutaneous infliximab. During the coronavirus disease 2019 pandemic, the benefits of subcutaneous over intravenous therapies became apparent: switching from intravenous to subcutaneous infliximab reduced the hospital visit-related healthcare resource burden and potential viral transmission. Clinical advantages observed in pivotal trials are also being seen in the real world. Accumulating experience from four European countries (the UK, Spain, France, and Germany) in patients with rheumatic diseases and inflammatory bowel disease supports clinical trial findings that subcutaneous infliximab is well tolerated, increases serum drug concentrations, and offers maintained or improved efficacy outcomes for patients switching from intravenous infliximab. Initial evidence is emerging with subcutaneous infliximab treatment after intravenous infliximab failure. High patient satisfaction and pharmacoeconomic benefits have also been reported with subcutaneous infliximab. Treatments aligned with patient preferences for the flexibility and convenience of at-home subcutaneous administration could boost adherence and treatment outcomes. Altogether, findings suggest that switching from intravenous to subcutaneous infliximab could be advantageous, and healthcare professionals should be prepared to discuss supporting data as part of shared decision making during patient consultations.
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16
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Schreiber S, Ben-Horin S, Alten R, Westhovens R, Peyrin-Biroulet L, Danese S, Hibi T, Takeuchi K, Magro F, An Y, Kim DH, Yoon S, Reinisch W. Perspectives on Subcutaneous Infliximab for Rheumatic Diseases and Inflammatory Bowel Disease: Before, During, and After the COVID-19 Era. Adv Ther 2022; 39:2342-2364. [PMID: 34988877 PMCID: PMC8731678 DOI: 10.1007/s12325-021-01990-6] [Citation(s) in RCA: 11] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/27/2021] [Accepted: 11/05/2021] [Indexed: 12/11/2022]
Abstract
The coronavirus disease 2019 (COVID-19) pandemic has prompted significant changes in patient care in rheumatology and gastroenterology, with clinical guidance issued to manage ongoing therapy while minimising the risk of nosocomial infection for patients and healthcare professionals (HCPs). Subcutaneous (SC) formulations of biologics enable patients to self-administer treatments at home; however, switching between agents may be undesirable. CT-P13 SC is the first SC formulation of infliximab that received regulatory approval and may be termed a biobetter as it offers significant clinical advantages over intravenous (IV) infliximab, including improved pharmacokinetics and a convenient mode of delivery. Potential benefits in terms of reduced immunogenicity have also been suggested. With a new SC formulation, infliximab provides an additional option for dual formulation, which enables patients to transition from IV to SC administration route without changing agent. Before COVID-19, clinical trials supported the efficacy and safety of switching from IV to SC infliximab for patients with rheumatoid arthritis and inflammatory bowel disease (IBD), and SC infliximab may have been selected on the basis of patient and HCP preferences for SC agents. During the pandemic, patients with rheumatic diseases and IBD have successfully switched from IV to SC infliximab, with some clinical benefits and high levels of patient satisfaction. As patients switched to SC therapeutics, the reduction in resource requirements for IV infusion services may have been particularly welcome given the pandemic, facilitating reorganisation and redeployment in overstretched healthcare systems, alongside pharmacoeconomic benefits and a reduction in exposure to nosocomial infection. Telemedicine and contactless healthcare have been pushed to the forefront during the pandemic, and a lasting shift towards remote patient management and community/home-based drug administration is anticipated. SC infliximab supports the implementation of this paradigm for future improvements of healthcare value delivered. The accumulation of real-world data during the pandemic supports the high level of confidence, with patients, physicians, and healthcare systems benefitting from its uptake.
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Affiliation(s)
- Stefan Schreiber
- Department of Medicine I, Christian-Albrechts-University, University Hospital Schleswig-Holstein, Kiel, Germany
| | - Shomron Ben-Horin
- Gastroenterology Department, Sheba Medical Center, Tel Aviv University, Tel-Hashomer, Israel
| | - Rieke Alten
- Department of Internal Medicine II, Rheumatology, Clinical Immunology, Osteology, Schlosspark Klinik, University Medicine Berlin, Berlin, Germany
| | - René Westhovens
- Department of Development and Regeneration, Skeletal Biology and Engineering Research Center, Leuven, Belgium
| | - Laurent Peyrin-Biroulet
- Department of Gastroenterology, Nancy University Hospital, Vandoeuvre-les-Nancy, France
- Inserm U1256 NGERE, Lorraine University, Vandoeuvre-les-Nancy, France
| | - Silvio Danese
- Gastroenterology and Endoscopy Unit, IRCCS Ospedale San Raffaele, University Vita-Salute San Raffaele, Milan, Italy
| | - Toshifumi Hibi
- Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, Japan
| | - Ken Takeuchi
- Department of Gastroenterology, IBD Center, Tsujinaka Hospital Kashiwanoha, Chiba, Japan
| | - Fernando Magro
- Department of Biomedicine, Unit of Pharmacology and Therapeutics, Faculty of Medicine, University of Porto, Porto, Portugal
- Department of Gastroenterology, Centro Hospitalar São João, Porto, Portugal
- MedInUP, Centre for Drug Discovery and Innovative Medicines, Porto, Portugal
| | - Yoorim An
- Celltrion Healthcare Co., Ltd, Incheon, Republic of Korea
| | - Dong-Hyeon Kim
- Celltrion Healthcare Co., Ltd, Incheon, Republic of Korea
| | - SangWook Yoon
- Celltrion Healthcare Co., Ltd, Incheon, Republic of Korea
| | - Walter Reinisch
- Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.
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Ahn SM, Oh JS, Heo HM, Hong S, Lee CK, Yoo B, Kim YG. Predictive Factors for Rheumatoid Arthritis Flare After Switching From Intravenous to Subcutaneous Formulation of Tocilizumab in Real-World Practice. J Korean Med Sci 2022; 37:e138. [PMID: 35502504 PMCID: PMC9062274 DOI: 10.3346/jkms.2022.37.e138] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/12/2022] [Accepted: 04/04/2022] [Indexed: 11/20/2022] Open
Abstract
BACKGROUND To evaluate the incidence and related factors of rheumatoid arthritis (RA) flares after switching from intravenous tocilizumab (TCZ-IV) to subcutaneous tocilizumab (TCZ-SC) injection in stable RA patients. METHODS We retrospectively evaluated the medical records of stable RA patients who used TCZ-IV for more than 6 months and switched to TCZ-SC between January 2013 and April 2020. RA flare was defined as an increase of more than 1.2 in the RA disease activity as assessed by the disease activity score in 28 joints. The factors associated with RA flare were evaluated by logistic regression analysis. RESULTS Among 106 patients treated with TCZ-IV for > 6 months, 37 patients were switched to TCZ-SC after the acquisition of remission or low disease activity. RA flares occurred in 11 (29.7%) of patients who switched TCZ-SC. Results from the multivariable logistic analysis revealed that the dose of TCZ-IV per weight at switching (odds ratio [OR], 20.70; 95% confidence interval [CI], 2.22-192.84; P = 0.008) and methotrexate (MTX) non-use (OR, 8.53; 95% CI, 1.21-60.40; P = 0.032) were associated with the risk of RA flares after switching to TCZ-SC. Interestingly, most patients who switched back to TCZ-IV had their RA activity controlled again. CONCLUSION MTX non-use and high dose of TCZ-IV per weight were associated with a risk of RA flare after switching to TCZ-SC. RA patients with these factors need to be carefully observed for flare after switching from TCZ-IV to TCZ-SC.
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Affiliation(s)
- Soo Min Ahn
- Department of Rheumatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Ji Seon Oh
- Department of Information Medicine, Big Data Research Center, Asan Medical Center, Seoul, Korea
| | - Hyun Mi Heo
- Department of Rheumatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Seokchan Hong
- Department of Rheumatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Chang-Keun Lee
- Department of Rheumatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Bin Yoo
- Department of Rheumatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Yong-Gil Kim
- Department of Rheumatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
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18
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Patient Perspectives and Expectations in Inflammatory Bowel Disease: A Systematic Review. Dig Dis Sci 2022; 67:1956-1974. [PMID: 34021425 PMCID: PMC8139371 DOI: 10.1007/s10620-021-07025-y] [Citation(s) in RCA: 15] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/26/2021] [Accepted: 04/21/2021] [Indexed: 12/09/2022]
Abstract
BACKGROUND In this systematic review, our objective was to assess inflammatory bowel disease (IBD) patient preferences and perspectives relating to their disease diagnosis, treatment, knowledge needs and telemedicine. METHODS This study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Four databases and conference proceedings were searched between January 1, 1980, and May 1, 2020. The methodological quality of the included studies was assessed using the Standards for reporting qualitative research checklist. RESULTS Our search identified 240 citations and 52 studies met the inclusion criteria. The major expectations of the patients are symptomatic and pain control, quality of life and normal endoscopy. Patients' main concerns are access to information and healthcare, and shared decision making. At the time of diagnosis, patients expressed a greater need for knowledge about their IBD, preferentially by their treating gastroenterologist. The main treatment expectations in active disease are efficacy, safety and convenience. Patients are willing to accept relatively high risks of complications from medical therapy to avoid a permanent ostomy and to achieve durable remission. Patients are more interested in disease monitoring, research and development during the time of remission. Telemedicine and self-management with supervised e-health tools are feasible and acceptable amongst patients with IBD. CONCLUSION This systematic review demonstrates that patients with IBD expect more information about their disease process, shared decision making and symptom control. Further research is needed to help align patient and physician expectations in order to improve the quality of care provided to patients with IBD.
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Yao L, Zhu X, Shao B, Liu R, Li Z, Wu L, Chen J, Cao Q. Reasons and Factors Contributing to Chinese Patients' Preference for Ustekinumab in Crohn's Disease: A Multicenter Cross-Sectional Study. Front Pharmacol 2021; 12:736149. [PMID: 34887751 PMCID: PMC8651007 DOI: 10.3389/fphar.2021.736149] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/04/2021] [Accepted: 10/22/2021] [Indexed: 12/02/2022] Open
Abstract
Background and Aims: Ustekinumab (UST) was approved in China for treating moderate-to-severe Crohn’s disease (CD) in 2020. We aimed to identify the reasons and possible contributing factors for UST preference in Chinese patients with CD. Methods: We conducted a multicenter cross-sectional survey among patients with moderate to severe CD who underwent UST treatment in 27 hospitals. Patients completed a 46-item questionnaire that included information on demographics, clinical characteristics, reasons in favor of UST and shared decision-making perception. Logistic regression analysis was performed to examine the predictive factors of different UST preferences. Results: Overall, 127 patients (73 males; mean age, 25.9 ± 9.9 years) completed the questionnaire. Most patients (74.8%) had biologic failure. The most common reason for the latest treatment disconnection was unresponsiveness to the previous medications. The major UST information sources were physicians (96.1%). Nearly half of the patients (44.9%) reported shared decision making regarding UST treatment. No difference was found in the decision-making patterns in terms of sex and age. The most influential reason for UST preference was “effectiveness” (77%, 98/127), followed by “safety” (65%, 83/127), “frequency of administration” (39%, 49/127), and “mode of administration” (37%, 47/127). Multivariate logistic regression analysis revealed that a positive self-rated health status was a contributing factor for UST preference with a low frequency of administration. Conclusion: This is the first multicenter survey of Chinese patients with CD to identify the possible contributing factors for UST preference. Treatment choice should be discussed with patients because individual preferences are determined by diverse factors.
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Affiliation(s)
- Lingya Yao
- Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine Zhejiang University, Hangzhou, China
| | - Xiao Zhu
- Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine Zhejiang University, Hangzhou, China
| | - Bule Shao
- Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine Zhejiang University, Hangzhou, China
| | - Rongbei Liu
- Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine Zhejiang University, Hangzhou, China
| | | | - Lexi Wu
- Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine Zhejiang University, Hangzhou, China
| | | | - Qian Cao
- Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine Zhejiang University, Hangzhou, China
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20
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Hanzel J, Bukkems LH, Gecse KB, D’Haens GR, Mathôt RAA. Population pharmacokinetics of subcutaneous infliximab CT-P13 in Crohn's disease and ulcerative colitis. Aliment Pharmacol Ther 2021; 54:1309-1319. [PMID: 34559426 PMCID: PMC9292975 DOI: 10.1111/apt.16609] [Citation(s) in RCA: 26] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/01/2021] [Revised: 08/12/2021] [Accepted: 09/05/2021] [Indexed: 12/30/2022]
Abstract
BACKGROUND Infliximab is a chimeric monoclonal antibody against tumour necrosis factor-alpha for the treatment of Crohn's disease (CD) and ulcerative colitis (UC). Recently, a subcutaneous formulation of CT-P13, an infliximab biosimilar, was approved for clinical use. AIMS To characterise CT-P13 pharmacokinetics (PK) and its clinically relevant determinants after subcutaneous administration through population PK modelling. METHODS Data from a two-part Phase I study with intravenous (5 mg/kg) and variable maintenance subcutaneous dosing of CT-P13 with frequent PK sampling in patients with CD or UC were used. Population PK analysis was conducted by non-linear mixed effects modelling. Covariates affecting PK parameters were chosen based on their clinical relevance (effect size of ≥20%) using a full fixed-effect modelling approach. RESULTS CT-P13 PK was described by a two-compartment model with linear elimination. The half-life in a typical 70 kg patient with serum albumin of 44 g/L was 10.8 days. The typical value for clearance was 0.355 L/d, absorption constant 0.273/d, bioavailability 79.1%, central volume of distribution 3.10 L and peripheral volume of distribution 1.93 L. Clinically relevant covariates affecting clearance were body weight (+43.2% from 70 to 120 kg), the presence of anti-drug antibodies (+39%) and serum albumin concentration (+30.1% from 44 to 32 g/L). Simulated drug exposure was comparable between routes of administration for patients weighing 50 or 70 kg, but lower with subcutaneous dosing in patients weighing 120 kg. CONCLUSIONS This first population PK model for subcutaneous CT-P13 supports fixed subcutaneous maintenance dosing, although heavy patients had lower cumulative drug exposure.
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Affiliation(s)
- Jurij Hanzel
- Department of Gastroenterology and HepatologyAmsterdam UMCAmsterdamthe Netherlands,Faculty of MedicineUniversity of LjubljanaUniversity Medical Centre LjubljanaLjubljanaSlovenia
| | - Laura H. Bukkems
- Department of Hospital Pharmacy – Clinical PharmacologyAmsterdam UMCAmsterdamthe Netherlands
| | - Krisztina B. Gecse
- Department of Gastroenterology and HepatologyAmsterdam UMCAmsterdamthe Netherlands
| | - Geert R. D’Haens
- Department of Gastroenterology and HepatologyAmsterdam UMCAmsterdamthe Netherlands
| | - Ron A. A. Mathôt
- Department of Hospital Pharmacy – Clinical PharmacologyAmsterdam UMCAmsterdamthe Netherlands
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21
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Denesh D, Carbonell J, Kane JS, Gracie D, Selinger CP. Patients with inflammatory bowel disease (IBD) prefer oral tablets over other modes of medicine administration. Expert Rev Gastroenterol Hepatol 2021; 15:1091-1096. [PMID: 33653185 DOI: 10.1080/17474124.2021.1898944] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/03/2023]
Abstract
Objectives: With increasing treatment choices for inflammatory bowel disease (IBD), patients' preferences should be considered to limit non-adherence. We explored patients' preferences for route, form and frequency of medication administration, and factors influencing these choices.Methods: Patients rated acceptability of different forms of medication on 10-point Likert scales and preferences for highest acceptable frequency.Results: Of 298 patients significantly more found tablets (91%) to be highly acceptable compared to granules (64%), infusions (33%) and subcutaneous injections (34%; p < 0.0001). The acceptable frequency for tablets was considered as daily by 63.5% and several times daily by 32.3%. Participants preferred nurse delivered over self-administered injections (median score 8 vs 5, p < 0.0001) and hospital-based infusions over infusions at home (median score 7 vs 5, p = 0.001). Patients with previous or current anti-TNF exposure were more accepting of self-administered injections (50.5% vs 23.3% anti-TNF naive; p < 0.001), more accepting of home based infusions (43.7% vs 28.0%; p = 0.001) and more accepting of hospital-based infusions (57.2% vs 37.8%; p = 0.02).Conclusion: Most patients with IBD prefer tablets. Those patients who already experienced biological agents, had a high level of acceptance for subcutaneous and intravenous forms of medication.
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Affiliation(s)
- Deepa Denesh
- Gastroenterology, Leeds Teaching Hospitals NHS Trust, Leeds, UK
| | | | - John S Kane
- Gastroenterology, Leeds Teaching Hospitals NHS Trust, Leeds, UK
| | - David Gracie
- Gastroenterology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.,Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK
| | - Christian P Selinger
- Gastroenterology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.,Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK
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22
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Kochar B, Jiang Y, Chen W, Bu Y, Barnes EL, Long MD. Home Infusions for Inflammatory Bowel Disease Are Safe: US Experience and Patient Perspectives. CROHN'S & COLITIS 360 2021; 3:otab063. [PMID: 34805985 PMCID: PMC8600957 DOI: 10.1093/crocol/otab063] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/27/2021] [Indexed: 12/04/2022] Open
Abstract
BACKGROUND Home infusions (HIs) for biologic medications are an option for inflammatory bowel disease (IBD) patients in the United States. We aimed to describe the population receiving HIs and report patient experience with HIs. METHODS We conducted a retrospective cohort study in the Quintiles-IMSLegacy PharMetrics Adjudicated Claims Database from 2010 to 2016 to describe the population receiving infliximab (IFX) and vedolizumab (VDZ) HIs and determine predictors for an urgent/emergent visit post-HIs. We then administered a cross-sectional survey to IBD Partners Internet-based cohort participants to assess knowledge and experience with infusions. RESULTS We identified claims for 11 892 conventional IFX patients, 1573 home IFX patients, 438 conventional VDZ patients, and 138 home VDZ patients. There were no differences in demographics or median charges with IFX home and conventional infusions. Home VDZ infusions had a greater median charge than conventional VDZ infusion. Less than 4% of patients had an urgent/emergent visit post-HIs. Charlson comorbidity index > 0 (odds ratio [OR]: 1.95; 95% confidence interval [CI], 1.01-3.77) and Medicaid (OR: 3.01; 95% CI, 1.53-5.94) conferred significantly higher odds of urgent/emergent visit post-HIs. In IBD Partners, 644 IBD patients responded; 56 received HIs. The majority chose HIs to save time and preferred HIs to conventional infusions. Only 2 patients reported an urgent/emergent visit for HI-related problems. CONCLUSIONS HI appears to be safe in IBD patients receiving IFX and VDZ. However, patients with fewer resources and more comorbidities are at increased risk for an urgent/emergent visit post-HIs. The overall patient experience with HI is positive. Expansion of HIs may result in decreased therapy-related logistic burden for carefully selected patients.
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Affiliation(s)
- Bharati Kochar
- Division of Gastroenterology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA,Address correspondence to: Bharati Kochar, MD, MSCR, Division of Gastroenterology, Massachusetts General Hospital, 165 Cambridge Street, 9th Floor, Boston, MA 02114, USA ()
| | - Yue Jiang
- Department of Statistical Science, Duke University, Durham, NC, USA
| | - Wenli Chen
- Center for Gastrointestinal Biology and Disease, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
| | - Yuting Bu
- Department of Statistics, University of North Carolina, Chapel Hill, NC, USA
| | - Edward L Barnes
- Center for Gastrointestinal Biology and Disease, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA,Multidisciplinary Center for Inflammatory Bowel Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
| | - Millie D Long
- Center for Gastrointestinal Biology and Disease, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA,Multidisciplinary Center for Inflammatory Bowel Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
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23
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Solitano V, Vuitton L, Peyrin-Biroulet L, Danese S. The Evolution of Biologics Administration From Intravenous to Subcutaneous: Treatments for Inflammatory Bowel Disease Go Home. Gastroenterology 2021; 160:2244-2247. [PMID: 33773995 DOI: 10.1053/j.gastro.2021.03.038] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/08/2021] [Accepted: 03/16/2021] [Indexed: 01/07/2023]
Affiliation(s)
- Virginia Solitano
- Department of Biomedical Sciences, Humanitas University, Milan, Italy
| | - Lucine Vuitton
- Department of Gastroenterology, Besançon University Hospital, Bourgogne-Franche-Comté University, Besançon, France
| | - Laurent Peyrin-Biroulet
- Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France
| | - Silvio Danese
- Department of Biomedical Sciences, Humanitas University, Milan, Italy; IBD Center, Humanitas Clinical and Research Center, IRCCS, Rozzano, Milan, Italy.
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24
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Schreiber S, Ben-Horin S, Leszczyszyn J, Dudkowiak R, Lahat A, Gawdis-Wojnarska B, Pukitis A, Horynski M, Farkas K, Kierkus J, Kowalski M, Lee SJ, Kim SH, Suh JH, Kim MR, Lee SG, Ye BD, Reinisch W. Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease. Gastroenterology 2021; 160:2340-2353. [PMID: 33676969 DOI: 10.1053/j.gastro.2021.02.068] [Citation(s) in RCA: 138] [Impact Index Per Article: 34.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/23/2020] [Revised: 02/26/2021] [Accepted: 02/28/2021] [Indexed: 12/24/2022]
Abstract
BACKGROUND & AIMS This study compared pharmacokinetics, symptomatic and endoscopic efficacy, safety, and immunogenicity of a subcutaneous formulation of the infliximab biosimilar CT-P13 (CT-P13 SC) vs intravenous CT-P13 (CT-P13 IV) in patients with inflammatory bowel disease (IBD). METHODS This randomized, multicenter, open-label, parallel-group, phase 1 study enrolled tumor necrosis factor inhibitor-naïve patients with active ulcerative colitis (total Mayo score 6-12 points with endoscopic subscore ≥2) or Crohn's disease (Crohn's Disease Activity Index 220-450 points) at 50 centers. After CT-P13 IV induction at Week (W) 0/W2, patients were randomized (1:1) to receive CT-P13 SC every 2 weeks (q2w) from W6 to W54 or CT-P13 IV every 8 weeks from W6 to W22. At W30, all patients receiving CT-P13 IV switched to CT-P13 SC q2w until W54. The primary endpoint was noninferiority of CT-P13 SC to CT-P13 IV for observed predose CT-P13 concentration at W22 (Ctrough,W22), concluded if the lower bound of the 2-sided 90% confidence interval (CI) for the ratio of geometric least-squares means exceeded 80%. RESULTS Overall, 66 and 65 patients were randomized to CT-P13 SC and CT-P13 IV, respectively. The primary endpoint of noninferiority was met with a geometric least-squares means ratio for Ctrough,W22 of 1154.17% (90% CI 786.37-1694.00; n = 59 [CT-P13 SC]; n = 57 [CT-P13 IV]). W30/W54 clinical remission rates were comparable between arms. Other efficacy, safety, and immunogenicity assessments were also broadly comparable between arms, including after switching. CONCLUSIONS The pharmacokinetic noninferiority of CT-P13 SC to CT-P13 IV, and the comparable efficacy, safety, and immunogenicity profiles, support the potential suitability of CT-P13 SC treatment in IBD. ClinicalTrials.gov ID: NCT02883452.
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Affiliation(s)
- Stefan Schreiber
- Department for Internal Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany
| | - Shomron Ben-Horin
- Gastroenterology Department, Chaim Sheba Medical Center and Sackler School of Medicine, Tel Aviv University, Tel-Hashomer, Israel
| | | | - Robert Dudkowiak
- Department of Gastroenterology, Melita Medical, Wroclaw, Poland; Department of Gastroenterology and Hepatology, Wroclaw Medical University, Wroclaw, Poland
| | - Adi Lahat
- Gastroenterology Department, Chaim Sheba Medical Center and Sackler School of Medicine, Tel Aviv University, Tel-Hashomer, Israel
| | - Beata Gawdis-Wojnarska
- Department of Gastroenterology, Twoja Przychodnia-Szczecińskie Centrum Medyczne, Szczecin, Poland
| | - Aldis Pukitis
- Center of Gastroenterology, Hepatology and Nutrition, Pauls Stradins Clinical University Hospital, Riga, Latvia
| | | | - Katalin Farkas
- Department of Clinical Pharmacology, Szent Imre Egyetemi Oktatókórház, Budapest, Hungary
| | - Jaroslaw Kierkus
- Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, The Children's Memorial Health Institute, Warsaw, Poland
| | - Maciej Kowalski
- Gastroenterology Department, Centrum Diagnostyczno-Lecznicze Barska sp. z o.o., Wloclawek, Poland
| | - Sang Joon Lee
- Clinical Development Division, Celltrion, Inc., Incheon, Republic of Korea
| | - Sung Hyun Kim
- Clinical Planning Department, Celltrion, Inc., Incheon, Republic of Korea
| | - Jee Hye Suh
- Clinical Planning Department, Celltrion, Inc., Incheon, Republic of Korea
| | - Mi Rim Kim
- Clinical Planning Department, Celltrion, Inc., Incheon, Republic of Korea
| | - Seul Gi Lee
- Biometrics Department, Celltrion, Inc., Incheon, Republic of Korea
| | - Byong Duk Ye
- Department of Gastroenterology and Inflammatory Bowel Disease Center, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
| | - Walter Reinisch
- Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.
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25
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Wu AA, Barros JRD, Ramdeen M, Baima JP, Saad-Hossne R, Sassaki LY. FACTORS ASSOCIATED WITH PATIENT´S PREFERENCE IN CHOOSING THEIR THERAPY FOR INFLAMMATORY BOWEL DISEASE IN BRAZIL. ARQUIVOS DE GASTROENTEROLOGIA 2021; 57:491-497. [PMID: 33331482 DOI: 10.1590/s0004-2803.202000000-86] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/26/2020] [Accepted: 09/11/2020] [Indexed: 01/06/2023]
Abstract
OBJECTIVE This study aims to evaluate patient's preferences in the choice of their therapy and the factors that influence this choice. METHODS This cross-sectional study enrolled 101 outpatients with Crohn's disease or ulcerative colitis. The inclusion criteria were age ≥18 years and no previous exposure to biological therapy. Patients' preferences were assessed through questions that addressed the preferred mode of administration (oral, subcutaneous, or intravenous) and the factors that determined the choice of medication (efficacy, medical indication, fear of medication, convenience, mode of application, and personal doctors' indication). RESULTS The mean age was 43.6±13.5 years, 75.3% were female, and 81.2% were cases of ulcerative colitis. Regarding the mode of administration, the majority of patients preferred oral (87.1%), followed by intravenous (6.93%) and subcutaneous (5.94%) medications. The reasons were "I prefer to take it at home" (42.57%), "I have more freedom" (36.63%), "I don't like self-application" (29.70%), and "I believe it works better" (19.80%). Younger patients and patients in clinical disease activity preferred intravenous mode compared to the oral route (P<0.05). Doctor's opinion (98%) was an important factor associated with the medication choice. CONCLUSION Oral route was the preferred mode of administration and most patients took their physician's opinion into account in their choice of medication.
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Affiliation(s)
- Adhan Amenomori Wu
- Universidade Estadual Paulista (Unesp), Faculdade de Medicina, Departamento de Clínica Médica, Botucatu, SP, Brasil
| | - Jaqueline Ribeiro de Barros
- Universidade Estadual Paulista (Unesp), Faculdade de Medicina, Departamento de Clínica Médica, Botucatu, SP, Brasil
| | | | - Julio Pinheiro Baima
- Universidade Estadual Paulista (Unesp), Faculdade de Medicina, Departamento de Clínica Médica, Botucatu, SP, Brasil
| | - Rogerio Saad-Hossne
- Unesp, Faculdade de Medicina, Departamento de Cirurgia, Botucatu, SP, Brasil
| | - Ligia Yukie Sassaki
- Universidade Estadual Paulista (Unesp), Faculdade de Medicina, Departamento de Clínica Médica, Botucatu, SP, Brasil
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D'Amico F, Solitano V, Peyrin-Biroulet L, Danese S. Nocebo effect and biosimilars in inflammatory bowel diseases: what's new and what's next? Expert Opin Biol Ther 2020; 21:47-55. [PMID: 32857634 DOI: 10.1080/14712598.2020.1817374] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
INTRODUCTION The use of biosimilars for the treatment of patients with chronic inflammatory bowel diseases (IBD) showed to be a valid strategy to reduce the economic burden of biologics on health-care costs and to increase patient access to treatment. However, the nocebo effect constitutes an important limitation to the wide use of biosimilars. AREAS COVERED We conducted a literature overview to summarize information on nocebo effect in IBD population and to provide physicians with practical key strategies to prevent the nocebo effect in daily clinical practice and to improve patients' outcomes. EXPERT OPINION Despite the proven efficacy and safety of biosimilars, further clinical studies are needed to define the effects of reverse and multiple switches in the management of patients with IBD. The development of new subcutaneous formulations, better accepted by patients, could contribute to reduce patients' negative expectations, and limit the nocebo effect.
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Affiliation(s)
- Ferdinando D'Amico
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele , Milan, Italy.,Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy , France
| | - Virginia Solitano
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele , Milan, Italy
| | - Laurent Peyrin-Biroulet
- Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy , France
| | - Silvio Danese
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele , Milan, Italy.,Department of Gastroenterology, IBD Center, Humanitas Clinical and Research Center - IRCCS, Rozzano , Milan, Italy
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Naeck-Boolauky P, Adio J, Burch J. Review of normal gastrointestinal tract, ulcerative colitis, proctitis and rectal medication adherence. BRITISH JOURNAL OF NURSING (MARK ALLEN PUBLISHING) 2020; 29:805-811. [PMID: 32697644 DOI: 10.12968/bjon.2020.29.14.805] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/07/2023]
Abstract
The gastrointestinal (GI) tract has a number of functions-ingestion, digestion, absorption and elimination. When the GI tract is working normally, it is efficient. However, this can change when disease, such as inflammatory bowel disease (IBD) occurs. IBD is a long-term relapsing and remitting autoimmune disease; it incorporates ulcerative colitis (UC). In UC, part or all the mucosa lining the rectum and colon becomes inflamed and ulcerated. UC that affects the rectum only is called proctitis. Effective treatment is essential. It is better to target the rectal mucosa directly in proctitis, using topical rectal medications in enemas or suppositories, as these have fewer side-effects and resolve symptoms more quickly than systemic drugs. However, patients may not feel clear about aspects of their IBD care and can find it difficult to initiate and comply with treatment and maintenance regimens. Nurses need to educate and support them to achieve optimal therapeutic outcomes in both the immediate and long terms.
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Affiliation(s)
| | - Jitka Adio
- Inflammatory Bowel Disease Clincial Nurse Specialist, St Mark's Hospital, Harrow, Middlesex
| | - Jennie Burch
- Head of Gastrointestinal Nurse Education, St Mark's Hospital, Harrow, Middlesex
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Hupé M, Rivière P, Nancey S, Roblin X, Altwegg R, Filippi J, Fumery M, Bouguen G, Peyrin-Biroulet L, Bourreille A, Caillo L, Simon M, Goutorbe F, Laharie D. Comparative efficacy and safety of vedolizumab and infliximab in ulcerative colitis after failure of a first subcutaneous anti-TNF agent: a multicentre cohort study. Aliment Pharmacol Ther 2020; 51:852-860. [PMID: 32201971 DOI: 10.1111/apt.15680] [Citation(s) in RCA: 32] [Impact Index Per Article: 6.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/05/2019] [Revised: 12/30/2019] [Accepted: 02/14/2020] [Indexed: 12/20/2022]
Abstract
BACKGROUND Few data exist to help select a second biologic agent in patients with refractory ulcerative colitis (UC). AIM To compare the efficacy of infliximab (IFX) and vedolizumab (VDZ) in UC patients who failed a first subcutaneous anti-tumor necrosing factor (TNF) agent. METHODS Consecutive UC patients from 12 French centres starting IFX or VDZ after at least one injection of adalimumab or golimumab have been included in a retrospective study. Outcomes were clinical remission at week 14, survival without treatment discontinuation and survival without UC-related event. RESULTS Among the 225 patients included, clinical remission at week 14 was achieved in 40/154 (26%) patients treated with IFX and in 35/71 (49%) treated with VDZ (P = 0.001). After a propensity score matching analysis, this difference remained significant (odds ratio: 1.67; 95% confidence interval: 1.08-2.56; P = 0.02). With a median follow-up of 117 weeks, survival rates without treatment discontinuation at years 1 and 3 were 50% and 29% with IFX, and 80% and 55% with VDZ, respectively (P < 0.001). Regarding survival without UC-related event, they were 49% and 27% with IFX, and 74% and 52% with VDZ (P < 0.01). CONCLUSION After failure of a first subcutaneous anti-TNF agent, UC patients were more likely to achieve clinical remission with VDZ than those treated with IFX. Although due to prescription habits patients in the IFX group had a significantly more severe disease, these differences remained after adjustments and subgroup analyses. Such results have to be confirmed prospectively and warrant dedicated head-to-head trials.
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Body Weight as a Determining Factor in the Predominance of Adverse Drug Reactions Induced by Fixed-Dose Adalimumab Injections in Female Patients in a Korean Hospital Setting. J Clin Med 2020; 9:jcm9020461. [PMID: 32046138 PMCID: PMC7074186 DOI: 10.3390/jcm9020461] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/10/2020] [Revised: 01/31/2020] [Accepted: 02/03/2020] [Indexed: 11/16/2022] Open
Abstract
Adalimumab is used at 40-mg dose to treat systemic inflammatory diseases. Given the impact of adverse drug reactions (ADRs), which particularly result in the discontinuation of adalimumab therapy in female patients, this study examined whether sex affects the frequency and type of ADRs induced by adalimumab. In this study, the prescription records and laboratory data of patients aged ≥19 years who had been admitted to the Seoul National University Hospital (SNUH) and prescribed adalimumab were analyzed using an electronic medical record database. The analysis revealed that female patients more frequently experienced adalimumab-induced ADRs compared with male patients (63.2% vs. 52.2%). The incidence of ADRs was significantly higher in female patients with ankylosing spondylitis or rheumatoid arthritis than in male patients with similar conditions (81.5% vs. 60.7% or 64.4% vs. 50.0%, respectively). The median body weight (BW) was lower in female patients than in male patients (54.0 vs. 66.0 kg). Moreover, the incidence of ADRs in patients with a BW of <54.0 kg (i.e., the median female BW) was higher than for those with a BW of ≥54.0 kg, in both males and females. Our results suggested that the predominance of ADRs induced by adalimumab in females was because of their relatively lower BW. This suggests the importance of BW as a determining factor in sex disparity of ADR occurrences.
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Little RD, Chu IE, van der Zanden EP, Flanagan E, Bell SJ, Gibson PR, Sparrow MP, Shelton E, Connor SJ, Roblin X, Ward MG. Comparison of Adalimumab Serum Drug Levels When Delivered by Pen Versus Syringe in Patients With Inflammatory Bowel Disease. An International, Multicentre Cohort Analysis. J Crohns Colitis 2019; 13:1527-1536. [PMID: 31094417 DOI: 10.1093/ecco-jcc/jjz103] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
BACKGROUND Adalimumab is administered via a pre-filled syringe or spring-loaded pen. In a previous study in Crohn's disease, higher drug levels were observed in syringe users. The aim of this study was to evaluate the impact of delivery device on adalimumab drug levels in patients with Crohn's disease. METHODS Consecutive Crohn's disease patients treated with maintenance adalimumab [40 mg fortnightly] were recruited from five centres. The first recorded drug level with matched clinical and biochemical markers of disease activity was compared between pen and syringe users. RESULTS Of 218 patients, 64% used pen, with a median faecal calprotectin 110 μg/g and serum C-reactive protein 4 mg/L. In comparison to pen, syringe users had higher albumin [39 vs 42 g/L; p = 0.016], lower Harvey-Bradshaw Index [2 vs 1; p = 0.017], and higher rates of concomitant immunomodulation [54% vs 71%; p = 0.014]. Drug levels were equivalent between pen and syringe users [median 5.3 vs 5.2 μg/ml; p = 0.584], even after controlling for disease activity and immunomodulation. Syringe users at Alfred Health had higher drug levels than pen [6.1 vs 4.5 μg/ml; p = 0.039]; a greater proportion achieved therapeutic levels [75% vs 44%; p = 0.045]. A higher proportion of pen users from Saint-Étienne had therapeutic levels [79% vs 42%; p = 0.027], yet no significant difference in drug levels [7.9 vs 4.5 μg/ml; p = 0.119]. CONCLUSIONS Delivery device does not appear to significantly affect adalimumab drug levels. Given differences between study sites, studies evaluating administration education and technique are warranted.
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Affiliation(s)
- Robert D Little
- Department of Gastroenterology, Alfred Health and Monash University, Melbourne, VIC, Australia
| | - Isabel E Chu
- Department of Gastroenterology, Alfred Health and Monash University, Melbourne, VIC, Australia
| | - Esmerij P van der Zanden
- Department of Gastroenterology, Liverpool Hospital and University of New South Wales, Sydney, NSW, Australia
| | - Emma Flanagan
- Department of Gastroenterology, St Vincent's Hospital and University of Melbourne, Melbourne, VIC, Australia
| | - Sally J Bell
- Department of Gastroenterology, St Vincent's Hospital and University of Melbourne, Melbourne, VIC, Australia
| | - Peter R Gibson
- Department of Gastroenterology, Alfred Health and Monash University, Melbourne, VIC, Australia
| | - Miles P Sparrow
- Department of Gastroenterology, Alfred Health and Monash University, Melbourne, VIC, Australia
| | - Edward Shelton
- Department of Gastroenterology, Monash Health and Monash University, Melbourne, VIC, Australia
| | - Susan J Connor
- Department of Gastroenterology, Liverpool Hospital and University of New South Wales, Sydney, NSW, Australia
| | - Xavier Roblin
- Gastro-entérologie et Hépatologie, CHU Saint-Étienne, Saint-Étienne, France
| | - Mark G Ward
- Department of Gastroenterology, Alfred Health and Monash University, Melbourne, VIC, Australia
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Lamb CA, Kennedy NA, Raine T, Hendy PA, Smith PJ, Limdi JK, Hayee B, Lomer MCE, Parkes GC, Selinger C, Barrett KJ, Davies RJ, Bennett C, Gittens S, Dunlop MG, Faiz O, Fraser A, Garrick V, Johnston PD, Parkes M, Sanderson J, Terry H, Gaya DR, Iqbal TH, Taylor SA, Smith M, Brookes M, Hansen R, Hawthorne AB. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut 2019; 68:s1-s106. [PMID: 31562236 PMCID: PMC6872448 DOI: 10.1136/gutjnl-2019-318484] [Citation(s) in RCA: 1456] [Impact Index Per Article: 242.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/10/2019] [Revised: 06/10/2019] [Accepted: 06/10/2019] [Indexed: 02/06/2023]
Abstract
Ulcerative colitis and Crohn's disease are the principal forms of inflammatory bowel disease. Both represent chronic inflammation of the gastrointestinal tract, which displays heterogeneity in inflammatory and symptomatic burden between patients and within individuals over time. Optimal management relies on understanding and tailoring evidence-based interventions by clinicians in partnership with patients. This guideline for management of inflammatory bowel disease in adults over 16 years of age was developed by Stakeholders representing UK physicians (British Society of Gastroenterology), surgeons (Association of Coloproctology of Great Britain and Ireland), specialist nurses (Royal College of Nursing), paediatricians (British Society of Paediatric Gastroenterology, Hepatology and Nutrition), dietitians (British Dietetic Association), radiologists (British Society of Gastrointestinal and Abdominal Radiology), general practitioners (Primary Care Society for Gastroenterology) and patients (Crohn's and Colitis UK). A systematic review of 88 247 publications and a Delphi consensus process involving 81 multidisciplinary clinicians and patients was undertaken to develop 168 evidence- and expert opinion-based recommendations for pharmacological, non-pharmacological and surgical interventions, as well as optimal service delivery in the management of both ulcerative colitis and Crohn's disease. Comprehensive up-to-date guidance is provided regarding indications for, initiation and monitoring of immunosuppressive therapies, nutrition interventions, pre-, peri- and postoperative management, as well as structure and function of the multidisciplinary team and integration between primary and secondary care. Twenty research priorities to inform future clinical management are presented, alongside objective measurement of priority importance, determined by 2379 electronic survey responses from individuals living with ulcerative colitis and Crohn's disease, including patients, their families and friends.
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Affiliation(s)
- Christopher Andrew Lamb
- Newcastle University, Newcastle upon Tyne, UK
- Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK
| | - Nicholas A Kennedy
- Royal Devon and Exeter NHS Foundation Trust, Exeter, UK
- University of Exeter, Exeter, UK
| | - Tim Raine
- Cambridge University Hospitals NHS FoundationTrust, Cambridge, UK
| | - Philip Anthony Hendy
- Chelsea and Westminster Hospital NHS Foundation Trust, London, UK
- Imperial College London, London, UK
| | - Philip J Smith
- Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK
| | - Jimmy K Limdi
- The Pennine Acute Hospitals NHS Trust, Manchester, UK
- University of Manchester, Manchester, UK
| | - Bu'Hussain Hayee
- King's College Hospital NHS Foundation Trust, London, UK
- King's College London, London, UK
| | - Miranda C E Lomer
- King's College London, London, UK
- Guy's and St Thomas' NHS Foundation Trust, London, UK
| | - Gareth C Parkes
- Barts Health NHS Trust, London, UK
- Barts and the London School of Medicine and Dentistry, London, UK
| | - Christian Selinger
- Leeds Teaching Hospitals NHS Trust, Leeds, UK
- University of Leeds, Leeds, UK
| | | | - R Justin Davies
- Cambridge University Hospitals NHS FoundationTrust, Cambridge, UK
- University of Cambridge, Cambridge, UK
| | - Cathy Bennett
- Systematic Research Ltd, Quorn, UK
- Royal College of Surgeons in Ireland (RCSI), Dublin, Ireland
| | | | - Malcolm G Dunlop
- University of Edinburgh, Edinburgh, UK
- Western General Hospital, Edinburgh, UK
| | - Omar Faiz
- Imperial College London, London, UK
- St Mark's Hospital, Harrow, UK
| | - Aileen Fraser
- University Hospitals Bristol NHS Foundation Trust, Bristol, UK
| | | | | | - Miles Parkes
- Cambridge University Hospitals NHS FoundationTrust, Cambridge, UK
| | - Jeremy Sanderson
- King's College London, London, UK
- Guy's and St Thomas' NHS Foundation Trust, London, UK
| | | | - Daniel R Gaya
- Glasgow Royal Infirmary, Glasgow, UK
- University of Glasgow, Glasgow, UK
| | - Tariq H Iqbal
- Queen Elizabeth Hospital Birmingham NHSFoundation Trust, Birmingham, UK
- University of Birmingham, Birmingham, UK
| | - Stuart A Taylor
- University College London, London, UK
- University College London Hospitals NHS Foundation Trust, London, UK
| | - Melissa Smith
- Brighton and Sussex University Hospitals NHS Trust, Brighton, UK
- Brighton and Sussex Medical School, Brighton, UK
| | - Matthew Brookes
- Royal Wolverhampton NHS Trust, Wolverhampton, UK
- University of Wolverhampton, Wolverhampton, UK
| | - Richard Hansen
- Royal Hospital for Children Glasgow, Glasgow, UK
- University of Glasgow, Glasgow, UK
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Abstract
Ulcerative colitis and Crohn's disease are the principal forms of inflammatory bowel disease. Both represent chronic inflammation of the gastrointestinal tract, which displays heterogeneity in inflammatory and symptomatic burden between patients and within individuals over time. Optimal management relies on understanding and tailoring evidence-based interventions by clinicians in partnership with patients. This guideline for management of inflammatory bowel disease in adults over 16 years of age was developed by Stakeholders representing UK physicians (British Society of Gastroenterology), surgeons (Association of Coloproctology of Great Britain and Ireland), specialist nurses (Royal College of Nursing), paediatricians (British Society of Paediatric Gastroenterology, Hepatology and Nutrition), dietitians (British Dietetic Association), radiologists (British Society of Gastrointestinal and Abdominal Radiology), general practitioners (Primary Care Society for Gastroenterology) and patients (Crohn's and Colitis UK). A systematic review of 88 247 publications and a Delphi consensus process involving 81 multidisciplinary clinicians and patients was undertaken to develop 168 evidence- and expert opinion-based recommendations for pharmacological, non-pharmacological and surgical interventions, as well as optimal service delivery in the management of both ulcerative colitis and Crohn's disease. Comprehensive up-to-date guidance is provided regarding indications for, initiation and monitoring of immunosuppressive therapies, nutrition interventions, pre-, peri- and postoperative management, as well as structure and function of the multidisciplinary team and integration between primary and secondary care. Twenty research priorities to inform future clinical management are presented, alongside objective measurement of priority importance, determined by 2379 electronic survey responses from individuals living with ulcerative colitis and Crohn's disease, including patients, their families and friends.
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Grisanti L, Kwiatkowski A, Dyrda P, Field E, Grisanti J, Hatem J, Dehoratius RJ, Gaylis N. Patient Perspectives on Intravenous Biologics for Rheumatologic Disease. Arthritis Care Res (Hoboken) 2019; 71:1234-1242. [PMID: 30221490 DOI: 10.1002/acr.23758] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/23/2017] [Accepted: 09/11/2018] [Indexed: 12/17/2022]
Abstract
OBJECTIVE Two surveys were conducted with patients with rheumatologic diseases to evaluate perceptions of different routes of administration (intravenous [IV] or subcutaneous [SC]) for biologic therapy. METHODS In Survey I, patient preferences toward biologic treatment were evaluated at a rheumatology practice in Buffalo, New York. In Survey II, Canadian patients enrolled in the BioAdvance patient support program and scheduled to receive IV biologic therapy were asked about their opinions of IV treatment. RESULTS In Survey I, 243 rheumatology patients participated. Median patient age was 60 years, 76% were female, and 44% were naive to treatment with biologic agents. Among biologic-naive patients, the majority (56%) were open to either SC or IV treatment; biologic-naive women were more likely than men to express a preference for the route of administration. In Survey II, 1,598 patients from the BioAdvance program (including 306 rheumatology patients) completed the full survey. Among the rheumatology patients, the median age was 49 years, 58% were female, and 61% had not previously taken biologics before enrolling in the BioAdvance program. The median rating of IV favorability (on a 10-point scale, with higher numbers indicating increased favorability) recalled by rheumatology patients was 5 prior to their first program infusion, which increased to 9 after multiple treatment infusions. CONCLUSION These survey results indicate that patients with rheumatoid arthritis are generally open to IV treatment and express high satisfaction with IV therapy. Additional patient and provider education may improve shared decision-making regarding biologic therapy administration options.
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Affiliation(s)
| | | | - Peter Dyrda
- Janssen Scientific Affairs, LLC, Horsham, Pennsylvania
| | - Ellen Field
- Private practice, Lehigh Valley, Pennsylvania
| | | | - James Hatem
- Buffalo Rheumatology, Orchard Park, New York
| | - Raphael J Dehoratius
- Janssen Scientific Affairs, LLC, Horsham, and Sidney Kimmel School of Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania
| | - Norman Gaylis
- Arthritis and Rheumatic Disease Specialties, Aventura, Florida
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Tran V, Shammas RM, Sauk JS, Padua D. Evaluating tofacitinib citrate in the treatment of moderate-to-severe active ulcerative colitis: design, development and positioning of therapy. Clin Exp Gastroenterol 2019; 12:179-191. [PMID: 31118734 PMCID: PMC6507103 DOI: 10.2147/ceg.s150908] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/13/2018] [Accepted: 04/06/2019] [Indexed: 12/14/2022] Open
Abstract
The etiology of ulcerative colitis (UC) is complex and involves a host of genetic, epigenetic and environmental factors. Over the last thirty years, signaling pathways like the Janus kinase (JAK) signaling pathway have been implicated in its pathogenesis. Pharmacologic blockade of this pathway is available through several small molecule inhibitors, including tofacitinib. Tofacitinib is an orally administered pan-JAK inhibitor that was first approved by the Food and Drug Administration (FDA) for use in rheumatologic disorders such as rheumatoid arthritis and psoriatic arthritis. The FDA approved its use in moderate-to-severe active ulcerative colitis in 2018. The aim of this review will be to discuss the role of tofacitinib in ulcerative colitis. We will discuss the role of JAK-STAT signaling, clinical data available for tofacitinib, and the safety profile for this therapy. Tofacitinib's place in the UC management algorithm is currently being debated. This effective oral therapy is poised to be a mainstay of UC therapeutics. This review will highlight the key clinical features and detail the UC experience to date.
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Affiliation(s)
- Vivy Tran
- Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
| | - Rania M Shammas
- Department of Rheumatology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
| | - Jenny S Sauk
- Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
- Tamar and Vatche Manoukian Division of Digestive Diseases, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
| | - David Padua
- Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
- Tamar and Vatche Manoukian Division of Digestive Diseases, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
- Department of Medicine, VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA
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Santus P, Ferrando M, Baiardini I, Radovanovic D, Fattori A, Braido F. Patients beliefs on intravenous and subcutaneous routes of administration of biologics for severe asthma treatment: A cross-sectional observational survey study. World Allergy Organ J 2019; 12:100030. [PMID: 31061688 PMCID: PMC6488569 DOI: 10.1016/j.waojou.2019.100030] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/21/2018] [Revised: 03/24/2019] [Accepted: 03/27/2019] [Indexed: 01/19/2023] Open
Abstract
Background Understanding how patients generate preferences for administration route alternatives may improve health-care delivery and clinical outcomes. Recently, novel biological therapies with subcutaneous (SC) and intravenous (IV) administration routes have been approved for severe uncontrolled asthma. The aim of our study was to assess the preferred route of biologic therapy administration and related beliefs among patients with severe uncontrolled asthma. Methods We conducted a cross-sectional observational survey study. Patients answered an anonymous, self-administered questionnaire after an outpatient visit in pulmonary disease clinics located throughout Italy. Socio-demographic and clinical information together with the 12-Item Short Form Survey (SF-12), Work Productivity Impairment Scale and the medical resources utilization module of the Health & Work Survey were collected. Patients beliefs and preference towards SC and IV administration were investigated by means of an ad hoc 13 item questionnaire. Results: the main findings 150 patients fulfilled the inclusion criteria and completed the questionnaire (47.3% males). Preference for IV and SC administration was 18.7% and 81.3%, respectively. Compared with patients preferring SC formulation, patients that favored IV were older (p = 0.04), less likely to escalate corticosteroid dose (p = 0.03) and had emergency room (ER) access (p = 0.009) during asthma exacerbations. Patients felt that SC was more convenient than IV, but this belief was not associated with higher likelihood of preferring SC administration. IV formulations were more likely associated with quicker and more effective drug action (p = 0.0001), procedural safety and medical oversight (p = 0.0002) and social support (p = 0.007). Predictors of IV preference were represented by the association of worse asthma control and increased use of ER services, and by beliefs toward formulation effectiveness/efficiency in reducing symptoms (p = 0.04 and p < 0.0001, respectively). The model achieved excellent discrimination of administration route preference (area under the curve = 0.87). Conclusions Preference is guided by partially misleading beliefs, which may generate wrong expectations that in turn can affect treatment satisfaction and adherence. Convenience and efficacy beliefs for drugs with different routes of administration always should be discussed with patients to achieve informed shared-decision making. Trial registration Not applicable.
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Affiliation(s)
- Pierachille Santus
- Department of Biomedical and Clinical Sciences (DIBIC), Section of Respiratory Diseases, L. Sacco Hospital, ASST Fatebenefratelli-Sacco, University of Milan, Via G.B. Grassi 74, 20157, Milan, Italy
| | - Matteo Ferrando
- Department of Internal Medicine, Respiratory Diseases and Allergy Clinic, University of Genova, Azienda Policlinico IRCCs San Martino, Viale Benedetto XV, 6, 16132, Genoa, Italy
| | - Ilaria Baiardini
- Department of Internal Medicine, Respiratory Diseases and Allergy Clinic, University of Genova, Azienda Policlinico IRCCs San Martino, Viale Benedetto XV, 6, 16132, Genoa, Italy
| | - Dejan Radovanovic
- Department of Biomedical and Clinical Sciences (DIBIC), Section of Respiratory Diseases, L. Sacco Hospital, ASST Fatebenefratelli-Sacco, University of Milan, Via G.B. Grassi 74, 20157, Milan, Italy
- Corresponding author. Department of Biomedical and Clinical Sciences (DIBIC), University of Milan Section of Respiratory Diseases, L. Sacco Hospital, ASST Fatebenefratelli-Sacco, Via G.B. Grassi 74, 20157, Milano, Italy.
| | - Alice Fattori
- Department of Preventive Medicine, IRCCS Maggiore Policlinico Hospital Ca’ Granda Foundation, Department of Clinical Sciences and Community Health, University of Milan, Via Francesco Sforza, 28, 20122, Milan, Italy
| | - Fulvio Braido
- Department of Internal Medicine, Respiratory Diseases and Allergy Clinic, University of Genova, Azienda Policlinico IRCCs San Martino, Viale Benedetto XV, 6, 16132, Genoa, Italy
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Kamp KJ, Brittain K. Factors that Influence Treatment and Non-treatment Decision Making Among Individuals with Inflammatory Bowel Disease: An Integrative Review. PATIENT-PATIENT CENTERED OUTCOMES RESEARCH 2018; 11:271-284. [PMID: 29313266 DOI: 10.1007/s40271-017-0294-0] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/30/2022]
Abstract
Inflammatory bowel disease (IBD) is a chronic illness with periods of varying disease activity called flares and remissions. Since IBD impacts quality of life, patients make IBD disease management decisions every day. Previous research indicates limited insight about factors that influence decisions regarding disease management and the types of decisions IBD patients make. The purpose of this integrative review is to identify types of treatment and non-treatment decisions and the factors that influence decision making regarding disease management among individuals with IBD. An integrative literature review was performed based on the Whittemore and Knafl framework. PubMed, Web of Science, and PsychINFO were searched for relevant articles, from 2010-2016, using the key terms: decision making, patient preferences, self-management, self-care, nutrition, diet, stress, symptom, Colitis, Crohns, and IBD. Twenty-eight articles met the inclusion criteria. From these, research showed two types of decisions: treatment decisions related to medication and surgery, and non-treatment decisions focused on diet modification. Five themes that influence decisions were identified: experiencing symptoms, provider recommendations, convenience attributes, psychosocial factors, and informational needs. Most of the studies found a positive relationship between an increased number of symptoms and a patient's willingness to engage in treatment decisions. Although support from providers is highly influential for treatment decisions, most studies reported that provider recommendations did not align with patient preferences. Future work is needed to understand factors that influence decisions among recently diagnosed patients, to focus on non-treatment-related decisions, and to clarify the role of psychosocial factors in promoting disease decision making among IBD patients. This integrative review identified that, for patients, experiencing symptoms is the most important factor that influences treatment and non-treatment decisions.
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Affiliation(s)
- Kendra J Kamp
- Michigan State University, 1355 Bogue St, East Lansing, MI, 48824, USA.
| | - Kelly Brittain
- Michigan State University, 1355 Bogue St, East Lansing, MI, 48824, USA
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Should we use anti-tumor necrosis factor agents or vedolizumab as first-line biological therapy in ulcerative colitis? Best Pract Res Clin Gastroenterol 2018; 32-33:17-25. [PMID: 30060934 DOI: 10.1016/j.bpg.2018.05.006] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/30/2018] [Revised: 03/17/2018] [Accepted: 05/03/2018] [Indexed: 01/31/2023]
Abstract
Randomized controlled trials with direct comparisons between the different available biological agents in ulcerative colitis are lacking. The comparative efficacy, safety and tolerability, patient profile, patient preference and costs should be taken into account when choosing an appropriate first-line biological. Tumor necrosis factor antagonists have a systemic mode of action, while vedolizumab is mainly gut-selective, and this influences the clinical profile of both treatment options. Tofacitinib will further expand the therapeutic armamentarium in ulcerative colitis. Results of ongoing head-to-head trials between biological agents are likely to change clinical practice in the near future. Biomarkers that predict response to different treatment options in an individual patient are warranted.
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Paschos P, Katsoula A, Giouleme O, Sarigianni M, Liakos A, Athanasiadou E, Bekiari E, Tsapas A. Tofacitinib for induction of remission in ulcerative colitis: systematic review and meta-analysis. Ann Gastroenterol 2018; 31:572-582. [PMID: 30174394 PMCID: PMC6102462 DOI: 10.20524/aog.2018.0276] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/11/2018] [Accepted: 03/24/2018] [Indexed: 12/16/2022] Open
Abstract
Background The aim of the study was to assess the efficacy and safety of tofacitinib and its impact on quality of life in patients with moderate-to-severe ulcerative colitis. Methods We conducted a systematic review and meta-analysis of randomized controlled trials comparing tofacitinib with placebo or any active comparator. We searched Medline, Embase, the Cochrane Library and gray literature for articles published up to May 2017. We synthesized data using a fixed-effect model. We conducted subgroup analysis based on prior exposure to anti-tumor necrosis factor (TNF). We summarized the strength of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results We included three trials with 1220 participants. Compared with placebo, tofacitinib was effective in inducing clinical remission (odds ratio [OR] 3.84, 95% confidence interval [CI] 2.29-6.44, I2: 41%, GRADE: moderate), clinical response (OR 2.95, 95%CI 2.21-3.95, I2: 0%, GRADE: high), mucosal healing (OR 2.70, 95%CI 1.81-4.03, I2: 0%, GRADE: high). Tofacitinib was effective in both anti-TNF-naïve and -experienced patients. Tofacitinib had a favorable effect on quality of life. There were no significant differences in the safety profile in terms of the incidence of any or serious adverse events compared to placebo. The risk for infections was increased (OR 1.51, 95%CI 1.05-2.19, I2: 0%, GRADE: moderate), but the incidence of serious infections did not differ between tofacitinib and placebo. Conclusion In patients with moderate-to-severe ulcerative colitis, short-term treatment with tofacitinib is effective for induction of remission and improvement of quality of life.
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Affiliation(s)
- Paschalis Paschos
- Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University of Thessaloniki, Thessaloniki, Greece (Paschalis Paschos, Anastasia Katsoula, Maria Sarigianni, Aris Liakos, Eleni Athanasiadou, Eleni Bekiari, Apostolos Tsapas).,First Department of Internal Medicine, "Papageorgiou" Hospital, Thessaloniki, Greece (Paschalis Paschos)
| | - Anastasia Katsoula
- Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University of Thessaloniki, Thessaloniki, Greece (Paschalis Paschos, Anastasia Katsoula, Maria Sarigianni, Aris Liakos, Eleni Athanasiadou, Eleni Bekiari, Apostolos Tsapas).,Second Propaedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece (Olga Giouleme, Anastasia Katsoula)
| | - Olga Giouleme
- Second Propaedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece (Olga Giouleme, Anastasia Katsoula)
| | - Maria Sarigianni
- Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University of Thessaloniki, Thessaloniki, Greece (Paschalis Paschos, Anastasia Katsoula, Maria Sarigianni, Aris Liakos, Eleni Athanasiadou, Eleni Bekiari, Apostolos Tsapas)
| | - Aris Liakos
- Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University of Thessaloniki, Thessaloniki, Greece (Paschalis Paschos, Anastasia Katsoula, Maria Sarigianni, Aris Liakos, Eleni Athanasiadou, Eleni Bekiari, Apostolos Tsapas)
| | - Eleni Athanasiadou
- Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University of Thessaloniki, Thessaloniki, Greece (Paschalis Paschos, Anastasia Katsoula, Maria Sarigianni, Aris Liakos, Eleni Athanasiadou, Eleni Bekiari, Apostolos Tsapas)
| | - Eleni Bekiari
- Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University of Thessaloniki, Thessaloniki, Greece (Paschalis Paschos, Anastasia Katsoula, Maria Sarigianni, Aris Liakos, Eleni Athanasiadou, Eleni Bekiari, Apostolos Tsapas)
| | - Apostolos Tsapas
- Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University of Thessaloniki, Thessaloniki, Greece (Paschalis Paschos, Anastasia Katsoula, Maria Sarigianni, Aris Liakos, Eleni Athanasiadou, Eleni Bekiari, Apostolos Tsapas).,Harris Manchester College, University of Oxford, Oxford, UK (Apostolos Tsapas)
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Greener T, Boland K, Steinhart AH, Silverberg MS. The Unfinished Symphony: Golimumab Therapy for Anti-Tumour Necrosis Factor Refractory Crohn's Disease. J Crohns Colitis 2018; 12:458-464. [PMID: 29293965 DOI: 10.1093/ecco-jcc/jjx176] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/17/2017] [Accepted: 12/26/2017] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIMS Golimumab is approved for the treatment of moderate-to-severely active ulcerative colitis. However, there have been no formal trials to assess its utility in Crohn's disease [CD]. Our aim was to determine the efficacy and safety of golimumab in patients with anti-tumour necrosis factor [TNF] refractory CD. METHODS Patients with CD treated with golimumab between 2010 and 2017 were included in a retrospective observational study. The vast majority of patients failed two anti-TNF agents. Clinical response was defined as a significant reduction in symptoms and biochemical markers of CD, and no requirement for surgery or introduction of immune-suppressants. RESULTS Forty-five patients were included, with a median follow-up of 22 months [interquartile range 12-34] following initiation of golimumab. Induction and maintenance regimens were generally higher than standard dosing with first month cumulative doses of 400 mg and above in 75% of the patients. Monthly maintenance doses ≥200 mg were administered in 52% of patients. Clinical response at 3 months was achieved in 35/45 [77.7%] patients. The cumulative probabilities that patients with an initial response maintained their clinical response for 12 and 36 months after introduction of golimumab were 81% and 64%, respectively. Endoscopic improvement and mucosal healing at 12 months was achieved in 73% and 47% of patients, respectively. CONCLUSIONS This study demonstrates the efficacy of golimumab in anti-TNF refractory CD patients. Further studies should be performed in CD to formally assess the efficacy of golimumab in a randomized controlled trial and to establish the optimal dosing regimen.
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Affiliation(s)
- Tomer Greener
- Zane Cohen Centre for Digestive Diseases, Mount Sinai Hospital IBD Group, Toronto, Ontario, Canada; Division of Gastroenterology, Department of Medicine, University of Toronto, Toronto, Canada
| | - Karen Boland
- Zane Cohen Centre for Digestive Diseases, Mount Sinai Hospital IBD Group, Toronto, Ontario, Canada; Division of Gastroenterology, Department of Medicine, University of Toronto, Toronto, Canada
| | - A Hillary Steinhart
- Zane Cohen Centre for Digestive Diseases, Mount Sinai Hospital IBD Group, Toronto, Ontario, Canada; Division of Gastroenterology, Department of Medicine, University of Toronto, Toronto, Canada
| | - Mark S Silverberg
- Zane Cohen Centre for Digestive Diseases, Mount Sinai Hospital IBD Group, Toronto, Ontario, Canada; Division of Gastroenterology, Department of Medicine, University of Toronto, Toronto, Canada
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Navas-López VM, Pujol Muncunill G, Llerena E, Navalón Rubio M, Gil-Ortega D, Varea-Calderón V, Sierra Salinas C, Martin-de-Carpi J. Efectividad y seguridad en nuestro entorno de adalimumab como tratamiento anti-TNF de primera linea en niños con enfermedad de Crohn. An Pediatr (Barc) 2018; 88:89-99. [PMID: 28434894 DOI: 10.1016/j.anpedi.2017.01.013] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/28/2016] [Revised: 01/03/2017] [Accepted: 01/09/2017] [Indexed: 10/19/2022] Open
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A real-world study focused on the effectiveness and safety of adalimumab as first-line anti-TNF treatment for paediatric Crohn's disease. An Pediatr (Barc) 2018. [DOI: 10.1016/j.anpede.2017.03.001] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/01/2023] Open
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Incidence of and Predictors for Early Discontinuation of Biological Therapies in Veteran Patients with Inflammatory Bowel Disease. Inflamm Bowel Dis 2017; 23:1434-1439. [PMID: 28570429 DOI: 10.1097/mib.0000000000001145] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/09/2022]
Abstract
BACKGROUND Biological therapies are effective for inducing and maintaining remission in inflammatory bowel disease (IBD), but patients often require changes in biological agents over the course of their illness. We sought to evaluate the rate of and reasons for discontinuing biological agents and to identify risk factors for their discontinuation. METHODS We performed a retrospective cohort study across 4 VA hospital systems (Dallas, TX; Houston, TX; Ann Arbor, MI; Richmond, VA). Patients with IBD who were started on biological therapy between 1998 and 2015 were identified, and their medical records were reviewed to confirm the diagnosis of IBD and to collect study data. RESULTS Of 1969 patients with IBD; 256 were treated with 346 courses of therapy. By 6 months after initiation of therapy, 82 (24%) had stopped the biological agent. Among patients starting their first biological agent, 21.5% had stopped by 6 months. Patients taking a concomitant thiopurine and those with ileocolonic disease or a nonpenetrating, nonstricturing phenotype were less likely to discontinue biological therapy, whereas those taking 5-ASA concomitantly were more likely to discontinue biological therapy. The most common reasons for discontinuation were primary nonresponse (40%) and adverse drug reactions (29%). CONCLUSIONS In conclusion, in a large multicenter VA cohort, we found that 24% of patients who are prescribed a biological stop their treatment early, most commonly for primary nonresponse or for an adverse drug reaction. Consideration should be given to treating patients with a concomitant thiopurine if at all possible, as this reduces the likelihood of early discontinuation.
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Mizoshita T, Katano T, Tanida S, Hirano A, Miyaki T, Ozeki K, Suzuki Y, Sugimura N, Kataoka H, Joh T. Prospective comparison of preference and efficacy of adalimumab and infliximab for treating ulcerative colitis naive to antitumor necrosis factor therapy. Medicine (Baltimore) 2017; 96:e7800. [PMID: 28796080 PMCID: PMC5556246 DOI: 10.1097/md.0000000000007800] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
There have been few reports on 2 tumor necrosis factor alpha inhibitors, infliximab and adalimumab, with respect to patient preference and efficacy in ulcerative colitis (UC).We used questionnaires to evaluate the preference and reasons for drug choice between infliximab and adalimumab in UC patients naive to antitumor necrosis factor alpha therapy. We also analyzed the efficacy of infliximab and adalimumab prospectively and endoscopically before treatment and at 14 and 54 weeks.Of the 25 UC patients, infliximab and adalimumab were chosen by 10 (40%) and 15 (60%), respectively. Patients who favored infliximab considered "fear of syringes" (7/10, 70%) as the most important influencing factor, whereas patients who favored adalimumab considered "ease of administration" (10/15, 66.7%) and "time required for therapy" (10/15, 66.7%) as the most important factors. There were no statistical differences in remission induction and maintenance between the infliximab and adalimumab groups with regard to response, remission, mucosal healing, steroid-free, and steroid-free remission rates at weeks 14 and 54.The efficacy of adalimumab in remission induction and maintenance was equivalent to that of infliximab in UC patients naive to antitumor necrosis factor alpha therapy in this prospective study, but more patients preferred adalimumab.
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Affiliation(s)
- Tsutomu Mizoshita
- Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
| | - Takahito Katano
- Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
| | - Satoshi Tanida
- Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
| | - Atsuyuki Hirano
- Department of Gastroenterology, Nagoya City West Medical Center
| | | | - Keiji Ozeki
- Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
| | - Yuka Suzuki
- Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital
| | - Naomi Sugimura
- Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
- Department of Gastroenterology, Nagoya Memorial Hospital, Nagoya, Japan
| | - Hiromi Kataoka
- Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
| | - Takashi Joh
- Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
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Kim ES, Kim KO, Jang BI, Lee CK, Kim HJ, Lee KM, Kim YS, Eun CS, Jung SA, Yang SK, Lee J, Kim TO, Jung Y, Seo GS, Yoon SM. Factors Contributing to the Preference of Korean Patients with Crohn's Disease When Selecting an Anti-Tumor Necrosis Factor Agent (CHOICE Study). Gut Liver 2017; 10:391-8. [PMID: 26347512 PMCID: PMC4849692 DOI: 10.5009/gnl15126] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/08/2023] Open
Abstract
Background/Aims Two comparable anti-tumor necrosis factor (TNF) agents with different routes of administration (intravenous [iv] infliximab [IFX] vs subcutaneous [sc] adalimumab [ADA]) are available for patients with Crohn’s disease (CD) in Korea. This study aimed to identify the preferences of Korean CD patients for a specific anti-TNF agent and the factors contributing to the decision. Methods A prospective survey was performed among anti-TNF-naive CD patients in 10 tertiary referral hospitals. A 16-item questionnaire addressed patient preferences and the factors contributing to the decision in favor of a particular anti-TNF agent. A logistic regression was conducted to assess predictive factors for ADA preference. Results Overall, 189 patients (139 males; mean age, 32.47±11.71 years) completed the questionnaire. IFX and ADA were preferred by 63.5% (120/189) and 36.5% (69/189) of patients, respectively. The most influential reason for choosing IFX was ‘doctor’s presence’ (68.3%, 82/120), and ADA was “easy to use” (34.8%, 24/69). Amid various clinicodemographic data, having a >60-minute travel time to the hospital was a significant independent predictive factor for ADA preference. Conclusions A large number of anti-TNF-naive Korean patients with CD preferred anti-TNFs with an iv route of administration. The reassuring effect of a doctor’s presence might be the main contributing factor for this decision.
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Affiliation(s)
- Eun Soo Kim
- Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea
| | - Kyeong Ok Kim
- Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea
| | - Byung Ik Jang
- Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea
| | - Chang Kyun Lee
- Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea
| | - Hyo Jong Kim
- Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea
| | - Kang-Moon Lee
- Department of Internal Medicine, The Catholic University of Korea College of Medicine, Suwon, Korea
| | - You Sun Kim
- Department of Internal Medicine, Inje University College of Medicine, Seoul, Korea
| | - Chang Soo Eun
- Department of Internal Medicine, Hanyang University College of Medicine, Guri, Korea
| | - Sung-Ae Jung
- Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea
| | - Suk-Kyun Yang
- Department of Internal Medicine, University of Ulsan College of Medicine, Seoul, Korea
| | - Jun Lee
- Department of Internal Medicine, Chosun University School of Medicine, Gwangju, Korea
| | - Tae-Oh Kim
- Department of Internal Medicine, Inje University College of Medicine, Busan, Korea
| | - Yunho Jung
- Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea
| | - Geom Seog Seo
- Department of Internal Medicine, Wonkwang University School of Medicine, Iksan, Korea
| | - Soon Man Yoon
- Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, Korea
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Milassin Á, Rutka M, Csontos ÁA, Miheller P, Palatka K, Szűcs M, Szepes Z, Bálint A, Bor R, Fábián A, Farkas K, Nagy F, Molnár T. What Is the Personal Experience of IBD Patients about Their Anti-TNF-Alpha Therapy? Health (London) 2017. [DOI: 10.4236/health.2017.97073] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
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Abstract
BACKGROUND Adalimumab (ADA) is an effective treatment for Crohn's disease (CD). In rheumatology, sex differences concerning the response to ADA therapy have been described. However, such differences have not yet been reported for patients with CD. As such, the aim of this study was to compare ADA treatment outcomes in male and female patients with CD. METHODS A clinical cohort was formed of consecutive patients with CD starting ADA in a single tertiary center between March 2006 and February 2011. The cohort was followed up to August 2015. Clinical outcomes were primary nonresponse, secondary nonresponse, and drug survival (ongoing ADA use). Reasons for stopping ADA were recorded. Kaplan-Meier analysis and Cox regression were used to assess drug survival. RESULTS The cohort consisted of 107 female and 81 male patients. Median follow-up was 6.0 years (range 0.3-9.2). Drug survival was higher in male than female patients (48.1% versus 30.8%, P = 0.016). Side effects were reported more often by female patients (81.3% versus 64.2%, P = 0.008), and female patients ceased ADA more often due to side effects (35.4% versus 18.4%, P = 0.017). In survival analysis, female sex was associated with higher cessation rates (P = 0.006). Cox regression also identified female sex (P = 0.020), along with higher baseline CD Activity Index (P = 0.003), as predictors of ADA cessation. CONCLUSIONS Female sex is negatively associated with ADA drug survival. Female patients report more side effects and cease ADA because of side effects more often. A more personalized and sex-specific approach seems warranted to increase drug survival in female patients.
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Bolge SC, Eldridge HM, Lofland JH, Ravin C, Hart PJ, Ingham MP. Patient experience with intravenous biologic therapies for ankylosing spondylitis, Crohn's disease, psoriatic arthritis, psoriasis, rheumatoid arthritis, and ulcerative colitis. Patient Prefer Adherence 2017; 11:661-669. [PMID: 28405158 PMCID: PMC5378465 DOI: 10.2147/ppa.s121032] [Citation(s) in RCA: 24] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/30/2023] Open
Abstract
OBJECTIVE The objective of this study was to describe patient experience with intravenous (IV) biologics for ankylosing spondylitis, Crohn's disease, psoriatic arthritis, psoriasis, rheumatoid arthritis, or ulcerative colitis. METHODS Semi-structured telephone interviews were conducted in 405 patients with these autoimmune diseases who were receiving an IV biologic to treat their disease. RESULTS On a 7-point scale (1= not at all satisfied; 7= very satisfied), mean satisfaction with IV medication was rated 6.1; 77% of patients rated satisfaction as 6 or 7. The most frequently perceived benefits of IV therapy were related to supervision provided by health care professionals. Most patients (82%, n=332) preferred their IV medication to subcutaneous injection. The three most common reasons for preferring IV were not wanting to self-inject (43%), less frequent dosing (34%), and preference for administration by a health care professional (24%). African-American/black patients had a stronger preference for IV administration than Caucasian/white patients (97% vs 80%, P<0.05) and a greater dislike of needles/self-injection (71% vs 40%, P<0.05). Hospital outpatient departments were not rated as well as physician in-office infusion. Only half (49%) of the patients reported that both they and their physician equally influenced the choice to switch from subcutaneous to IV therapy, and only 30% were given a choice of infusion center. CONCLUSION Users of IV biologics are highly satisfied with their medications and perceive the opportunity for health care provider interaction at their infusion facilities as an advantage of their regimen. These findings support continued need for IV therapeutic options and shared decision-making between patients and physicians while selecting biologic treatments.
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Affiliation(s)
- Susan C Bolge
- Health Economics and Outcomes Research, Janssen Scientific Affairs, LLC, Raritan
- Correspondence: Susan C Bolge, Health Economics and Outcomes Research, Janssen Scientific Affairs, LLC, 1000 Route 202 – Room 3348, Raritan, NJ 08869, USA, Tel +1 908 927 7426, Fax +1 908 927 3166, Email
| | - Helen M Eldridge
- Payer Provider Insights & Analytics, Janssen Services, LLC, Titusville, NJ
| | - Jennifer H Lofland
- Health Economics and Outcomes Research, Janssen Scientific Affairs, LLC, Horsham, PA
| | - Caitlin Ravin
- Health Economics and Outcomes Research, Janssen Scientific Affairs, LLC, Horsham, PA
| | - Philip J Hart
- Value Communications, Medaxial Group, New York, NY, USA
| | - Michael P Ingham
- Health Economics and Outcomes Research, Janssen Scientific Affairs, LLC, Raritan
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Pouillon L, Bossuyt P, Peyrin-Biroulet L. Considerations, challenges and future of anti-TNF therapy in treating inflammatory bowel disease. Expert Opin Biol Ther 2016; 16:1277-90. [PMID: 27329436 DOI: 10.1080/14712598.2016.1203897] [Citation(s) in RCA: 37] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
INTRODUCTION Crohn's disease (CD) and ulcerative colitis (UC) are chronic disabling conditions. Monoclonal antibody therapy directed against tumor necrosis factor-alpha (anti-TNF) has revolutionized the care of patients with inflammatory bowel disease (IBD). AREAS COVERED Considerations before starting anti-TNF therapy are highlighted: the best time to start with anti-TNF therapy, either alone or in combination with an immunomodulator, the choice of an anti-TNF agent and the contra-indications to anti-TNF therapy. Primary nonresponse and secondary loss of response are discussed. De-escalating therapy, the role of therapeutic drug monitoring and the use of biosimilars, are handled. Finally, the future directions of anti-TNF therapy are emphasized. EXPERT OPINION Anti-TNF therapy remains the cornerstone in the treatment of IBD. When initiating long-term therapy, safety and cost issues are of great importance. The therapeutic armamentarium in the treatment of IBD is rapidly growing. Therefore, the challenge is to optimize the use and refine the exact position of anti-TNF therapy in the near future, with personalized medicine as the ultimate goal.
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Affiliation(s)
- Lieven Pouillon
- a Department of Hepato-Gastroenterology , University Hospitals Leuven, Uz Gasthuisberg , Leuven , Belgium
| | - Peter Bossuyt
- b Imelda GI Clinical Research Centre , Imeldaziekenhuis Bonheiden , Bonheiden , Belgium
| | - Laurent Peyrin-Biroulet
- c Inserm U954 and Department of Gastroenterology , Nancy University Hospital, Université de Lorraine , Vandœuvre-lès-Nancy , France
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Peyrin-Biroulet L, Van Assche G, Sturm A, Gisbert JP, Gaya DR, Bokemeyer B, Mantzaris GJ, Armuzzi A, Sebastian S, Lara N, Lynam M, Rojas-Farreras S, Fan T, Ding Q, Black CM, Kachroo S. Treatment satisfaction, preferences and perception gaps between patients and physicians in the ulcerative colitis CARES study: A real world-based study. Dig Liver Dis 2016; 48:601-7. [PMID: 27012447 DOI: 10.1016/j.dld.2016.01.013] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/20/2015] [Revised: 01/04/2016] [Accepted: 01/26/2016] [Indexed: 12/11/2022]
Abstract
BACKGROUND Ulcerative colitis (UC) is a life time disease and issues with therapy may impact on patient satisfaction and treatment preferences. AIMS To assess disease and treatment perception gaps from patients' and physicians' perspectives in UC patients. METHODS Adult patients with moderate-to-severe UC (Mayo score ≥6) naïve to biologic therapy were enrolled in a European, observational, cross-sectional, retrospective study. Treatment satisfaction was assessed by the TSQM questionnaire and treatment preferences and patient's knowledge with pre-defined questions. Physicians' and patients' perceptions were compared through the level of agreement. RESULTS 256 patients from 11 European countries were included. 48.0% of patients were dissatisfied with their current treatment. Effectiveness, long lasting action, rapid start of action, and fewer side effects were the attributes more frequently considered important or very important by patients (96.9%, 89.1%, 83.8%, and 81.8%, respectively). 26.2% patients rated their overall disease knowledge as very knowledgeable. The agreement between patients' and physicians on disease severity was good (kappa=0.62). CONCLUSION Half patients with moderate-to-severe UC managed with conventional therapy, are dissatisfied with their treatments. Effectiveness, long lasting action and rapidity of action were the most frequently rated items in treatment preferences. There are major gaps between physicians and patients when evaluating disease burden.
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Affiliation(s)
- Laurent Peyrin-Biroulet
- Department of Hepato-Gastroenterology and Inserm U954, University Hospital of Nancy, Lorraine University, Vandoeuvre-lès-Nancy, France.
| | - Gert Van Assche
- Division of Gastroenterology, University Hospitals Leuven, Leuven Belgium
| | - Andreas Sturm
- Department of Gastroenterology, DRK Kliniken Berlin I Westend, Berlin, Germany
| | - Javier P Gisbert
- Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
| | - Daniel R Gaya
- Gastroenterology Unit, Glasgow Royal Infirmary, Glasgow, United Kingdom
| | | | | | - Alessandro Armuzzi
- IBD Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy
| | - Shaji Sebastian
- Gastroenterology and IBD Unit, Hull and East Yorkshire Hospitals NHS Trust, Hull, United Kingdom
| | - Nuria Lara
- IMS Health, Real World Evidence Solutions, Spain
| | - Mark Lynam
- IMS Health, Real World Evidence Solutions, Spain
| | | | - Tao Fan
- Merck & Co., Inc., Kenilworth, NJ, United States
| | - Qian Ding
- Merck & Co., Inc., Kenilworth, NJ, United States
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Seo H, Ye BD. Patients' Preference for a Specific Anti-Tumor Necrosis Factor Agent: Korea versus Western. Gut Liver 2016; 10:327-9. [PMID: 27114431 PMCID: PMC4849682 DOI: 10.5009/gnl16109] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/10/2022] Open
Affiliation(s)
- Hyungil Seo
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Byong Duk Ye
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.,Inflammatory Bowel Disease Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
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