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Karami H, Shirvani Shiri M, Ebadi Fard Azar F, Bagheri Lankarani K, Ghahramani S, Rezapour A, Tatari M, Heidari Javargi Z. Factors associated with health-related quality of life in patients with Crohn's disease in Iran: A prospective observational study. Front Med (Lausanne) 2023; 9:1091330. [PMID: 36760884 PMCID: PMC9907090 DOI: 10.3389/fmed.2022.1091330] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/06/2022] [Accepted: 12/30/2022] [Indexed: 01/20/2023] Open
Abstract
This was a 1-year prospective observational study of the health-related quality of life (HRQoL) of moderate to severe crohn's disease (CD) patients in Iran. Patients' HRQoL were measured using the EQ-5D 3L, EQ-VAS, and IBDQ-9 tools. HRQoL among CD patients were compared using the T-test, Mann-Whitney, Chi-square, and Fisher's exact tests. To discover factors influencing patients' HRQoL, multivariate linear regression and multivariate logistic regression tests were utilized. The study included 222 CD patients, with a mean age of 34.67 and mean disease duration of 7.32 years. The dimensions with the worst reported "relatively or extreme problems" were P/D: 77.5% and A/D: 63.1%. Employment, having "other chronic diseases," and ADA consumption were the most important independent predictors of HRQoL in CD patients, [β = 0.21 (EQ-5D index), β = 19.61 (EQ-VAS), β = 12.26 (IBDQ-9), OR: 0.09 (MO), OR: 0.12 (UA), OR: 0.21 (P/D), OR: 0.22 (A/D)], [β = -0.15 (EQ-5D index), β = -5.84 (IBDQ-9), β = -11.06 (EQ-VAS), OR: 4.20 (MO), OR: 6.50 (UA)], and [OR: 2.29 (A/D)], respectively. Unemployment, presence of "other chronic conditions" had the greatest negative impact on HRQoL of CD patients. There were significant differences in the probability of reporting "relatively or extreme problems" in the SC and A/D dimensions between patients using adalimumab (ADA) and infliximab (IFX).
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Affiliation(s)
- Hassan Karami
- Department of Economics, School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran
| | - Maryam Shirvani Shiri
- Department of Health Management and Economics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
| | - Farbod Ebadi Fard Azar
- Health Promotion Research Center, Iran University of Medical Sciences, Tehran, Iran,*Correspondence: Farbod Ebadi Fard Azar ✉
| | - Kamran Bagheri Lankarani
- Health Policy Research Center, Institute of Health, Shiraz University of Medical Sciences, Shiraz, Fars, Iran
| | - Sulmaz Ghahramani
- Health Policy Research Center, Institute of Health, Shiraz University of Medical Sciences, Shiraz, Fars, Iran
| | - Aziz Rezapour
- Health Management and Economics Research Center, Iran University of Medical Sciences, Tehran, Iran
| | - Maryam Tatari
- Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran,Vice Chancellery of Health, Torbat Heydariyeh University of Medical Sciences, Torbat Heydariyeh, Iran
| | - Zahra Heidari Javargi
- Department of Clinical Medicine, School of Medicine, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran
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Yang HH, Huang Y, Zhou XC, Wang RN. Efficacy and safety of adalimumab in comparison to infliximab for Crohn's disease: A systematic review and meta-analysis. World J Clin Cases 2022; 10:6091-6104. [PMID: 35949827 PMCID: PMC9254215 DOI: 10.12998/wjcc.v10.i18.6091] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/29/2021] [Revised: 02/14/2022] [Accepted: 04/30/2022] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Adalimumab (ADA) and infliximab (IFX) are the cornerstones of the treatment of Crohn’s disease (CD). It remains controversial whether there is a difference in the effectiveness and safety between IFX and ADA for CD.
AIM To perform a meta-analysis to compare the effectiveness and safety of ADA and IFX in CD.
METHODS PubMed, Embase, Cochrane Library, and Web of Science databases were searched. Cohort studies were considered for inclusion. The primary outcomes were induction of response and remission, maintenance of response and remission, and secondary loss of response. Adverse events were secondary outcomes.
RESULTS Fourteen cohort studies were included. There was no apparent difference between the two agents in the induction response [odds ratio (OR): 1.27, 95% confidence interval (CI): 0.93-1.74, P = 0.14] and remission (OR: 1.11, 95%CI: 0.78–1.57, P = 0.57), maintenance response (OR: 1.08, 95%CI: 0.76–1.53, P = 0.67) and remission (OR: 1.26, 95%CI: 0.87–1.82, P = 0.22), and secondary loss of response (OR: 1.01, 95%CI: 0.65–1.55, P = 0.97). Subgroup analysis revealed ADA and IFX had similar rates of response, remission, and loss of response either in anti-tumor necrosis factor-α naïve or non-naïve patients. Further, there was a similar result regardless of whether CD patients were treated with optimized therapy, including dose intensification, shortening interval, and combination immunomodulators. However, ADA had a fewer overall adverse events than IFX (OR: 0.62, 95%CI: 0.42–0.91, P = 0.02).
CONCLUSION ADA and IFX have similar clinical benefits for anti-tumor necrosis factor-α naïve or non-naïve CD patients. Overall adverse events rate is higher in patients in the IFX group.
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Affiliation(s)
- Hua-Hua Yang
- Department of Gastroenterology, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China
| | - Yi Huang
- Department of Gastroenterology, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China
| | - Xu-Chun Zhou
- Department of Gastroenterology, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China
| | - Ruo-Nan Wang
- Department of Endocrinology, Liyuan Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430077, Hubei Province, China
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Bronsky J, Copova I, Kazeka D, Lerchova T, Mitrova K, Pospisilova K, Sulovcova M, Zarubova K, Hradsky O. Adalimumab vs Infliximab in Pediatric Patients With Crohn's Disease: A Propensity Score Analysis and Predictors of Treatment Escalation. Clin Transl Gastroenterol 2022; 13:e00490. [PMID: 35363628 PMCID: PMC9132518 DOI: 10.14309/ctg.0000000000000490] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/27/2021] [Accepted: 03/04/2022] [Indexed: 11/21/2022] Open
Abstract
INTRODUCTION Two antitumor necrosis factor therapies (infliximab [IFX] and adalimumab [ADA]) have been approved for the treatment of pediatric Crohn's disease (CD) but have not been compared in head-to-head trials. The aim of this study was to compare the efficacy and safety of ADA and IFX by propensity score matching in a prospective cohort of pediatric patients with luminal CD and at least a 24-month follow-up. METHODS Among 100 patients, 75 met the inclusion criteria, and 62 were matched by propensity score. We evaluated time to treatment escalation as the primary outcome and primary nonresponse, predictors of treatment escalation and relapse, serious adverse events, pharmacokinetics, and effect of concomitant immunomodulators as secondary outcomes. RESULTS There was no difference between ADA and IFX in time to treatment escalation (HR = 0.63 [95% CI 0.31-1.28] P = 0.20), primary nonresponse (P = 0.95), or serious adverse events. The median (interquartile range) trough levels at the primary outcome were 14.05 (10.88-15.40) and 6.15 (2.08-6.58) µg/mL in the ADA and IFX groups, respectively. On a multivariate analysis, the combination of anti-Saccharomyces cerevisiae antibody negativity and antineutrophil cytoplasmic antibody positivity was a strong independent predictor of treatment escalation (HR 5.19, [95% CI 2.41-11.18], P < 0.0001). The simple endoscopic score for CD, L3 disease phenotype, and use of concomitant immunomodulators for at least the first 6 months revealed a trend toward significance on a univariate analysis. DISCUSSION Propensity score matching did not reveal substantial differences in efficacy or safety between ADA and IFX. The anti-S. cerevisiae antibody negativity and antineutrophil cytoplasmic antibody positivity combination is a strong predictor of treatment escalation.
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Affiliation(s)
- Jiri Bronsky
- Gastroenterology and Nutrition Unit, Department of Paediatrics, 2nd Faculty of Medicine, Charles University and University Hospital Motol, Prague, Czech Republic;
| | - Ivana Copova
- Gastroenterology and Nutrition Unit, Department of Paediatrics, 2nd Faculty of Medicine, Charles University and University Hospital Motol, Prague, Czech Republic;
| | - Denis Kazeka
- Gastroenterology and Nutrition Unit, Department of Paediatrics, 2nd Faculty of Medicine, Charles University and University Hospital Motol, Prague, Czech Republic;
| | - Tereza Lerchova
- Gastroenterology and Nutrition Unit, Department of Paediatrics, 2nd Faculty of Medicine, Charles University and University Hospital Motol, Prague, Czech Republic;
| | - Katarina Mitrova
- Gastroenterology and Nutrition Unit, Department of Paediatrics, 2nd Faculty of Medicine, Charles University and University Hospital Motol, Prague, Czech Republic;
- IBD Clinical and Research Centre, ISCARE, Prague, Czech Republic.
| | - Kristyna Pospisilova
- Gastroenterology and Nutrition Unit, Department of Paediatrics, 2nd Faculty of Medicine, Charles University and University Hospital Motol, Prague, Czech Republic;
| | - Miroslava Sulovcova
- Gastroenterology and Nutrition Unit, Department of Paediatrics, 2nd Faculty of Medicine, Charles University and University Hospital Motol, Prague, Czech Republic;
| | - Kristyna Zarubova
- Gastroenterology and Nutrition Unit, Department of Paediatrics, 2nd Faculty of Medicine, Charles University and University Hospital Motol, Prague, Czech Republic;
| | - Ondrej Hradsky
- Gastroenterology and Nutrition Unit, Department of Paediatrics, 2nd Faculty of Medicine, Charles University and University Hospital Motol, Prague, Czech Republic;
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Hou Q, Huang J, Ayansola H, Masatoshi H, Zhang B. Intestinal Stem Cells and Immune Cell Relationships: Potential Therapeutic Targets for Inflammatory Bowel Diseases. Front Immunol 2021; 11:623691. [PMID: 33584726 PMCID: PMC7874163 DOI: 10.3389/fimmu.2020.623691] [Citation(s) in RCA: 72] [Impact Index Per Article: 18.0] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/30/2020] [Accepted: 12/03/2020] [Indexed: 12/11/2022] Open
Abstract
The mammalian intestine is the largest immune organ that contains the intestinal stem cells (ISC), differentiated epithelial cells (enterocytes, Paneth cells, goblet cells, tuft cells, etc.), and gut resident-immune cells (T cells, B cells, dendritic cells, innate lymphoid cell, etc.). Inflammatory bowel disease (IBD), a chronic inflammatory disease characterized by mucosa damage and inflammation, threatens the integrity of the intestine. The continuous renewal and repair of intestinal mucosal epithelium after injury depend on ISCs. Inflamed mucosa healing could be a new target for the improvement of clinical symptoms, disease recurrence, and resection-free survival in IBD treated patients. The knowledge about the connections between ISC and immune cells is expanding with the development of in vitro intestinal organoid culture and single-cell RNA sequencing technology. Recent findings implicate that immune cells such as T cells, ILCs, dendritic cells, and macrophages and cytokines secreted by these cells are critical in the regeneration of ISCs and intestinal epithelium. Transplantation of ISC to the inflamed mucosa may be a new therapeutic approach to reconstruct the epithelial barrier in IBD. Considering the links between ISC and immune cells, we predict that the integration of biological agents and ISC transplantation will revolutionize the future therapy of IBD patients.
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Affiliation(s)
- Qihang Hou
- State Key Laboratory of Animal Nutrition, Department of Animal Nutrition & Feed Science, College of Animal Science & Technology, China Agricultural University, Haidian District, Beijing, China
| | - Jingxi Huang
- State Key Laboratory of Animal Nutrition, Department of Animal Nutrition & Feed Science, College of Animal Science & Technology, China Agricultural University, Haidian District, Beijing, China
| | - Hammed Ayansola
- State Key Laboratory of Animal Nutrition, Department of Animal Nutrition & Feed Science, College of Animal Science & Technology, China Agricultural University, Haidian District, Beijing, China
| | - Hori Masatoshi
- Department of Veterinary Pharmacology, Graduate School of Agricultural and Life Sciences, The University of Tokyo, Bunkyo-ku, Tokyo, Japan
| | - Bingkun Zhang
- State Key Laboratory of Animal Nutrition, Department of Animal Nutrition & Feed Science, College of Animal Science & Technology, China Agricultural University, Haidian District, Beijing, China
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Jung YS, Han M, Park S, Cheon JH. Comparison of Long-term Outcomes of Infliximab versus Adalimumab in 1,488 Biologic-Naive Korean Patients with Crohn's Disease. Gut Liver 2021; 15:92-99. [PMID: 32839359 PMCID: PMC7817934 DOI: 10.5009/gnl19377] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/07/2019] [Revised: 12/07/2019] [Accepted: 12/15/2019] [Indexed: 12/17/2022] Open
Abstract
BACKGROUND/AIMS Data on the comparative effectiveness of infliximab (IFX) or adalimumab (ADA) in patients with Crohn's disease (CD) are rare, particularly for Asian patients. We compared the key clinical outcomes (surgery, hospitalization, and corticosteroid use) of use of these two drugs in biologic-naive Korean patients with CD. METHODS Using National Health Insurance claims, we collected data on patients who were diagnosed with CD and exposed to IFX or ADA between 2010 and 2016. RESULTS We included 1,488 new users of biologics (1,000 IFX users and 488 ADA users). Over a median follow-up period of 2.1 years after starting biological therapy, no significant differences were found between IFX and ADA users in the risks for surgery (ADA vs IFX: adjusted hazard ratio [aHR], 1.22; 95% confidence interval [CI], 0.81 to 1.84), hospitalization (aHR, 1.02; 95% CI, 0.81 to 1.28), and corticosteroid use (aHR, 0.82; 95% CI, 0.56 to 1.19). These results were unchanged even when only patients who used biologics for over 6 months were analyzed (aHR [95% CI]: surgery, 1.31 [0.82 to 2.11]; hospitalization, 1.02 [0.80 to 1.30]; corticosteroid use, 0.80 [0.54 to 1.18]). Additionally, these results were unchanged in patients treated with biologics as monotherapy or in combination with immunomodulators. CONCLUSIONS In this nationwide population-based study, no significant difference was found in the long-term effectiveness of IFX and ADA in the real-world setting of biologic-naive Korean patients with CD. In the absence of trials to directly compare IFX and ADA, our study indicates that the selection of one of these two biologics can be determined by patient and/or physician preference.
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Affiliation(s)
- Yoon Suk Jung
- Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Minkyung Han
- Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics, Yonsei University College of Medicine, Seoul, Korea
| | - Sohee Park
- Department of Biostatistics, Graduate School of Public Health, Yonsei University, Seoul, Korea
| | - Jae Hee Cheon
- Department of Internal Medicine and Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea
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6
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Varma P, Rajadurai AS, Holt DQ, Devonshire DA, Desmond CP, Swan MP, Nathan D, Shelton ET, Prideaux L, Sorrell C, Rusli F, Crantock LRF, Dev A, Ratnam DT, Pianko S, Moore GT. Immunomodulator use does not prevent first loss of response to anti-tumour necrosis factor alpha therapy in inflammatory bowel disease: long-term outcomes in a real-world cohort. Intern Med J 2020; 49:753-760. [PMID: 30381884 DOI: 10.1111/imj.14150] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/14/2018] [Revised: 10/22/2018] [Accepted: 10/25/2018] [Indexed: 01/11/2023]
Abstract
BACKGROUND Recent prospective studies suggest combination therapy with immunomodulators improves efficacy, but long-term data is limited. AIM To assess whether anti-tumour necrosis factor alpha (anti-TNF) monotherapy was associated with earlier loss of response (LOR) than combination therapy in a real-world cohort with long-term follow up. METHODS A retrospective audit was conducted of inflammatory bowel disease patients receiving anti-TNF therapy in a tertiary centre and specialist private practices. All patients with accurate data for anti-TNF commencement and adequate correspondence to determine end-points were included. Outcomes measured included time to first LOR, causes and biochemical parameters. RESULTS Two hundred and twenty-four patients were identified; 139 (62.1%) on combination therapy and 85 (37.9%) on monotherapy. Forty-five percent of patients had LOR during follow up until a maximum of 8.5 years; 59.4% on combination therapy and 40.6% on monotherapy (P = 0.533). The median time to LOR was not different between groups; 1069 days for combination therapy and 1489 days for monotherapy (P = 0.533). There was no difference in time to LOR between patients treated with different combination regimens or different anti-TNF agents. CONCLUSION In this large cohort of patients in a real-world setting, patients treated with anti-TNF monotherapy had similar rates of LOR as patients on anti-TNF combination therapy, at both short- and long-term follow up.
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Affiliation(s)
- Poornima Varma
- Department of Gastroenterology and Hepatology, Monash Medical Centre, Melbourne, Victoria, Australia
| | - Anton S Rajadurai
- Department of Gastroenterology and Hepatology, Monash Medical Centre, Melbourne, Victoria, Australia
| | - Darcy Q Holt
- Department of Gastroenterology and Hepatology, Monash Medical Centre, Melbourne, Victoria, Australia.,School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia
| | - David A Devonshire
- Department of Gastroenterology and Hepatology, Monash Medical Centre, Melbourne, Victoria, Australia
| | - Chris P Desmond
- Department of Gastroenterology and Hepatology, Monash Medical Centre, Melbourne, Victoria, Australia
| | - Michael P Swan
- Department of Gastroenterology and Hepatology, Monash Medical Centre, Melbourne, Victoria, Australia
| | - Debra Nathan
- Department of Gastroenterology and Hepatology, Monash Medical Centre, Melbourne, Victoria, Australia
| | - Edward T Shelton
- Department of Gastroenterology and Hepatology, Monash Medical Centre, Melbourne, Victoria, Australia
| | - Lani Prideaux
- Department of Gastroenterology and Hepatology, Monash Medical Centre, Melbourne, Victoria, Australia
| | - Catherine Sorrell
- Department of Gastroenterology and Hepatology, Monash Medical Centre, Melbourne, Victoria, Australia
| | - Ferry Rusli
- Department of Gastroenterology and Hepatology, Monash Medical Centre, Melbourne, Victoria, Australia
| | - Luke R F Crantock
- Department of Gastroenterology and Hepatology, Monash Medical Centre, Melbourne, Victoria, Australia
| | - Anouk Dev
- Department of Gastroenterology and Hepatology, Monash Medical Centre, Melbourne, Victoria, Australia
| | - Dilip T Ratnam
- Department of Gastroenterology and Hepatology, Monash Medical Centre, Melbourne, Victoria, Australia
| | - Stephen Pianko
- Department of Gastroenterology and Hepatology, Monash Medical Centre, Melbourne, Victoria, Australia
| | - Gregory T Moore
- Department of Gastroenterology and Hepatology, Monash Medical Centre, Melbourne, Victoria, Australia.,School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia
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Sparrow MP, Melmed GY, Devlin S, Kozuch P, Raffals L, Loftus Jr EV, Rubin DT, Spiegel B, Baidoo L, Bressler B, Cheifetz A, Irving P, Jones J, Kaplan GG, Velayos F, Siegel CA. De‐escalating medical therapy in Crohn’s disease patients who are in deep remission: A RAND appropriateness panel. ACTA ACUST UNITED AC 2019. [DOI: 10.1002/ygh2.337] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Affiliation(s)
- Miles P. Sparrow
- The BRIDGe Group
- The Alfred Hospital Melbourne Victoria Australia
| | - Gil Y. Melmed
- The BRIDGe Group
- Cedars‐Sinai Medical Center Los Angeles California
| | - Shane Devlin
- The BRIDGe Group
- University of Calgary Calgary Alberta Canada
| | - Patricia Kozuch
- The BRIDGe Group
- Jefferson University Philadelphia Pennsylvania
| | | | | | | | | | | | - Brian Bressler
- The BRIDGe Group
- University of British Columbia Vancouver British Columbia Canada
| | - Adam Cheifetz
- The BRIDGe Group
- Beth Israel Deaconess Medical Center Boston Massachusetts
| | - Peter Irving
- The BRIDGe Group
- Guy's and St. Thomas' Hospitals London UK
| | - Jennifer Jones
- The BRIDGe Group
- Dalhousie University Halifax Nova Scotia Canada
| | | | | | - Corey A. Siegel
- The BRIDGe Group
- Dartmouth‐Hitchcock IBD Center Lebanon New Hampshire
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Michopoulos S, Paspatis G, Triantafyllou K, Potamianos S, Nikolopoulou V, Akriviadis E, Karagiannis JA, Ladas S, Tampaki M, Tzathas C. A multicenter, prospective, observational study of the long-term outcomes of Crohn's disease patients under routine care management in Greece. Ann Gastroenterol 2018; 31:583-592. [PMID: 30174395 PMCID: PMC6102459 DOI: 10.20524/aog.2018.0295] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/08/2018] [Accepted: 06/12/2018] [Indexed: 11/11/2022] Open
Abstract
BACKGROUND Real-world data on management patterns and long-term outcomes of patients with inadequately controlled Crohn's disease (CD) in Greece are scarce. METHODS This was a multicenter, prospective observational study of 18-65-year-old CD patients whose physicians judged that their current therapy was inadequate to control their condition and therefore decided to switch treatment. Data were collected at enrollment (time of switch), and 30, 54 and 104 weeks post-enrollment. RESULTS Sixty-six eligible patients (median age: 35.8 years; 56.1% males; median CD diagnosis duration: 2.3 years) were enrolled by nine hospital sites. At the time of treatment switch, 66.7% had "mild" (CD activity index [CDAI] <220) and 30.3% "moderate-to-severe" (220≤CDAI≤450) disease activity. Ileocolonic involvement, extraintestinal manifestations, prior CD-related surgeries and prior corticosteroid use were reported in 65.2%, 51.5%, 24.2% and 78.8% of patients, respectively. Throughout the study, most patients were managed with anti-tumor necrosis factor (TNF) medications (74.2%/74.1% infliximab; 10.6%/13.8% adalimumab at enrollment/end of study, respectively). At 54 and 104 weeks post-enrollment, the baseline CDAI score (median 174.5) decreased to 145.5 and 146.0 points (P<0.001) and the baseline C-reactive protein level (median: 13.6 mg/L) decreased to 3.5 and 3.0 mg/L (P<0.001), respectively, not differing statistically between patients with "mild" and "moderate-to-severe" disease activity. In this patient population, 56.1% were corticosteroid-free throughout observation, while for the remaining 43.9%, the mean percentage corticosteroid-free period was 80.2%. CD-related surgeries and hospitalizations were reported in 8.1% and 19.4%, respectively. CONCLUSION Under routine care in Greece, inadequately controlled CD patients were mainly switched to anti-TNFs, which lowered disease activity and reduced corticosteroid use.
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Affiliation(s)
- Spyridon Michopoulos
- Gastroenterology Department, “Alexandra” General Hospital of Athens (Spyridon Michopoulos), Greece
| | - Gregorios Paspatis
- Gastroenterology Department, “Venizeleio Pananeio” General Hospital of Heraklion, Crete (Gregorios Paspatis), Greece
| | - Konstantinos Triantafyllou
- Hepatogastroenterology Unit, Second Department of Internal Medicine – Propaedeutic, Research Institute and Diabetes Center, Medical School, National and Kapodistrian University of Athens, “Attikon” University General Hospital, Athens (Konstantinos Triantafyllou), Greece
| | - Spyridon Potamianos
- Gastroenterology Department, University General Hospital of Larissa (Spyridon Potamianos), Greece
| | - Vassiliki Nikolopoulou
- Gastroenterology Department, University General Hospital of Patras, Rio (Vassiliki Nikolopoulou), Greece
| | - Evangelos Akriviadis
- 3 Internal Medicine Department, “Diavalkaniko” Medical Center of Thessaloniki, Thessaloniki (Evangelos Akriviadis), Greece
| | - John A. Karagiannis
- Gastroenterology Department, “Konstantopouleio–Agia Olga” General Hospital of Nea Ionia, Athens (John A. Karagiannis†), Greece
| | - Spyridon Ladas
- First Propaedeutic Clinic of Internal Medicine, “Laiko” General Hospital of Athens (Spyridon Ladas), Greece
| | - Maria Tampaki
- Merck Sharp & Dohme Pharmaceutical, Industrial and Commercial S.A., Athens (Maria Tampaki), Greece
| | - Charalambos Tzathas
- Gastroenterology Department, “Tzaneio” General Hospital of Piraeus, Piraeus (Charalambos Tzathas), Greece
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9
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Benmassaoud A, Al-Taweel T, Sasson MS, Moza D, Strohl M, Kopylov U, Paradis-Surprenant L, Almaimani M, Bitton A, Afif W, Lakatos PL, Bessissow T. Comparative Effectiveness of Infliximab Versus Adalimumab in Patients with Biologic-Naïve Crohn's Disease. Dig Dis Sci 2018; 63:1302-1310. [PMID: 29243105 DOI: 10.1007/s10620-017-4874-6] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/07/2017] [Accepted: 11/29/2017] [Indexed: 12/18/2022]
Abstract
BACKGROUND Direct head-to-head studies comparing the long-term outcomes of infliximab (IFX) to adalimumab (ADA) in Crohn's disease (CD) are sparse. AIMS We compared the short-term and long-term efficacy and safety of IFX and ADA in CD. METHODS We performed a single-center retrospective study including biologic-naïve adult patients with CD who were started on IFX or ADA at the McGill University Health Center. The primary end points were clinical response and remission at 12 months. Secondary end points included corticosteroid-free remission at 12 months, durable remission, and treatment failure with need for steroids, hospitalization or surgery. Safety was also assessed. RESULTS Two hundred and twenty patients were included (143 IFX, 77 ADA). Patients on IFX had a higher prevalence of fistulizing or perianal disease and corticosteroid treatment at baseline. Rates of clinical remission and corticosteroid-free remission at 12 months were similar between both groups: 63.8 versus 76.3% (p = 0.139) and 54.1 versus 44.7% (p = 0.354), respectively, for IFX and ADA. Combination therapy led to significantly higher remission rates at 12 months compared to monotherapy for patients on IFX (81.2 vs. 52.1%, p = 0.008), but not for those on ADA. Higher rates of adverse events were reported with IFX compared to ADA (p = 0.006). CONCLUSIONS Our real-life experience in biologic-naïve CD patients demonstrated that patients started on IFX were more likely to have a harder-to-treat phenotype. Despite that, efficacy end points were similar between both groups. Clinical remission was higher in patients with combination therapy for IFX, but not for those on ADA. This warrants further investigation.
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Affiliation(s)
- Amine Benmassaoud
- Division of Gastroenterology, Montreal General Hospital, McGill University Health Center, 1650, Cedar Avenue, C7-200, Montreal, QC, H3G 1A4, Canada
| | - Talal Al-Taweel
- Division of Gastroenterology, Montreal General Hospital, McGill University Health Center, 1650, Cedar Avenue, C7-200, Montreal, QC, H3G 1A4, Canada
- Haya Al-Habeeb Gastroenterology Center, Mubarak Al-Kabeer Hospital, Jabriya, Kuwait
| | - Mark Solomon Sasson
- Division of Gastroenterology, Montreal General Hospital, McGill University Health Center, 1650, Cedar Avenue, C7-200, Montreal, QC, H3G 1A4, Canada
| | - Dasha Moza
- Division of Gastroenterology, Montreal General Hospital, McGill University Health Center, 1650, Cedar Avenue, C7-200, Montreal, QC, H3G 1A4, Canada
| | - Matthew Strohl
- Division of Gastroenterology, Montreal General Hospital, McGill University Health Center, 1650, Cedar Avenue, C7-200, Montreal, QC, H3G 1A4, Canada
| | - Uri Kopylov
- Division of Gastroenterology, Montreal General Hospital, McGill University Health Center, 1650, Cedar Avenue, C7-200, Montreal, QC, H3G 1A4, Canada
- Department of Gastroenterology, Sheba Medical Centre, Tel-Aviv, Israel
| | - Laurence Paradis-Surprenant
- Division of Gastroenterology, Montreal General Hospital, McGill University Health Center, 1650, Cedar Avenue, C7-200, Montreal, QC, H3G 1A4, Canada
| | - Mohanad Almaimani
- Division of Gastroenterology, Montreal General Hospital, McGill University Health Center, 1650, Cedar Avenue, C7-200, Montreal, QC, H3G 1A4, Canada
| | - Alain Bitton
- Division of Gastroenterology, Montreal General Hospital, McGill University Health Center, 1650, Cedar Avenue, C7-200, Montreal, QC, H3G 1A4, Canada
| | - Waqqas Afif
- Division of Gastroenterology, Montreal General Hospital, McGill University Health Center, 1650, Cedar Avenue, C7-200, Montreal, QC, H3G 1A4, Canada
| | - Peter L Lakatos
- Division of Gastroenterology, Montreal General Hospital, McGill University Health Center, 1650, Cedar Avenue, C7-200, Montreal, QC, H3G 1A4, Canada
- First Department of Medicine, Semmelweis University, Budapest, Hungary
| | - Talat Bessissow
- Division of Gastroenterology, Montreal General Hospital, McGill University Health Center, 1650, Cedar Avenue, C7-200, Montreal, QC, H3G 1A4, Canada.
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Infliximab Versus Adalimumab in Patients with Biologic-Naïve Crohn's Disease: Is the Difference Real? Dig Dis Sci 2018; 63:1094-1096. [PMID: 29417327 DOI: 10.1007/s10620-018-4952-4] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
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11
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Real-world Experience of Anti-tumor Necrosis Factor Therapy for Internal Fistulas in Crohn's Disease: A Retrospective Multicenter Cohort Study. Inflamm Bowel Dis 2017; 23:2245-2251. [PMID: 29084079 DOI: 10.1097/mib.0000000000001276] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/29/2022]
Abstract
BACKGROUND Internal fistula in Crohn's disease is a condition likely to require surgery, although few reports showed successful medical treatments such as anti-tumor necrosis factor (TNF) therapy. We performed a multicenter retrospective cohort study to investigate the outcome of anti-TNF therapy for internal fistula in Crohn's disease. METHODS Data were retrospectively collected from patients with Crohn's disease diagnosed with internal fistula treated with anti-TNF agents (infliximab or adalimumab) between January 2002 and November 2015. Need for surgery and fistula closure were assessed as primary and secondary endpoints. Cumulative rate of surgery was evaluated by the Kaplan-Meier analysis. Prognostic factors for the outcomes were also assessed by univariate and multivariate analyses. RESULTS A total of 93 Crohn's disease cases were included in the study with a mean follow-up period of 1452.8 days. Fistula locations were entero-entero/colonic (n = 72, 77.4%), enterovesical (n = 16, 17.2%), or enterovaginal (n = 5, 5.4%). Cumulative surgery rate was 47.2%, and fistula closure rate was 27.0% at 5 years from the induction of anti-TNF agents. Lower Crohn's Disease Activity Index and shorter duration from the diagnosis of fistula were independently associated with the lower risk of surgery (P = 0.017 and 0.048, respectively). Single fistula was associated with the successful fistula closure. Second-line surgical treatments were mostly successful for anti-TNF failures. CONCLUSIONS In the present retrospective cohort study, approximately half of patients with internal fistulas avoided surgery for long periods. It may be reasonable to treat quiescent single internal fistulas with anti-TNF agents soon after the diagnosis of internal fistulas.
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12
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Chalhoub JM, Rimmani HH, Gumaste VV, Sharara AI. Systematic Review and Meta-analysis: Adalimumab Monotherapy Versus Combination Therapy with Immunomodulators for Induction and Maintenance of Remission and Response in Patients with Crohn's Disease. Inflamm Bowel Dis 2017; 23:1316-1327. [PMID: 28719541 DOI: 10.1097/mib.0000000000001203] [Citation(s) in RCA: 33] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
BACKGROUND It is unclear whether the combination of adalimumab (ADA) and immunomodulators is superior to ADA monotherapy in patients with Crohn's disease. METHODS PubMed, Medline, Embase, Web of Science, and other databases were searched. Randomized controlled trials, open-label, prospective cohort, and retrospective studies, and pooled analyses were included. Primary outcomes were induction (≤12 wk) and maintenance (up to 56 wk) of remission and response. Secondary outcomes were severe adverse events, opportunistic infections, and development of antibodies to adalimumab. RESULTS Twenty-four of 1194 articles were eligible for inclusion. No significant difference was noted between regimens for induction of remission (odds ratio [OR] 0.86; 95% confidence interval [CI]: 0.70-1.06; P = 0.19) and response (OR 1.01; 95% CI: 0.62-1.65; P = 0.96). Similarly, no difference was noted for maintenance of remission (OR 0.97; 95% CI: 0.79-1.14; P = 0.75) or response (OR 0.91; 95% CI: 0.54-1.54; P = 0.74). Severe adverse events and opportunistic infections were not different between arms. Patients on combination therapy had lower odds of developing antibodies to adalimumab (OR 0.24; 95% CI: 0.07-0.82; P = 0.02). Subgroup and sensitivity analyses showed significantly higher odds of successful induction (OR 1.26; 95% CI: 1.06-1.49, P = 0.008) and opportunistic infections (OR 2.44; 95% CI: 1.07-5.54, P = 0.03) in anti-TNF-experienced patients. CONCLUSIONS The combination of ADA and immunomodulators does not seem superior to ADA monotherapy for induction and maintenance of remission and response in Crohn's disease. Combination therapy is associated with lower immunogenicity. Analyses associating combination therapy with better induction of remission in anti-TNF-experienced patients and a higher rate of opportunistic infections deserve further evaluation.
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Affiliation(s)
- Jean M Chalhoub
- *Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon; and †Division of Gastroenterology, Department of Internal Medicine, Staten Island University Hospital, Northwell Health, New York, New York
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