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Ghosh S, Feagan BG, Parra RS, Lopes S, Steinlauf A, Kakuta Y, Joshi N, Lee WJ, Lacerda AP, Zhou Q, Xuan S, Kligys K, Shukla N, Louis E. Impact of Upadacitinib Induction and Maintenance Therapy on Health-related Quality of Life, Fatigue, and Work Productivity in Patients with Moderately-to-severely Active Crohn's Disease. J Crohns Colitis 2024; 18:1804-1818. [PMID: 38835235 PMCID: PMC11532615 DOI: 10.1093/ecco-jcc/jjae083] [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: 03/11/2024] [Revised: 05/14/2024] [Accepted: 06/03/2024] [Indexed: 06/06/2024]
Abstract
BACKGROUND AND AIMS Quality of life in patients with active Crohn's disease may be significantly reduced. We evaluated the effects of upadacitinib induction and maintenance therapy on fatigue, quality of life, and work productivity in the phase 3 trials U-EXCEL, U-EXCEED, and U-ENDURE. METHODS Clinical responders to upadacitinib 45 mg in U-EXCEL and U-EXCEED induction trials were re-randomised 1:1:1 to upadacitinib 30 mg, 15 mg, or placebo for 52 weeks of maintenance in U-ENDURE. Clinically meaningful improvements in Inflammatory Bowel Disease Questionnaire [IBDQ] response, IBDQ remission, Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-Fatigue], and Work Productivity and Activity Impairment were evaluated. Percentages of patients achieving clinically meaningful improvements were assessed at induction Weeks 4 and 12 and maintenance Week 52. CLINICAL REGISTRATION NUMBER U-EXCEED induction trial [NCT03345836], U-EXCEL induction trial [NCT03345849], U-ENDURE maintenance trial [NCT03345823]. RESULTS Analysis included 1021 and 502 patients assessed at induction and maintenance, respectively. In U-EXCEL, greater improvements [all p ≤ 0.001] in IBDQ response [71.0% vs 50.2%], IBDQ remission [44.2% vs 23.7%], and FACIT-Fatigue [42.0% vs 27.0%] were observed in upadacitinib-treated patients versus placebo at Week 4. Improvements in IBDQ response, IBDQ remission, and FACIT-Fatigue were similar or greater at Week 12. Clinically meaningful improvement in overall work impairment [52.1% vs 38.1%, p ≤ 0.05] was demonstrated at Week 12. Similar results were observed in U-EXCEED. Improvements were sustained through 52 weeks of upadacitinib maintenance treatment. CONCLUSIONS In patients with active Crohn's disease, upadacitinib treatment relative to placebo significantly improved fatigue, quality of life, and work productivity as early as Week 4. These effects were sustained through 52 weeks of maintenance.
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Affiliation(s)
- Subrata Ghosh
- College of Medicine and Health and APC Microbiome Ireland, University College Cork, Cork, Ireland
| | - Brian G Feagan
- Robarts Research Institute, Western University, London, ON, Canada
- Alimentiv Inc., London, ON, Canada
| | | | - Susana Lopes
- Centro Hospitalar e Universitário São João, Porto, Portugal
| | - Adam Steinlauf
- IBD Clinical Center, Mount Sinai Hospital, New York, NY, USA
| | - Yoichi Kakuta
- Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan
| | - Namita Joshi
- Health Economics & Outcomes Research, AbbVie Inc., North Chicago, IL, USA
| | - Wan-Ju Lee
- Health Economics & Outcomes Research, AbbVie Inc., North Chicago, IL, USA
| | - Ana P Lacerda
- Health Economics & Outcomes Research, AbbVie Inc., North Chicago, IL, USA
| | - Qian Zhou
- Health Economics & Outcomes Research, AbbVie Inc., North Chicago, IL, USA
| | - Si Xuan
- Health Economics & Outcomes Research, AbbVie Inc., North Chicago, IL, USA
| | - Kristina Kligys
- Health Economics & Outcomes Research, AbbVie Inc., North Chicago, IL, USA
| | - Nidhi Shukla
- Health Economics & Outcomes Research, AbbVie Inc., North Chicago, IL, USA
| | - Edouard Louis
- Department of Gastroenterology, Centre Hospitalier Universitaire de Liège, Liège, Belgium
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Youssef M, Hossein-Javaheri N, Hoxha T, Mallouk C, Tandon P. Work Productivity Impairment in Persons with Inflammatory Bowel Diseases: A Systematic Review and Meta-analysis. J Crohns Colitis 2024; 18:1486-1504. [PMID: 38647194 PMCID: PMC11369077 DOI: 10.1093/ecco-jcc/jjae057] [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: 02/03/2024] [Revised: 03/23/2024] [Accepted: 04/19/2024] [Indexed: 04/25/2024]
Abstract
BACKGROUND AND AIMS The impact of inflammatory bowel disease [IBD] on work productivity remains unclear. In this systematic review and meta-analysis, we quantify work-related outcomes and employment data among persons with IBD. METHODS A systematic literature search was conducted in MEDLINE, EMBASE, the Cochrane library, Scopus, ProQuest, and clinicaltrials.gov from inception to February 2023, to identify studies on work productivity in persons with IBD aged > 18 years. Work productivity was defined primarily by the Work Productivity and Activity Impairment [WPAI] questionnaire which includes absenteeism, presenteeism, overall work impairment, and non-work activity impairment. In addition, we included data on employment, sick leaves, disability pensions, and indirect costs due to productivity loss. Pooled effect analysis was conducted using a random-effects model for pooled estimates of continuous and proportional data with 95% confidence intervals. RESULTS Among all patients with IBD, the pooled estimates were 16.4% for absenteeism, 35.9% for presenteeism, 39.4% for overall work impairment, and 46.0% for non-work activity impairment. Indirect costs from overall work impairment were 5131.09 euros/patient/year. Only two-thirds of IBD patients were employed, and one in three lost their jobs due to IBD. Among those employed, 39.5% report sick days, 21.3% report work disability, and 12.3% receive disability pensions. Most studies demonstrate clinically meaningful improvements in work productivity with medical and/or surgical therapies. CONCLUSION Persons with IBD experience significant work impairment and associated indirect costs. This highlights the need for appropriate workplace accommodations and timely medical therapy to alleviate the burden of disease and improve work outcomes.
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Affiliation(s)
- Michael Youssef
- Department of Internal Medicine, University of Toronto, Toronto, ON, Canada
| | | | - Tedi Hoxha
- Department of Internal Medicine, University of Toronto, Toronto, ON, Canada
| | | | - Parul Tandon
- Division of Gastroenterology and Hepatology, University Health Network, University of Toronto, Toronto, ON, Canada
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Peyrin-Biroulet L, Ghosh S, Lee SD, Lee WJ, Griffith J, Wallace K, Berg S, Liao X, Panes J, Loftus EV, Louis E. Effect of risankizumab on health-related quality of life in patients with Crohn's disease: results from phase 3 MOTIVATE, ADVANCE and FORTIFY clinical trials. Aliment Pharmacol Ther 2023; 57:496-508. [PMID: 36266762 DOI: 10.1111/apt.17242] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/27/2022] [Revised: 05/12/2022] [Accepted: 09/17/2022] [Indexed: 12/09/2022]
Abstract
BACKGROUND Crohn's disease has a substantial negative impact on health-related quality of life (HRQoL). AIM To examine the effects of risankizumab on HRQoL in Crohn's disease METHODS: We analysed data from patients with Crohn's disease from 12-week induction trials ADVANCE (N = 850) and MOTIVATE (N = 569) with risankizumab 600 mg or 1200 mg intravenous (IV) versus placebo IV and a 52-week maintenance trial FORTIFY (N = 462) with risankizumab 180 or 360 mg subcutaneous (SC) versus placebo SC. Outcomes included Inflammatory Bowel Disease Questionnaire (IBDQ), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), 36-item Short Form Health Survey (SF-36), EuroQol 5-Dimension-5-Level (EQ-5D-5L) and work productivity. The mean change and percentages of patients achieving clinically meaningful improvement in all outcomes were determined at weeks 12 and 52. RESULTS At week 12, more patients in the risankizumab 600 or 1200 mg groups achieved IBDQ response than with placebo (ADVANCE: 70.2%, 75.5% vs. 47.8%, p ≤ 0.001; MOTIVATE: 61.7%, 68.5% vs. 48.2%, p ≤ 0.01) and FACIT-F response (ADVANCE: 51.3%, 48.0% vs. 35.7%, p ≤ 0.01; MOTIVATE: 44.2%, 49.1% vs. 33.7%, p < 0.05). These improvements persisted at week 52 with risankizumab maintenance treatment. Similar trends were observed for SF-36 physical and mental component summary scores, EQ-5D-5L and activity impairment within work productivity measures. CONCLUSIONS Risankizumab induction therapy (600 or 1200 mg IV) led to clinically meaningful improvements in disease-specific and general patient-reported outcomes, including fatigue, in patients with moderate to severe Crohn's disease. These improvements were sustained after 52 weeks of risankizumab (180 or 360 mg SC) maintenance therapy.
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Affiliation(s)
- Laurent Peyrin-Biroulet
- Department of Gastroenterology, University of Lorraine, CHRU-Nancy, Nancy, France.,University of Lorraine, Inserm, NGERE, Nancy, France
| | - Subrata Ghosh
- APC Microbiome Ireland, University College Cork, Cork, Ireland
| | - Scott D Lee
- University of Washington, Seattle, Washington, USA
| | - Wan-Ju Lee
- AbbVie Inc., North Chicago, Illinois, USA
| | | | | | - Sofie Berg
- AbbVie Inc., North Chicago, Illinois, USA
| | | | - Julian Panes
- Hospital Clínic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain
| | - Edward V Loftus
- Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA
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Zhang W, Tocher P, L'Heureux J, Sou J, Sun H. Measuring, Analyzing, and Presenting Work Productivity Loss in Randomized Controlled Trials: A Scoping Review. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2023; 26:123-137. [PMID: 35961865 DOI: 10.1016/j.jval.2022.06.015] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/04/2021] [Revised: 05/14/2022] [Accepted: 06/08/2022] [Indexed: 06/15/2023]
Abstract
OBJECTIVES This study aimed to conduct a scoping review of randomized controlled trials (RCTs) and investigate which work productivity loss outcomes were measured in these RCTs, how each outcome was measured and analyzed, and how the results for each outcome were presented. METHODS A systematic search was conducted from January 2010 to April 2020 from 2 databases: PubMed and Cochrane Central Register of Controlled Trials. Data on country, study population, disease focus, sample size, work productivity loss outcomes measured (absenteeism, presenteeism, employment status changes), and methods used to measure, report, and analyze each work productivity loss outcome were extracted and analyzed. RESULTS We found 435 studies measuring absenteeism or presenteeism, of which 155 studies (35.6%) measured both absenteeism and presenteeism and were included in our final review. Only 9 studies also measured employment status changes. The most used questionnaire was the Work Productivity and Activity Impairment Questionnaire. The analysis of absenteeism and presenteeism data was mostly done using regression models (n = 98, n = 98, respectively) for which a normal distribution was assumed (n = 77, n = 89, respectively). Absenteeism results were most often presented in time whereas presenteeism was commonly presented using a percent scale or score. CONCLUSIONS There is a lack of consensus on how to measure, analyze, and present work productivity loss outcomes in RCTs published in the past 10 years. The diversity of measurement, analysis, and presentation methods used in RCTs may make comparability challenging. There is a need for guidelines providing recommendations to standardize the comprehensiveness and the appropriateness of methods used to measure, analyze, and report work productivity loss in RCTs.
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Affiliation(s)
- Wei Zhang
- School of Population and Public Health, The University of British Columbia, Vancouver, BC, Canada; Centre for Health Evaluation and Outcome Sciences, Vancouver, BC, Canada.
| | - Paige Tocher
- Centre for Health Evaluation and Outcome Sciences, Vancouver, BC, Canada
| | - Jacynthe L'Heureux
- School of Population and Public Health, The University of British Columbia, Vancouver, BC, Canada
| | - Julie Sou
- Centre for Health Evaluation and Outcome Sciences, Vancouver, BC, Canada
| | - Huiying Sun
- Centre for Health Evaluation and Outcome Sciences, Vancouver, BC, Canada
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Okabayashi S, Yamazaki H, Yamamoto R, Anan K, Matsuoka K, Kobayashi T, Shinzaki S, Honzawa Y, Kataoka Y, Tsujimoto Y, Watanabe N. Certolizumab pegol for maintenance of medically induced remission in Crohn's disease. Cochrane Database Syst Rev 2022; 6:CD013747. [PMID: 35771590 PMCID: PMC9246061 DOI: 10.1002/14651858.cd013747.pub2] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Abstract
BACKGROUND Crohn's disease (CD) is a disease with an impaired immune response characterized by chronic, relapsing-remitting, and progressive inflammation mainly affecting the gastrointestinal tract. Certolizumab pegol (CZP) is a biological agent that regulates the impaired immune response by controlling tumour necrosis factor-α (TNFα). However, the efficacy and safety of long-term administration of CZP for people with CD with inflammation under control are not well understood. OBJECTIVES To assess the efficacy and safety of CZP for maintenance of remission in people with CD. SEARCH METHODS We searched CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, WHO ICTRP, and conference abstracts from inception to 23 March 2022. We contacted pharmaceutical companies involved with the production of CZP for further relevant information. SELECTION CRITERIA We included randomized controlled trials (RCTs) comparing CZP with placebo in adults with CD. DATA COLLECTION AND ANALYSIS Two review authors independently selected studies and extracted data. The main outcomes were failure to maintain clinical remission at week 26, failure to maintain clinical response at week 26, and serious adverse events. We planned to perform meta-analyses including all available studies if similar enough for pooling to be appropriate and calculated risk ratios (RRs) with 95% confidence intervals (CIs) for dichotomous outcomes and mean differences with 95% CIs for continuous outcomes. We analyzed the number needed to treat for an additional beneficial outcome (NNTB) and the number needed to treat for an additional harmful outcome (NNTH) to indicate the magnitude of treatment effects. The same two review authors independently evaluated the risk of bias by using the Cochrane RoB 2 tool and evaluated the certainty of evidence using the GRADE framework. MAIN RESULTS We identified one study meeting our prespecified eligibility criteria. The included study enrolled 428 adults with CD who responded to induction therapy with CZP 400 mg at weeks 0, 2, and 4. The study evaluated long-term efficacy and safety of CZP administered subcutaneously every four weeks compared with placebo. The proportion of participants who failed to maintain clinical remission at week 26 was 52.3% (113/216) in the CZP group compared to 71.7% (152/212) in the placebo group. Treatment of CZP probably results in a large reduction in failure to maintain clinical remission at week 26 (RR 0.73, 95% CI 0.63 to 0.85). The NNTB was 5 (95% CI 4 to 9). We judged this outcome at low risk of bias. Using the GRADE assessment, we judged the certainty of evidence as moderate due to the low number of events occurred. The proportion of participants who failed to maintain clinical response at week 26 was 37.5% (81/216) in the CZP group compared to 64.2% (136/212) in the placebo group. Treatment of CZP probably results in a large reduction in failure to maintain clinical response at week 26 (RR 0.58, 95% CI 0.48 to 0.71). The NNTB was 4 (95% CI 3 to 5). We judged this outcome at low risk of bias. Using the GRADE assessment, we judged the certainty of evidence as moderate due to the low number of events occurred. The proportion of participants who developed serious adverse events was 5.6% (12/216) in the CZP group compared to 6.6% (14/212) in the placebo group. Treatment of CZP may lead to no difference in serious adverse events compared to placebo when used as a remission maintenance treatment (RR 0.84, 95% CI 0.40 to 1.78). The NNTB was 95 (95% CI NNTH 19 to NNTB 25). We evaluated the risk of bias for this outcome as low. We evaluated the certainty of evidence as low due to the low number of events occurred and the CIs were not sufficiently narrow. AUTHORS' CONCLUSIONS CZP probably results in a large reduction in failure to maintain clinical remission and response at week 26 in people with CD. The evidence suggests that CZP may lead to no difference in serious adverse events compared to placebo when used as a remission maintenance treatment. However, the current studies are limited to 26 weeks of follow-up and only included adults. Therefore, these conclusions cannot be used to guide longer term treatment or for treatment in children at present.
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Affiliation(s)
- Shinji Okabayashi
- Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Hajime Yamazaki
- Department of Healthcare Epidemiology, Department of Community Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Ryohei Yamamoto
- Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Keisuke Anan
- Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Katsuyoshi Matsuoka
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Sakura Medical Center, Chiba, Japan
| | - Taku Kobayashi
- Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan
| | - Shinichiro Shinzaki
- Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Japan
| | - Yusuke Honzawa
- Department of Gastroenterology and Hepatology, Kyoto University Hospital, Kyoto, Japan
| | - Yuki Kataoka
- Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Hyogo, Japan
| | - Yasushi Tsujimoto
- Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Norio Watanabe
- Department of Health Promotion and Human Behavior, Kyoto University School of Public Health, Kyoto, Japan
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van Linschoten RCA, van Leeuwen N, Nieboer D, Birnie E, Scherpenzeel M, Verweij KE, de Jonge V, Hazelzet JA, van der Woude CJ, West RL, van Noord D. Value-based care pathway for inflammatory bowel disease: a protocol for the multicentre longitudinal non-randomised parallel cluster IBD Value study with baseline period. BMJ Open 2022; 12:e050539. [PMID: 35022169 PMCID: PMC8756277 DOI: 10.1136/bmjopen-2021-050539] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/10/2022] Open
Abstract
INTRODUCTION Biologics are effective for the treatment of inflammatory bowel disease (IBD). However, unwarranted variation in processes and outcomes has been reported in the treatment of IBD. A care pathway for the treatment of IBD has the potential to reduce practice variation and improve outcomes. This study aims to compare the effect of a uniform care pathway for the treatment of patients with IBD with biologics to the current situation. METHODS AND ANALYSIS IBD Value is a longitudinal multicentre non-randomised parallel cluster trial with a baseline period. The study takes place in eight centres in the Netherlands. The baseline period will run for 12 months, after which the care pathway will be implemented in 6 of the 8 participating hospitals during the implementation phase of 3 months. Hereafter, the effect of the care pathway will be assessed for 12 months. Total study period is 27 months. The primary outcome is the effect of the care pathway on disease control (IBD-Control questionnaire). Secondary outcomes are the effect of the care pathway on the other outcomes of the International Consortium of Health Outcomes Measurement IBD standard set, health-related generic quality of life, patient experiences and degree of variation; cost effectiveness of the care pathway; and the variation between hospitals in the aforementioned outcomes in the baseline period. Outcomes will be measured every 6 months. The study started on 1 December 2020 and a minimum of 200 patients will be included. ETHICS AND DISSEMINATION The study was deemed not to be subject to Dutch law (WMO; Medical Research Involving Human Subjects Act) by the Medical Ethics Committee of the Erasmus MC, the Netherlands (registration number: MEC-2020-075) and a waiver was provided. Results will be disseminated through peer-reviewed journals and presented at (inter)national conferences. TRIAL REGISTRATION NUMBER NL8276.
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Affiliation(s)
- Reinier Cornelis Anthonius van Linschoten
- Department of Gastroenterology and Hepatology, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands
- Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands
| | - Nikki van Leeuwen
- Department of Public Health, Erasmus Medical Center, Rotterdam, The Netherlands
| | - Daan Nieboer
- Department of Public Health, Erasmus Medical Center, Rotterdam, The Netherlands
| | - Erwin Birnie
- Department of Statistics and Education, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands
- Department of Genetics, University of Groningen, Groningen, The Netherlands
| | | | - Karen Evelyne Verweij
- Department of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, The Netherlands
| | - Vincent de Jonge
- Department of Gastroenterology and Hepatology, Albert Schweitzer Ziekenhuis, Dordrecht, The Netherlands
| | | | - C Janneke van der Woude
- Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands
| | - Rachel Louise West
- Department of Gastroenterology and Hepatology, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands
| | - Desirée van Noord
- Department of Gastroenterology and Hepatology, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands
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Lechner-Scott J, Reeves P, Ribbons K, Saugbjerg B, Lea R. Do people with multiple sclerosis receive appropriate support from the National Disability Insurance Scheme matching their level of disability? A description of disease 'burden and societal cost in people with multiple sclerosis in Australia. AUST HEALTH REV 2021; 45:745-752. [PMID: 34543604 DOI: 10.1071/ah21056] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/19/2021] [Accepted: 05/24/2021] [Indexed: 11/23/2022]
Abstract
ObjectiveThis study is the first to assess if the National Disability Insurance Scheme (NDIS) package allocated to people with multiple sclerosis (pwMS) is correlated with the disability level measured by standardised neurological assessment.MethodsWe aimed to recruit 10 pwMS per expanded disability status score (EDSS) step, including EDSS 0 (no disability) up to 9 (bedridden), and requested information about their NDIS application. Value of their packages was compared with mobility, cognition and psychological impact.ResultsOut of 186 pwMS, only 49% of all patients had an NDIS package approved. The mean values of the annual allowance were AU$30318 for patients with mild disability, AU$38361 for moderate disability and AU$115113 for severe disability. There was a striking variability in packages approved, but restricted mobility seems to be the driving factor. Rejection rates were <20% in patients with mild and moderate disability and none in those with severe disability. The package value correlated with EDSS steps, cognitive impairment and physical impact, but not psychological impact.ConclusionsThis is the first study to assess if NDIS packages correlate with internationally accepted disability scales. The NDIS support was correlated with disability measured by EDSS steps and cognition, but not psychological impact of the disease.What is known about the topic?There are over 25000 Australians living with multiple sclerosis, which is one of the most common neurological diseases leading to disability in early age. The National Disability Insurance Scheme has been introduced since 2013 to particularly assist young disabled Australians to participate in the community. Whether the approved package correlates with internationally accepted disability scores has not yet been assessed.What does this paper add?This study is the first to correlate disability, as assessed by the Expanded Disability Severity Scale (EDSS), with the approved package value.What are the implications for practitioners?Multiple sclerosis is a very variable disease affecting quality of life not only due to impairment of mobility, but also cognition and mental health. Although the NDIS package value was correlated with an EDSS and cognition, the psychological impact of the disease is often neglected.
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Affiliation(s)
- Jeannette Lechner-Scott
- John Hunter Hospital, Department of Neurology, New Lambton Heights, NSW 2305, Australia; and Hunter Medical Research Institute, University of Newcastle, New Lambton Heights, NSW 2305, Australia. ; ; ; ; and Corresponding author.
| | - Penny Reeves
- Hunter Medical Research Institute, University of Newcastle, New Lambton Heights, NSW 2305, Australia. ; ; ;
| | - Karen Ribbons
- Hunter Medical Research Institute, University of Newcastle, New Lambton Heights, NSW 2305, Australia. ; ; ;
| | - Bente Saugbjerg
- Hunter Medical Research Institute, University of Newcastle, New Lambton Heights, NSW 2305, Australia. ; ; ;
| | - Rodney Lea
- Hunter Medical Research Institute, University of Newcastle, New Lambton Heights, NSW 2305, Australia. ; ; ; ; and Queensland University of Technology, Brisbane, Qld 4000, Australia
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van Linschoten RCA, Visser E, Niehot CD, van der Woude CJ, Hazelzet JA, van Noord D, West RL. Systematic review: societal cost of illness of inflammatory bowel disease is increasing due to biologics and varies between continents. Aliment Pharmacol Ther 2021; 54:234-248. [PMID: 34114667 PMCID: PMC8361769 DOI: 10.1111/apt.16445] [Citation(s) in RCA: 56] [Impact Index Per Article: 14.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/05/2021] [Revised: 03/24/2021] [Accepted: 05/10/2021] [Indexed: 12/13/2022]
Abstract
BACKGROUND Knowledge of the cost of illness of inflammatory bowel disease (IBD) is essential for health policy makers worldwide. AIM To assess the cost of illness of IBD from the societal perspective taking into account time trends and geographical differences. METHODS A systematic review of all population-based studies on cost of illness of IBD published in Embase, Medline, Web of Science and Google Scholar. Methodology of included studies was assessed and costs were adjusted to 2018 US dollars. RESULTS Study methodologies differed considerably, with large differences in perspective, valuation method and population. For prevalent Crohn's disease (CD) cases in the last ten years annual healthcare costs were in Asia $4417 (range $1230-$31 161); Europe $12 439 ($7694-$15 807) and North America $17 495 ($14 454-$20 535). For ulcerative colitis (UC), these were $1606 ($309-$14 572), $7224 ($3228-$9779) and $13 559 ($13 559-$13 559). The main cost driver was medication, the cost of which increased considerably between 1985 and 2018, while outpatient and inpatient costs remained stable. IBD had a negative impact on work productivity. Annual costs of absenteeism for CD and UC were in Asia (with presenteeism) $5638 ($5638-$5638) and $4828 ($4828-$4828); Europe $2660 ($641-$5277) and $2394 ($651-$5992); North America $752 ($307-$1303) and $1443 ($85-$2350). CONCLUSION IBD societal cost of illness is increasing, driven by growing costs of medication, and varies considerably between continents. While biologic therapy was expected to decrease inpatient costs by reducing hospitalisations and surgery, these costs have not declined.
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Affiliation(s)
- Reinier Cornelis Anthonius van Linschoten
- Department of Gastroenterology & HepatologyFranciscus Gasthuis & VlietlandRotterdamthe Netherlands,Department of Gastroenterology & HepatologyErasmus Medical CenterRotterdamthe Netherlands
| | - Elyke Visser
- Department of Gastroenterology & HepatologyFranciscus Gasthuis & VlietlandRotterdamthe Netherlands
| | | | | | | | - Desirée van Noord
- Department of Gastroenterology & HepatologyFranciscus Gasthuis & VlietlandRotterdamthe Netherlands
| | - Rachel Louise West
- Department of Gastroenterology & HepatologyFranciscus Gasthuis & VlietlandRotterdamthe Netherlands
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Everhov ÅH, Sachs MC, Ludvigsson JF, Khalili H, Askling J, Neovius M, Myrelid P, Halfvarson J, Nordenvall C, Söderling J, Olén O. Work Loss in Relation to Pharmacological and Surgical Treatment for Crohn's Disease: A Population-Based Cohort Study. Clin Epidemiol 2020; 12:273-285. [PMID: 32210631 PMCID: PMC7073449 DOI: 10.2147/clep.s244011] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/28/2019] [Accepted: 02/18/2020] [Indexed: 12/25/2022] Open
Abstract
Purpose Patients with Crohn’s disease have increased work loss. We aimed to describe changes in work ability in relation to pharmacological and surgical treatments. Patients and Methods We linked data from the Swedish National Patient Register, The Swedish Quality Register for Inflammatory Bowel Disease SWIBREG, The Prescribed Drug Register, The Longitudinal Integrated Database for Health Insurance and Labour Market Studies, and the Social Insurance Database. We identified working-age (19–59 years) patients with incident Crohn’s disease 2006–2013 and population comparator subjects matched by sex, birth year, region, and education level. We assessed the number of lost workdays due to sick leave and disability pension before and after treatments. Results Of 3956 patients (median age 34 years, 51% women), 39% were treated with aminosalicylates, 52% with immunomodulators, 22% with TNF inhibitors, and 18% with intestinal surgery during a median follow-up of 5.3 years. Most patients had no work loss during the study period (median=0 days). For all treatments, the mean number of lost workdays increased during the months before treatment initiation, peaked during the first month of treatment and decreased thereafter, and was heavily influenced by sociodemographic factors and amount of work loss before first Crohn’s disease diagnosis. The mean increase in work loss days compared to pre-therapeutic level was ~3 days during the first month of treatment for all pharmacological therapies and 11 days for intestinal surgery. Three months after treatment initiation, 88% of patients treated surgically and 90–92% of patients treated pharmacologically had the same amount of work loss as before treatment start. Median time to return to work was 2 months for all treatments. Conclusion In this regular clinical setting, patients treated surgically had more lost workdays than patients treated pharmacologically, but return to work was similar between all treatments.
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Affiliation(s)
- Åsa H Everhov
- Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.,Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden
| | - Michael C Sachs
- Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden
| | - Jonas F Ludvigsson
- Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.,Department of Pediatrics, Örebro University Hospital, Örebro University, Örebro, Sweden
| | - Hamed Khalili
- Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.,Gastroenterology Unit, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
| | - Johan Askling
- Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden
| | - Martin Neovius
- Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden
| | - Pär Myrelid
- Division of Surgery, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Linköping, Sweden.,Department of Surgery, County Council of Östergötland Linköping, Linköping, Sweden
| | - Jonas Halfvarson
- Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
| | - Caroline Nordenvall
- Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.,Center for Digestive Disease, Division of Coloproctology, Karolinska University Hospital, Stockholm, Sweden
| | - Jonas Söderling
- Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden
| | - Ola Olén
- Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.,Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.,Department of Pediatric Gastroenterology and Nutrition, Sachs' Children and Youth Hospital, Stockholm, Sweden
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10
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Le Berre C, Peyrin-Biroulet L, Buisson A, Olympie A, Ravel MH, Bienenfeld C, Gonzalez F. Impact of inflammatory bowel diseases on working life: A French nationwide survey. Dig Liver Dis 2019; 51:961-966. [PMID: 30826278 DOI: 10.1016/j.dld.2019.01.024] [Citation(s) in RCA: 24] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/01/2018] [Revised: 01/10/2019] [Accepted: 01/26/2019] [Indexed: 12/11/2022]
Abstract
BACKGROUND Inflammatory bowel diseases (IBD) affect working-age patients. Data was lacking concerning the impact on working life. AIMS The French IBD patient association conducted a nationwide survey to assess the burden of IBD at work. METHODS An online survey was performed in 2016, targeting IBD patients working or having worked previously. The results were compared to those observed in the general population. RESULTS Data from 1410 IBD patients were analyzed (62% Crohn's disease, 35% ulcerative colitis). Four-fifth of respondents were actively employed. Half of them stated that working with IBD was a problem. Compared to the general population, IBD employees had higher rates of permanent contracts, public employment but also of part-time contracts, and highly graduated patients were less likely to reach high qualified jobs. Among the disabling symptoms at work, fatigue was the most frequent (41%) followed by diarrhea (25%) and fecal incontinence (18%). Despite these difficulties, 76% were satisfied with their job. Most patients shared their IBD diagnosis with their colleagues, but 25% of them regretted it. CONCLUSION IBD has a strong negative impact on working life. While work satisfaction remains high, IBD affects career plans, highlighting the need for supporting measures to improve patients' work experience.
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Affiliation(s)
- Catherine Le Berre
- Department of Gastroenterology, Nantes University Hospital, Nantes, France; Inserm U954 and Department of Gastroenterology, Nancy University Hospital, Lorraine University, Vandoeuvre-lès-Nancy, France
| | - Laurent Peyrin-Biroulet
- Inserm U954 and Department of Gastroenterology, Nancy University Hospital, Lorraine University, Vandoeuvre-lès-Nancy, France.
| | | | | | | | | | - Florent Gonzalez
- Department of Gastroenterology, Grand-Sud Polyclinic, Nîmes, France
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11
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Armuzzi A, Riegler G, Furfaro F, Baldoni M, Costa F, Fortuna M, Iaquinto G, Paese P, Papi C, Bossa F, Tontini GE, Di Fino S, Gualberti G, Merolla R, Rizzello F. Epidemiological features and disease-related concerns of a large cohort of Italian patients with active Crohn's disease. Dig Liver Dis 2019; 51:804-811. [PMID: 30685416 DOI: 10.1016/j.dld.2018.12.019] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/20/2018] [Revised: 12/13/2018] [Accepted: 12/22/2018] [Indexed: 12/11/2022]
Abstract
BACKGROUND-AIMS The SOLE study was conducted on a large cohort of Italian patients with moderate-severe Crohn's disease (CD) to assess epidemiological and disease characteristics and their correlation with disease-related worries, treatment satisfaction and adherence, workability. METHODS The following tools were used over 12 months to assess: Results were correlated with demographic and clinical variables with linear regression models. RESULTS 552 patients with active CD (51% men) were recruited. Higher worries were having an ostomy bag and undergoing surgery. Variables associated with a higher RFIPC score included female sex, higher disease activity, lower treatment adherence (p < 0.001), previous surgical treatments (p = 0.003). 60% of patients claimed difficulties with activities of daily living. Lower VAS scores were reported by patients with disease duration >6years; treatment satisfaction/adherence was higher with anti-TNF-α treatment. Decreased hospitalizations during follow-up and improved workability/daily activities occurred with adalimumab, infliximab, azathioprine (p < 0.001). CONCLUSION Worries included having an ostomy bag, undergoing surgery, developing cancer: conditions significantly associated with worsened disease activity and low treatment adherence. Higher treatment adherence scores/greater workability improvements were observed in patients treated with anti-TNF-α agents.
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Affiliation(s)
- Alessandro Armuzzi
- IBD Unit, "Presidio Columbus" Foundation Hospital "A. Gemelli IRCCS" - Sacro Cuore Catholic University, Rome, Italy.
| | - Gabriele Riegler
- Unit of Gastroenterology - Reference Center for IBD - Second University of Naples, Naples, Italy
| | | | - Monia Baldoni
- Section of Gastroenterology, Hepatology and Digestive Endoscopy of the Department of Medicine, University of Perugia, Perugia, Italy
| | - Francesco Costa
- University Gastroenterology Unit - Pisana University Hospital, Pisa, Italy
| | - Manuela Fortuna
- Center for Rectal-Intestinal Diseases, S. Cuore Don Calabria Hospital, Negrar - Verona, Italy
| | - Gaetano Iaquinto
- Gastroenterology and Digestive Endoscopy, Santa Rita Hospital, Atripalda, Avellino, Italy
| | - Pietro Paese
- Gastroenterology Unit, Cosenza Civil Hospital, Cosenza, Italy
| | | | - Fabrizio Bossa
- Division of Gastroenterology, Foundation "IRCCS Casa Sollievo della Sofferenza", San Giovanni Rotondo - Foggia, Italy
| | - Gian Eugenio Tontini
- Gastroenterology ed Endoscopy Unit, Foundation "IRCCS Ca' Granda Ospedale Maggiore" Hospital, Milan, Italy
| | | | | | | | - Fernando Rizzello
- IBD Unit, University of Bologna, Emilia-Romagna Region IBD Reference Center, S. Orsola-Malpighi Hospital, Bologna, Italy
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12
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Varu A, Wilson FR, Dyrda P, Hazel M, Hutton B, Cameron C. Treatment sequence network meta-analysis in Crohn's disease: a methodological case study. Curr Med Res Opin 2019; 35:733-756. [PMID: 30727745 DOI: 10.1080/03007995.2019.1580094] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/19/2018] [Revised: 02/05/2019] [Accepted: 02/05/2019] [Indexed: 12/18/2022]
Abstract
OBJECTIVE Several biologic therapies are available for the treatment of mild-to-moderate Crohn's disease (CD). This network meta-analysis (NMA) aimed to assess the comparative efficacy of ustekinumab, adalimumab, vedolizumab and infliximab in the maintenance of clinical response and remission after 1 year of treatment. METHODS A systematic literature search was performed to identify relevant randomized controlled trials (RCTs). Key outcomes of interest were clinical response (CD activity index [CDAI] reduction of 100 points; CDAI-100) and remission (CDAI score under 150 points; CDAI < 150). A treatment sequence Bayesian NMA was conducted to account for the re-randomization of patients based on different clinical definitions, the lack of similarity of the common comparator for each trial and the full treatment pathway from the induction phase onwards. RESULTS Thirteen RCTs were identified. Ustekinumab 90 mg q8w was associated with statistically significant improvement in clinical response relative to placebo and vedolizumab 300 mg. For clinical remission, ustekinumab 90 mg q8w was associated with statistically significant improvement relative to placebo and vedolizumab 300 mg q8w. Findings from sub-population analyses had similar results but were not statistically significant. CONCLUSIONS The NMA suggest that ustekinumab is associated with the highest likelihood of reaching response or remission at 1 year compared with placebo, adalimumab and vedolizumab. Results should be interpreted with caution because this is a novel methodology; however, the treatment sequence analysis may be the most methodologically sound analysis to derive estimates of comparative efficacy in CD in the absence of head-to-head evidence.
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Affiliation(s)
- Abhishek Varu
- a Evidence Synthesis , Cornerstone Research Group , Burlington , Ontario , Canada
| | - Florence R Wilson
- a Evidence Synthesis , Cornerstone Research Group , Burlington , Ontario , Canada
| | - Peter Dyrda
- b Janssen Inc., Janssen Canada , Toronto , Ontario , Canada
| | - Maureen Hazel
- b Janssen Inc., Janssen Canada , Toronto , Ontario , Canada
| | - Brian Hutton
- a Evidence Synthesis , Cornerstone Research Group , Burlington , Ontario , Canada
- c Research , Ottawa Hospital Research Institute , Ottawa , Ontario , Canada
- d Public Health and Preventative Medicine , University of Ottawa School of Epidemiology , Ottawa , Ontario , Canada
| | - Chris Cameron
- a Evidence Synthesis , Cornerstone Research Group , Burlington , Ontario , Canada
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13
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Jackson BD, Con D, Gorelik A, Liew D, Knowles S, De Cruz P. Examination of the relationship between disease activity and patient-reported outcome measures in an inflammatory bowel disease cohort. Intern Med J 2019; 48:1234-1241. [PMID: 29663629 DOI: 10.1111/imj.13937] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/16/2018] [Revised: 03/04/2018] [Accepted: 04/09/2018] [Indexed: 12/22/2022]
Abstract
BACKGROUND The extent to which disease activity impacts patient-reported outcomes (PRO) is unclear. AIMS To examine the relationship between disease activity and PRO. METHODS Adult inflammatory bowel disease (IBD) patients attending a tertiary clinic from May to June 2015 were included. Assessment of disease activity (Simple Clinical Colitis Activity Index (SCCAI), Harvey Bradshaw Index (HBI)), IBD knowledge (CCKNOW), medication adherence (MMAS8), psychological distress (Hospital Anxiety and Depression Scale (HADS)), work productivity (WPAI) and quality of life (IBDQ) was performed to investigate any correlations between disease activity and PRO. RESULTS A total of 81 participants was included: 49% female, 57% Crohn disease (CD), 38% ulcerative colitis (UC) and 5% IBD-unclassified, with a median age of 34 years. At least mild levels of depression were present in 21 of 81 (26%) of patients; 37 of 81 (46%) expressed some level of anxiety. A moderate-to-strong correlation was found between disease activity and depression in UC (r = 0.84, P = 0.002) but not in CD (r = 0.53, P = 0.29). Disease activity correlated with: overall work impairment due to health (r = 0.85, P = 0.001), health-related impairment while working (r = 0.76, P = 0.02) and percentage of activity impaired due to health (r = 0.83, P = 0.002) in UC only. CONCLUSIONS Disease activity significantly affects mood and work productivity in patients with UC. Monitoring patients' ability to function and work, rather than minimising disease activity alone, should become a routine part of IBD care.
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Affiliation(s)
- Belinda D Jackson
- Department of Gastroenterology, The Austin Hospital, Melbourne, Victoria, Australia.,Department of Medicine, Austin Academic Centre, The University of Melbourne, Melbourne, Victoria, Australia
| | - Danny Con
- Department of Gastroenterology, The Austin Hospital, Melbourne, Victoria, Australia.,Department of Medicine, Austin Academic Centre, The University of Melbourne, Melbourne, Victoria, Australia
| | - Alexandra Gorelik
- Melbourne EpiCentre, Royal Melbourne Hospital, Melbourne, Victoria, Australia
| | - Danny Liew
- School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
| | - Simon Knowles
- Department of Psychology, Swinburne University of Technology, Melbourne, Victoria, Australia.,Department of Psychiatry, The University of Melbourne, Melbourne, Victoria, Australia
| | - Peter De Cruz
- Department of Gastroenterology, The Austin Hospital, Melbourne, Victoria, Australia.,Department of Medicine, Austin Academic Centre, The University of Melbourne, Melbourne, Victoria, Australia
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14
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Saro C, Ceballos D, Muñoz F, de la Coba C, Aguilar MD, Lázaro P, García-Sánchez V, Hernández M, Barrio J, de Francisco R, Fernández LI, Barreiro-de Acosta M. Clinical status, quality of life, and work productivity in Crohn's disease patients after one year of treatment with adalimumab. REVISTA ESPANOLA DE ENFERMEDADES DIGESTIVAS 2017; 109:122-129. [PMID: 28026199 DOI: 10.17235/reed.2016.4600/2016] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/07/2022]
Abstract
OBJECTIVE Clinical trials have shown the efficacy of adalimumab in Crohn's disease, but the outcome in regular practice remains unknown. The aim of the study was to examine clinical status, quality of life, and work productivity of Crohn's disease patients receiving adalimumab for one year in the context of usual clinical practice. MATERIAL AND METHODS This was a prospective, observational study with a one-year follow-up. After baseline, Crohn's disease patients were evaluated at 1, 3, 6, 9, and 12 months after starting treatment with adalimumab. Outcome variables included: clinical status (measured with CDAI), quality of life (measured with EuroQoL-5D and IBDQ), and work productivity (measured with WPAI questionnaire). These outcome variables were compared using the Student's t test or Wilcoxon test for paired comparison data according to the data distribution. Statistical significance was set at two-sided p < 0.05. RESULTS The sample was composed of 126 patients (age [mean] 39.1 ± [standard deviation] 13.8 years; 51% male). Significant changes were observed during the follow-up period: CDAI decreased from [median] 194 ([25-75 percentiles] 121-269) to 48.2 (10.1-122.0) (p < 0.05); the EuroQoL-5D increased from 0.735 (0.633-0.790) to 0.797 (0.726-1.000) (p < 0.05); the EuroQoL-5D visual analogue scale increased from 50.0 (40-70) to 80.0 (60-90); (p < 0.05) and the IBDQ increased from 56.7 (51.6-61.5) to 67.5 (60.1-73.6) (p < 0.05). The total work productivity impact decreased from 53% to 24% (p < 0.05). CONCLUSIONS In regular practice, adalimumab is clinically effective in the treatment of Crohn's disease patients and results in a significant improvement in quality of life and work productivity.
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Affiliation(s)
| | | | - Fernando Muñoz
- Aparato digestivo, Complejo Asistencial Universitario de Salamanca, España
| | | | | | - Pablo Lázaro
- Advanced Techniques in Health Services Research. Madrid
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15
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Braithwaite GC, Lee MJ, Hind D, Brown SR. Prognostic factors affecting outcomes in fistulating perianal Crohn's disease: a systematic review. Tech Coloproctol 2017. [PMID: 28639073 PMCID: PMC5550543 DOI: 10.1007/s10151-017-1647-3] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
BACKGROUND One in three patients with Crohn's disease will develop a perianal fistulae, and one third of these will achieve long-term healing or closure. A barrier to conducting well-designed clinical trials for these patients is a lack of understanding of prognostic factors. This systematic review sets out to identify factors associated with prognosis of perianal Crohn's fistulae. METHODS This review was registered on the PROSPERO database (CRD42016050316) and conducted in line with PRISMA guidelines along a predefined protocol. English-language studies assessing baseline factors related to outcomes of fistulae treatment in adult patients were included. Searches were performed on MEDLINE and Embase databases. Screening of abstracts and full texts for eligibility was performed prior to extraction of data into predesigned forms. Bias was assessed using the QUIPS tool. RESULTS Searches identified 997 papers. Following removal of duplicates and secondary searches, 923 were screened for inclusion. Forty-seven papers were reviewed at full-text level and 13, 2 of which were randomised trials, were included in the final qualitative review. Two studies reported distribution of Crohn's disease as a prognostic factor for healing. Two studies found that CARD15 mutations decreased response of fistulae to antibiotics. Complexity of fistulae anatomy was implicated in prognosis by 4 studies. CONCLUSIONS This systematic review has identified potential prognostic markers, including genetic factors and disease behaviour. We cannot, however, draw robust conclusions from this heterogeneous group of studies; therefore, we recommend that a prospective cohort study of well-characterised patients with Crohn's perianal fistulae is undertaken.
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Affiliation(s)
| | - M J Lee
- University of Sheffield Medical School, Sheffield, UK. .,Department of General Surgery, Northern General Hospital, Herries Road, Sheffield, S5 7AU, UK.
| | - D Hind
- Clinical Trials Research Unit, University of Sheffield, Sheffield, UK
| | - S R Brown
- Department of General Surgery, Northern General Hospital, Herries Road, Sheffield, S5 7AU, UK.,Clinical Trials Research Unit, University of Sheffield, Sheffield, UK
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16
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Sofia MA, Rubin DT. The Impact of Therapeutic Antibodies on the Management of Digestive Diseases: History, Current Practice, and Future Directions. Dig Dis Sci 2017; 62:833-842. [PMID: 28197743 DOI: 10.1007/s10620-017-4479-0] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
The development of therapeutic antibodies represents a revolutionary change in medical therapy for digestive diseases. Beginning with the initial studies that confirmed the pathogenicity of cytokines in inflammatory bowel disease, the development and application of therapeutic antibodies brought challenges and insights into their potential and optimal use. Infliximab was the first biological drug approved for use in Crohn's disease and ulcerative colitis. The lessons learned from infliximab include the importance of immunogenicity and the influence of pharmacokinetics on disease response and outcomes. Building on this foundation, other therapeutic antibodies achieved approval for inflammatory bowel disease and many more are in development for several digestive diseases. In this review, we reflect on the history of therapeutic antibodies and discuss current practice and future directions for the field.
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Affiliation(s)
- M Anthony Sofia
- Inflammatory Bowel Disease Center, University of Chicago Medicine, 5841 South Maryland Avenue, MC 4076, Chicago, IL, 60637, USA.
| | - David T Rubin
- Inflammatory Bowel Disease Center, University of Chicago Medicine, 5841 South Maryland Avenue, MC 4076, Chicago, IL, 60637, USA
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Abstract
Certolizumab pegol (Cimzia®) is a subcutaneously administered polyethylene glycolylated (PEGylated) antigen-binding fragment of a recombinant human monoclonal antibody that selectively neutralizes TNFα. The drug is indicated for a variety of inflammatory autoimmune diseases, including Crohn's disease (CD), rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), based on its benefit in these settings in well-designed clinical trials. In these studies, certolizumab pegol (as first- or subsequent-line therapy) reduced the severity of CD when used as an induction or maintenance therapy, and improved the signs/symptoms and slowed the radiographic progression of RA (with or without concomitant methotrexate), PsA and axSpA. Certolizumab pegol is generally well tolerated, with upper respiratory tract infections, rash and urinary tract infections being among the most frequent adverse reactions. Thus, certolizumab pegol is an effective option for the management of these autoimmune diseases.
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Affiliation(s)
- Emma D Deeks
- Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
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18
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Health-Related Quality of Life Impairment and Indirect Cost of Crohn's Disease: A Self-Report Study in Poland. PLoS One 2016; 11:e0168586. [PMID: 27992531 PMCID: PMC5161376 DOI: 10.1371/journal.pone.0168586] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/23/2016] [Accepted: 12/02/2016] [Indexed: 12/16/2022] Open
Abstract
BACKGROUND AND AIMS Evidence on indirect cost of Crohn's disease (CD) is available but typically provides information on the loss of productivity at paid work of patients. In the present study, the quality of life and indirect costs of CD patients were assessed (overall and by disease severity). METHODS A self-report questionnaire-based study among adult Polish patients with CD was performed. We collected data on patients' characteristics, quality of life, loss of productivity, consumption of medical resources, and out-of-pocket expenses. The disease severity was determined using the patient's version of the Harvey-Bradshaw index. Productivity costs were assessed from the social perspective, using a human capital approach. The cost of absenteeism, presenteeism and permanent work disability was valuated using the gross domestic product per worker. The patients' productivity loss at unpaid work was measured by time inputs of others to assist patients. The productivity loss among informal caregivers and patients' productivity loss at unpaid work were valuated with the average wage in Poland. The results were adjusted for confounders. RESULTS The responses from 200 patients (47% in remission) were analysed. The mean utility index was 0.839 (SD 0.171). The total indirect cost was estimated at €462.47 per patient per month (24.0%, absenteeism; 35.0%, work disability; 30.4%, presenteeism; 0.4%, productivity loss at unpaid work; and 10.4%, informal care). A significant correlation of the quality of life and productivity losses with disease severity was observed. Compared with active disease, the remission subgroup had a higher utility index by 16% (p<0.001) and lower indirect costs by 71% (p = 0.003) for absenteeism, 41% (p = 0.030) for presenteeism, 76% (p<0.001) for productivity loss at unpaid work, and 75% (p<0.001) for informal care. CONCLUSIONS Our study revealed the social burden of CD and high dependency of indirect costs and quality of life on the severity of CD in Poland.
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Tundia N, Kotze PG, Rojas Serrano J, Mendes de Abreu M, Skup M, Macaulay D, Signorovitch J, Chaves L, Chao J, Bao Y. Economic impact of expanded use of biologic therapy for the treatment of rheumatoid arthritis and Crohn's disease in Argentina, Brazil, Colombia, and Mexico. J Med Econ 2016; 19:1187-1199. [PMID: 27376404 DOI: 10.1080/13696998.2016.1209508] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
OBJECTIVES To estimate economic impact resulting from increased biologics use for treatment of rheumatoid arthritis (RA) and Crohn's disease (CD) in Argentina, Brazil, Colombia, and Mexico. METHODS The influence of increasing biologics use for treatment of RA during 2012-2022 and for treatment of CD during 2013-2023 was modeled from a societal perspective. The economic model incorporated current and projected medical, indirect, and drug costs and epidemiologic and economic factors. Costs associated with expanded biologics use for RA were compared with non-expanded use in Argentina, Brazil, Colombia, and Mexico. A similar analysis was conducted for CD in Brazil, Colombia, and Mexico. RESULTS Accounting for additional costs of biologics and medical and indirect cost offsets, the model predicts that expanded use of biologics for patients with RA from 2012 to 2022 will result in cumulative net cost savings of ARS$2.351 billion in Argentina, R$9.004 billion in Brazil, COP$728.577 billion in Colombia, and MXN$18.02 billion in Mexico; expanded use of biologics for patients with CD from 2013 to 2023 will result in cumulative net cost savings for patients with CD of R$0.082 billion in Brazil, COP$502.74 billion in Colombia, and MXN$1.80 billion in Mexico. Indirect cost offsets associated with expanded biologics use were a key driver in reducing annual per-patient net costs for RA and CD. LIMITATIONS Future economic projections are limited by the potential variance between projected and actual future values of biologic prices, wages, medical costs, and gross national product for each country. CONCLUSIONS Increasing biologics use to treat RA and CD may limit cost growth over time by reducing medical and indirect costs. These findings may inform policy decisions regarding biologics use in Argentina, Brazil, Colombia, and Mexico.
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Affiliation(s)
| | | | | | | | | | | | | | | | | | - Yanjun Bao
- a AbbVie Inc. , North Chicago , IL , USA
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20
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Costs of Crohn's Disease According to Severity States in France: A Prospective Observational Study and Statistical Modeling over 10 Years. Inflamm Bowel Dis 2016; 22:2924-2932. [PMID: 27846194 DOI: 10.1097/mib.0000000000000967] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/26/2023]
Abstract
BACKGROUND To describe the medico-economic characteristics of Crohn's disease (CD), we implemented a multicenter study in France. METHODS From 2004 to 2006, disease severity states, direct (hospital and extra hospital) and indirect costs were prospectively collected over 1 year in patients with CD naive from anti-tumor necrosis factor alpha (infliximab) at inclusion. Economic valorization was performed from the French Social Insurance perspective, and a statistical modeling over 10 years was performed. RESULTS In 341 patients, the mean total costs of management were &OV0556;6024 per year (&OV0556;4675 for direct costs). As compared to patients in remission, costs were 4 to 6 times higher in patients in an active period and 19 times higher for patients requiring surgery (SURG). The most important expense items were medical and surgical hospitalizations (56% of total costs), including cost of infliximab (36% of hospitalization costs, i.e., 20% of total costs), indirect costs (22%), and drugs (11%). The statistical modeling over 10 years showed that most of the clinical course was spent in drug-responsive state (54%) with 26% of costs or in remission (32%) with 11% of costs; time spent in a SURG state was small (3.2%) but generated 48% of total costs. CONCLUSIONS Before the introduction of self-injectable anti-tumor necrosis factor alpha, the most important expenses were supported by hospitalizations, explaining why the most costly states were for patients requiring SURG or dependent on inhospital administrated drugs. Projected data show that most time is spent in a stabilized state with appropriate treatments or in remission, and that costs associated with SURG are high.
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Song YD, Liu SX, Zhong YQ. Biological agents for treatment of inflammatory bowel disease: Research progress and associated risks. Shijie Huaren Xiaohua Zazhi 2016; 24:2964-2973. [DOI: 10.11569/wcjd.v24.i19.2964] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
Inflammatory bowel disease (IBD) is a group of chronic inflammatory gastrointestinal diseases with unknown etiology, which makes it difficult to reach an ideal treatment. Fortunately, with advances in the research of pathogenesis of IBD, several biological agents aiming diverse targets have been developed, bringing good news to patients with IBD. However, these new drugs carry some new risks, which should draw the attention of clinicians. The following review discusses the research progress in biological agents utilized in IBD and the related risks, with an aim to offer a new direction for the clinical treatment of IBD in the future.
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Steenholdt C, Brynskov J, Thomsen OØ, Munck LK, Christensen LA, Pedersen G, Kjeldsen J, Ainsworth MA. Implications of Infliximab Treatment Failure and Influence of Personalized Treatment on Patient-reported Health-related Quality of Life and Productivity Outcomes in Crohn's Disease. J Crohns Colitis 2015; 9:1032-42. [PMID: 26245216 DOI: 10.1093/ecco-jcc/jjv139] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/13/2015] [Accepted: 07/18/2015] [Indexed: 12/21/2022]
Abstract
BACKGROUND This study assessed the effects of infliximab (IFX) treatment failure on patient-reported outcomes and explored the influence of using personalized treatment in this situation. METHODS Sixty-nine Crohn's disease patients with IFX treatment failure were randomized to an intensified IFX regimen (n = 36) or personalized treatment defined by IFX and anti-IFX antibodies (n = 33). Health-related quality of life evaluated with the Short Inflammatory Bowel Disease Questionnaire (IBDQ) and productivity evaluated with the Work Productivity and Activity Impairment Questionnaire (WPAI:CD) were assessed at treatment failure and after 4, 8, 12 and 20 weeks. RESULTS Median IBDQ score at manifestation of IFX treatment failure was 40 and improved markedly in responders by 11 at weeks 4 and 8 (p < 0.001) and by 13 at weeks 12 and 20 (p < 0.001). Non-responders improved modestly at weeks 12 and 20 (increase of median 4, p < 0.05). Overall activity impairment was high at IFX failure (median 70%) and decreased substantially in responders (40-50%, p < 0.001) and to a lesser extent in non-responders (15-40%, p < 0.05). In employed patients (55%), absenteeism was negligible during the entire study period. However, median presenteeism was 40% at manifestation of IFX failure and decreased only among responders across time (decrease 10-30%, p < 0.05). Although anti-tumour necrosis factor (TNF) therapy was discontinued in most patients handled by personalized treatment, IBDQ and WPAI:CD scores were similar in these patients compared with patients routinely dose-intensified on IFX. CONCLUSION Regaining low disease activity after IFX failure is necessary for minimizing patient impairment and indirect disease-related costs. A personalized treatment strategy does not have a negative influence on patient-reported outcomes.
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Affiliation(s)
| | - Jørn Brynskov
- Department of Gastroenterology, Herlev Hospital, Herlev, Denmark
| | - Ole Ø Thomsen
- Department of Gastroenterology, Herlev Hospital, Herlev, Denmark
| | - Lars K Munck
- Department of Medical Gastroenterology, Køge Hospital, Køge, Denmark
| | - Lisbet A Christensen
- Deartment. of Hepatology and Gastroenterology V, Aarhus Hospital, Aarhus, Denmark
| | - Gitte Pedersen
- Department of Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark
| | - Jens Kjeldsen
- Department of Medical Gastroenterology S, Odense Hospital, Odense, Denmark
| | - Mark A Ainsworth
- Department of Gastroenterology, Herlev Hospital, Herlev, Denmark
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Resources Utilization and Costs the Year Before and After Starting Treatment with Adalimumab in Crohn's Disease Patients. Inflamm Bowel Dis 2015; 21:1631-40. [PMID: 25961910 DOI: 10.1097/mib.0000000000000413] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
BACKGROUND This study examines the resources utilization in patients with Crohn's disease (CD) during the year before (Y - 1) and after (Y + 1) starting treatment with adalimumab and the drug's efficiency. METHODS Observational, multicenter, prospective cohort study of patients with CD naive to biological drugs. The proportion of patients with CD Activity Index (CDAI) <150 was considered as the effectiveness variable. Costs considered were direct costs (DC) related to the use of health care resources, and indirect costs (IC) related to sick leave in Y - 1 and Y + 1. Adalimumab efficiency was estimated as the incremental cost/effectiveness ratio. A deterministic sensitivity analysis was performed building 3 scenarios: base case, the least favorable, and the most favorable case for adalimumab. RESULTS In the cohort of 126 patients (50.8% men; age 39.1 ± 13.8 yr), the proportion of patients in remission increased from 34.1% by the end of Y - 1 to 83.3% by the end of Y + 1. Although the DC increase by the use of adalimumab, the use of doctor visits, emergency room visits, laboratory tests, diagnostic examinations, and nonbiological drug treatment were lower (P < 0.05) in Y + 1 than Y - 1. In the base case scenario, considering only DC, the incremental cost/effectiveness ratio was €31,308 and including IC, it was €28,936. In patients with CDAI > 150 at the onset, incremental cost/effectiveness ratio was €20,119 and €18,223, considering DC alone or included IC, respectively. CONCLUSIONS In patients with CD, adalimumab increases pharmacological costs at the expense of biological therapy but reduces the cost of other drugs, the use of health care resources, and IC. Adalimumab efficiency is 30% greater in patients with CDAI > 150.
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Abstract
BACKGROUND Indirect costs associated with impaired productivity at work (presenteeism) due to inflammatory bowel disease (IBD) are a major contributor to health expenditures. Studies estimating indirect costs in the United States did not take presenteeism into account. We aimed to quantify work limitations and presenteeism and its associated costs in an IBD population to generate recommendations to reduce presenteeism and decrease indirect costs. METHODS We performed a prospective study at a tertiary IBD center. During clinic visits, work productivity, work-related problems and adjustments, quality of life, and disease activity were assessed in patients with IBD. Work productivity and impairment were assessed in a control population as well. Indirect costs associated with lost work hours (absenteeism) and presenteeism were estimated, as well as the effect of disease activity on those costs. RESULTS Of the 440 included patients with IBD, 35.6% were unemployed. Significantly more presenteeism was detected in patients with IBD (62.9%) compared with controls (27.3%) (P = 0.004), with no significant differences in absenteeism. Patients in remission experienced significantly more presenteeism than controls (54.7% versus 27.3%, respectively, P < 0.01), and indirect costs were significantly higher for remissive patients versus controls ($17,766 per yr versus $9179 per yr, respectively, P < 0.03). Only 34.3% had made adjustments to battle work-related problems such as fatigue, irritability, and decreased motivation. CONCLUSIONS Patients with IBD in clinical remission still cope with significantly more presenteeism and work limitations than controls; this translates in higher indirect costs and decreased quality of life. The majority have not made any adjustments to battle these problems.
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Büsch K, da Silva SA, Holton M, Rabacow FM, Khalili H, Ludvigsson JF. Sick leave and disability pension in inflammatory bowel disease: a systematic review. J Crohns Colitis 2014; 8:1362-77. [PMID: 25001582 DOI: 10.1016/j.crohns.2014.06.006] [Citation(s) in RCA: 41] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/31/2014] [Revised: 05/16/2014] [Accepted: 06/17/2014] [Indexed: 12/12/2022]
Abstract
BACKGROUND & AIMS Inflammatory bowel disease has considerable effects on work-related outcomes and leads to high societal costs due to sick leave and disability pension. The aims of this study were to systematically review evidence on work-related outcomes that are relevant to productivity losses and to evaluate whether medical or surgical interventions have a positive impact on patients' work ability. METHODS A systematic literature search in PubMed was conducted in June 2013. Abstracts were screened by two independent reviewers, and full-text articles describing the frequency of work-related outcomes were retrieved. Two independent reviewers extracted data according to the PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses. Findings were organized by study design (non-interventional/interventional). Non-interventional studies were structured according to whether they presented data in comparison to control groups or not and interventional studies were summarized according to type of intervention. RESULTS This review included 30 non-interventional (15 with comparison groups and 15 without comparison group) and 17 interventional studies (9 surgical and 8 medical). The majority of the studies reported a high burden of work-related outcomes among inflammatory bowel disease patients regardless of the methodology used. While biologic agents showed positive effect on work absenteeism and presenteeism in randomized clinical trials, the impact of surgical interventions needs further evaluation. CONCLUSIONS Inflammatory bowel disease patients experience a high burden in work-related outcomes. Additional data on productivity losses and the long-term impact of interventions is needed to help inform decision-makers about treatment options and their benefits in reducing productivity losses in inflammatory bowel disease patients.
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Affiliation(s)
- Katharina Büsch
- Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
| | - Simone A da Silva
- Department of Preventive Medicine, University of São Paulo, São Paulo, Brazil
| | | | - Fabiana M Rabacow
- Department of Preventive Medicine, University of São Paulo, São Paulo, Brazil
| | - Hamed Khalili
- Digestive Healthcare Center, Massachusetts General Hospital, Boston, MA, USA
| | - Jonas F Ludvigsson
- Department of Pediatrics, Örebro University Hospital, Örebro, Sweden; Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Sweden
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Abstract
BACKGROUND Moderate-to-severe Crohn's Disease (CD) has been shown to reduce daily activities; however, little is known of the impact on employees' salary growth. METHODS Employment and health care benefit data were extracted from the OptumHealth Reporting and Insights database, aggregating data from 23 self-insured U.S. companies with approximately 2.5 million covered beneficiaries. Employees diagnosed with moderate-to-severe CD (i.e., ≥1 prescription fill for systemic corticosteroids, immunosuppressive drugs, methotrexate or cyclosporine, or biologic agents within 6 months after the first observed CD diagnosis) between January 1999 and December 2006 were retrospectively matched with controls without CD based on year of birth, sex, industry, and geographic region. Employees' salaries and salary growth rates were estimated and compared between cohorts. Both descriptive comparison and multivariate regression analyses controlling for baseline characteristics and differences in comorbidities were performed. RESULTS A total of 918 employees with moderate-to-severe CD were matched to 2154 CD-free controls. The 2 cohorts did not differ in their annual salary in the first year of observation. However, regression analyses revealed that the 2 groups had significantly different adjusted annualized salary growth rates (0.69% versus 1.01%, P < 0.001), and employees with CD had a 31% lower salary increase rate than controls. A total income loss of $3195 per person was estimated for employees with CD compared with their CD-free peers over a cumulative 5 years after the first calendar year. CONCLUSIONS In the United States, employees with moderate-to-severe CD had a substantially lower salary growth rate than their peers without CD, suggesting an impaired career progression.
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Augustine JM, Lee JK, Armstrong EP. Health outcomes and cost-effectiveness of certolizumab pegol in the treatment of Crohn's disease. Expert Rev Pharmacoecon Outcomes Res 2014; 14:599-609. [PMID: 25209304 DOI: 10.1586/14737167.2014.957680] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
Crohn's disease (CD) causes chronic inflammation of the gastrointestinal tract and leads to fluctuations between active disease and remission. Certolizumab pegol is one of the newer biological treatments for patients with moderate-to-severe CD. Certolizumab pegol was shown to be effective in CD patients achieving response and remission in both randomized and non-randomized studies, and is an alternative biological treatment for CD. The available data show that certolizumab pegol achieves similar therapeutic efficacy and health-related quality of life scores in CD patients as the other biological agents, but at a higher cost, if dose escalation of other biologics is not considered. Considering subcutaneous self-administration, and lower number and frequency of injections, patients may prefer certolizumab pegol over the other biological treatments.
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Affiliation(s)
- Jill M Augustine
- University of Arizona College of Pharmacy, 1295 N. Martin Ave. Tucson, AZ 85721-0202, USA
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Williet N, Sandborn WJ, Peyrin-Biroulet L. Patient-reported outcomes as primary end points in clinical trials of inflammatory bowel disease. Clin Gastroenterol Hepatol 2014; 12:1246-56.e6. [PMID: 24534550 DOI: 10.1016/j.cgh.2014.02.016] [Citation(s) in RCA: 206] [Impact Index Per Article: 18.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/23/2013] [Revised: 12/29/2013] [Accepted: 02/06/2014] [Indexed: 02/07/2023]
Abstract
The Food and Drug Administration (FDA) is moving from the Crohn's Disease Activity Index to patient-reported outcomes (PROs) and objective measures of disease, such as findings from endoscopy. PROs will become an important aspect of assessing activity of inflammatory bowel disease (IBD) and for labeling specific drugs for this disease. PROs always have been considered in the management of patients with rheumatoid arthritis or multiple sclerosis, and have included measurements of quality of life, disability, or fatigue. Several disease-specific scales have been developed to assess these PROs and commonly are used in clinical trials. Outcomes reported by patients in clinical trials of IBD initially focused on quality of life, measured by the Short-Form 36 questionnaire or disease-specific scales such as the Inflammatory Bowel Disease Questionnaire or its shorter version. Recently considered factors include fatigue, depression and anxiety, and work productivity, as measured by the Functional Assessment Chronic Illness Therapy-Fatigue, the Hospital Anxiety Depression, and the Work Productivity Activity Impairment Questionnaire, respectively. However, few data are available on how treatment affects these factors in patients with IBD. Although disability generally is recognized in patients with IBD, it is not measured. The international IBD disability index currently is being validated. None of the PROs currently used in IBD were developed according to FDA guidance for PRO development. PROs will be a major primary end point of future trials. FDA guidance is needed to develop additional PROs for IBD that can be incorporated into trials, to better compare patients' experience with different therapies.
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Affiliation(s)
- Nicolas Williet
- Inserm, U954 et Service d'Hepato-Gastroenterologie, Hôpital Universitaire de Nancy, Université Henri Poincaré 1, Vandoeuvre-lès-Nancy, France
| | - William J Sandborn
- Division of Gastroenterology, University of California San Diego, La Jolla, California
| | - Laurent Peyrin-Biroulet
- Inserm, U954 et Service d'Hepato-Gastroenterologie, Hôpital Universitaire de Nancy, Université Henri Poincaré 1, Vandoeuvre-lès-Nancy, France.
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van der Valk ME, Mangen MJJ, Leenders M, Dijkstra G, van Bodegraven AA, Fidder HH, de Jong DJ, Pierik M, van der Woude CJ, Romberg-Camps MJL, Clemens CHM, Jansen JM, Mahmmod N, van de Meeberg PC, van der Meulen-de Jong AE, Ponsioen CY, Bolwerk CJM, Vermeijden JR, Siersema PD, van Oijen MGH, Oldenburg B. Risk factors of work disability in patients with inflammatory bowel disease--a Dutch nationwide web-based survey: work disability in inflammatory bowel disease. J Crohns Colitis 2014; 8:590-7. [PMID: 24351733 DOI: 10.1016/j.crohns.2013.11.019] [Citation(s) in RCA: 52] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/23/2013] [Revised: 11/15/2013] [Accepted: 11/15/2013] [Indexed: 12/12/2022]
Abstract
BACKGROUND Inflammatory bowel disease (IBD) is associated with high costs to society. Few data on the impact of IBD on work disability and potential predictive factors are available. AIM To assess the prevalence of and predictive factors for work disability in Crohn's disease (CD) and ulcerative colitis (UC). METHODS A web-based questionnaire was sent out in seven university hospitals and seven general hospitals in the Netherlands. Initially, 3050 adult IBD patients were included in this prospective, nationwide cohort study, whereof 2629 patients were within the working-age (18-64 years). We used the baseline questionnaire to assess the prevalence rates of work disability in CD and UC patients within working-age. Prevalence rates were compared with the Dutch background population using age- and sex-matched data obtained from Statistics Netherlands. Multivariable logistic regression analyses were performed to identify independent demographic- and disease-specific risk factors for work disability. RESULTS In CD, 18.3% of patients was fully disabled and 8.8% partially disabled, compared to 9.5% and 5.4% in UC patients (p<0.01), respectively. Compared to Dutch controls, the prevalence was significantly higher, especially in CD patients. Higher age, low education, depression, chronic back pain, joint manifestations and typical disease-related risk factors such as penetrating disease course and surgery in the past were all found to be associated with work disability. CONCLUSION We report high work disability rates in a large sample of IBD patients in the Netherlands. CD patients suffer more frequently from work disability than UC patients. A combination of demographic and disease-related factors is predictive of work disability.
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Affiliation(s)
- Mirthe E van der Valk
- Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, The Netherlands
| | - Marie-Josée J Mangen
- Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands
| | - Max Leenders
- Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, The Netherlands
| | - Gerard Dijkstra
- Department of Gastroenterology and Hepatology, University Medical Centre Groningen, Groningen, The Netherlands
| | - Ad A van Bodegraven
- Department of Gastroenterology and Hepatology, VU University Medical Centre, Amsterdam, The Netherlands
| | - Herma H Fidder
- Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, The Netherlands
| | - Dirk J de Jong
- Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
| | - Marieke Pierik
- Department of Gastroenterology and Hepatology, Maastricht University Medical Centre, Maastricht, The Netherlands
| | - C Janneke van der Woude
- Department of Gastroenterology and Hepatology, Erasmus University Medical Centre, Rotterdam, The Netherlands
| | | | - Cees H M Clemens
- Department of Gastroenterology and Hepatology, Diaconessenhuis, Leiden, The Netherlands
| | - Jeroen M Jansen
- Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands
| | - Nofel Mahmmod
- Department of Gastroenterology and Hepatology, Antonius Hospital, Nieuwegein, The Netherlands
| | - Paul C van de Meeberg
- Department of Gastroenterology and Hepatology, Slingeland Hospital, Doetinchem, The Netherlands
| | | | - Cyriel Y Ponsioen
- Department of Gastroenterology and Hepatology, Academic Medical Centre Amsterdam, The Netherlands
| | - Clemens J M Bolwerk
- Department of Gastroenterology and Hepatology, Reinier de Graaf Groep, Delft, The Netherlands
| | - J Reinoud Vermeijden
- Department of Gastroenterology and Hepatology, Meander Medical Centre, Amersfoort, The Netherlands
| | - Peter D Siersema
- Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, The Netherlands
| | - Martijn G H van Oijen
- Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, The Netherlands; Division of Digestive Diseases, David Geffen School of Medicine at University of California, Los Angeles, United States
| | - Bas Oldenburg
- Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, The Netherlands.
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Bello S, Moustgaard H, Hróbjartsson A. The risk of unblinding was infrequently and incompletely reported in 300 randomized clinical trial publications. J Clin Epidemiol 2014; 67:1059-69. [PMID: 24973822 DOI: 10.1016/j.jclinepi.2014.05.007] [Citation(s) in RCA: 34] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/26/2013] [Revised: 05/20/2014] [Accepted: 05/21/2014] [Indexed: 01/09/2023]
Abstract
OBJECTIVES To assess the proportion of clinical trials explicitly reporting the risk of unblinding, to evaluate the completeness of reporting on unblinding risk, and to describe the reported procedures involved in assessing unblinding. STUDY DESIGN AND SETTING We sampled at random 300 blinded randomized clinical trials indexed in PubMed in 2010. Two authors read the trial publications and extracted data independently. RESULTS Twenty-four trial publications, or 8% (95% confidence interval [CI], 5, 12%), explicitly reported the risk of unblinding, of which 16 publications, or 5% (95% CI, 3, 8%), reported compromised blinding; and 8 publications, or 3% (95% CI, 1, 5%), intact blinding. The reporting on risk of unblinding in the 24 trial publications was generally incomplete. The median proportion of assessments per trial affected by unblinding was 3% (range 1-30%). The most common mechanism for unblinding was perceptible physical properties of the treatments, for example, a difference in the taste and odor of a typhoid vaccine compared with its placebo. CONCLUSION Published articles on randomized clinical trials infrequently reported risk of unblinding. This may reflect a tendency for avoiding reporting actual or suspected unblinding or a genuine low risk of unblinding.
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Affiliation(s)
- Segun Bello
- The Nordic Cochrane Centre, Rigshospitalet, Department 7811, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark.
| | - Helene Moustgaard
- The Nordic Cochrane Centre, Rigshospitalet, Department 7811, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark
| | - Asbjørn Hróbjartsson
- The Nordic Cochrane Centre, Rigshospitalet, Department 7811, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark
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Mozaffari S, Nikfar S, Abdolghaffari AH, Abdollahi M. New biologic therapeutics for ulcerative colitis and Crohn's disease. Expert Opin Biol Ther 2014; 14:583-600. [PMID: 24502344 DOI: 10.1517/14712598.2014.885945] [Citation(s) in RCA: 46] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/03/2023]
Abstract
INTRODUCTION Some inflammatory bowel disease (IBD) patients especially those with refractory Crohn's disease (CD) or relapsing ulcerative colitis (UC) do not respond to current therapies. The newly introduced biological drugs have got some interest due to their specificity and selectivity in modulation of inflammatory elements. AREAS COVERED In 46 included randomized, placebo-controlled clinical trials, the efficacy and safety of different biologic drugs have been evaluated in moderately to severely active CD or UC patients. Current investigated drugs include new anti-TNF drugs (adalimumab, certolizumab pegol, etanercept, onercept and golimumab), anti-CD20 (rituximab), T-cell inhibitors (abatacept) and anti-α4 integrins (natalizumab and vedolizumab). Adalimumab, certolizumab, and golimumab showed significant efficacy in induction of remission and maintenance in CD and UC patients with a rate of adverse events similar to placebo in the major trials. Natalizumab and vedolizumab were effective in the treatment of moderately to severely active CD and UC patients. However, vedolizumab caused less adverse effects than natalizumab. onercept, etanercept, rituximab and abatacept were all well tolerated but were not effective in CD or UC patients. EXPERT OPINION Anti-TNF drugs, except for onercept and etanercept, and anti-α4 integrins exhibit beneficial therapeutic effects. Although they were all well tolerated, the incidence of progressive multifocal leukoencephalopathy associated with natalizumab should not be missed.
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Affiliation(s)
- Shilan Mozaffari
- Tehran University of Medical Sciences, Faculty of Pharmacy, and Pharmaceutical Sciences Research Center, Department of Toxicology and Pharmacology , Tehran 1417614411 , Iran +00 98 21 66959104 ; ,
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Linguistic Validation into 20 Languages and Content Validity of the Rheumatoid Arthritis-Specific Work Productivity and Activity Impairment Questionnaire. PATIENT-PATIENT CENTERED OUTCOMES RESEARCH 2014; 7:171-6. [DOI: 10.1007/s40271-014-0053-4] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 10/25/2022]
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van der Valk ME, Mangen MJJ, Leenders M, Dijkstra G, van Bodegraven AA, Fidder HH, de Jong DJ, Pierik M, van der Woude CJ, Romberg-Camps MJL, Clemens CHM, Jansen JM, Mahmmod N, van de Meeberg PC, van der Meulen-de Jong AE, Ponsioen CY, Bolwerk CJM, Vermeijden JR, Siersema PD, van Oijen MGH, Oldenburg B. Healthcare costs of inflammatory bowel disease have shifted from hospitalisation and surgery towards anti-TNFα therapy: results from the COIN study. Gut 2014; 63:72-9. [PMID: 23135759 DOI: 10.1136/gutjnl-2012-303376] [Citation(s) in RCA: 413] [Impact Index Per Article: 37.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
OBJECTIVE The introduction of anti tumour necrosis factor-α (anti-TNFα) therapy might impact healthcare expenditures, but there are limited data regarding the costs of inflammatory bowel diseases (IBD) following the introduction of these drugs. We aimed to assess the healthcare costs and productivity losses in a large cohort of IBD patients. DESIGN Crohn's disease (CD) and ulcerative colitis (UC) patients from seven university hospitals and seven general hospitals were invited to fill-out a web-based questionnaire. Cost items were derived from a 3 month follow-up questionnaire and categorised in outpatient clinic, diagnostics, medication, surgery and hospitalisation. Productivity losses included sick leave of paid and unpaid work. Costs were expressed as mean 3-month costs per patients with a 95% CI obtained using non-parametric bootstrapping. RESULTS A total of 1315 CD patients and 937 UC patients were included. Healthcare costs were almost three times higher in CD as compared with UC, €1625 (95% CI €1476 to €1775) versus €595 (95% CI €505 to €685), respectively (p<0.01). Anti-TNFα use was the main costs driver, accounting for 64% and 31% of the total cost in CD and UC. Hospitalisation and surgery together accounted for 19% and <1% of the healthcare costs in CD and 23% and 1% in UC, respectively. Productivity losses accounted for 16% and 39% of the total costs in CD and UC. CONCLUSIONS We showed that healthcare costs are mainly driven by medication costs, most importantly by anti-TNFα therapy. Hospitalisation and surgery accounted only for a minor part of the healthcare costs.
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Affiliation(s)
- Mirthe Emilie van der Valk
- Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, , Utrecht, The Netherlands
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Ferrante M, Vermeire S, Rutgeerts P. Certolizumab pegol in the treatment of Crohn's disease. Expert Opin Biol Ther 2013; 13:595-605. [DOI: 10.1517/14712598.2013.777039] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/28/2023]
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Louis E, Löfberg R, Reinisch W, Camez A, Yang M, Pollack PF, Chen N, Chao J, Mulani PM. Adalimumab improves patient-reported outcomes and reduces indirect costs in patients with moderate to severe Crohn's disease: results from the CARE trial. J Crohns Colitis 2013; 7:34-43. [PMID: 22480772 DOI: 10.1016/j.crohns.2012.02.017] [Citation(s) in RCA: 41] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/30/2011] [Revised: 02/23/2012] [Accepted: 02/23/2012] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIMS Crohn's disease negatively affects patients' quality of life and ability to work. We investigated the impact of adalimumab on work productivity, daily activities, and quality of life in an open-label trial (N=945). The population comprised both infliximab-naïve and -exposed patients, including infliximab primary non-responders. METHODS Patients received adalimumab induction therapy (160 mg/80 mg at Weeks 0/2), followed by adalimumab 40 mg every other week for up to 20 weeks (patients with flares/non-response could receive 40 mg weekly at/after Week 12). The Work Productivity and Activity Impairment Questionnaire and Short Inflammatory Bowel Disease Questionnaire were assessed. Indirect cost savings were estimated based on the average work productivity improvements at Week 20. RESULTS Mean baseline scores indicated severe productivity impairment and poor quality of life. At Week 20, 60% of infliximab-naïve and 47% of infliximab primary non-responders achieved clinically important improvements (≥9 points) on the Short Inflammatory Bowel Disease Questionnaire, and 51% and 43%, respectively, achieved the minimum clinically important difference (improvement ≥7 percentage points) for total work productivity impairment (non-responder imputation). At Week 20, 64% of infliximab-naïve and 55% of infliximab primary non-responders achieved clinically important improvements in total activity impairment. Estimated 20-week total indirect productivity-related cost savings were €3070 per infliximab-naïve patient and €2059 per infliximab-exposed patient. CONCLUSIONS Adalimumab therapy significantly improved work productivity and disease-specific quality of life for patients with moderate to severe Crohn's disease. Patients who failed prior infliximab therapy and patients naïve to infliximab benefited from adalimumab, with potentially greater benefits for infliximab-naïve patients (NCT00409617).
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Thomson ABR, Gupta M, Freeman HJ. Use of the tumor necrosis factor-blockers for Crohn's disease. World J Gastroenterol 2012; 18:4823-54. [PMID: 23002356 PMCID: PMC3447266 DOI: 10.3748/wjg.v18.i35.4823] [Citation(s) in RCA: 24] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/28/2011] [Revised: 06/13/2012] [Accepted: 08/14/2012] [Indexed: 02/06/2023] Open
Abstract
The use of anti-tumor necrosis factor-α therapy for inflammatory bowel disease represents the most important advance in the care of these patients since the publication of the National Co-operative Crohn's disease study thirty years ago. The recommendations of numerous consensus groups worldwide are now supported by a wealth of clinical trials and several meta-analyses. In general, it is suggested that tumor necrosis factor-α blockers (TNFBs) are indicated (1) for persons with moderately-severe Crohn's disease or ulcerative colitis (UC) who have failed two or more causes of glucocorticosteroids and an acceptably long cause (8 wk to 12 wk) of an immune modulator such as azathioprine or methotrexate; (2) non-responsive perianal disease; and (3) severe UC not responding to a 3-d to 5-d course of steroids. Once TNFBs have been introduced and the patient is responsive, therapy given by the IV and SC rate must be continued. It remains open to definitive evidence if concomitant immune modulators are required with TNFB maintenance therapy, and when or if TNFB may be weaned and discontinued. The supportive evidence from a single study on the role of early versus later introduction of TNFB in the course of a patient's illness needs to be confirmed. The risk/benefit profile of TNFB appears to be acceptable as long as the patient is immunized and tested for tuberculosis and viral hepatitis before the initiation of TNFB, and as long as the long-term adverse effects on the development of lymphoma and other tumors do not prone to be problematic. Because the rates of benefits to TNFB are modest from a population perspective and the cost of therapy is very high, the ultimate application of use of TNFBs will likely be established by cost/benefit studies.
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Evans AT, Lee SD. A review and expert opinion of the use of certolizumab for Crohn's disease. Expert Opin Biol Ther 2012; 12:363-70. [PMID: 22339409 DOI: 10.1517/14712598.2012.658770] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/05/2023]
Abstract
INTRODUCTION Crohn's disease (CD) is a chronic, idiopathic, inflammatory bowel disease with no known cure. In those patients with moderate to severe disease, the result is often a clinically debilitating condition. In the last decade, one of the most significant developments in therapy has been a class of biological agents that neutralize TNFa. Certolizumab pegol (CZP) is the most recently FDA approved anti-TNF agent for the induction and maintenance of moderate to severely active Crohn's disease. AREAS COVERED The currently available evidence regarding the use of CZP in CD, the expected efficacy and possible adverse events associated with this population. EXPERT OPINION CZP is a TNFa inhibitor that is a safe and effective agent for treatment of CD. It has several unique features which make it useful in patients with moderate to severe disease.
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Affiliation(s)
- Ashley T Evans
- University of Washington, Medical Center, Gastroenterology, 1959 NE Pacific St, WA 98195, USA
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Effect of adalimumab on work productivity and indirect costs in moderate to severe Crohn's disease: a meta-analysis. CANADIAN JOURNAL OF GASTROENTEROLOGY = JOURNAL CANADIEN DE GASTROENTEROLOGIE 2011; 25:492-6. [PMID: 21912760 DOI: 10.1155/2011/938194] [Citation(s) in RCA: 29] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
OBJECTIVE To assess the effect of adalimumab on work productivity and indirect costs in patients with Crohn's disease (CD) using a meta-analysis of clinical trials. METHODS Study-level results were pooled from all clinical trials of adalimumab for moderate to severe CD in which work productivity outcomes were evaluated. Work Productivity and Activity Impairment Questionnaire outcomes (absenteeism, presenteeism and total work productivity impairment [TWPI]) were extracted from adalimumab trials. Meta-analyses were used to estimate pooled averages and 95% CIs of one-year accumulated reductions in work productivity impairment with adalimumab. Pooled averages were multiplied by the 2008 United States national average annual salary ($44,101) to estimate per-patient indirect cost savings during the year following adalimumab initiation. RESULTS The four included trials (ACCESS, CARE, CHOICE and EXTEND) represented a total of 1202 employed adalimumab-treated patients at baseline. Each study followed patients for a minimum of 20 weeks. Pooled estimates (95% CIs) of one-year accumulated work productivity improvements were as follows: -9% (-10% to -7%) for absenteeism; -22% (-26% to -18%) for presenteeism; and -25% (-30% to -20%) for TWPI. Reductions in absenteeism and TWPI translated into per-patient indirect cost savings (95% CI) of $3,856 ($3,183 to $4,529) and $10,964 ($8,833 to $13,096), respectively. CONCLUSION Adalimumab provided clinically meaningful improvements in work productivity among patients with moderate to severe CD, which may translate into substantial indirect cost savings from an employer's perspective.
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Abstract
In this article we provide a contemporary overview of available clinical data on certolizumab pegol, a pegylated anti-tumor necrosis factor (TNF) alpha agent that comprises a uniquely small protein, and its emerging role as a therapy for Crohn's disease (CD). The results from a comprehensive clinical trial program suggest that certolizumab pegol offers rapid and sustained remission of moderate to severe CD. Certolizumab pegol is an effective and well-tolerated therapy both in patients who have already received biologics and in patients who are anti-TNF naïve. Benefits of therapy include a stable dosing regimen, which allows for rapid induction of a clinical response followed by long-term maintenance of response and remission under one fixed dose. Treatment with certolizumab pegol has been shown to improve function and quality of life in patients with CD, and insights into the potential mechanisms by which certolizumab pegol effects a response in CD suggest that this agent may have the potential to slow or even modify disease progression. Early therapy is particularly effective and could help control CD progression and lessen the burden of disease on patients.
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Feagan BG, Hanauer SB, Coteur G, Schreiber S. Evaluation of a daily practice composite score for the assessment of Crohn's disease: the treatment impact of certolizumab pegol. Aliment Pharmacol Ther 2011; 33:1143-51. [PMID: 21443536 DOI: 10.1111/j.1365-2036.2011.04636.x] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
BACKGROUND Successful treatment of systemic inflammatory symptoms is essential for improving health-related quality of life in patients with active Crohn's disease. Patient-reported outcomes provide unique perspectives on the impact of chronic disease. It is unknown whether a combination of different instruments might improve sensitivity to clinically relevant changes in health status. AIM To develop a composite score based upon Crohn's Disease Activity Index (CDAI) and Inflammatory Bowel Disease Questionnaire (IBDQ) items. METHODS Patients from the PRECiSE 2 trial who responded at week 6 to certolizumab pegol (CZP) were randomised to receive treatment with CZP 400 mg or placebo for up to 26 weeks. IBDQ and CDAI scores were assessed at weeks 0, 6, 16 and 26. A 'daily practice' composite score (DP-6) containing two items from the CDAI and four items from IBDQ was constructed. RESULTS Correlation coefficients between the CDAI score and IBDQ total score at baseline and at week 26 were -0.344 and -0.603, respectively (P<0.05). All IBDQ items were improved following CZP treatment. The DP-6 had the highest responsiveness at assessing response to treatment, relative to CDAI total score, when compared with other scores. CONCLUSIONS The DP-6 composite score could be used to optimise the use of existing instruments by serving as an index of symptoms due to systemic inflammation. Additional studies are needed to determine if the DP-6 composite score differentiates the impact of different treatments on patient-reported outcomes, and to determine if the use of the DP-6 improves the care of patients in clinical practice.
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Affiliation(s)
- B G Feagan
- Robarts Research Institute, University of Western Ontario, 100 Perth Drive, London, ON, Canada.
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Certolizumab pegol in the treatment of Crohn’s disease: evidence from the PRECiSE clinical trial program. ACTA ACUST UNITED AC 2011. [DOI: 10.4155/cli.10.33] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/09/2023]
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Feagan BG, Sandborn WJ, Wolf DC, Coteur G, Purcaru O, Brabant Y, Rutgeerts PJ. Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn's disease with prior loss of response to infliximab. Aliment Pharmacol Ther 2011; 33:541-50. [PMID: 21223344 DOI: 10.1111/j.1365-2036.2010.04568.x] [Citation(s) in RCA: 25] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
BACKGROUND Crohn's disease (CD) is associated with impaired health-related quality of life (HRQoL). Certolizumab pegol, administered either every 2 weeks (q2w) or q4w, maintains efficacy in patients previously failing on the anti-TNF agent infliximab (WELCOME study). AIM To investigate the impact of certolizumab pegol administered q2w and q4w on work productivity and HRQoL in the WELCOME study. METHODS Patients with loss of response to infliximab received open-label certolizumab pegol induction and were randomised to receive double-blind maintenance treatment with certolizumab pegol 400 mg either q4w or q2w through week 24, with a final evaluation at week 26. Work productivity and HRQoL were assessed using the Work Productivity and Activity Impairment:CD questionnaire and Inflammatory Bowel Disease Questionnaire respectively. RESULTS Baseline HRQoL burden was representative of moderately to severely active CD. HRQoL, daily activity and work productivity improved in both treatment groups as early as week 6 and were maintained through week 26. Treatment benefits to HRQoL, daily activity and work productivity were similar between the certolizumab pegol q2w vs. q4w groups. CONCLUSIONS Certolizumab pegol therapy results in meaningful improvements in work productivity, daily activities and HRQoL in patients with active CD who previously responded to but either lost response or could not tolerate infliximab (ClinicalTrials.gov number: NCT00308581).
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Affiliation(s)
- B G Feagan
- Department of Medicine, Robarts Research Institute, University of Western Ontario, London, Canada.
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