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Pharmacologic Therapies for the Management of Crohn's Disease: Comparative Effectiveness
Comparative Effectiveness Reviews, No. 131
Investigators: Susan Hutfless, PhD, Sammy Almashat, MD, MPH, Zackary Berger, MD, PhD, Lisa M Wilson, ScM, Elizabeth Bonson, MD, MPH, Qi Chen, MD, MPH, Elie Donath, MD, Frank Herlong, MD, Milo A Puhan, MD, PhD, Saranya Selvaraj, Anne Tuskey, MD, Alexandra Vasilescu, DO, Eric B Bass, MD, MPH, Mark Worthington, MD, Ghanshyam Palamaner Subash Shantha, MBBS, MD, and Mark Lazarev, MD.
Author Information and AffiliationsStructured Abstract
Objectives:
The purpose of this review was to compare the efficacy and safety of biologics, immunomodulators, corticosteroids, and aminosalicylates in the treatment of Crohn's disease.
Data sources:
We searched MEDLINE® (1966 through June 2011), Embase® (1974 through June 2011), and the Cochrane Central Register of Controlled Trials (Issue 2, 2011).
Review methods:
Two reviewers independently reviewed titles, abstracts, and articles, and included English-language articles that reported on induction or maintenance of remission in placebo-controlled or head-to-head randomized controlled trials. We also included observational studies with a comparison group if they reported on the safety of treatment. Two reviewers extracted study information using standardized forms and independently assessed study quality. Efficacy was measured by induction and maintenance of remission. Remission was defined using the Crohn's Disease Activity Index, mucosal healing, the absence of Crohn's disease hospitalizations or surgeries, reduction of steroids, fistula healing, and patient-reported outcomes. A difference of 10 percentage points in the outcome between treatment groups was considered clinically meaningful. The safety outcomes of interest were mortality, occurrence of lymphomas and other cancers, infections, infusion- and injection-site reactions, and bone fractures for adults and children. Growth was an additional safety concern for children.
Results:
We included 136 studies involving 148,733 patients. Twenty-three percent of trials directly compared different treatment strategies. The majority of trials excluded patients with mild disease and those with a history of surgical resection. The majority of trials allowed patients to take other Crohn's disease treatments during the trial. For adults, infliximab and 6-methyl-prednisolone were consistently favored over placebo across the induction and maintenance outcomes. Natalizumab and azathioprine were favored over placebo across the maintenance outcomes. Other comparisons either did not have more than one outcome reported or had inconsistent results. The quality of the safety evidence was poor due to poor reporting of the methods in trials and poor confounding control in observational studies, and no strong signals of harm were identified. For children, the strength of evidence was low or insufficient to support the efficacy of any medication to induce or maintain remission. No pediatric study reported on serious adverse events such as mortality, lymphoma, or other cancers.
Conclusions:
Measuring the efficacy of medications using multiple outcomes, infliximab and 6-methyl-prednisolone induce and maintain remission in adults with Crohn's disease. Natalizumab and azathioprine maintain remission. Comparing Crohn's disease medications directly using pragmatic clinical trials will help to understand the effectiveness of medications in clinical practice using outcomes other than the Crohn's Disease Activity Index.
Contents
- Preface
- Acknowledgments
- Key Informants
- Technical Expert Panel
- Peer Reviewers
- Executive Summary
- Introduction
- Methods
- Results
- Search Results
- Key Question 1 Effectiveness of Therapies To Induce Remission in Adults
- Key Question 2 Effectiveness of Therapies To Maintain Remission in Adults
- Key Question 3 Safety of Therapies in Adults
- Key Question 4 Effectiveness of Therapies Used To Prevent Post-Operative Recurrence as Pertains to Patient-Reported Outcomes
- Pediatric Results
- Discussion
- References
- Appendix A Detailed Electronic Database Search Strategies
- Appendix B Forms
- Appendix C Excluded Articles
- Appendix D Evidence Tables
- Appendix E Additional Meta-Analyses
- Appendix F Summary of Studies Comparing the Safety of Pharmacologic Therapies Among Patients With Inflammatory Bowel Disease
- Appendix G Subgroup Analysis Tables
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2007-10061-I. Prepared by: Johns Hopkins University Evidence-based Practice Center, Baltimore, MD
Suggested citation:
Hutfless S, Almashat, S, Berger Z, Wilson LM, Bonson E, Chen Q, Donath E, Herlong F, Puhan MA, Selvaraj S, Tuskey A, Vasilescu A, Bass EB, Worthington M, Palamaner G, Lazarev M. Pharmacologic Therapies for the Management of Crohn's Disease: Comparative Effectiveness. Comparative Effectiveness Review No. 131. (Prepared by Johns Hopkins Evidence-based Practice Center under Contract No. 290-2007-10061-I.) AHRQ Publication No. 14-EHC012-EF. Rockville, MD: Agency for Healthcare Research and Quality; February 2014. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
This report is based on research conducted by the Johns Hopkins University Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10061-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
This report may periodically be assessed for the urgency to update. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at: www.effectivehealthcare.ahrq.gov. Search on the title of the report.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
- 1
540 Gaither Road, Rockville, MD 20850; www
.ahrq.gov
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- Comparative effectiveness of immunosuppressants and biologics for inducing and maintaining remission in Crohn's disease: a network meta-analysis.[Gastroenterology. 2015]Comparative effectiveness of immunosuppressants and biologics for inducing and maintaining remission in Crohn's disease: a network meta-analysis.Hazlewood GS, Rezaie A, Borman M, Panaccione R, Ghosh S, Seow CH, Kuenzig E, Tomlinson G, Siegel CA, Melmed GY, et al. Gastroenterology. 2015 Feb; 148(2):344-54.e5; quiz e14-5. Epub 2014 Oct 16.
- Review Certolizumab pegol for the management of Crohn's disease in adults.[Clin Ther. 2009]Review Certolizumab pegol for the management of Crohn's disease in adults.Rivkin A. Clin Ther. 2009 Jun; 31(6):1158-76.
- Review Pharmacological Management of Crohn's Disease: Future Research Needs: Identification of Future Research Needs From Comparative Effectiveness Review No. 131[ 2014]Review Pharmacological Management of Crohn's Disease: Future Research Needs: Identification of Future Research Needs From Comparative Effectiveness Review No. 131Hutfless S, Lau BD, Wilson LM, Lazarev M, Bass EB. 2014 Feb
- Inhaled corticosteroids in children with persistent asthma: effects on growth.[Evid Based Child Health. 2014]Inhaled corticosteroids in children with persistent asthma: effects on growth.Zhang L, Prietsch SO, Ducharme FM. Evid Based Child Health. 2014 Dec; 9(4):829-930.
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