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This publication is provided for historical reference only and the information may be out of date.

Cover of Drug Class Review: Targeted Immune Modulators

Drug Class Review: Targeted Immune Modulators

Final Update 3 Report

Drug Class Reviews

, MD, MPH, , MD, MPH, , MSc, , MSIS, , MPA:HA, , MPH, , PhD, and , PharmD.

Portland (OR): Oregon Health & Science University; .

Structured Abstract

Purpose:

We systematically compared the efficacy, effectiveness, and safety (adverse events) of abatacept, adalimumab, alefacept, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, natalizumab, rituximab, tocilizumab, and ustekinumab in patients with rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

Data Sources:

To identify published studies, we searched PubMed, EMBASE, CINAHL, Centre for Reviews and Dissemination, The Cochrane Library, and International Pharmaceutical Abstracts from 2009 (January) to 2011 (October). We also searched the US Food and Drug Administration Center for Drug Evaluation and Research website for additional unpublished data, requested dossiers of information from pharmaceutical manufacturers, and retrieved relevant citations from reference lists of included studies.

Review Methods:

Study selection, data abstraction, validity assessment, grading the strength of the evidence, and data synthesis were all carried out according to our standard review methods.

Results and Conclusion:

Overall, targeted immune modulators are highly effective medications for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis that substantially improve the burden of disease and are generally safe for short-term treatment.

For rheumatoid arthritis, low-and moderate-strength evidence indicated that some targeted immune modulators are more efficacious than others. These results were based on three head-to-head trials, several large observational studies, and indirect comparisons of placebo-controlled trials. The evidence is currently insufficient to reliably determine the comparative effectiveness for other indications and in subgroups.

Low-strength evidence indicated that serious infections are less common with abatacept than the other drugs and that the rate of adverse events is greater with infliximab than adalimumab or etanercept. Likewise, more patients receiving infliximab withdrew due to adverse events than abatacept, adalimumab, etanercept, and golimumab. Infusion or allergic reactions contributed to the difference in risk.

Contents

Update 2: November 2009
Update 1: January 2007
Original Report: December 2005

The medical literature relating to this topic is scanned periodically. (See http://www.ohsu.edu/xd/research/centers-institutes/evidence-based-policy-center/derp/documents/methods.cfm for description of scanning process). Prior versions of this report can be accessed at the DERP website.

Produced by RTI-UNC Evidence-based Practice Center, Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill. Tim Carey, M.D., M.P.H., Director.

Drug Effectiveness Review Project: Marian McDonagh, PharmD, Principal Investigator

Oregon Evidence-based Practice Center: Mark Helfand, MD, MPH, Director.

Acknowledgments: We thank Evelyn Auer and Michaela Strobelberger for administrative assistance and Leah Williams, our publications editor, for putting this report into its present form for you to read.

Clinical Advisory Group: We extend our appreciation to the clinical advisor listed below for their thoughtful advice and input during our research process.

Paula Morris, MD, University of Arkansas for Medical Sciences.

Funding: The Drug Effectiveness Review Project, composed of 12 organizations including 11 State Medicaid agencies, and the Canadian Agency for Drugs and Technology in Health commissioned and funded for this report. These organizations selected the topic of the report and had input into its Key Questions. The content and conclusions of the report were entirely determined by the Evidence-based Practice Center researchers. The authors of this report have no financial interest in any company that makes or distributes the products reviewed in this report.

Suggested citation:

Thaler KJ, Gartlehner G, Kien C, Van Noord MG, Thakurta S, Wines RCM, Hansen RA, McDonagh MS. Drug class review: Targeted immune modulator. Final update 3 report. Prepared by the RTI-UNC Evidence-based Practice Center for the Drug Effectiveness Review Project. Oregon Health & Science University. Portland, OR. 2012. Available at: http://derp.ohsu.edu/about/final-document-display.cfm

The Agency for Healthcare Research and Quality has not yet seen or approved this report

The purpose of Drug Effectiveness Review Project reports is to make available information regarding the comparative clinical effectiveness and harms of different drugs. Reports are not usage guidelines, nor should they be read as an endorsement of or recommendation for any particular drug, use, or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports.

Copyright © 2012, Oregon Health & Science University, Portland, Oregon.
Bookshelf ID: NBK110098PMID: 23166955

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