Targeted immune modulators, commonly referred to as biological response modifiers or simply biologics, are a relatively new category of medications used in the treatment of certain types of immunologic and inflammatory diseases, including rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ulcerative colitis. The US Food and Drug Administration approved the first of the biologics (infliximab) in 1998 and approved 9 additional agents since that time for treating various rheumatic conditions and plaque psoriasis: etanercept (1998), anakinra (2001), adalimumab (2002), alefacept (2003), efalizumab (2003), abatacept (2005), rituximab (2006), natalizumab (2008), and certolizumab pegol (2008). In this report, we review the comparative effectiveness, safety, and tolerability of targeted immune modulators.

Contents

• Introduction
  • Rheumatoid Arthritis
  • Juvenile Idiopathic Arthritis
  • Ankylosing Spondylitis
  • Psoriatic Arthritis
  • Crohn’s Disease
  • Ulcerative Colitis
  • Plaque Psoriasis
  • Purpose and Limitations of Systematic Reviews
  • Scope and Key Questions
• Methods
  • Literature Search
  • Study Selection
  • Data Abstraction
  • Validity Assessment
  • Data Synthesis
  • Rating the Strength of the Evidence
• Results
  • Key Question 1. Efficacy and Effectiveness
  • Key Question 2. Adverse Events
  • Key Question 3. Subgroups
• Summary
  • Key Question 1. Comparative Effectiveness
  • Key Question 2. Comparative Safety
  • Key Question 3. Subgroups
• Conclusions
• Addendum
• References
• Appendix A Glossary
• Appendix B Search strategies
• Appendix C Component studies of included systematic reviews
• Appendix D Quality assessment for the Drug Effectiveness Review Project
• Appendix E Instruments used to measure outcomes in trials involving targeted immune modulators
• Appendix F Study characteristics, pooled relative risks and forest plots of meta-analyses
• Appendix G Black box warnings of drugs approved by the US Food and Drug Administration
• Appendix H Excluded studies
• Appendix I Characteristics of studies with poor internal validity
• Evidence Tables

Update 1: January 2007
Original Report: December 2005

The medical literature relating to this topic is scanned periodically. (See http://www.ohsu.edu/ohsuedu/research/policycenter/DERP/about/methods.cfm for description of scanning process). Prior versions of this report can be accessed at the DERP website.

Drug Effectiveness Review Project, Marian McDonagh, PharmD, Principal Investigator, Oregon Evidence-based Practice Center, Oregon Health & Science University, Mark Helfand, MD, MPH, Director

The Drug Effectiveness Review Project, composed of 15 organizations including 14 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:

Gartlehner G, Thieda P, Morgan LC, Thaler K, Hansen RA, Jonas B. Drug class review: Targeted immune modulators. Update 2 final report. http://www.ohsu.edu/drugeffectiveness/reports/final.cfm

This report reviews information about the comparative effectiveness and safety of drugs within a pharmaceutical class. The report is neither a usage guideline nor an endorsement or recommendation of any drug, use, or approach. Oregon Health & Science University does not endorse any guideline or recommendation developed by users of this report.