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Does safety make a difference in selecting the right TNF antagonist
Arthritis Research Therapy Vol 6 Suppl 2 Fleischmann and Yocum
Review
Does safety make a difference in selecting the right
TNF antagonist?
Roy Fleischmann1 and David Yocum2
1University of Texas Southwestern Medical Center, Dallas, TX, USA
2University of Arizona Arthritis Center, Tucson, AZ, USA
Corresponding author: Roy Fleischmann (e-mail: royfleischmann@)
Received: 17 Jul 2003 Accepted: 6 Aug 2003 Published: 21 Jun 2004
Arthritis Res Ther 2004, 6(Suppl 2):S12-S18 (DOI 10.1186/ar995)
? 2004 BioMed Central Ltd (Print ISSN 1478-6354; Online ISSN 1478-6362)
Abstract
Tumor necrosis factor (TNF) antagonists are biologic response modifiers that have significantly
improved the outcomes in patients with rheumatoid arthritis (RA). At this report, safety data were
collected on approximately 271,000 patients administered infliximab (as of February 2002), 121,000
patients administered etanercept (as of December 2001), and on 2400 patients who received
adalimumab in trials in connection with the regulatory approval process (approval granted December
2002 in the US and September 2003 in European Union). Infliximab and etanercept have predictable
and manageable safety profiles, and preliminary data suggest that the profile of adalimumab is
comparable. Safety issues involving the anti-TNF agents as a class include the risk of injection-site
reactions or infusion-related reactions, infection (for example, serious, opportunistic, or tubercular),
malignancy, autoimmunity, and demyelinating and neurologic disorders. Injection-site and infusion-
related reactions are most often easily managed and rarely lead to discontinuation of therapy.
Infections can be minimized or prevented by screening and careful monitoring and follow-up; most
infections respond to appropriate medical treatment. More studies are needed to evaluate the
occurrence of malignancies in patients wi
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