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Concomitant Medication Use in a Large, International, Multicenter, Placebo Controlled Trial of Anakinra, a Recombinant Interleukin 1 Receptor Antagonist, in Patients with Rheumatoid Arthritis
JOHN TESSER, ROY FLEISCHMANN, ROBIN DORE, RALPH BENNETT, ALAN SOLINGER, TENSHANG JOH, DENNIS MODAFFERI, and JOY SCHECHTMAN, for the 990757 Study Group
ABSTRACT.
Methods. This analysis further evaluates data from the first 6 months of a blinded, placebo controlled safety trial that had a subsequent 30 month, open label portion (not reported here). Patients with RA with a wide range of comorbid conditions, disease activity, and background medications were randomly assigned in a 4:1 allocation ratio to treatment with anakinra 100 mg or placebo administered daily by injection. Safety was assessed by comparing adverse event profiles between anakinra and placebo patients according to concomitant medications received. Results. Anakinra patients (n = 1116) showed no difference in the incidence of upper respiratory infections or overall serious adverse events compared with placebo patients (n = 283). The anakinra group had more injection site reactions (72.6% vs 32.9% in placebo) and a small increase in serious infections (2.1% vs 0.4% in placebo). Anakinra's safety profile did not differ in patients receiving antihypertensive, antidiabetic, or statin drugs. Conclusion. This study indicates that anakinra has a good safety profile in patients typically seen in a rheumatology practice who are considered candidates for therapy with agents that are immunomodulatory and disease modifying. Except for injection site reactions and a nonstatistically although potentially clinically significant increase in serious infections in the anakinra versus the placebo groups, the addition of anakinra to a stable background regimen of RA medications introduced no other important safety risk in patients with RA. (J Rheumatol 2004;31:649-54) Key Indexing Terms:
INTERLEUKIN 1 RECEPTOR ANTAGONIST
From the University of Arizona Health Sciences Center, Arizona Rheumatology Center, Phoenix, Arizona, USA. Supported by a grant from Amgen Inc., Thousand Oaks, California, USA. J. Tesser, MD, Clinical Lecturer, University of Arizona Health Sciences Center, Arizona Rheumatology Center; R. Fleischmann, MD, Clinical Professor of Medicine, University of Texas Southwestern Medical Center at Dallas, Dallas, TX; R. Dore, MD, Anaheim, CA; R. Bennett, MD, Arizona Arthritis and Rheumatism Associates, Mesa, AZ; A. Solinger, MD; T. Joh, PhD; D. Modafferi, BS, Amgen Inc., Thousand Oaks, CA; J. Schechtman, DO, Sun Valley Arthritis Center, Glendale, AZ. Address reprint requests to Dr. J. Tesser, Arizona Rheumatology Center, 6707 North 19th Avenue, Suite 201, Phoenix, AZ 85015-2160. E-mail: johntesser@radiantresearch.com Submitted April 14, 2003; revision accepted October 6, 2003. |