Furst, et al: Safety trial of adalimumab 2563 From the Division of Rheumatology, Department of Medicine, University of California, Los Angeles, California, USA. Supported by Abbott Laboratories, Abbott Park, Illinois, USA. D.E. Furst, MD, University of California; M.H. Schiff, MD, Denver Arthritis Clinic, Denver, CO; R.M. Fleischmann, MD, St. Paul Medical Center, Dallas, TX; V. Strand, MD, Stanford University School of Medicine, Palo Alto, CA; C.A. Birbara, MD, University of Massachusetts, Worcester, MA, USA; D. Compagnone, PhD, Abbott GmbH & Co. KG, Ludwigshafen, Germany; S.A. Fischkoff, MD; E.K. Chartash, MD, Abbott Laboratories, Parsippany, NJ, USA. Address reprint requests to Dr. D.E. Furst, Division of Rheumatology, Department of Medicine, 32-59 Rehabilitation Center, 1000 Veteran Avenue, Box 951670, Los Angeles, CA 90095-1670. E-mail: defurst@mednet.ucla.edu Submitted December 9, 2002; revision accepted April 28, 2003. Adalimumab, a Fully Human Anti–Tumor Necrosis Factor-α Monoclonal Antibody, and Concomitant Standard Antirheumatic Therapy for the Treatment of Rheumatoid Arthritis: Results of STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis) DANIEL E. FURST, MICHAEL H. SCHIFF, ROY M. FLEISCHMANN, VIBEKE STRAND, CHARLES A. BIRBARA, DANIELE COMPAGNONE, STEVEN A. FISCHKOFF, and ELLIOTK. CHARTASH ABSTRACT. Objective. This study, known as STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis), eval- uated the safety and efficacy of adalimumab (Humira TM ), a fully human monoclonal tumor necrosis factor-alpha (TNF-α) antibody, when given with standard antirheumatic therapy in patients with active rheumatoid arthritis (RA) not adequately responding to such therapies. Standard antirheumatic therapy included traditional disease modifying antirheumatic drugs (DMARD), low dose corticosteroids, nonsteroidal antiinflammatory drugs (NSAID), and/or analgesics. Methods. In this 24-week, double-blind, placebo-controlled study, 636 patients with RA were randomly assigned to receive adalimumab 40 mg subcutaneously (sc) every other week (n = 318) or placebo (n = 318) while continuing standard antirheumatic therapy. The frequencies of adverse events, serious adverse events, severe or life-threatening adverse events, adverse events leading to withdrawal, infection, or serious infection were the primary endpoints. Secondary endpoints were determined by American College of Rheumatology (ACR) response criteria. Results. During the study, the majority of patients received concomitant traditional DMARD (83.5%) and/or corticosteroids, NSAID, and/or analgesics (97.3%). Overall, 56.0% of patients continued treatment with one, 23.6% with 2, and 3.9% with ≥ 3 traditional DMARD. At 24 weeks, there were no statistically significant differences between the adalimumab and placebo groups in their respective rates of adverse events (86.5% vs 82.7%), serious adverse events (5.3% vs 6.9%), severe or life-threatening adverse events (11.9% vs 15.4%), or those leading to withdrawal (2.8% vs 2.2%). There were also no statistically significant differences in the rates of infections (52.2% vs 49.4%) or serious infections (1.3% vs 1.9%) between the groups. The incidence and types of adverse events did not vary between adalimumab- and placebo-treated patients by the number of concomi- tant traditional DMARD (0, 1, or 2). Adalimumab-treated patients compared with placebo-treated patients achieved statistically superior ACR20 (52.8% vs 34.9%), ACR50 (28.9% vs 11.3%), and ACR70 (14.8% vs 3.5%) response rates at Week 24 (p ≤ 0.001). Conclusion. This study demonstrated that addition of adalimumab 40 mg given sc every other week to concomitant standard antirheumatic therapy is well tolerated and provides significant improve- ments in signs and symptoms of RA. The data indicate that adalimumab is a safe and effective ther- apeutic option in patients with active RA who have an inadequate response to standard antirheumatic therapy, including one or more traditional DMARD, corticosteroids, NSAID, and analgesics. (J Rheumatol 2003;30:2563–71) Key Indexing Terms: ADALIMUMAB DISEASE MODIFYING ANTIRHEUMATIC DRUGS MONOCLONAL ANTIBODY RHEUMATOID ARTHRITIS TUMOR NECROSIS FACTOR-α Personal, non-commercial use only. The Journal of Rheumatology Copyright © 2003. All rights reserved. www.jrheum.org Downloaded on October 11, 2022 from