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Adalimumab Reduces Pain, Fatigue, and Stiffness in Patients with Ankylosing Spondylitis: Results from the Adalimumab Trial Evaluating Long-Term Safety and Efficacy for Ankylosing Spondylitis (ATLAS) DENNIS A. REVICKI, MICHELLE P. LUO, PAUL WORDSWORTH, ROBERT L. WONG, NAIJUN CHEN, JOHN C. DAVIS Jr, for the ATLAS Study Group
ABSTRACT. Methods. The Adalimumab Trial Evaluating Long-Term Safety and Efficacy for Ankylosing Spondylitis (ATLAS) was an ongoing 5-year study that included an initial 24-week, randomized, placebo-controlled, double-blind period. Patients were randomized to adalimumab 40 mg or placebo by subcutaneous injection every other week. Pain was assessed by the bodily pain domain scores of the Medical Outcomes Study Short Form-36 Health Survey (SF-36) and also by total back pain and nocturnal pain using visual analog scales. Fatigue was measured by the SF-36 vitality domain and question 1 of the Bath AS Disease Activity Index (BASDAI). Morning stiffness was measured by the mean of BASDAI questions 5 and 6. Results. Of 315 patients enrolled, 208 received adalimumab 40 mg and 107 received placebo. At Week 12, adalimumab-treated patients experienced significant improvement compared with placebo-treated patients in the SF-36 bodily pain score (p < 0.001), total back pain score (p < 0.001), nocturnal pain score (p < 0.001), fatigue (p < 0.01), and morning stiffness (p < 0.001). Pain, fatigue, and morning stiffness were significantly correlated (p < 0.001) with baseline values of patient-reported health-related quality of life (HRQOL), and physical function, and with improvements in these values at Week 12 by regression analysis. Treatment effects occurred rapidly (within 2 wks) and were maintained through 24 weeks of treatment. Conclusion. Adalimumab significantly improved symptoms of pain, fatigue, and stiffness in patients with AS. Improved symptoms were associated with improved physical function and HRQOL. (First Release May 15 2008; J Rheumatol 2008;35:1346-53) Key Indexing Terms:
ANKYLOSING SPONDYLITIS
From the Center for Health Outcomes Research, United BioSource Corporation, Bethesda, Maryland; Abbott Laboratories, Abbott Park, Illinois; Abbott Laboratories, Parsippany, New Jersey; University of California, San Francisco, California, USA; and Nuffield Orthopaedic Centre, Oxford, UK. Supported by Abbott Laboratories, Abbott Park, IL, USA. D.A. Revicki, PhD, Senior Vice President, Scientific Director, Center for Health Outcomes Research, United BioSource Corporation; M.P. Luo, PhD, Associate Director; N. Chen, MS, Statistician, Global Health Economics and Outcomes Research, Abbott Laboratories; P. Wordsworth, MA, MB, FRCP, Professor of Rheumatology, Nuffield Department of Orthopaedic Surgery, Nuffield Orthopaedic Centre; R.L. Wong, MD, Senior Medical Director, Abbott Laboratories; J.C. Davis Jr, MD, MPH, Assistant Professor of Medicine, University of California, San Francisco. Address reprint requests to Dr. D.A. Revicki, Center for Health Outcomes Research, United BioSource Corporation, 7101 Wisconsin Ave., Suite 600, Bethesda, MD 20814. E-mail: dennis.revicki@unitedbiosource.com Accepted for publication February 7, 2008. |
