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Interleukin 1 Receptor Antagonist Anakinra
Improves Functional Status in Patients with Rheumatoid Arthritis
STANLEY B. COHEN, J. MICHAEL WOOLLEY, and WING W. CHAN for the Anakinra 960180 Study Group
ABSTRACT. Methods. Patients (n = 419) were randomized to receive, in addition to MTX (15 to 25 mg/wk), placebo or anakinra doses of 0.04, 0.1, 0.4, 1, or 2 mg/kg once daily for 24 weeks. Functional status measured on 8 scales (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities) was evaluated at baseline and every 4 weeks with the Health Assessment Questionnaire (HAQ). A weighted sum of the scale scores is the HAQ disability index (HAQ-DI). Primary analysis of the HAQ-DI was based on an omnibus test for a positive dose-response relationship between anakinra treatment and change in HAQ-DI from baseline to week 24. Results. Patients receiving anakinra experienced rapid and sizeable improvements in their HAQ-DI scores in a dose-related fashion. For patients receiving either of the 2 highest doses of anakinra, improvements in the HAQ-DI occurred by week 4 that were of a magnitude considered clinically important and statistically significantly superior to placebo. Conclusion. In patients with persistence of RA despite MTX therapy, treatment with anakinra results in a rapid improvement in functional status as measured by the HAQ-DI. (J Rheumatol 2003;30:225-31) Key Indexing Terms:
ANAKINRA
From the St. Paul Medical Center, Dallas, Texas, and Amgen Inc., Thousand Oaks, California, USA. Support by Amgen Inc., Thousand Oaks, CA, USA. S.B. Cohen, MD; J.M. Woolley, PhD; W.W. Chan, MS. Address reprint requests to Dr. S.B. Cohen, St. Paul Medical Center, Department of Rheumatology, 5939 Harry Hines Boulevard, Suite 400, Dallas, TX 75235. Submitted February 5, 2002; revision accepted August 13, 2002. |