Anakinra reduces the rate of joint destruction after 1 year of treatment in a randomised controlled cohort of patients with rheumatoid arthritis

B Bresnihan, RD Newmark, S Robbins, D McCabe, HK GenantDepartment of Rheumatology, St. Vincent’s University Hospital, Dublin, Ireland Clinical Development, Amgen Inc., Thousand Oaks, USA Department of Radiology, University of San Francisco, San Francisco, USABackground Objectives To assess the effect of ankinra on progressive joint damage in patients with rheumatoid arthritis after 12 months of treatment. Methods 472 patients were randomised to a 24 week study. On completing the 24 week, placebo-controlled, randomised clinical trial, patients receiving anakinra 30, 75 or 150 mg daily continued blinded treatment for a further 24 weeks. Patients originally randomised to placebo were re-randomised to blinded treatment with one of the 3 anakinra doses for an additional 24 weeks resulting in a blinded cohort of patients (N = 309) followed for up to 1 year by radiographic assessments, using a modified Sharp method (Genant A&R, 41:1583, 98). Results Treatment with 75 or 150 mg anakinra was significantly superior in terms of reducing joint destruction after 1 year, when compared to the group of patients originally randomised to placebo. This analysis demonstrated a dose proportional relationship with increasing doses of anakinra providing superior reduction of joint destruction when measured by a modified Sharp score. Abstract FRI0063 Table 1 p-values for pairwise comparisons vs placebo are the result of an analysis using a repeated measures mixed model. Placebo n = 59 30 mg n = 66 75 mg n = 64 150 mg n = 48 Mean change in mod. Sharp score after 1 year 3.81 2.43 p = 0.099 1.91 p = 0.025 1.90 p = 0.025 Conclusion Anakinra provides a statistically significant reduction in joint destruction, compared with patients originally randomised to placebo after 1 year of treatment. The reduction in joint destruction was dose proportional. Citation: Ann Rheum Dis, volume 60, supplement 1, year 2001, page A471Session: Rheumatoid Arthritis – Treatment