Effectiveness, safety, and predictors of good clinical response in 1250 patients treated with adalimumab for active ankylosing spondylitis.

Journal article

OBJECTIVE: We evaluated the effectiveness and safety of adalimumab in a large cohort of patients with active ankylosing spondylitis (AS) and identified clinical predictors of good clinical response. METHODS: Patients with active AS [Bath AS Disease Activity Index (BASDAI)>or=4] received adalimumab 40 mg every other week in addition to their standard antirheumatic therapies in a multinational 12-week, open-label study. We used 3 definitions of good clinical response: 50% improvement in the BASDAI (BASDAI=50), 40% improvement in the ASsessments of SpondyloArthritis International Society criteria (ASAS40), or ASAS partial remission. Response predictors were determined by logistic regression with backward elimination (selection level 5%). RESULTS: Of 1250 patients, 1159 (92.7%) completed 12 weeks of adalimumab treatment. At Week 12, 57.2% of patients achieved BASDAI 50, 53.7% achieved ASAS40, and 27.7% achieved ASAS partial remission. Important predictors of good clinical response (BASDAI 50, ASAS40, and partial remission) were younger age (p<0.001), and greater C-reactive protein (CRP) concentration (p

Authors: Rudwaleit, M; Claudepierre, P; Wordsworth, P; Cortina, E; Sieper, J

• Publication status: Published
• Journal: Journal of rheumatology
• Volume: 36
• Issue: 4
• Pages: 801-808
• Publication date: 2009-04-01
• DOI: 10.3899/jrheum.081048
• EISSN: 1499-2752
• ISSN: 0315-162X
• Language: English
• Keywords: Remission Induction; Antibodies, Monoclonal, Humanized; Adult; Antirheumatic Agents; Treatment Outcome; Prospective Studies; Middle Aged; Humans; Spondylitis, Ankylosing; Antibodies, Monoclonal