JOURNAL ARTICLE
MULTICENTER STUDY

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

Martin Rudwaleit, Pascal Claudepierre, Paul Wordsworth, Eduardo Loza Cortina, Joachim Sieper, Martina Kron, Roberto Carcereri-De-Prati, Hartmut Kupper, Sonja Kary
Journal of Rheumatology 2009, 36 (4): 801-8
19273449

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<or=0.001), HLA-B27 positivity (p<or=0.01), and tumor necrosis factor (TNF) antagonist naivety (p<0.001).

CONCLUSION: Adalimumab was effective in this large cohort of patients with AS, with more than half of patients achieving a BASDAI 50 or ASAS40 response and more than a quarter of patients reaching partial remission at Week 12.Younger age, greater CRP concentrations, HLA-B27 positivity, and TNF antagonist naivety were strongly associated with BASDAI 50, ASAS40, and partial remission responses. ClinicalTrials.gov identifier: NCT00478660.

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