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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. identifier: NCT00478660.

Original publication




Journal article


The Journal of rheumatology

Publication Date





801 - 808


Charité-University Medicine Berlin, Campus Benjamin Franklin Hospital, Medical Department I, Rheumatology, Hindenburgdamm 30, 12200 Berlin, Germany.


Humans, Spondylitis, Ankylosing, Antirheumatic Agents, Antibodies, Monoclonal, Treatment Outcome, Remission Induction, Prospective Studies, Adult, Middle Aged, Antibodies, Monoclonal, Humanized