RT Journal Article
SR Electronic
T1 Effectiveness, Safety, and Predictors of Good Clinical Response in 1250 Patients Treated with Adalimumab for Active Ankylosing Spondylitis
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP jrheum.081048
DO 10.3899/jrheum.081048
A1 Martin  Rudwaleit
A1 Pascal Claudepierre
A1 Paul Wordsworth
A1 Eduardo Loza Cortina
A1 Joachim Sieper
A1 Martina Kron
A1 Roberto  Carcereri-De-Prati
A1 Hartmut Kupper
A1 Sonja Kary
YR 2009
UL http://www.jrheum.org/content/early/2009/02/25/jrheum.081048.abstract
AB 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) ≥ 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), orASAS 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 ≤ 0.001), HLA-B27 positivity (p ≤ 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.