Abbott Laboratories Announces Phase 3 Study Results for Investigational Use of HUMIRA (Adalimumab) in Patients with Active Non-radiographic Axial Spondyloarthritis

Abbott Laboratories announced results from the open-label extension of the Phase 3 ABILITY-1 investigational study of HUMIRA (adalimumab), which assessed the improvement in signs and symptoms of disease for patients with active axial spondyloarthritis (axSpA) who have no X-ray evidence of structural damage. Results were presented at the European League Against Rheumatism (EULAR) 2012 Congress in Berlin, Germany. ABILITY-1 is the first large, pivotal study to use the Assessment of SpondyloArthritis international Society (ASAS) criteria to classify non-radiographic axial SpA patients, and to evaluate an anti-tumor necrosis factor medication (anti-TNF) in treating patients with non-radiographic axSpA. ABILITY-1 used the ASAS 40 response criteria for the primary endpoint, which is a more stringent outcome measure than the ASAS 20 response criteria used in pivotal AS clinical trials. ASAS 40 is defined as at least a 40% improvement from baseline using the ASAS criteria. The initial 12-week results from this study showed that a significantly higher percentage of HUMIRA patients, compared to those receiving placebo, achieved ASAS 40 (36.3% vs. 14.9%, P<0.001). Following this 12-week, double-blind period, 67% of HUMIRA patients who continued into the open-label extension and had data available for the analysis at 68 weeks (n=144) achieved ASAS 40.