Phase 3 Study of Humira for Active Non-Radiographic Axial Spondyloarthritis
Abbott announced results from its Phase 3 ABILITY-1 study of Humira (adalimumab) in patients with active non-radiographic axial spondyloarthritis (axSpA). ABILITY-1 is an ongoing, multi-country, randomized trial evaluating the efficacy and safety of Humira for 12 weeks in axSpA patients without radiographic sacroiliitis. At Week 12, more than twice as many Humira patients compared to those receiving placebo achieved the primary endpoint of 40% improvement in the Assessment of SpondyloArthritis international Society criteria (ASAS 40).
A significantly higher percentage of Humira patients achieved the primary endpoint (36.3% vs. 14.9%, P<0.001) and other clinical and imaging outcomes compared to placebo. During the double-blind period, safety analyses for all 192 randomized patients revealed comparable results for Humira and placebo: adverse events (AEs) (57.9% and 58.8%, respectively), serious AEs (3.2% and 1.0%, respectively) and infectious AEs (29.5% and 28.9%, respectively).
Humira, a tumor necrosis factor-alpha blocker, is already indicated for the treatment of Crohn's disease, adult rheumatoid arthritis, psoriatic arthritis, chronic plaque psoriasis, and ankylosing spondylitis.
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