Abbott announced the first long-term patient-reported health outcomes data from an open-label analysis of the ongoing, Phase 3 ABILITY-1 trial of Humira (adalimumab), evaluating improvements in physical function and health-related quality of life (HRQOL) after 52 weeks in patients with active non-radiographic axial spondylarthritis (nr-axSpA). Humira is a tumor necrosis factor alpha blocker.
Eligible patients were randomized 1:1 to receive either Humira (40mg every other week, n=91) or placebo (n=94) for 12 weeks. The primary endpoint results from this double-blind, placebo-controlled study showed that a significantly higher percentage of Humira patients, compared to those receiving placebo, achieved ASAS 40 at Week 12 (36.3% vs. 14.9%; P<0.001). ASAS 40 is defined as ≥40% improvement from baseline in the Assessment of SpondyloArthritis International Society (ASAS) response criteria.
The double-blind period was followed by the open-label extension phase in which all patients could receive Humira (40mg every other week) for up to an additional 144 weeks (n=179). An exploratory, post-hoc analysis of data from the open-label extension showed that nr-axSpA patients taking Humira continued to experience improvement in physical function and HRQOL measures at Week 52. In both the double-blind and open-label phases of the study, physical function was assessed using the disability index of the Health Assessment Questionnaire for Spondyloarthropathies (HAQ-S). Approximately 62% of patients met the minimum important difference (MID) for the HAQ-S of 0.26 at Week 52.
Humira is indicated for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, chronic plaque psoriasis, ulcerative colitis, and psoriatic arthritis in adults. Humira is also indicated for the treatment of polyarticular juvenile idiopathic arthritis in children ≥4 years of age.
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