Humira adalimumab: Additional Phase III data
Additional data from the double-blind, international Phase III ABILITY-1 trial in 179 patients with active non-radiographic axial spondyloarthritis showed that Humira significantly improved Health Assessment Questionnaire for Spondyloarthropathies (HAQ-S) scores at week 12 vs. placebo (reductions of 0.3 vs. 0.1 points, p=0.025). Humira also significantly improved SF-36 physical component summary scores at week 12 vs. placebo (5.5 vs. 2 points, p<0.001).
A post hoc analysis of the open-label extension study of the ABILITY-1 trial showed that 62% patients receiving Humira met the minimum important difference (MID) for HAQ-S score of 0.26 points at week 52. Additionally, 77% of patients receiving Humira met the MID at week 52 in health-related quality of life (QoL) as measured by Short Form 36 Health Survey (SF-36) physical component score of 3 points. Patients who received placebo and crossed over to Humira had similar improvements in health-related QoL. Data were presented at the American College of Rheumatology meeting in Washington. ...