Abbott Laboratories Announces First Long-Term Patient-Reported Health Outcomes Data For Investigational Use Of HUMIRA (Adalimumab) In Patients

Abbott Laboratories 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). The study evaluated improvements in physical function and health-related quality of life (HRQOL) after 52 weeks in patients with active non-radiographic axial spondyloarthritis (nr-axSpA). These results are being presented at the American College of Rheumatology Annual Scientific Meeting (ACR) in Washington, D.C. 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. Additional results from the double-blind period showed that nr-axSpA patients taking HUMIRA experienced a statistically significantly greater improvement in HAQ-S as compared to placebo (-0.3 versus -0.1 respectively; P=0.025.) at week 12, as well as a statistically significantly greater improvement in SF-36 PCS (5.5 versus 2.0, respectively; p <0.001) at week 12.