Abbott Announces First Long-term Patient-reported Health Outcomes Data For Investigational Use Of HUMIRA® (Adalimumab) In Patients With Active Non-Radiographic Axial Spondyloarthritis (nr-axSpA)
ABBOTT PARK, Ill., Nov. 12, 2012 /PRNewswire/ -- Abbott (NYSE: ABT) today 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.
"There are many adults, especially younger, with nr-axSpA whose disease can be as painful, and have similar adverse impact on the ability to function, as those with more classic ankylosing spondylitis," said Professor Philip Mease, University of Washington and Swedish Medical Center, Seattle, Washington. "This study evaluated adalimumab treatment on reduction of signs and symptoms in nr-axSpA patients and the improvement of important patient-reported outcomes including physical function and health-related quality of life, goals we all want for this often inadequately recognized and treated patient group."
Study ResultsAn 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 percent of patients met the minimum important difference (MID) for the HAQ-S of 0.26 at week 52.
The HRQOL was assessed using the Short Form 36 Health Survey (SF-36) score. 77 percent of patients met the MID for SF-36 Physical Component Summary (PCS) score of 3.0 at week 52. Placebo patients who switched to open-label HUMIRA experienced improvements in HRQOL comparable to patients who received HUMIRA through week 52. By week 52, patients in both groups achieved SF-36 scores (42.8 and 44.1, respectively), expressed on a scale of 0-100, where higher scores indicate better health and well-being.
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