Humira effectively treated patients with non-radiographic axial spondyloarthritis

WASHINGTON — Patients with active non-radiographic axial spondyloarthritis experienced improved physical function and quality of life measurements after 1 year of treatment with adalimumab, according to information announced by Abbott at the American College of Rheumatology Annual Meeting.

Results of the ongoing phase 3 trial of adalimumab (Humira, Abbott) evaluated improvement in physical function and health-related quality of life (HRQOL) among patients with non-radiographic axial spondyloarthritis (nr-axSpA), according to a press release. Physical function was determined by using the disability index of the Health Assessment Questionnaire for Spondyloarthropathies (HAQ-S) in the trial’s double blind and open-label phases. Investigators and patients were aware that Humira was assigned to patients in the open-label extension.

A minimum important difference of 0.26 for HAQ-S was met by approximately 62% of patients at week 52. HRQOL was determined by Short Form 36 Health Survey (SF-36) scores (0 to 100, with higher scores indicating better health and well-being). Seventy-seven percent of patients achieved a SF-36 Physical Component Summary score of 3.0 at 1 year. According to Abbott, placebo patients (n=94) who switched to open-label Humira at week 12 experienced improvements in HRQOL comparable to patients (n=91) who were assigned Humira (40 mg biweekly) through week 52. SF-36 scores of 42.8 and 44.1 at 52 weeks were attained by Humira and placebo patients, respectively.

“Patient-reported outcomes data focusing on physical function and health-related quality of life help measure the impact treatment has on patients in their day-to-day life,” John R. Medich, PhD, Abbott’s divisional vice president of immunology clinical development for global pharmaceutical research and development, said in the release.

Humira is being investigated in the United States for treating nr-axSpA; it already is approved as therapy for ankylosing spondylitis and psoriatic arthritis. Humira was approved by the European Commission in July 2012 for treating adults with severe nr-axSpA.