Trial extension found two-thirds of patients achieved ASAS 40 response.
Treating nonradiographic axial spondyloarthritis (axSpA) using Abbott’s TNF-blocker Humira® (adalimumab) results in significant improvements in major disease scores, according to data from an open-label extension to the Phase III Ability-1 study. The ongoing placebo-controlled study is the first large, pivotal trial to use Assessment of Spondyloarthritis International Society (ASAS) criteria to classify nonradiographic axSpA patients, Abbott notes. The study has also applied an ASAS 40 response (at least a 40% improvement in ASAS criteria from baseline) rather than ASAS 20, as the primary endpoint.
Following positive data from the initial 12-week double-blind phase of the trial, the placebo-controlled open-label stage assessed Humira therapy over 68 weeks in 179 patients. The results showed that 80% of the 144 patients for whom data was available achieved at least a 20% improvement in the ASAS criteria (ASAS 20) at week 68, while 67% achieved ASAS 40, and 65% achieved at least a 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index. The trial’s secondary endpoint, ADAS inactive disease state, was achieved by 47%, and ASAS partial remission by 36% of patients.
Humira is currently approved for treating ankylosing spondylitis and psoriatic arthritis, but has yet to be approved for treating axSpA. “Biologics like Humira have advanced the care for patients who may have dealt with unresolved disease symptoms for a variety of immunological conditions,” comments John Medich, Ph.D., divisional vp, clinical development, immunology at Abbott. “Abbott continues to explore new indications for Humira, such as nonradiographic axSpA, that would potentially provide rheumatologists with more treatment options to chose from.”