Abbott has announced results from the open-label extension of the Phase 3 ABILITY-1 investigational study of Humira (adalimumab) evaluating an anti-tumour necrosis factor medication (anti-TNF) in treating patients with non-radiographic active axial spondyloarthritis (axSpA).
The pivotal study used the assessment of spondyloarthritis international society (ASAS) criteria to classify non-radiographic axSpA patients.
Abbott immunology clinical development divisional vice president, John Medich, said biologics like Humira have advanced the care for patients who may have dealt with unresolved disease symptoms for a variety of immunological conditions.
"Abbott continues to explore new indications for Humira, such as non-radiographic axSpA, that would potentially provide rheumatologists with more treatment options to choose from and help even more patients around the world," Medich added.
The primary end point of the ABILITY-1 study was ASAS 40 defined as at least a 40% improvement from baseline using the ASAS criteria, which is a more rigorous measure than the ASAS 20 response criteria used in pivotal AS clinical trials.
The study found that a significantly higher percentage of Humira patients achieved ASAS 40 in the initial 12-weeks, compared to those receiving placebo.
Following the 12-week double-blind period, 67% of Humira patients who continued into the open-label extension, and had data available for the analysis at 68 weeks, achieved ASAS 40.
The study also assessed the patients for the level of disease activity based on the ankylosing spondylitis disease activity score (ASDAS), a measure used to assess disease activity in spondyloarthritides.
The study reported that 47% of patients achieved an inactive disease state, defined by an ASDAS score of less than 1.3.
Humira is not approved for the treatment of spondyloarthritides, other than ankylosing spondylitis and psoriatic arthritis.
