Abbott (NYSE: ABT) today announced results from the Phase 3 ABILITY-1 study of HUMIRA® (adalimumab) in patients with active non-radiographic axial spondyloarthritis (axSpA). AxSpA is a debilitating condition that primarily presents with inflammatory low back pain and can be accompanied by the presence of the HLA-B27 gene, arthritis, and inflammation in the eye and/or gastrointestinal tract. At week 12, more than twice as many HUMIRA patients compared to those receiving placebo achieved the primary endpoint of 40 percent improvement in the Assessment of SpondyloArthritis international Society criteria (ASAS 40). These results were presented at the American College of Rheumatology Annual Scientific Meeting (ACR) in Chicago.
Spondyloarthritis (SpA) is a group of diseases that share common clinical, radiographic and genetic features. SpA includes ankylosing spondylitis (AS), psoriatic arthritis (PsA), reactive arthritis, enteropathic or inflammatory bowel disease (IBD)-related arthritis and undifferentiated SpA. SpA can be categorized according to which part of the body is mainly affected – axial or peripheral. ASAS has proposed and validated new classification criteria for axial and peripheral SpA that incorporate the use of magnetic resonance imaging (MRI), in addition to traditional X-rays, for visualizing sacroiliitis (inflammation of the sacroiliac joint which connects the lower spine and pelvis). People with non-radiographic axSpA have similar signs and symptoms as those with AS but do not have X-ray evidence of structural damage in the form of sacroiliitis. The ASAS criteria are designed to facilitate classification of people with non-radiographic axSpA who may otherwise remain undiagnosed.
ABILITY-1 is the first large pivotal study to use the ASAS criteria to classify non-radiographic axial SpA patients, as well as evaluate an anti-tumor necrosis factor medication (anti-TNF) in treating patients with non-radiographic axSpA. ABILITY-1 also used the ASAS 40 response criteria for the primary endpoint instead of the less stringent ASAS 20 response criteria.
"There is a tremendous unmet need for effective treatments for patients with non-radiographic axSpA," said Philip Mease, M.D., Chief, Swedish Hospital Rheumatology Clinical Research Division, Seattle, WA. "Adalimumab has been shown to be an effective treatment for two other spondyloarthritides: ankylosing spondylitis and psoriatic arthritis. The results of this study are encouraging for its potential in treating another condition within this group of diseases."
In the study, a significantly higher percentage of HUMIRA patients achieved the primary endpoint (36.3 percent vs. 14.9 percent, P<0.001) and other clinical and imaging outcomes compared to placebo. During the double-blind period, safety analyses for all 192 randomized patients revealed comparable results for HUMIRA and placebo: adverse events (AEs) (57.9 and 58.8 percent, respectively), serious AEs (3.2 and 1.0 percent, respectively) and infectious AEs (29.5 and 28.9 percent, respectively).
"HUMIRA is one of the most comprehensively studied biologics on the market, and Abbott continues to innovate by exploring new treatment arenas," said John Leonard, M.D., senior vice president, Pharmaceuticals Research and Development, Abbott. "Our scientific experience with HUMIRA serves as a strong foundation to fulfill unmet clinical needs, such as non-radiographic axSpA, and expand treatment options available to patients."