In July 2012, the European Commission approved HUMIRA for the treatment of adults with severe nr-axSpA, making it the first biologic and only approved medication available for this disease in Europe. In the U.S., HUMIRA is being investigated for the treatment of nr-axSpA and is not approved for the treatment of spondyloarthritides other than AS and psoriatic arthritis.
About SpASpondyloarthritis (SpA) is a group of diseases that share common clinical, radiographic and genetic features. SpA can be categorized according to which part of the body is mainly affected – axial or peripheral. Assessment of SpondyloArthritis International Society (ASAS) developed improved classification criteria for axial and peripheral SpA designed to facilitate identification and classification of people with SpA who share similar symptoms. Criteria for axial SpA 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), one of the hallmarks of axial spondyloarthritis. While worldwide epidemiologic data does not exist for axSpA, studies have shown it is estimated that axSpA affects up to 1 percent of adults in the United States.
About ABILITY-1ABILITY-1 is the first large, pivotal study to use the ASAS criteria to classify nr-axSpA patients, and to evaluate an anti-tumor necrosis factor medication (anti-TNF) in treating patients with nr-axSpA. It is an ongoing, multi-country, Phase 3 study designed to evaluate the efficacy and safety of HUMIRA in nr-axSpA patients.
Eligible patients were randomized 1:1 to receive either HUMIRA (40 mg every other week, n=91) or placebo (n=94) for 12 weeks. The primary endpoint results from this double-blind, placebo-controlled study showed that a significantly higher percentage of HUMIRA patients, compared to those receiving placebo, achieved ASAS 40 at week 12 (36.3 percent versus 14.9 percent; p<0.001). ASAS 40 is defined as at least a 40 percent improvement from baseline in the Assessment of SpondyloArthritis International Society (ASAS) response criteria.