Abbott (NYSE: ABT) today announced results from the open-label extension of the Phase 3 ABILITY-1 investigational study of HUMIRA® (adalimumab), which assessed the improvement in signs and symptoms of disease for patients with active axial spondyloarthritis (axSpA) who have no X-ray evidence of structural damage. Results were presented at the European League Against Rheumatism (EULAR) 2012 Congress in Berlin, Germany.
ABILITY-1 is the first large, pivotal study to use the Assessment of SpondyloArthritis international Society (ASAS) criteria to classify non-radiographic axial SpA patients, and to evaluate an anti-tumor necrosis factor medication (anti-TNF) in treating patients with non-radiographic axSpA. ABILITY-1 used the ASAS 40 response criteria for the primary endpoint, which is a more stringent outcome measure than the ASAS 20 response criteria used in pivotal AS clinical trials. ASAS 40 is defined as at least a 40 percent improvement from baseline using the ASAS criteria.
The initial 12-week results from this study showed that a significantly
higher percentage of HUMIRA patients, compared to those receiving placebo,
achieved ASAS 40 (36.3 percent vs. 14.9 percent, P<0.001). Following this
12-week, double-blind period, 67 percent of HUMIRA patients who continued into
the open-label extension and had data available for the analysis at 68 weeks
(n=144) achieved ASAS 40.
AxSpA can be a debilitating condition that primarily presents with chronic back pain and stiffness, and can be accompanied by the presence of arthritis, inflammation in the eye and/or gastrointestinal tract. People with non-radiographic axSpA can have similar signs and symptoms as ankylosing spondylitis (AS) – including inflammation in the back joints that can lead to severe, chronic pain and discomfort – but do not have X-ray evidence of structural damage. AxSpA is most often seen in younger individuals and can go unrecognized for years.