Phase III trial of Humira (Abbott) shows significant benefits for Axial Spondyloarthritis treatment

The Phase III ABILITY-1 study of Humira (adalimumab), from Abbott, in patients with active non-radiographic Axial Spondyloarthritis (axSpA), has reported encouraging results. 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). 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. People with non-radiographic axSpA have similar signs and symptoms as those with Ankylosing Spondylitis but do not have X-ray evidence of structural damage in the form of sacroiliitis. 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. 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. the safety analyses for all 192 patients revealed comparable results for humira and placebo. these results were presented by philip mease chief swedish hospital rheumatology clinical research division seattle at the american college of rheumatology annual scientific meeting in chicago.>