Atlas was a randomized, placebo-controlled, double-blind, Phase III study conducted in the US and Europe. The study involved 315 patients with active ankylosing spondylitis (AS) who had an inadequate response to at least one non-steroidal anti-inflammatory drug or disease modifying anti-rheumatic drug. Patients received Humira 40mg subcutaneously or placebo every other week (EOW).
Results at 12 and 24 weeks showed Humira patients experienced a statistically significant reduction in signs and symptoms according to the Assessment in SpondyloArthritis International Society (ASAS) measure, or ASAS20 compared to placebo. ASAS20 represents at least a 20% improvement in at least three of the four assessments to measure patient improvement and response to therapy. At 24 weeks, all patients were switched to an open-label Humira 40mg EOW dose trial for an additional 236 weeks.
Improvement was observed through three years of treatment. After three years, 74% (174/234) of patients achieved ASAS20 and 42% (97/234) of patients achieved ASAS partial remission.