Abbott announces results from HUMIRA Phase 3 study on axSpA

October 31, 2017

"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."