AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ (upadacitinib; 15 mg, once daily) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.
“Ankylosing spondylitis is a debilitating disease that often affects younger adults and, over time, can result in lasting structural damage that can take an emotional toll on a patient’s life,” said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. “This latest approval demonstrates another important step forward in our mission to advance the standards of care in rheumatic diseases.”
The FDA approval in AS is supported by efficacy and safety data from the Phase 3 SELECT-AXIS 2 clinical trial (Study 1) evaluating RINVOQ in patients who had an inadequate response or intolerance to one or two biologic disease-modifying anti-rheumatic drugs (bDMARDs) and the Phase 2/3 SELECT-AXIS 1 clinical trial evaluating RINVOQ in patients who were naïve to bDMARDs and had an inadequate response or intolerance to at least two nonsteroidal anti-inflammatory drugs (NSAIDs).
“Many patients with ankylosing spondylitis do not achieve disease control with current biologic therapies and additional treatments are needed to help relieve the signs and symptoms of this disease,” said Atul Deodhar, M.D., professor of medicine and medical director of the Rheumatology Clinics for the Division of Arthritis and Rheumatic Diseases at Oregon Health & Science University, and investigator of the SELECT-AXIS 1 trial. “With today’s FDA approval, patients who do not respond to a TNF inhibitor have an additional oral treatment option, in partnership with their rheumatologist, to help take control of this disease.”
In both SELECT-AXIS 1 and SELECT-AXIS 2 clinical trials, a significantly greater proportion of patients receiving RINVOQ 15 mg achieved an ASAS40 response, the primary endpoint, (51% and 44.5%, respectively) compared to those receiving placebo (26% and 18.2%, respectively) at week 14. Clinical responses were observed as early as week four in SELECT-AXIS 2 for ASAS40.
“Currently, there are limited treatment options for people living with ankylosing spondylitis, particularly when painful symptoms persist despite being on a TNF blocker treatment,” said Cassie Shafer, chief executive officer, Spondylitis Association of America (SAA). “The approval of a new medicine is welcome news to our community of patients, offering the potential to help more people find meaningful relief from the symptoms of AS and to help reach their treatment goals.”
AS is a chronic inflammatory musculoskeletal disease primarily affecting the spine and characterized by debilitating symptoms of inflammatory back pain, stiffness and restricted mobility. An estimated one out of every 200 adults in the U.S., or approximately 1.1 million people, is affected by AS.