FDA Approves Upadacitinib for Active Ankylosing Spondylitis


FDA approves 15 mg upadacitinib (Rinvoq; AbbVie) for the treatment of adult patients with active ankylosing spondylitis who previously showed an inadequate response or intolerance to 1 or more tumor necrosis factor inhibitors.

The FDA has approved once-daily 15 mg upadacitinib (Rinvoq; AbbVie) for the treatment of adult patients with active ankylosing spondylitis (AS) who previously showed an inadequate response or intolerance to 1 or more tumor necrosis factor (TNF) inhibitors. AS, which is characterized by inflammatory back pain, stiffness, and restricted mobility, affects an estimated 1 out of every 200 US adults.

The approval of the Janus kinase (JAK) inhibitor provides a new option for patients unable to achieve a treatment response to AS, a chronic musculoskeletal inflammatory disease. The approval marks the fifth FDA indication for upadacitinib in the treatment of chronic immune-mediated diseases.

"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, MD, senior vice president, research and development, chief scientific officer, AbbVie, in a press release. "This latest approval demonstrates another important step forward in our mission to advance the standards of care in rheumatic diseases."

The approval was based on efficacy and safety data from the phase 3 SELECT-AXIS 2 clinical trial, which analyzed upadacitinib in patients who showed an inadequate response or intolerance to 1-2 biologic disease-modifying anti-rheumatic drugs (bDMARDs); as well as the phase 2/3 SELECT-AXIS 1 trial of upadacitinib in patients naïve to bDMARDs and showed an inadequate response or intolerance to at least 2 nonsteroidal anti-inflammatory drugs.

In both trials, data showed a significantly greater proportion of patients administered upadacitinib 15 mg achieved the trial’s primary endpoint, which was an ASAS40 response versus patients administered placebo (26% and 18.2%, respectively) at week 14. Clinical responses were shown as early as week 4 in SELECT-AXIS 2 for ASAS40, according to the study.

"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 SELECT-AXIS 1 trial investigator Atul Deodhar, MD, professor of medicine and medical director of the Rheumatology Clinics for the Division of Arthritis and Rheumatic Diseases at Oregon Health & Science University, in a press release. "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."

The data also showed a significantly greater mean decrease from baseline in Total Back Pain (-3.1 change from baseline) versus placebo (-1.5) and a significantly greater improvement in physical function (-2.3 change from baseline) as assessed by mean change from baseline in BASFI versus placebo (-1.09).

The safety profile in patients with active AS administered upadacitinib 15 mg was consistent with what was previously observed in patients with rheumatoid arthritis and psoriatic arthritis.

"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, in a press release. "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."


RINVOQ® (upadacitinib) Approved by U.S. FDA as an Oral Treatment for Adults with Active Ankylosing Spondylitis. AbbVie. News release. April 29, 2022. https://news.abbvie.com/news/press-releases/rinvoq-upadacitinib-approved-by-us-fda-as-an-oral-treatment-for-adults-with-active-ankylosing-spondylitis.htm

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