April 29, 2022
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FDA approves oral upadacitinib for adults with ankylosing spondylitis

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The FDA has approved once-daily oral upadacitinib for the treatment of adults with active ankylosing spondylitis who are intolerant, or have had an inadequate response, to one or more TNF inhibitors.

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

Sign outside FDA HQ in Washington, DC.
The FDA has approved once-daily oral upadacitinib for the treatment of adults with AS who are intolerant, or have had an inadequate response, to one or more TNF inhibitors. Source: Adobe Stock.

FDA approval follows recent efficacy and safety data from two trials, which found that upadacitinib (Rinvoq, AbbVie) demonstrated rapid and meaningful disease control among adults with AS, with nearly half achieving ASAS40 at week 14, compared with placebo, according to the company. One of the studies, the phase 3 SELECT-AXIS 2 clinical trial, evaluated upadacitinib in patients who had an inadequate response or intolerance to one or two biologic disease-modifying anti-rheumatic drugs (DMARDs). Meanwhile, the phase 2/3 SELECT-AXIS 1 clinical trial examined those who were naïve to biologic DMARDs and had an inadequate response or intolerance to at least two NSAIDs.

In both trials, a significantly greater proportion of patients receiving upadacitinib 15 mg achieved an ASAS40 response — 51% in SELECT-AXIS 1 and 44.5% in SELECT-AXIS 2 — compared with those receiving placebo — 26% and 18.2%, respectively — at week 14. In addition, clinical responses were observed as early as week four in SELECT-AXIS 2 for ASAS40.

“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,” Atul Deodhar, MD, of Oregon Health & Science University, and investigator of the SELECT-AXIS 1 trial, said in the 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.”

Additional data from the trials found that upadacitinib 15 mg resulted in improvements in AS signs and symptoms, including total back pain, as well as physical function — as measured by the Bath Ankylosing Spondylitis Functional Index — and disease activity — via Patient Global Assessment of Disease Activity score — compared with placebo at week 14.

The observed safety profile of upadacitinib 15 mg in patients with AS was consistent with those seen in patients with rheumatoid arthritis and psoriatic arthritis, according to the release.

“Currently, there are limited treatment options for people living with ankylosing spondylitis, particularly when painful symptoms persist despite being on a TNF blocker treatment,” Cassie Shafer, CEO of Spondylitis Association of America, said in the 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.”