FDA Approves Upadacitinib for Adults with Ankylosing Spondylitis

The newest indication for the AbbVie biologic marks the fifth for treating a chronic immune-mediated disease.

The US Food and Drug Administration (FDA) has approved once-daily 15 mg upadacitinib (RINVOQ) for the treatment of adults with active ankylosing spondylitis who previously had inadequate response or intolerance to ≥1 tumor necrosis factor (TNF) inhibitor.

The approval, granted to AbbVie, adds the JAK inhibitor as an option with difficulties achieving treatment response to the chronic musculoskeletal inflammation disease—and marks the fifth FDA indication for upadacitinib in the treatment of chronic immune-mediated diseases.

AbbVie’s application for upadacitinib was supported by data from the SELECT-AXIS trial program, a pair of pivotal phase 2/3 clinical studies in which a significantly greater proportion of patients receiving 15 mg therapy achieved composite assessment ankylosing spondylitis improvement of ≥40% (ASAS40) than patients receiving placebo at week 14.

The trial participants included adult patients with active ankylosing spondylitis who were naïve to biologic disease-modifying antirheumatic drugs and had inadequate response or intolerance to ≥2 non-steroidal anti-inflammatory drugs. In SELECT-AXIS 1 and 2, ASAS40 rates included 51.0% and 44.5% of patients on upadacitinib, respectively, versus 26.0% and 18.2% of patients on placebo, respectively.

Investigators reported observation of clinical response as early as week 4 among patients treated with upadacitinib in ASAS40.

In a statement accompanying the approval, SELECT-AXIS 1 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, stressed the impact of the approval for the in-need patient population.

“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,” Deodhar said. "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."