FDA Approves Rinvoq for Another Inflammatory Condition

The FDA approval in active ankylosing spondylitis is the fifth indication for Rinvoq in chronic immune-mediated diseases. It joins Xeljanz, which was the first approved JAK inhibitor for this condition in December 2021.

The FDA has approved AbbVie’s Rinvoq (upadacitinib) for the treatment of adults with active ankylosing spondylitis, an inflammatory disease that can cause vertebrae to fuse and can lead to a hunched posture.

It is the second JAK inhibitor approved to treat this condition when patients have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. The first was Pfizer’s Xeljanz (tofacitinib), which was approved in December 2021.

“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, 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 2 study, said in a press release.

The approval of Rinvoq for ankylosing spondylitis is supported by the phase 3 SELECT-AXIS 2 clinical trial evaluating patients who had an inadequate response or intolerance to one or two biologic disease-modifying anti-rheumatic drugs and the phase 2/3 SELECT-AXIS 1 clinical trial evaluating patients who were naïve to bDMARDs and had an inadequate response or intolerance to at least two nonsteroidal anti-inflammatory drugs.

Treatment with Rinvoq resulted in improvements in the signs and symptoms of AS, including total back pain, as well as improvements in physical function and disease activity compared with placebo at week 14. Overall, the safety profile observed in patients with active AS treated was consistent with the safety profile observed in patients with rheumatoid arthritis and psoriatic arthritis.

Rinvoq is a JAK-inhibitor that is also approved to treat severe rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and atopic dermatitis. In December 2021, the FDA required JAK inhibitors, including Rinvoq, to include on their labels the risk of cardiovascular events and cancer.

Related: FDA Requires New Boxed Warning on Xeljanz, other JAK Inhibitors