FDA Approves Upadacitinib for Active PsA

Upadacitnib received FDA approval for the treatment of adults with active psoriatic arthritis (PsA) who previously had inadequate response or intolerance to tumor necrosis factor blockers. The approval is the second indication for upadacitinib, which previously was approved for moderate to severe rheumatoid arthritis (RA).

This newest approval comes after two pivotal phase 3 trials (SELECT-PsA 1, SELECT-PsA 2) that evaluated the efficacy and safety of upadacitinib for PsA. After 12 weeks of treatment, patients who received upadacitinib 15 mg once daily achieved significantly higher American College of Rheumatology 20, 50, and 70 responses vs placebo. In addition, upadacitinib treatment was associated with improvements in dactylitis, enthesitis, inhibition of progressive structural joint damage, physical function, fatigue, and skin manifestations of psoriatic disease.

The safety profile of upadacitinib in patients with active PsA was consistent with that seen in patients with RA. The boxed warning includes risk of serious infections, increased risk of death and major cardiovascular events, malignancy, and blood clots.

Upadacitinib is an oral selective Janus kinase 1 inhibitor, and it is currently being evaluated in additional phase 3 trials for atopic dermatitis, Crohn disease, ulcerative colitis, and others.

Reference
RINVOQ® (upadacitinib) Receives U.S. FDA Approval for Active Psoriatic Arthritis. Press release. AbbVie; December 14, 2021. Accessed December 14, 2021. https://prnmedia.prnewswire.com/news-releases/rinvoq-upadacitinib-receives-us-fda-approval-for-active-psoriatic-arthritis-301444790.html