FDA Okays Upadacitinib for GCA

The U.S. Food and Drug Administration has approved upadacitinib 15 mg once daily for the treatment of adults with giant cell arteritis (GCA). This marks the first and only oral Janus kinase (JAK) inhibitor approved for GCA.

Approval was based on results from the Phase 3 SELECT-GCA trial, in which 46.4% of patients receiving upadacitinib 15mg with a 26-week steroid taper achieved sustained remission from week 12 to 52, compared to 29.0% in the placebo group with a 52-week taper (p=0.002). The safety profile during the 52-week period was consistent with existing indications.

GCA, the most common vasculitis in Western adults, involves inflammation of cranial and large arteries, and can result in severe complications like blindness or stroke. It predominantly affects Caucasian women over 50, though men may have higher rates of ocular involvement.

Upadacitinib presents a promising steroid-sparing treatment option, addressing the need for alternatives to long-term glucocorticoid use, which carries significant toxicity and a high relapse rate. Notable safety concerns with the use of upadacitinib include serious infections, malignancies, cardiovascular events, blood clots, and gastrointestinal perforations, especially in patients over 50 with cardiovascular risk factors.

The SELECT-GCA trial continues with a second phase assessing the benefits of continuing versus withdrawing upadacitinib in patients who achieved remission.

Reference: RINVOQ® (upadacitinib) Receives U.S. FDA Approval for Giant Cell Arteritis (GCA). News release. AbbVie; April 29, 2025. Accessed May 5, 2025. https://news.abbvie.com/2025-04-29-RINVOQ-R-upadacitinib-Receives-U-S-FDA-Approval-for-Giant-Cell-Arteritis-GCA