FDA

Rinvoq approved for giant cell arteritis

May 1, 2025

FDA approved Rinvoq (upadacitinib), a Janus kinase (JAK) inhibitor, for the treatment of adults with giant cell arteritis (GCA).

Efficacy

Approval was based on data from the phase 3 SELECT-GCA trial (NCT03725202) that evaluated the safety and efficacy of upadacitinib in 428 patients ≥50 years of age with GCA. The primary endpoint was the percentage of participants achieving sustained remission at week 52, defined as the absence of GCA signs and symptoms from week 12 through week 52 and adherence to the protocol-defined corticosteroid taper regimen. Results showed that 46.4% of patients receiving Rinvoq 15 mg in combination with a 26-week corticosteroid taper regimen achieved sustained remission from week 12 to week 52, vs. 29.0% of participants receiving placebo in combination with a 52-week steroid taper regimen (p=0.002).

Safety

Adverse reactions reported in ≥5% of trial participants included upper respiratory tract infections, headache, fatigue, peripheral edema, cough, anemia, rash, herpes zoster, and nausea.

Recommended dose

The recommended dosage of Rinvoq is 15 mg once daily in combination with a tapering course of corticosteroids. Rinvoq 15 mg once daily can be used as monotherapy following discontinuation of corticosteroids.

Sources:

Rinvoq (upadacitinib) [package insert]. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211675s025lbl.pdf Revised April 2025. Accessed April 30, 2025.

Rinvoq® (upadacitinib) receives US FDA approval for giant cell arteritis (GCA). [News release]. 2025. https://news.abbvie.com/2025-04-29-RINVOQ-R-upadacitinib-Receives-U-S-FDA-Approval-for-Giant-Cell-Arteritis-GCA