Rinvoq (upadacitinib) receives U.S. FDA approval for giant cell arteritis – AbbVie

AbbVie announced the FDA has approved Rinvoq (upadacitinib), 15 mg, once daily, for the treatment of adults with giant cell arteritis (GCA). This comes after the European Commission recently granted marketing authorization of Rinvoq for the treatment of GCA in adult patients.

The approvals are supported by results of the pivotal Phase III SELECT-GCA clinical trial, which met the primary endpoint of sustained remission (46.4% of patients receiving Rinvoq 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission from week 12 to week 52, compared to 29.0% of patients receiving placebo in combination with a 52-week steroid taper regimen; p=0.002). During the 52-week, placebo-controlled period, the safety profile of Rinvoq was generally consistent with that observed in other approved indications. Other important secondary endpoints were also achieved including: a) reduction in disease flares (34.3% UPA 15 mg vs 55.6% PBO); and b) lower cumulative steroid use by 52 weeks (median exposure of 1615 mg versus 2882 mg, respectively; p<0.001). Results of this trial were recently published in the New England Journal of Medicine.

SELECT-GCA (M16-852) is a Phase III, multicenter, randomized, double-blind placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib ( Rinvoq) in 428 patients with GCA ((NCT03725202). The study consists of two periods. The first period, previously reported in April 2024, evaluated the efficacy of upadacitinib in combination with a 26-week corticosteroid taper regimen compared to placebo in combination with a 52-week corticosteroid taper regimen. In addition, the study assessed the safety and tolerability of upadacitinib in these patients. The second period will evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in the first period.

“This FDA approval will now provide an alternative treatment option that can offer patients with GCA the possibility of tapering off steroids and achieving sustained remission,” said Dr. Roopal Thakkar, executive VP, research and development, CSO, AbbVie. “With this new indication for RINVOQ, we are underscoring AbbVie’s commitment to exploring how we can identify and address unmet needs for patients with immune-mediated diseases.”

“Glucocorticoids remain a mainstay of treatment of GCA but lead to substantial drug-associated toxicities. Additionally, relapse remains common for patients with this disease,” said Dr. Peter A. Merkel, chief of rheumatology at the University of Pennsylvania, Philadelphia and SELECT-GCA trial investigator. “We now have a new option to treat GCA. The results of this clinical trial show that upadacitinib offers patients the chance to reach sustained remission.”

See citation- Blockmans D, Penn SK, Setty AR, Schmidt WA et al. A Phase 3 Trial of Upadacitinib for Giant-Cell Arteritis. N Engl J Med. 2025 Apr 2. doi: 10.1056/NEJMoa2413449. Online ahead of print. PMID: 40174237