FDA Approves Upadacitinib, Expanding Treatment for Adults With Giant Cell Arteritis

The FDA has approved Upadacitinib 15 mg once daily for the treatment of adults with giant cell arteritis (GCA), under the name Rinvoq.1

"Glucocorticoids remain a mainstay of treatment of GCA but lead to substantial drug-associated toxicities. Additionally, relapse remains common for patients with this disease," investigator Peter A. Merkel, MD, MPH, chief of rheumatology at the University of Pennsylvania, said in a statement.1 "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."

The approval was based off of data from the phase 3 SELECT-GCA clinical trial in which 46.4% (95% CI, 39.6-53.2) of patients receiving upadacitinib 15 mg in combination with a 26-week steroid taper regimen achieving sustained remission from week 12 to week 52, compared with 29.0% (95% CI, 20.6-37.5) of patients receiving placebo in combination with a 52-week steroid taper regimen (P = .002).2

“The primary endpoint was the proportion of patients in the different treatment arms in sustained remission. And this turned out to be positive. Upadacitinib 15 milligrams was significantly better than placebo… it also met 9 out of 11 multiplicity-controlled secondary end points. It was a positive study. It couldn't be more positive,” lead investigator Daniel Blockmans, MD, PhD, Department of General Internal Medicine, University Hospitals Leuven, Leuven, Belgium, previously told HCPLive at the 2024 European Congress of Rheumatology (EULAR) conference during which he presented interim data from SELECT-GCA.

In the trial, a total of 209 patients received upadacitinib at a dose of 15 mg, 107 received upadacitinib at a dose of 7.5 mg, and 112 received placebo. Most participants (70%) had new-onset GCA. SELECT-GCA also evaluated a 7.5 mg dose, which did not show statistical significance compared with the placebo group (41.1% [95% CI, 31.8-50.4]). Importantly, safety outcomes over the 52 weeks were similar in the upadacitinib and placebo groups, and no major adverse cardiovascular events occurred in the upadacitinib groups, although cardiovascular risk is a potential concern with a JAK inhibitor.2

"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 Roopal Thakkar, MD, executive vice president, research and development, chief scientific officer, AbbVie, added to the statement.1 "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."

REFERENCES

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

2. Blockmans D, Penn SK, Setty AR, et al. A Phase 3 Trial of Upadacitinib for Giant-Cell Arteritis. New Eng J Med. Published online April 2, 2025. DOI: 10.1056/NEJMoa2413449