In a large international clinical trial, researchers found that oral upadacitinib helped more patients with giant-cell arteritis achieve sustained remission when used with a 26-week glucocorticoid taper, compared to placebo with a 52-week taper.
The 15 mg dose of upadacitinib significantly reduced disease flares, lowered steroid exposure, and improved patient-reported outcomes.
Giant-cell arteritis (GCA) is a chronic inflammatory disease of blood vessels that primarily affects adults over 50. It commonly causes headache, scalp tenderness, jaw pain, and vision problems. Treatment typically involves prolonged use of high-dose glucocorticoids, which carry substantial risk, especially for older adults.
The randomized trial, led by Daniel Blockmans of the Department of General Internal Medicine, University Hospitals Leuven, Leuven, Belgium, and colleagues, enrolled 428 patients aged 50 and above across 24 countries. Participants had either new-onset or relapsing GCA and were assigned to receive upadacitinib 15 mg, 7.5 mg, or placebo with a prespecified steroid taper. The primary outcome was sustained remission at week 52, defined as the absence of GCA symptoms from week 12 onward and compliance with the taper.
Sustained remission at 1 year was achieved by 46.4% of patients in the 15 mg group, compared to 29.0% in the placebo group. The 15 mg group also had fewer disease flares (34.3% vs 55.6%) and longer time to first flare. Median cumulative steroid exposure over 52 weeks was lower in the 15 mg group (1,615 mg) than in the placebo group (2,882 mg).
Patients taking 15 mg of upadacitinib also reported less fatigue and improved physical function, as measured by standardized surveys. While several patient-reported outcomes showed significant improvement, others, such as treatment satisfaction, did not reach statistical significance. Complete remission off steroids at week 52 was observed in 50.2% of the 15 mg group versus 19.6% of the placebo group.
The 7.5 mg dose did not show a significant difference from placebo in the primary outcome.
The safety profile of upadacitinib was generally similar to placebo. Common adverse events in the 15 mg group included headache, joint pain, and COVID-19 infection. Serious infections occurred less often in the upadacitinib group. No major cardiovascular events were reported in the upadacitinib groups, compared to two events in the placebo group. Herpes zoster was more frequent in the 15 mg group, including two serious cases involving the eye.
Four deaths occurred during the treatment period—two in the 15 mg group and two in the placebo group. One additional stroke-related death in the 15 mg group occurred more than 30 days after the last dose.
Researchers concluded that upadacitinib 15 mg may serve as an effective steroid-sparing option for patients with GCA. Ongoing follow-up will further assess long-term safety.
Full disclosures can be found in the published study.
