Two-year treatment with upadacitinib shows high remission in patients with giant cell arteritis

Upadacitinib 15 mg treatment compared with placebo switch led to higher rates of complete remission and lower rates of flares, with increased rates of herpes zoster and bone fractures, according to an analysis presented by Prof. Wolfgang Schmidt (Medical Centre for Rheumatology Berlin-Buch, Germany) [1].

Patients with giant-cell arteritis in the phase 3 trial SELECT-GCA (NCT03725202) received ≥52 weeks of upadacitinib 15 mg daily, 7 mg daily, or placebo, with tapering of their baseline glucocorticoid treatment [2]. In period 2 of the trial, participants were re-randomised to their original upadacitinib dose or placebo if they received upadacitinib, while placebo participants continued with placebo for an additional 52 weeks. Outcomes included disease flares (recurrence of signs/symptoms or erythrocyte sedimentation rate >30mm/h requiring initiation of glucocorticoids) and complete remission rates (no signs/symptoms, no glucocorticoid use, normalisation of the erythrocyte sedimentation rate, and normalisation of high-sensitivity C-reactive protein). In total, 181 patients were included [1].

Assessments were carried out 30 days after the 104-week treatment period ended. Significantly more participants who switched from upadacitinib 15 mg to placebo had ≥1 disease flare than those on continuous upadacitinib 15 mg treatment (59.1% vs 15.5%; P<0.0001). Furthermore, the time to first disease flare was longer with continuous upadacitinib than placebo switch (P<0.0001). Additionally, significantly more participants receiving continuous upadacitinib 15 mg than those who switched from upadacitinib 15 mg to placebo achieved complete remission after 104 weeks of treatment (71.9% vs 20.0%; P<0.0001). Safety assessments compared continuous upadacitinib 15 mg to continuous placebo. Overall, there were increased rates of bone fractures and herpes zoster with upadacitinib.

“There is a lower risk of flare and higher rates of remission if you continue upadacitinib compared with placebo,” concluded Prof. Schmidt. “There were no new clinically significant safety signals, and the results demonstrate a favourable benefit-risk profile for upadacitinib 15 mg in giant cell arteritis.”

1. Schmidt W, et al. Efficacy and safety of upadacitinib in giant cell arteritis: 2-year results from the re-randomized, double-blind SELECT-GCA phase 3 trial. ACR Convergence, 24–29 October 2025, Chicago, IL, USA.
2. Blockmans D, et al. N Engl J Med. 2025;392(20):2013-2024.

Medical writing support was provided by Mihai Surducan, PhD.

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Posted on 29 October 2025