SELECT-GCA (upadacitinib 7.5 mg)
Trial question
What is the effect of upadacitinib in patients with giant cell arteritis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
72.0% female
28.0% male
N = 219
219 patients (157 female, 62 male).
Inclusion criteria: patients with new-onset or relapsing giant cell arteritis.
Key exclusion criteria: prior exposure to JAK inhibitors; disease flare while receiving an IL-6 inhibitor; infections including herpes zoster or herpes simplex, HIV, active tuberculosis, active or chronic recurring infection, active hepatitis B or C; pregnancy or lactation.
Interventions
N=107 upadacitinib (at a dose of 7.5 mg PO once daily plus a 26-week glucocorticoid taper).
N=112 placebo (matching placebo plus a 52-week glucocorticoid taper).
Primary outcome
Sustained remission at week 52
41.1%
29%
41.1 %
30.8 %
20.6 %
10.3 %
0.0 %
Upadacitinib
Placebo
No significant
difference ↔
No significant difference in sustained remission at week 52 (41.1% vs. 29%; AD 12.1%, 95% CI -0.4 to 24.6).
Secondary outcomes
No significant difference in sustained complete remission at week 52 (26.2% vs. 16.1%; AD 9.9%, 95% CI -0.8 to 20.6).
Significant decrease in median cumulative glucocorticoid exposure through week 52 (1905 mg vs. 2882 mg; MD -1206, 95% CI -1452 to -802).
No significant difference in the rate of ≥ 1 disease flare through week 52 (41.3% vs. 55.6%; OR 0.6, 95% CI 0.35 to 1.03).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with new-onset or relapsing giant cell arteritis, upadacitinib was not superior to placebo with respect to sustained remission at week 52.
Reference
Daniel Blockmans, Sara K Penn, Arathi R Setty et al. A Phase 3 Trial of Upadacitinib for Giant-Cell Arteritis. N Engl J Med. 2025 Apr 2. Online ahead of print.
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