SELECT-GCA (upadacitinib 15 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
73.0% female
27.0% male
N = 321
321 patients (233 female, 88 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=209 upadacitinib (at a dose of 15 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
46.4%
29%
46.4 %
34.8 %
23.2 %
11.6 %
0.0 %
Upadacitinib
Placebo
Significant
increase ▲
NNT = 5
Significant increase in sustained remission at week 52 (46.4% vs. 29%; AD 17.1%, 95% CI 6.3 to 27.8).
Secondary outcomes
Significant increase in sustained complete remission at week 52 (37.1% vs. 16.1%; AD 20.7%, 95% CI 11.3 to 30.2).
Significant decrease in median cumulative glucocorticoid exposure through week 52 (1615 mg vs. 2882 mg; MD -1267, 95% CI -1587 to -1133).
Significant decrease in the rate of ≥ 1 disease flare through week 52 (34.3% vs. 55.6%; OR 0.47, 95% CI 0.29 to 0.74).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with new-onset or relapsing giant cell arteritis, upadacitinib was 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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