Vasculitis & polymyalgia rheumatica
A Phase 3 Trial of Upadacitinib for Giant-Cell Arteritis
Authors' conclusion
In patients with giant-cell arteritis, upadacitinib at a dose of 15 mg - but not 7.5 mg - with a 26-week glucocorticoid taper showed efficacy superior to that of placebo with a 52-week glucocorticoid taper.
Study context
- Population
- Patients with new-onset or relapsing GCA70% new-onset GCA
- Participants
- 209 / 107 / 112
- Comparison
- Upadacitinib 15 mg or 7.5 mg orally once daily plus 26-week GC taper vs placebo plus 52-week GC taper
- Upadacitinib 15 mgn = 209
- Upadacitinib 7.5 mgn = 107
- Placebon = 112reference
- Primary endpoint
- Sustained remission: absence of signs or symptoms of GCA from week 12 through week 52 and adherence to the protocol-specified GC taper
- Follow-up
- Week 52
Methodological detailsplacebo-controlled, 2:1:1 randomisation, hierarchically prespecified, multiplicity-controlled key secondary end points
- Placebo-controlled
- 2:1:1 randomisation
- Hierarchically prespecified, multiplicity-controlled key secondary end points
Primary result
As reported in the abstract
Sustained remission
P = 0.002
Secondary outcomes
Key secondary end points (hierarchically prespecified, multiplicity-controlled): sustained complete remission, time to flare, cumulative GC exposure, patient-reported outcomes
- Upadacitinib 15 mg superior to placebo
Safety
Safety outcomes during the 52-week treatment period
- Similar in the upadacitinib and placebo groups
MACE
- No MACE occurred in the upadacitinib groups
Original publication
A Phase 3 Trial of Upadacitinib for Giant-Cell Arteritis. N Engl J Med. Published 2 April 2025. doi:10.
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