Vasculitis & polymyalgia rheumatica
A phase 2, randomised, placebo-controlled study of guselkumab in adults with new-onset or relapsing giant cell arteritis
Authors' conclusion
The study's primary endpoint (GC-free remission) was not met
Study context
- Population
- Patients ≥50 years with new-onset or relapsing giant cell arteritis (GCA) (all White, 70% female, mean age 71.5 years; 60% new-onset, 40% relapsing)
- Participants
- 35 vs 18
- Comparison
- Guselkumab vs placebo, both with background glucocorticoid (GC) therapy
- Guselkumabn = 35
- Placebon = 18reference
- Primary endpoint
- Proportion of patients achieving GC-free remission
- Follow-up
- Week 28
Methodological detailsdouble-blind, placebo-controlled, phase 2
- Double-blind
- Placebo-controlled
- Phase 2
Primary result
As reported in the abstract
GC-free remission
P = 0.64
Further findings
GCA flare or discontinuation due to worsening GCA · week 28
| Outcome | Guselkumab | Placebo | P value |
|---|---|---|---|
| Time to first GCA flare through week 28 | median NE (90% CI 27.7-NE) | median 29.7 (90% CI 20.1-NE) weeks | P = 0.64 |
Safety
Any AEs · through week 60
Worsening of GCA (AE) · through week 60
COVID-19 infection · through week 60
Headache · through week 60
Original publication
A phase 2, randomised, placebo-controlled study of guselkumab in adults with new-onset or relapsing giant cell arteritis. Ann Rheum Dis. Published 12 February 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →