Vasculitis & polymyalgia rheumatica
Safety and efficacy of secukinumab in patients with giant cell arteritis (TitAIN): a randomised, double-blind, placebo-controlled, phase 2 trial
Authors' conclusion
Patients with active giant cell arteritis had a higher sustained remission rate in the secukinumab group than in the placebo group at week 28, in combination with glucocorticoid taper regimen.
Study context
- Population
- Patients aged ≥50 years with new-onset or relapsing GCA, naive to biological therapy, receiving GC (prednisolone equivalent 25–60 mg/day), 11 clinics or hospitals in Germanymedian age 75 years
- Participants
- 52 patients
- Comparison
- Secukinumab 300 mg SC vs placebo, both with 26-week prednisolone taper
- Secukinumabn = 27
- Placebon = 25reference
- Primary endpoint
- Median proportion (Bayesian analysis) of patients with sustained remission until week 28, full analysis set
- Follow-up
- Week 28
Methodological detailsBayesian, parallel-group, double-blind, placebo-controlled, multicentre, phase 2
- Bayesian
- Parallel-group
- Double-blind
- Placebo-controlled
- Multicentre
- Phase 2
Primary result
As reported in the abstract
Sustained remission until week 28 (median proportion, Bayesian)
Further findings
Events
| Outcome | Secukinumab | Placebo |
|---|---|---|
| DeathsNeither considered related to study treatment | 1 | 1 |
Safety
Any adverse event
Hypertension
Nasopharyngitis
Events
| Outcome | Secukinumab | Placebo |
|---|---|---|
| Treatment discontinuation by week 28 | 4 | 8 |
Any adverse event
- Incidence of adverse events similar in the two groups
Original publication
Safety and efficacy of secukinumab in patients with giant cell arteritis (TitAIN): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Rheumatol. Published June 2023. doi:10. 1016/ s2665-9913(23)00101-7
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