Vasculitis & polymyalgia rheumatica

Safety and efficacy of secukinumab in patients with giant cell arteritis (TitAIN): a randomised, double-blind, placebo-controlled, phase 2 trial

Lancet RheumatolPublished Randomised controlled 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

OutcomeSecukinumabPlacebo
DeathsNeither considered related to study treatment11

Safety

Any adverse event

Hypertension

Nasopharyngitis

Events

OutcomeSecukinumabPlacebo
Treatment discontinuation by week 2848

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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