Spondyloarthritis & psoriatic arthritis
Efficacy and Safety of Intravenous Secukinumab for the Treatment of Active Psoriatic Arthritis: Results From a Randomized, Placebo‐Controlled Phase 3 Study
Authors' conclusion
IV secukinumab led to rapid and sustained improvements in clinical measures of PsA, and the safety profile was consistent with that of secukinumab administered subcutaneously.
Study context
- Population
- Patients with active psoriatic arthritis (PsA)177 and 170 completed
- Participants
- 191 vs 190
- Comparison
- Intravenous (IV) secukinumab vs placebo
- IV SECUKINUMABn = 191
- PLACEBOn = 190reference
- Primary endpoint
- ACR50
- Follow-up
- Week 16
Methodological detailsplacebo-controlled, phase 3, 1:1 randomisation, placebo switched to IV secukinumab at week 16, Efficacy evaluated through week 52, safety through week 60
- Placebo-controlled
- Phase 3
- 1:1 randomisation
- Placebo switched to IV secukinumab at week 16
- Efficacy evaluated through week 52, safety through week 60
Primary result
As reported in the abstract
Adjusted P < 0.0001
Secondary outcomes
- Deaths before week 16 — PLACEBO
- 1 events
All secondary efficacy endpoints · week 16
- All met (all adjusted P < 0.05 using the predefined hypothesis-testing hierarchy)
Efficacy outcomes · week 52
- Both treatment arms experienced similar improvements in efficacy outcomes
Deaths before week 16
- No new or unexpected safety signals with IV secukinumab
Original publication
Efficacy and Safety of Intravenous Secukinumab for the Treatment of Active Psoriatic Arthritis: Results From a Randomized, Placebo‐Controlled Phase 3 Study. Arthritis Rheumatol. Published 17 October 2024. doi:10.
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