Phase 3, multicentre, randomised, double-blind, placebo-controlled, parallel-group study of ustekinumab in Japanese patients with active polymyositis and dermatomyositis who have not adequately responded to one or more standard-of-care treatments
Authors' conclusion
UST was safe and well tolerated but did not meet the primary efficacy endpoint in adult Japanese participants with active PM/DM based on the primary analysis at week 24 in the study.
Study context
- Population
- Japanese adults with active polymyositis (PM)/dermatomyositis (DM) who did not respond adequately to one or more standard-of-care treatments
- Participants
- 51 adults
- Comparison
- Ustekinumab (UST) 6 mg/kg IV at week 0, then 90 mg subcutaneous (SC) every 8 weeks from week 8 to week 24, vs placebo
- USTn = 25
- Placebon = 26reference
- Primary endpoint
- Proportion achieving minimal improvement (≥20) in IMACS TIS
- Follow-up
- Week 24
Methodological detailsmulticentre, double-blind, placebo-controlled, parallel-group, placebo crossover to UST at week 24
- Multicentre
- Double-blind
- Placebo-controlled
- Parallel-group
- Placebo crossover to UST at week 24
Primary result
As reported in the abstract
Minimal improvement (≥20) in IMACS TIS
P = 0.94
Original publication
Phase 3, multicentre, randomised, double-blind, placebo-controlled, parallel-group study of ustekinumab in Japanese patients with active polymyositis and dermatomyositis who have not adequately responded to one or more standard-of-care treatments. RMD Open. Published 31 August 2023. doi:10.
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