- Design
- Phase 3, multicentre, four-part study with a randomised comparison against ustekinumab
- Population
- 137 children with moderate-to-severe plaque psoriasis
- Primary outcome
- sPGA 0/1 and PASI 75/90/100 at week 16
- Effect
- PASI 75 85.2% vs 85.7%; PASI 100 40.7% vs 17.9% (risankizumab vs ustekinumab)
OptIMMize-1, a phase 3, multipart study in the British Journal of Dermatology, published on 26 September, enrolled 137 children with moderate-to-severe psoriasis. In the randomised part, 54 received risankizumab and 28 ustekinumab for 16 weeks.
At week 16, most response measures were similar: PASI 75 85.2% vs 85.7%, clear or almost clear 79.6% vs 75.0%. Complete clearance (PASI 100) was more frequent with risankizumab (40.7% vs 17.9%). In an open-label part, responses were maintained or improved at week 52. Itch and quality of life improved, and the safety profile matched adult data.
The randomised comparison is small and PASI 100 was not the primary measure, so the difference in complete clearance needs confirmation. The broader point is reassurance that an IL-23 inhibitor behaves in children as it does in adults.
- For children needing a biologic for psoriasis, IL-23 and IL-12/23 inhibitors gave similar PASI 75 responses at 16 weeks.
- Expect complete clearance in some children; it was more frequent with risankizumab.
- Assess itch and quality of life in children, both of which improved.
- Check local paediatric licensing before prescribing.
Why it matters
Paediatric psoriasis has few tested options, and these data extend the IL-23 class to children.
The statistics, in plain English
With only 82 children in the randomised comparison, the PASI 100 difference (40.7% vs 17.9%) is striking but imprecise. The headline PASI 75 rates were almost identical.
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