- Design
- Phase 3, multi-part study; 16-week randomised comparison with ustekinumab plus open-label periods to 52 weeks
- Population
- 137 children with moderate-to-severe plaque psoriasis
- Primary outcome
- sPGA 0/1 and PASI 75/90/100 at week 16, maintained to week 52
- Effect
- sPGA 0/1 79.6% vs 75.0% (ustekinumab); PASI 100 40.7% vs 17.9%
Children with moderate-to-severe psoriasis have few advanced options. OptIMMize-1, a phase 3 multi-part study of 137 paediatric patients, tested the interleukin-23 inhibitor risankizumab, already approved in adults, including a head-to-head period against ustekinumab.
At week 16, risankizumab and ustekinumab gave similar overall clearance: clear or almost clear skin (sPGA 0/1) in 79.6% versus 75.0%, and PASI 90 in 64.8% versus 60.7%. Complete clearance was higher with risankizumab (PASI 100 40.7% versus 17.9%). Responses were maintained or improved to week 52, with improvements in itch and quality of life, and a safety profile consistent with adult experience.
For practice this supports risankizumab as an effective, well-tolerated option for children with moderate-to-severe psoriasis, broadly comparable to ustekinumab and with a higher rate of complete clearance. As with all paediatric biologics, availability and cost will shape its real-world use, particularly in India.
- Phase 3 OptIMMize-1 studied risankizumab in 137 children with moderate-to-severe psoriasis.
- Week 16 clearance was similar to ustekinumab (sPGA 0/1 79.6% vs 75.0%; PASI 90 64.8% vs 60.7%).
- Complete clearance was higher with risankizumab (PASI 100 40.7% vs 17.9%).
- Responses were maintained or improved at week 52, with better itch and quality of life.
- Safety matched adult experience, supporting use where access and cost allow.
Why it matters
It adds a validated advanced therapy for a group, children, where treatment choices have been limited.
Don't overread it
The comparative period was small and short; beyond the higher complete-clearance rate, the data show risankizumab is comparable to ustekinumab, not clearly superior.
The statistics, in plain English
The head-to-head period was small (54 vs 28 children) and to week 16, so apart from the complete-clearance difference the trial shows comparability rather than proven superiority; the open-label parts describe maintained response, not a controlled comparison.
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