Risankizumab in children with psoriasis: more complete clearance than ustekinumab

Design

Phase 3 multicentre study with a randomised risankizumab vs ustekinumab part

Population

137 children with moderate-to-severe psoriasis (82 randomised)

Primary outcome

sPGA 0/1 and PASI responses at week 16

Effect

sPGA 0/1 79.6% vs 75.0%; PASI 100 40.7% vs 17.9%

OptIMMize-1 enrolled 137 children with moderate-to-severe psoriasis across four parts. In the randomised part, 54 received risankizumab and 28 ustekinumab for 16 weeks.

Most measures were similar at week 16: sPGA 0/1 79.6% vs 75.0%, PASI 75 85.2% vs 85.7%, PASI 90 64.8% vs 60.7%. Complete clearance (PASI 100) was higher with risankizumab, 40.7% vs 17.9%. In an open-label part, 90.0% reached sPGA 0/1 at week 16, and responses held or improved to week 52. Itch and quality of life improved, and safety matched adult experience.

For paediatric dermatologists, this supports risankizumab as an option alongside ustekinumab, with a quarterly maintenance schedule that suits children. The randomised comparison is small and not powered to show superiority, so the PASI 100 difference should be read as encouraging rather than definitive.

• Consider risankizumab for children with moderate-to-severe psoriasis who need a biologic, where licensed and available.
• Expect most children to reach clear or almost clear skin by week 16.
• Screen for tuberculosis and check vaccinations are up to date before starting any biologic in a child.
• Measure itch and quality of life at baseline; both improved and are what families notice.

Why it matters

Children with severe psoriasis have had fewer biologic choices than adults.

Don't overread it

The randomised arms were small (54 vs 28) and not powered to show one drug is better.

The statistics, in plain English

With only 28 children on ustekinumab, each child is about 3.6 percentage points, so modest differences could be chance. The PASI 100 gap (40.7% vs 17.9%) is large enough to be notable, but the abstract gives no confidence interval for it.

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