Risankizumab in children with psoriasis: matches ustekinumab, clears more

Design

Phase 3, multicentre, four-part study with a randomised active-comparator part

Population

137 children with moderate-to-severe plaque psoriasis

Primary outcome

sPGA 0/1 and PASI 75/90/100 at week 16

Effect

sPGA 0/1 79.6% vs 75.0%; PASI 100 40.7% vs 17.9% (risankizumab vs ustekinumab)

OptIMMize-1, a multipart phase 3 study, enrolled 137 children with moderate-to-severe plaque psoriasis. In its randomised part, 54 received risankizumab and 28 ustekinumab for 16 weeks; open-label parts followed others for 52 weeks, and responders were later randomised to continue or withdraw.

At week 16, clear or almost-clear skin (sPGA 0/1) was reached by 79.6% on risankizumab and 75.0% on ustekinumab, and PASI 75 by 85.2% and 85.7%. Complete clearance (PASI 100) was more frequent with risankizumab, 40.7% against 17.9%. In an open-label cohort of 30, sPGA 0/1 was 90.0% at week 16, and responses were maintained or improved at week 52. Itch and quality of life improved, and safety matched the adult experience.

The comparison with ustekinumab was small and not powered for superiority, so the PASI 100 difference is suggestive rather than proven. The study widens the options for children who need a biologic, with quarterly maintenance dosing an advantage for families.

• Risankizumab gave week-16 response rates similar to ustekinumab in children with moderate-to-severe psoriasis.
• Complete clearance was more than twice as frequent with risankizumab in the randomised comparison.
• Responses were maintained to one year, and safety resembled that seen in adults.
• Check local licensing for risankizumab in children before prescribing; status varies by country.
• Screen children for latent tuberculosis before starting any biologic, as in adults.

Why it matters

Children have had fewer biologic choices than adults, and less frequent dosing eases the burden on families.

Don't overread it

The randomised comparison involved 82 children and was not designed to show risankizumab is superior.

The statistics, in plain English

With 54 and 28 children, a difference of a few percentage points in PASI 75 means nothing. The PASI 100 gap, 40.7% against 17.9%, is larger but still rests on small numbers.

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