New Horizon in Pediatric Psoriasis: EC Approval of Guselkumab

The European Commission has approved guselkumab for moderate-to-severe plaque psoriasis in children — the first pediatric IL‑23 inhibitor indication in the EU. The decision creates a systemic option for patients who need treatment beyond topical therapy.

This broadens biologic choices beyond agents that primarily target TNF or IL‑17 and introduces a different mechanism of action into pediatric practice.

The Phase 3 PROTOSTAR trial was a multicenter, randomized, placebo- and active-comparator-controlled study in patients aged 6-18. It enrolled 120 children and used co-primary endpoints of IGA 0/1 and PASI 75 at Week 16. The investigators reported higher response rates with guselkumab versus placebo (PASI 75 ≈76% vs 20%; IGA 0/1 ≈66% vs 16%).

The safety profile was reported as consistent with adult studies, with the most common adverse events listed as respiratory tract infections, increased transaminases, headache, diarrhea, arthralgia, rash, and injection‑site reactions.

The EC approval covers children and adolescents aged 6 years and older who are candidates for systemic therapy for moderate-to-severe plaque psoriasis. In clinical practice, pediatric patients with inadequate response or intolerance to first-line biologics may be considered for earlier sequencing to guselkumab.