- EC approval extends TREMFYA® use to children aged 6+ for moderate to severe plaque psoriasis.
- PROTOSTAR Phase 3 study involved 120 pediatric patients, achieving PASI 75 and IGA 0/1 at Week 16.
- 76% of patients on guselkumab achieved PASI 75 vs. 20% on placebo; 66% achieved IGA 0/1 vs. 16% on placebo.
- Guselkumab's safety profile in children aligns with adult studies.
EC Approval for Pediatric Use
The European Commission has approved the use of TREMFYA® (guselkumab) for treating moderate to severe plaque psoriasis in children aged 6 and above. This marks the first approval of an IL-23 inhibitor for any pediatric indication, expanding on its 2017 approval for adults.
PROTOSTAR Study Results
The approval is based on the Phase 3 PROTOSTAR study, which involved 120 pediatric patients. The study achieved its co-primary endpoints of Psoriasis Area Severity Index (PASI) 75 and Investigator’s Global Assessment (IGA) score of 0/1 at Week 16. Approximately 76% of patients receiving guselkumab reached PASI 75, compared to 20% on placebo. Additionally, 66% achieved high levels of skin clearance (IGA score of 0/1) versus 16% on placebo.
Safety Profile
The safety profile of guselkumab in children aged 6 to 17 was consistent with that observed in adult plaque psoriasis studies. Common adverse reactions included respiratory tract infections, increased transaminases, headache, and injection site reactions.
Impact on Pediatric Psoriasis
Pediatric plaque psoriasis affects nearly one-third of psoriasis cases, often leading to comorbidities such as obesity, hypertension, and diabetes. The approval of guselkumab provides a new treatment option for children, addressing a significant gap in available therapies for this chronic immune-mediated disease.
