pharmatimes.com
European Commission approves ustekinumab for paediatric Crohn’s disease
A new EC approval makes ustekinumab an approved treatment option for children and adolescents (≥40 kg) with moderate–severe Crohn’s disease, potentially expanding choices for patients who haven’t responded to other therapies.
Pediatric patients with moderate–severe Crohn’s disease, parents and caregivers, pediatric and adult gastroenterologists, and patients currently on or considering biologic therapy.
What To Know
The European Commission has approved ustekinumab for treating moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg. The decision is supported by data from the phase 3 UNITI-Jr trial (52-week follow-up) and real-world evidence from the REALITI study.
Reported trial outcomes in the article include clinical remission rates at week 8 and at week 44, and an overall paediatric safety profile consistent with adult studies.
This approval extends an existing adult Crohn’s indication to younger patients meeting the weight threshold, offering another biologic option for children and adolescents with moderate to severe disease who have not responded to conventional or biologic therapies.
The article summarizes key trial results (early response by week 3; remission rates reported at weeks 8 and 44) and mentions supportive real-world safety and effectiveness data.
If you or your child are considering treatment changes, clinicians will use the full trial and regulatory documents to decide whether ustekinumab is appropriate based on individual history, prior therapies, and growth/weight considerations. Dosing, monitoring, and eligibility (including the 40 kg weight cutoff) should be discussed with a treating specialist.
This news reflects a regulatory approval (European Commission) rather than new practice guidance; local availability, reimbursement, and national prescribing rules may vary.
The approval is based on a phase 3 trial (UNITI-Jr) and supporting real‑world data (REALITI). This is a regulatory update extending an existing adult indication; it does not itself provide detailed clinical guidance. Treatment decisions will depend on individual clinical factors and national reimbursement/availability.
