STELARA® Receives CHMP Backing for Pediatric Crohn's Disease Treatment in Europe
Key Insights
The European Medicines Agency's CHMP has recommended expanding STELARA® (ustekinumab) approval for treating moderate to severe Crohn's disease (search) in children weighing at least 40 kg who failed conventional or biologic therapy.
Phase 3 UNITI-Jr trial demonstrated strong efficacy with 52.1% of pediatric patients achieving clinical remission at week 8, with safety profile comparable to adult studies.
The treatment addresses a critical need in pediatric Crohn's disease (search), which significantly impacts children's growth, development, and mental health, affecting their overall quality of life.
Johnson & Johnson announced a significant advancement in pediatric Crohn's disease (search) treatment as the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended expanding STELARA® (ustekinumab) authorization for children weighing at least 40 kg with moderately to severely active disease.
The recommendation specifically targets pediatric patients who have shown inadequate response or intolerance to conventional or biologic therapies, offering a new treatment option for this challenging condition.
Clinical Trial Success
The Phase 3 UNITI-Jr study provided compelling evidence supporting the recommendation. The trial evaluated ustekinumab's efficacy and safety through a comprehensive 52-week treatment period, including 8 weeks of induction and 44 weeks of maintenance therapy. Key findings revealed:
- 52.1% of patients achieved clinical remission at week 8
- Clinical response observed as early as week 3
- Safety profile aligned with previous adult studies
- Treatment evaluation continued up to week 240 in Phase 1 trials
Treatment Protocol
The UNITI-Jr program administered ustekinumab through:
- Initial intravenous dose of approximately 6mg/kg
- Followed by randomized maintenance doses of 90mg subcutaneously every 8 or 12 weeks
Addressing Critical Pediatric Needs
Pediatric Crohn's disease (search) presents unique challenges compared to adult cases. The condition significantly impacts children during crucial developmental stages:
- Disrupts critical growth periods
- Leads to malnutrition
- Increases risk of mental health conditions
- Affects overall quality of life
Real-World Evidence
The REALITI study provided additional supporting data, comparing treatment outcomes between pediatric patients and young adults in routine clinical practice, further strengthening the recommendation's foundation.
Disease Impact and Prevalence
Crohn's disease (search) affects over 1.5 million people across Europe, with pediatric cases representing a rare subset. The condition manifests through:
- Abdominal pain
- Rectal bleeding
- Weight loss
- Nutrient absorption issues
About STELARA®
As the first biologic treatment to selectively inhibit both IL-12 (search) and IL-23 (search) pathways, STELARA® has demonstrated effectiveness across multiple immune-mediated conditions. Beyond Crohn's disease (search), it holds EU approval for:
- Ulcerative colitis
- Plaque psoriasis
- Psoriatic arthritis
The European Commission's final decision on this expanded indication is expected later in 2025, potentially marking a significant advancement in pediatric Crohn's disease (search) treatment options.