European Commission Approves Ustekinumab for Paediatric Crohn’s Disease
In a major development for paediatric inflammatory bowel disease (IBD) care, the European Commission (EC) has officially approved ustekinumab for the treatment of moderately to severely active Crohn’s disease in children and adolescents weighing at least 40 kilograms.
This decision marks a critical milestone in expanding treatment options for young patients suffering from a condition that often presents more aggressively in childhood.
Crohn’s disease, although widely associated with adults, is diagnosed in around 25% of patients during childhood or adolescence. Early onset of the disease is frequently tied to severe disease progression, malnutrition, and disruption of growth and developmental milestones, with far-reaching impacts on a young person’s mental health and overall quality of life.
Until now, treatment options for this vulnerable group have been limited, especially when standard therapies fail to deliver results.
The EC’s approval follows robust data from the UNITI-Jr phase 3 clinical trial and the REALITI real-world evidence study, both of which demonstrated ustekinumab’s efficacy and safety in treating paediatric patients who had previously not responded adequately to conventional or biologic therapies.
The UNITI-Jr study monitored paediatric patients over a 52-week period. The findings were promising: 52.1% of participants achieved clinical remission within just 8 weeks, and many began to show a clinical response as early as week 3.
Furthermore, it was found that at 44 weeks, the remission rate stood at 43.5% for those on an 8-week treatment regimen, rising to 60.0% for patients receiving ustekinumab every 12 weeks.
Complementing these trial results, the REALITI study provided real-world confirmation of ustekinumab’s benefits in both paediatric and young adult populations. The study reinforced the drug’s ability to deliver meaningful clinical improvements in day-to-day medical settings, beyond controlled trial environments.
Importantly, ustekinumab’s safety profile in children mirrored what has already been established in adult populations, supporting its use over extended periods.
This approval not only widens the therapeutic landscape for paediatric Crohn’s disease but also reaffirms ustekinumab’s growing role in managing complex, treatment-resistant cases. With clinical trials and real-world studies aligned in their findings, young patients and their families now have renewed hope for better disease control and improved quality of life.
In summary
The EC’s decision to approve ustekinumab for paediatric use signals a significant advancement in the management of Crohn’s disease during childhood and adolescence.
With strong evidence of safety and effectiveness, this approval offers a powerful new tool in tackling a challenging condition, ultimately helping young patients regain stability in health, growth, and everyday life.
News Credits: European Commission approves ustekinumab for paediatric Crohn’s disease
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