A large-scale observational study using the French National Health Data System has validated the safety and efficacy of biosimilars for treating inflammatory bowel disease (IBD) in pediatric patients, addressing a critical knowledge gap in childhood IBD management.
Disease Burden and Current Landscape
IBD, encompassing ulcerative colitis and Crohn's disease, affects approximately 10 per 100,000 children, with a prevalence of 100 to 200 per 100,000 children in the US and Canada. The chronic inflammatory disorders of the gastrointestinal tract typically manifest through weight loss, abdominal pain, and bloody diarrhea, though some pediatric patients present with non-classical symptoms such as poor growth or anemia.
Notably, about 25% of IBD cases are diagnosed before age 20, with research indicating that children with Crohn's disease often experience more severe symptoms than adults, necessitating aggressive immunosuppressive therapy.
Study Design and Patient Population
The research tracked children under 18 years old who began treatment with either infliximab (Remicade) or adalimumab (Humira) for Crohn's disease or ulcerative colitis. The study period extended from the initial biosimilar launches (January 2015 for infliximab and October 2018 for adalimumab) through December 2022.
The comprehensive analysis included:
- Total participants: 5,870
- Infliximab group: 3,491 patients
- Adalimumab group: 2,379 patients
- Crohn's disease represented approximately 70% of initiations for both medications
Key Findings and Safety Outcomes
Using inverse hazard ratio probability of treatment weighted Cox regressions, the study revealed no increased risk of treatment failure with biosimilars compared to original drugs:
For Crohn's disease:
- Infliximab: HR 0.92 (95% CI: 0.78–1.09)
- Adalimumab: HR 0.98 (95% CI: 0.85–1.14)
For ulcerative colitis:
- Infliximab: HR 0.98 (95% CI: 0.76–1.27)
- Adalimumab: HR 1.01 (95% CI: 0.82–1.24)
All-cause hospitalization rates showed no significant differences between biosimilars and originators:
- Infliximab: HR 0.96 (95% CI: 0.78–1.18)
- Adalimumab: HR 1.03 (95% CI: 0.80–1.33)
Clinical Implications
The study's findings carry particular significance given the high adoption rate of biosimilars, especially for infliximab, where they constituted 76% of new prescriptions. The primary adverse events reported were limited to gastrointestinal and dermatological infections, consistent with the known safety profile of these medications.
These results provide robust evidence supporting the use of biosimilars in pediatric IBD patients, potentially expanding access to these essential treatments while maintaining therapeutic standards. The data is especially valuable given the limited availability of pediatric-specific studies in this area, despite the growing incidence of IBD diagnoses in younger populations.
