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Study: Biosimilar Efficacy and Safety in Pediatric Inflammatory Bowel Disease
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Key Takeaways
- Biosimilars for infliximab and adalimumab showed no increased risk of treatment failure in pediatric IBD patients.
- The study found no significant difference in all-cause hospitalization rates between biosimilars and originators.
Biosimilar use is not linked to an increased risk of treatment failure among pediatric patients with inflammatory bowel disease (IBD).
New study findings aimed to identify the effectiveness and safety of biosimilars among pediatric patients with inflammatory bowel disease (IBD), compared to originators in the same patient population. The study aimed to provide additional data for pediatric patients with IBD, as studies are limited compared to adults with the disease.1
IBDs are chronic inflammatory disorders of the gastrointestinal tract, including ulcerative colitis and Crohn disease that occurs following a dysregulated mucosal immune response to the intestinal microflora in genetically predisposed hosts. The disease commonly impacts adolescence and young adulthood; however, there has been an increase of diagnoses among pediatrics, with an incidence of approximately 10 per 100,000 children and a prevalence of 100 to 200 per 100,000 children in the US and Canada, according to research published in JAMA Pediatrics.2
Previous research published in Inflammatory Bowel Diseases found that children with Crohn disease were more likely to have severe disease compared to adult-onset Crohn disease, resulting in the need for further immunosuppressive therapy in this patient population.3
Classic symptoms of pediatric IBD include weight loss, abdominal pain, and bloody diarrhea; although many pediatric patients have reported non-classic symptoms like isolated poor growth, anemia, or additional extraintestinal manifestations. Symptoms can present early on, with approximately 25% of cases diagnosed before the age of 20 years, emphasizing the need for additional research to aid this patient population.1,2
Using data from the French National Health Data System, the researchers identified children younger than 18 years of age that initiated treatment with infliximab (Remicade; Janssen Biotech Inc) or adalimumab (Humira; AbbVie) for the treatment of Crohn disease or ulcerative colitis, from the first biosimilar launch that occurred in January 2015 and October 2018, respectively, to 31 December 2022.1
The study included a total of 5870 individuals with 3491 patients treated with infliximab and 2379 patients treated with adalimumab. Biosimilars represented 76.0% of infliximab and 29.0% of adalimumab initiations, respectively. Additionally, Crohn disease represented 70.9% of infliximab and 69.0% adalimumab initiations.1
The researchers reported to use inverse hazard ratio (HR) of probability of treatment weighted Cox regressions (IPTW) to compare the risks of treatment failure and overnight hospitalization in biosimilars compared to the originator in new users. The results demonstrated that biosimilar use was not linked to an increased risk of treatment failure among pediatric patients with IBD [IPTW HR (95% confidence interval, CI): infliximab 0.92 (0.78–1.09) in Crohn disease, 0.98 (0.76–1.27) in ulcerative colitis; adalimumab 0.98 (0.85–1.14) in CD, 1.01 (0.82–1.24) in UC].1
Further results demonstrated that the occurrence of all-cause hospitalization was not different between the exposure groups [IPTW HR (95% CI): infliximab 0.96 (0.78–1.18); adalimumab 1.03 (0.80–1.33)]. The main infections reported include gastro-intestinal or dermatological, suggesting that biosimilars are safe and effective among pediatric patients with IBD.1
