Existing Data Support the Use of Biosimilars in Pediatric IBD

Early-onset inflammatory bowel disease (IBD) can have a more aggressive course than later-onset disease, making prompt treatment for children with IBD especially important. Given the high cost of biologics that treat pediatric IBD—adalimumab and infliximab—biosimilars are emerging as an important cost-saving option that can prevent the premature termination of biologic therapy for financial reasons.

A new paper, published in World Journal of Gastroenterology, reviews the available data on biosimilars in treating children with IBD, concluding that these studies support using biosimilars in this patient population.

Shortly after biosimilars became available in Europe, the authors note, the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and the Paediatric IBD Porto Group released an expert opinion paper directed toward pediatric gastroenterologists. The paper put forth 3 positions on using biosimilars in pediatric patients with IBD: high priority should be given to conducting pediatric trials with long-term follow-up, switching patients during sustained remission was discouraged until data were more mature, and postmarketing surveillance should be undertaken in children with IBD.

Despite those cautions—particularly because of the limited availability or even lack of availability of the reference products—some centers did adopt or switch to biosimilars to treat children with IBD.

One multicenter study in 278 pediatric patients reported on patients who started reference infliximab (n = 175), infliximab biosimilars (n = 82), or adalimumab (n = 21), but few patients had Pediatric Crohn’s Disease Activity Index (PCDAI) scores available at baseline or at the 3-month follow-up. However, at follow-up, 85% of the reference infliximab group and 86% of the biosimilar infliximab group had a response, and 68% and 79%, respectively, achieved remission. No unexpected adverse events (AEs) were observed.

Another study, concerning induction with biosimilar infliximab, was conducted in 36 patients in 3 Polish hospitals. Three induction doses were given to 34 (94.4%) of the patients. After 14 weeks following the first dose, 86% of patients had a clinical response, and 67% achieved remission. One allergic reaction was reported. No serious AEs were reported.

A study from the United Kingdom found that, among 40 patients, most of whom were naïve to anti—tumor necrosis factor therapy, treatment with biosimilar infliximab resulted in remission for 67% of patients. One patient had an allergic reaction.

Two studies in pediatric patients with IBD have reported on switching. The first, conducted in Poland, involved 39 patients, all over 16 years of age. These patients were switched to biosimilars because of unavailability of the reference infliximab. None of them presented with disease exacerbation after the switch, and no serious AEs occurred.

A second switching study, conducted in the Republic of Korea, compared 36 patients who remained on reference infliximab to 38 patients who switched to CT-P13. Sustained remission was attained by 77.8% of those who continued with the reference versus 78.9% of those who switched. Nos serious AEs or infusion-related reactions were observed.

“To date, published data on pediatric IBD remain limited. Nevertheless, the above-mentioned studies show that the efficacy and safety of biosimilars and the originator infliximab are similar,” concluded the authors.

Reference

Sieczkowska-Golub J, Jarzebicka D, Oracz G, Kierkus J. Biosimilars in paediatric inflammatory bowel disease. World J Gastroenterol. 2018;24(35):4021-4027. doi: 10.3748/wjg.v24.i35.4021.