No Difference in Pediatric Growth Rates with Infliximab Biosimilar vs Reference Agent

Ross Maltz, MD
Credit: Nationwide Children's Hospital

Data from a propensity-scored matched analysis of pediatric patients with inflammatory bowel disease is providing insight into the effects of biosimilar infliximab compared to the reference agent.¹

A single-center study of patients aged less than 17 years using reference infliximab or infliximab biosimilar, results of the study suggest weight, height, and body mass index z-scores increased over time for both groups and similar rates of change were observed among those receiving the reference agent and an infliximab biosimilar.¹

“There were similar improvements in growth and clinical outcomes in patients initiated on the infliximab originator compared to an infliximab biosimilar agent,” investigators wrote.¹

A TNF inhibitor with a host of FDA-approved indications, infliximab has become a staple in the treatment algorithms for a slew of different patient populations dating back to its initial approval in Crohn’s disease in August 1998. Infliximab received its first pediatric approval in inflammatory bowel disease in May 2006 with approval for pediatric Crohn’s disease and approval for pediatric ulcerative colitis.²

In the US, infliximab-dyyb became the first biosimilar of infliximab and the second overall to receive approval from the FDA in April 2016. With the approval, the biosimilar received indications for adult patients with moderately to severely active ulcerative colitis, patients with active ankylosing spondylitis, patients with active psoriatic arthritis, and more. The approval also indicated the biosimilar for use in adult patients and pediatric patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy.³

Stunted pubertal growth is common among pediatric patients with inflammatory bowel disease.⁴ In previous research examining use of infliximab among children with inflammatory bowel disease, results have provided evidence of significant catch up growth among these children.⁵ As investigators of the current study note, much less research has been dedicated to examining whether a similar effect might be observed with use of biosimilar infliximab.¹

With this in mind, investigators designed the current study as a retrospective review of data from a single center between April 2016-February 2021. For inclusion in the study, patients needed to have a confirmed diagnosis of inflammatory bowel disease, be younger than 17 years of age, and have been initiated on infliximab originator or biosimilar for a minimum of 12 months prior to study entry. Overall, 113 patients using reference infliximab and 39 using biosimilar infliximab were identified for inclusion.¹

The primary outcomes of interest were changes from baseline to 12 months post initiation for laboratory values, disease activity scores, and growth values. For the purpose of analysis, investigators used linear mixed models with random intercepts to test differences in measures over time and between study groups. Of note, propensity score-matching was used to limit confounding between groups. Following propensity score-matching, Investigators identified 37 dyads for inclusion in their study.¹

Upon analysis, results indicated the z-scores for weight, height, and body mass index from baseline to 12 months increased in both groups (P < .05), with a similar rate of change observed among those using reference infliximab and biosimilar infliximab. Further analysis of laboratory values, including albumin, C-reactive protein, and hemoglobin, as well as disease activity scoring were similar from baseline to 12 months among both the reference infliximab and biosimilar infliximab groups.¹

“This study adds to the limited research evaluating whether infliximab biosimilars have similar growth outcomes in children with [inflammatory bowel disease]," wrote investigaotors.¹

References:

1. McClinchie MG, Lakhani A, Abdel-Rasoul M, et al. Similar Growth Outcomes in Children with Inflammatory Bowel Disease Initiated on Infliximab Originator or Biosimilar [published online ahead of print, 2023 Jul 13]. J Pediatr Gastroenterol Nutr. 2023;10.1097/MPG.0000000000003890. doi:10.1097/MPG.0000000000003890
2. Remicade (infliximab) FDA approval history. Drugs.com. Accessed July 20, 2023. https://www.drugs.com/history/remicade.html.
3. Office of the Commissioner. FDA approves Inflectra, a biosimilar to remicade. U.S. Food and Drug Administration. April 5, 2016. Accessed July 20, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-inflectra-biosimilar-remicade.
4. Amaro F, Chiarelli F. Growth and Puberty in Children with Inflammatory Bowel Diseases. Biomedicines. 2020;8(11):458. Published 2020 Oct 29. doi:10.3390/biomedicines8110458
5. Walters TD, Gilman AR, Griffiths AM. Linear growth improves during infliximab therapy in children with chronically active severe Crohn's disease. Inflamm Bowel Dis. 2007;13(4):424-430. doi:10.1002/ibd.20069