Posters Demonstrate Switching Safety Between Originator, Biosimilar Infliximab in IBD

Switching patients with inflammatory bowel disease (IBD) from originator infliximab (Remicade) to an infliximab biosimilar did not impact clinical outcomes, according to 2 posters from Digestive Disease Week. One study focused on switches in pediatric patients and the other focused on patients undergoing multiple switches.

Switching From Originator to Biosimilar Infliximab in Pediatric Patients¹

The first study evaluated clinical and laboratory outcomes in adolescents and young adults with IBD who switched from originator infliximab to a biosimilar (Inflectra) compared with a control group of patients who remained on Remicade.

Over recent years, many children with IBD have switched from originator infliximab to an infliximab biosimilar due to payer mandates. Despite concerns about clinical worsening, pediatric data on switching is limited.

The study included patients with IBD aged 6 to 26 years treated at Connecticut Children's who were in clinical remission or had low disease activity on Remicade before switching to the biosimilar. Control patients, matched by age, gender, IBD type, and time since diagnosis, remained on the originator. Data on demographics, laboratory results, drug levels, and clinical information were collected with at least 6 months of follow-up.

The study involved 93 patients who switched to Inflectra and 186 control patients who stayed on Remicade. Over 6 months, there were no significant changes in key laboratory markers or disease activity in either group. Both groups had similar low-level antibodies to infliximab rates.

Researchers said the findings suggest that switching from Remicade to a biosimilar in adolescents and young adults with IBD is safe, with no impact on clinical or laboratory disease activity. Clinicians can use this data to reassure patients and families about the safety of switching. Further follow-up will provide more data on younger patients and dose intensification frequency.

Real-World Switching Data Demonstrates Clinical Efficacy of Infliximab Biosimilar²

A second study aimed to evaluate the safety and outcomes of switching between multiple infliximab biosimilars in patients with IBD. The researchers used data from the Veterans Affairs health care system to conduct the retrospective cohort study of patients who received infliximab maintenance therapy from 2017 to 2019.

Patients were categorized into 3 groups: no-switch (NS) who remained on originator infliximab, single switch (SS) who switched to 1 biosimilar, and double switch (DS) who underwent 2 switches to 2 different biosimilars. The primary outcome was IBD flare within 12 months, and secondary outcomes included immunogenicity, serious infection, and infusion reaction.

Among 789 patients (n = 487 with Crohn disease; n = 298 with ulcerative colitis), 410 were the NS group, 249 were placed into the SS group, and 130 were put in the DS group. The flare rates within 12 months were 22.2% for the NS group, 15.3% for the SS group, and 21.5% for the DS cohort, with no significant differences identified between groups.

Infection rates were higher in the DS group (16.2%) compared to the NS (11.5%) and SS (8%) groups, with the SS group associated with a lower infection rate than the DS group. Multivariate analyses showed no significant difference in flare rates between the DS group and the other groups, but the SS group had a lower rate of infection compared to the DS cohort.

The researchers concluded that multiple infliximab biosimilar switching did not increase the risk of IBD flare but was associated with a higher risk of infection compared to a single biosimilar switch. The findings suggested that multiple infliximab biosimilar switching is effective, but further studies are needed to assess infection risks.

Reference

1. Solomon V, Kuzoian S, Michel G, Brimacombe M, Pinci E, Hyams JS. Change from Remicade® to infliximab biosimilar does not affect short-term outcome in children with inflammatory bowel disease. Presented at: DDW 2024; May 18-21, 2024; Washington, DC. Poster Tu1817.

2. Hou JK, Pham C, Xu A, Sansgiry S, Modi V, Waljee A. Multiple biosimilar infliximab switching is not associated with adverse outcomes in inflammatory bowel disease: A real-world effectiveness analyses in a national U.S. cohort. Presented at: DDW 2024; May 18-21, 2024; Washington, DC. Poster Sa1746.