Biosimilar Infliximab Not Shown to Cause Adverse Outcomes in Patients With IBD


Hesitation from patients and providers to switch to an infliximab biosimilar may not be necessary, new study finds.

Though infliximab (IFX) biosimilars are widely available across the United States for patients with Crohn disease (CD) and ulcerative colitis (UC)—about 1 in 100 adults have inflammatory bowel disease—concerns regarding their safety and efficacy have made patients and providers hesitant about implementing them. However, switching to an infliximab biosimilar was not associated with more adverse events compared with remaining on the originator product says new data presented during the first week of May at Digestive Disease Week in Chicago1.

Almost 800 patients—488 with CD, 298 with UC, and 4 with inflammatory bowel disease unclassified— in Veterans Affairs who received the reference infliximab from 2017 to 2019 participated in the study. Overall, 380 of the participants switched to a biosimilar, and 410 continued on the originator drug. Adverse outcomes were observed in over 35% of patients over 12 months, including “infusion reaction, serious infection (intravenous antibiotic, or delay of IFX), or immunogenicity (anti-IFX antibody or IFX escalation).”

However, there was statistically no difference in the number of patients using the biosimilar who experienced those effects versus the number of patients using the originator who experienced them. Race, age, gender, and concomitant medication use were all taken into account as well, and still no statistically significant changes existed between the group taking the biosimilar and the group taking the original.

“We observed IFX biosimilar switching was not associated with adverse events compared to continuation on IFX originator. These findings provide further reassurance that IFX biosimilar switching for CD and UC is safe,” the researchers concluded.

1. Hou JK, Pham C, Sansgiry S, Modi V, et al. Biosimilar infliximab switching is not associated with adverse outcomes: a real-world effectiveness analyses in a national cohort of u.s. military veterans with inflammatory bowel disease. Presented at Digestive Disease Week; May 6-9, 2023; Chicago, Illinois. Abstract 1708.
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