Infliximab and its biosimilar produced similar first-year therapy outcomes in patients with inflammatory bowel disease

Aim Tumour necrosis factor alpha inhibitors (anti-TNF alpha) are the main therapy for moderate to severe inflammatory bowel disease (IBD) in children. Biosimilars to the original drug infliximab are now available, but there are few reports on their real-life use. We compared the outcomes of patients treated with infliximab and its biosimilar, CT-P13. Methods We collected outcome data on anti-TNF alpha-naive patients who started infliximab in the Children's Hospital, University of Helsinki, Finland, in 2015-2016. We studied 51 paediatric patients with IBD at a median age of 12 (range 4-16): 65% had Crohn disease, 23 received the original infliximab drug and 28 received the biosimilar. During 2015, infliximab was introduced to all treatment-naive patients, and during 2016, all treatment-naive patients received the biosimilar. Results We found no statistically significant differences between the two drug products related to the outcome of the therapy during the first year. There were no significant differences in the trough levels between the treatment groups. Likewise, the proportion of patients with therapy enhancement was comparable between the two treatment groups. Conclusion The first-year therapy outcomes of infliximab and its biosimilar were comparable. There were no alarming signs of differences in safety.