Anne Nikkonen1, Kaija-Leena Kolho1,2. 1. Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland. 2. University of Tampere and Tampere University Hospital, Tampere, Finland.
Abstract
AIM: Tumour necrosis factor α inhibitors (anti-TNFα) 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-TNFα-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-naïve patients, and during 2016, all treatment-naïve 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.
AIM: Tumour necrosis factor α inhibitors (anti-TNFα) 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-TNFα-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-naïve patients, and during 2016, all treatment-naïve 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.