• Raguprakash Ratnakumaran, Natalie To, David J Gracie, Christian P Selinger, Anthony O'Connor, Tanya Clark, Nicola Carey, Katherine Leigh, Lynsey Bourner, Alexander C Ford, and P John Hamlin.
• a Leeds Institute of Biomedical and Clinical Sciences , University of Leeds , Leeds , UK.
• Scand. J. Gastroenterol. 2018 Jun 1; 53 (6): 700-707.

ObjectivesRecently, the infliximab biosimilar (CT-P13) received market authorisation for inflammatory bowel disease (IBD), allowing cost benefits when switching to CT-P13. We aim to assess the efficacy and safety of switching from originator infliximab to CT-P13 for new and existing patients.Material And MethodsTreatment response, remission, primary and secondary loss of response rates, and adverse events in patients who initiated infliximab originator in the 12 months pre-switch (n = 53) were compared with the patients who initiated CT-P13 in the 12 months post-switch (n = 69). Sustained responses were compared for existing infliximab originator patients who switched to CT-P13 (n = 191) and those who continued with the originator (n = 19).ResultsThere was no difference in remission (58.1% vs. 47.4%, p = .37), response (12.6% vs. 10.5%, p = .80), secondary loss of response (24.6% vs. 42.1%, p = .10), or adverse events (4.7% vs. 0% p = 1.0) between those who switched to CT-P13 and those who continued infliximab originator. There was no difference in remission (42.0% vs. 26.4%, p = .074), response (21.7% vs. 22.6%, p = .91), primary non-response (5.8% vs. 15.1%, p = .09), secondary loss of response (21.7% vs. 22.6%, p = .91), or adverse events (8.7% vs. 11.3%, p = .63) in those who initiated CT-P13 compared with infliximab originator.ConclusionsThere was no difference in the efficacy and safety of infliximab originator and CT-P13 during the first 12 months after switching.

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