Ratnakumaran, R, To, N, Gracie, DJ orcid.org/0000-0001-9616-981X et al. (8 more authors) (2018) Efficacy and tolerability of initiating, or switching to, infliximab biosimilar CT-P13 in inflammatory bowel disease (IBD): a large single-centre experience. Scandinavian Journal of Gastroenterology, 53 (6). pp. 700-707. ISSN 0036-5521
Abstract
Objectives: Recently, 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 methods: Treatment 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). Results: There 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. Conclusions: There was no difference in the efficacy and safety of infliximab originator and CT-P13 during the first 12 months after switching.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2018 Informa UK Limited, trading as Taylor & Francis Group. This is an author produced version of a paper published in Scandinavian Journal of Gastroenterology. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | Biosimilar, infliximab, CT-P13, inflammatory bowel disease, biologics |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > Institute of Molecular Medicine (LIMM) (Leeds) > Section of Molecular Gastroenterology (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 16 Jul 2018 13:17 |
Last Modified: | 24 Apr 2019 00:42 |
Status: | Published |
Publisher: | Taylor and Francis |
Identification Number: | 10.1080/00365521.2018.1464203 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:133357 |