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An observational study of switching infliximab biosimilar: no adverse impact on inflammatory bowel disease control or drug levels with first or second switch

Research output: Contribution to journalArticlepeer-review

Raphael P. Luber, Rhona O'Neill, Sukhpreet Singh, Esha Sharma, Georgina Cunningham, Sailish Honap, Susanna Meade, Shuvra Ray, Simon H. Anderson, Joel Mawdsley, Jeremy D. Sanderson, Mark A. Samaan, Zehra Arkir, Peter M. Irving

Original languageEnglish
Pages (from-to)678-688
Number of pages11
JournalAlimentary Pharmacology and Therapeutics
Volume54
Issue number5
DOIs
Accepted/In press2021
PublishedSep 2021

Bibliographical note

Funding Information: : R. P. L. has received educational grants from Ferring, Pfizer and Vifor Pharma. S. H. has served as speaker for Janssen, Pfizer and Takeda. M. A. S. served as a speaker, a consultant and/or an advisory board member for Sandoz, Janssen, Takeda, MSD, Falk and Samsung Bioepis. P. M. I. served as a speaker, a consultant and/or an advisory board member for Abbvie, Warner Chilcott, Ferring, Falk Pharma, Takeda, MSD, Johnson & Johnson, Shire, Vifor Pharma, Pharmacosmos, Topivert, Genentech, Hospira and Samsung Bioepis and has received research funding from MSD and Takeda. The remaining authors have no conflicts of interest to declare. Declaration of personal interests Funding Information: Declaration of personal interests: R.?P.?L. has received educational grants from Ferring, Pfizer and Vifor Pharma. S.?H. has served as speaker for Janssen, Pfizer and Takeda. M.?A.?S. served as a speaker, a consultant and/or an advisory board member for Sandoz, Janssen, Takeda, MSD, Falk and Samsung Bioepis. P.?M.?I. served as a speaker, a consultant and/or an advisory board member for Abbvie, Warner Chilcott, Ferring, Falk Pharma, Takeda, MSD, Johnson & Johnson, Shire, Vifor Pharma, Pharmacosmos, Topivert, Genentech, Hospira and Samsung Bioepis and has received research funding from MSD and Takeda. The remaining authors have no conflicts of interest to declare. Declaration of funding interests: None Publisher Copyright: © 2021 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

King's Authors

Abstract

Background: Biologics account for a significant cost in inflammatory bowel disease (IBD) management; however, switching from infliximab originator to its biosimilars has enabled cost saving without compromising disease control. The effects on IBD activity and infliximab trough levels of a second switch to another biosimilar are, however, uncertain. Aims: To assess the effects on disease activity and infliximab trough levels associated with switching from infliximab biosimilar CT-P13 to another biosimilar SB2 and compare outcomes in those switching for the first and second time. Methods: IBD patients on CT-P13, including some previously switched from originator, were prospectively followed during a switch to SB2. C-reactive protein (CRP), trough infliximab level and clinical disease activity indices were collected at baseline, Infusion 3 or 4 (‘early’ after switch), and 1 year. Results: One hundred eighty-six patients (n = 99 second switch) on stable infliximab dosing underwent switching. Compared with baseline, there was no significant change in CRP, clinical disease activity scores or median trough infliximab level at the early time point among first-switch (baseline vs early: 5.7 vs 6.6 µg/mL, P = 0.05) and second-switch (4.3 vs 4.9 µg/mL, P = 0.07) patients nor at 1 year (median infliximab trough levels, baseline vs 1 year, in first-switch [5.7 vs 5.7 µg/mL, P = 0.37] and second-switch [4.3 vs 4.7 µg/mL, P = 0.06] patients). The proportion of patients in clinical remission did not significantly change at the early (92% vs 91% at baseline, P = 0.75) or 1 year (95% vs 91% at baseline, P = 0.16) time points. There was no significant difference in time to loss of response between patients switching for the first or second time (P = 0.69). Conclusions: Switching from one infliximab biosimilar to another had no adverse impact on infliximab trough levels, and clinical and biochemical disease activity, regardless of whether switching for the first or second time.

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