Switching maintenance infliximab therapy to biosimilar infliximab in inflammatory bowel disease patients

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Eberl , A , Huoponen , S , Pahikkala , T , Blom , M , Arkkila , P & Sipponen , T 2017 , ' Switching maintenance infliximab therapy to biosimilar infliximab in inflammatory bowel disease patients ' , Scandinavian Journal of Gastroenterology , vol. 52 , no. 12 , pp. 1348-1353 . https://doi.org/10.1080/00365521.2017.1369561

Title: Switching maintenance infliximab therapy to biosimilar infliximab in inflammatory bowel disease patients
Author: Eberl, Anja; Huoponen, Saara; Pahikkala, Tapio; Blom, Marja; Arkkila, Perttu; Sipponen, Taina
Contributor organization: Faculty of Pharmacy
Division of Pharmacology and Pharmacotherapy
University of Helsinki
Department of Medicine
Clinicum
Gastroenterologian yksikkö
Pharmacoeconomics
HUS Abdominal Center
Date: 2017
Language: eng
Number of pages: 6
Belongs to series: Scandinavian Journal of Gastroenterology
ISSN: 0036-5521
DOI: https://doi.org/10.1080/00365521.2017.1369561
URI: http://hdl.handle.net/10138/308455
Abstract: Background: Clinical use of biosimilar infliximab (CT-P13) in inflammatory bowel diseases (IBDs) is based on extrapolation of indication from clinical studies performed in rheumatological diseases. Only few data exist of behaviour of infliximab trough levels (TLs) and anti-drug antibodies (ADAs) during switching.Aim: The objective of this study was to evaluate changes in TLs, ADA formation and disease activity after switching from originator infliximab to biosimilar one.Methods: All our IBD patients receiving maintenance infliximab therapy were switched to biosimilar infliximab. TLs and ADAs were measured before the last originator infusion and before the third biosimilar infusion. Laboratory values, disease activity indices (partial Mayo score and Harvey-Bradshaw index) and demographic data were collected from patient records.Results: A total of 62 patients were included in the final analysis (32 Crohn's disease, 30 ulcerative colitis (UC) or IBD-unclassified). No significant changes in median TLs before (5.5mg/l) and after switching (5.5mg/l, p=.05) occurred in the entire study group or in the Crohn's disease (CD) subgroup (5.75 and 6.5mg/l, p=.68). However, in the subgroup of ulcerative colitis, the change in median TL was significantly different (from 5.2 to 4.25mg/l, p=.019). Two patients developed ADAs after switching. No changes in disease activity were detected during switching and no safety concerns occurred.Conclusions: Switching from originator to biosimilar infliximab resulted in statistically significant differences in infliximab TLs in patients with UC but not in patients with Crohn's disease. The clinical significance for this difference is doubtful and in neither group changes in disease activity occurred.
Subject: Infliximab
biosimilar
CT-P13
Crohn's disease
ulcerative colitis
trough levels
TNF- antagonist
ULCERATIVE-COLITIS
CROHNS-DISEASE
DOUBLE-BLIND
INNOVATOR INFLIXIMAB
PARALLEL-GROUP
EFFICACY
SAFETY
MULTICENTER
ANTIBODIES
3121 General medicine, internal medicine and other clinical medicine
Peer reviewed: Yes
Rights: unspecified
Usage restriction: openAccess
Self-archived version: acceptedVersion


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