Efficacy and Safety of CT-P13 in Inflammatory Bowel Disease After Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trials

Overview

Journal BioDrugs

Specialties Allergy & Immunology
Genetics
Pharmacology

Date 2020 Sep 23

PMID 32965617

Citations 10

Authors

Kristin K Jorgensen

Guro L Goll

Joe Sexton

Nils Bolstad

Inge C Olsen

Oivind Asak

Ingrid P Berset

Ingrid M Blomgren

Katrine Dvergsnes

Jon Florholmen

Svein O Frigstad

Magne Henriksen

Jon Hagfors

Gert Huppertz-Hauss

Espen A Haavardsholm

Rolf A Klaasen

Bjorn Moum

Geir Noraberg

Ulf Prestegard

Jan H Rydning

Liv Sagatun

Kathrine A Seeberg

Roald Torp

Cecilia Vold

David J Warren

Carl M Ystrom

Knut E A Lundin

Tore Kvien

Jorgen Jahnsen

Affiliations

Soon will be listed here.

Abstract

Background: The NOR-SWITCH main and extension trials demonstrated that switching from originator to biosimilar infliximab (CT-P13) is efficacious and safe across six diseases. However, a subgroup analysis of Crohn's disease (CD) in the main trial displayed a close to significant difference favouring originator infliximab, and more scientific data have therefore been requested.

Objective: The aim was to assess treatment efficacy, safety, and immunogenicity in an explorative subgroup analysis in CD and ulcerative colitis (UC) in the NOR-SWITCH trials.

Patients And Methods: The 52-week, randomised, non-inferiority, double-blind, multicentre, phase 4 NOR-SWITCH study was followed by a 26-week open extension trial where all patients received treatment with CT-P13. Treatment efficacy, safety, and immunogenicity in CD and UC were assessed throughout the 78-week study period.

Results: The main and extension trials included 155 and 93 patients with CD and 93 and 80 patients with UC, respectively. Demographic and baseline characteristics were comparable in both treatment arms within patient groups. There were no differences in the main and extension trials regarding changes in activity indices, C-reactive protein, faecal calprotectin, patient's and physician's global assessment of disease activity and patient-reported outcome measures in CD and UC. Moreover, comparable results were also demonstrated for trough serum levels, presence of anti-drug antibodies, and reported adverse events.

Conclusion: Efficacy, safety, and immunogenicity of both the originator and biosimilar infliximab were comparable in CD and UC in the NOR-SWITCH main and extension trials. These explorative subgroup analyses confirm that there are no significant concerns related to switching from originator infliximab to CT-P13 in CD and UC.

Trial Registration: ClinicalTrials.gov, number NCT02148640.

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