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.

Espen A Haavardsholm, Jørgen Jahnsen, Tore Kvien, Knut E A Lundin, Carl M Ystrøm, David J Warren, Cecilia Vold, Roald Torp, Kathrine A Seeberg, Liv Sagatun, Jan H Rydning, Ulf Prestegård, Geir Noraberg, Bjørn Moum, Rolf A Klaasen, Kristin K Jørgensen, Gert Huppertz-Hauss, Jon Hagfors, Magne Henriksen, Svein O Frigstad, Jon Florholmen, Katrine Dvergsnes, Ingrid M Blomgren, Ingrid P Berset, Øivind Asak, Inge C Olsen, Nils Bolstad, Joe Sexton, Guro L Goll

Journal: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy 2021;34(5):681-694

PMID: 32965617

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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.

Address: Department of Gastroenterology, Akershus University Hospital, Sykehusveien 75, 1478, Lørenskog, Norway. [email protected].; Division of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway.; Department of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Oslo, Norway.; Research Support Services CTU, Oslo University Hospital, Oslo, Norway.; Department of Gastroenterology, Gjøvik Hospital, Gjøvik, Norway.; Department of Gastroenterology, Ålesund Hospital, Ålesund, Norway.; Department of Gastroenterology, Haugesund Hospital, Haugesund, Norway.; Department of Gastroenterology, Sørlandet Hospital, Kristiansand, Norway.; Department of Gastroenterology, University Hospital North Norway, Tromsø, Norway.; Research Group Gastroenterology and Nutrition, Norwegian Arctic University, Tromsø, Norway.; Department of Medicine, Vestre Viken Bærum Hospital, Gjettum, Norway.; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Gastroenterology, Østfold Hospital, Fredrikstad, Norway.; Patient Representative, Landsforeningen for Fordøyelsessykdommer, Oslo, Norway.; Department of Gastroenterology, Telemark Hospital, Skien, Norway.; Department of Gastroenterology, Oslo University Hospital Ullevål, Oslo, Norway.; Department of Gastroenterology, Sørlandet Hospital, Arendal, Norway.; Department of Gastroenterology, Lillehammer Hospital, Lillehammer, Norway.; Department of Gastroenterology, Akershus University Hospital, Sykehusveien 75, 1478, Lørenskog, Norway.; Department of Gastroenterology, Diakonhjemmet Hospital, Oslo, Norway.; Department of Gastroenterology, Sankt Olav's Hospital, Trondheim, Norway.; Department of Gastroenterology, Vestfold Hospital, Tønsberg, Norway.; Department of Gastroenterology, Hamar Hospital, Hamar, Norway.; Department of Gastroenterology, Bodø Hospital, Bodø, Norway.; Department of Gastroenterology, Elverum Hospital, Elverum, Norway.; Department of Gastroenterology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.; K.G. Jebsen Coeliac Disease Research Centre, University of Oslo, Oslo, Norway.

DOI: 10.1007/s40259-020-00438-7

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MeSH Terms: Antibodies, Monoclonal, Biosimilar Pharmaceuticals, Drug Substitution, Gastrointestinal Agents, Humans, Inflammatory Bowel Diseases, Infliximab, Treatment Outcome