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dc.contributor.authorJørgensen, Kristin Kaasen
dc.contributor.authorGoll, Guro Løvik
dc.contributor.authorSexton, Joe
dc.contributor.authorBolstad, Nils
dc.contributor.authorOlsen, Inge C.
dc.contributor.authorAsak, Øivind Wessel
dc.contributor.authorBerset, Ingrid Prytz
dc.contributor.authorBlomgren, Ingrid
dc.contributor.authorDvergsnes, Katrine
dc.contributor.authorFlorholmen, Jon
dc.contributor.authorFrigstad, Svein Oskar
dc.contributor.authorHenriksen, Magne
dc.contributor.authorHagfors, Jon
dc.contributor.authorHuppertz-Hauss, Gert
dc.contributor.authorHaavardsholm, Espen Andre
dc.contributor.authorKlaasen, Rolf Anton
dc.contributor.authorMoum, Bjørn
dc.contributor.authorNoraberg, Geir
dc.contributor.authorPrestegård, Ulf
dc.contributor.authorRydning, Jan Henrik
dc.contributor.authorSagatun, Liv
dc.contributor.authorSeeberg, Kathrine
dc.contributor.authorTorp, Roald
dc.contributor.authorVold, Cecilia
dc.contributor.authorWarren, David J.
dc.contributor.authorYstrøm, Carl Magnus
dc.contributor.authorLundin, Knut Erik Aslaksen
dc.contributor.authorKvien, Tore Kristian
dc.contributor.authorJahnsen, Jørgen
dc.date.accessioned2020-09-30T07:07:23Z
dc.date.available2020-09-30T07:07:23Z
dc.date.issued2020-09-23
dc.description.abstract<i>Background</i> - 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.<p><p> <i>Objective</i> - 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.<p><p> <i>Patients and Methods</i> - 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.<p><p> <i>Results</i> - 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.<p><p> <i>Conclusion</i> - 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.en_US
dc.identifier.citationJørgensen, Goll, Sexton, Bolstad, Olsen, Asak, Berset, Blomgren, Dvergsnes, Florholmen, Frigstad, Henriksen, Hagfors, Huppertz-Hauss, Haavardsholm, Klaasen, Moum, Noraberg, Prestegård, Rydning, Sagatun, Seeberg K, Torp, Vold, Warren, Ystrøm, Lundin, Kvien, Jahnsen. 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. BioDrugs. 2020en_US
dc.identifier.cristinIDFRIDAID 1833332
dc.identifier.doi10.1007/s40259-020-00438-7
dc.identifier.issn1173-8804
dc.identifier.issn1179-190X
dc.identifier.urihttps://hdl.handle.net/10037/19510
dc.language.isoengen_US
dc.publisherSpringeren_US
dc.relation.journalBioDrugs
dc.rights.accessRightsopenAccessen_US
dc.rights.holderCopyright 2020 The Author(s)en_US
dc.subjectVDP::Medical disciplines: 700en_US
dc.subjectVDP::Medisinske Fag: 700en_US
dc.titleEfficacy and Safety of CT-P13 in Inflammatory Bowel Disease after Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trialsen_US
dc.type.versionpublishedVersionen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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