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dc.contributor.authorGoll, Guro Løvik
dc.contributor.authorJørgensen, Kristin Kaasen
dc.contributor.authorSexton, Joseph
dc.contributor.authorOlsen, Inge Christoffer
dc.contributor.authorBolstad, Nils
dc.contributor.authorHaavardsholm, Espen A.
dc.contributor.authorLundin, Knut Erik Aslaksen
dc.contributor.authorTveit, Kåre Steinar
dc.contributor.authorLorentzen, Merete
dc.contributor.authorBerset, Ingrid Prytz
dc.contributor.authorFevang, Bjørg-Tilde Svanes
dc.contributor.authorKalstad, Synnøve
dc.contributor.authorRyggen, Kristin
dc.contributor.authorWarren, David
dc.contributor.authorKlaasen, Rolf
dc.contributor.authorAsak, Øivind Wessel
dc.contributor.authorBaigh, Somyeh
dc.contributor.authorBlomgren, Ingrid
dc.contributor.authorBrenna, Øystein
dc.contributor.authorBruun, Trude J
dc.contributor.authorDvergsnes, Katrine
dc.contributor.authorFrigstad, Svein Oskar
dc.contributor.authorMyrnes, Inger
dc.contributor.authorHatten, Ingvild Helgheim
dc.contributor.authorHuppertz-Hauss, Gert
dc.contributor.authorHenriksen, Magne
dc.contributor.authorHoie, Sunniva S.
dc.contributor.authorKrogh, Jan Reidar
dc.contributor.authorMidtgard, Irina P.
dc.contributor.authorMielnik, Pawel
dc.contributor.authorMoum, Bjørn
dc.contributor.authorNoraberg, Geir
dc.contributor.authorPoyan, Armin
dc.contributor.authorPrestegård, Ulf
dc.contributor.authorRashid, Haroon Ur
dc.contributor.authorStrand, Eldri Kveine
dc.contributor.authorSkjetne, Kristine
dc.contributor.authorSeeberg, Kathrine
dc.contributor.authorTorp, Roald
dc.contributor.authorYstrøm, Carl Magnus
dc.contributor.authorVold, Cecilia
dc.contributor.authorZettel, Camilla C.
dc.contributor.authorWaksvik, Kenneth
dc.contributor.authorGulbrandsen, Bjørn
dc.contributor.authorHagfors, Jon
dc.contributor.authorMørk, Cato
dc.contributor.authorJahnsen, Jørgen
dc.contributor.authorKvien, Tore Kristian
dc.identifier.citationJournal of Internal Medicine. 2019, 285 (6), 653-669.nb_NO
dc.description.abstractBACKGROUND AND OBJECTIVES: The 52-week, randomized, double-blind, noninferiority, government-funded NOR-SWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CT-P13 was not inferior to continued treatment with infliximab originator. The NOR-SWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CT-P13 throughout the 78-week study period (maintenance group) versus patients switched to CT-P13 at week 52 (switch group). The primary outcome was disease worsening during follow-up based on disease-specific composite measures. METHODS: Patients were recruited from 24 Norwegian hospitals, 380 of 438 patients who completed the main study: 197 in the maintenance group and 183 in the switch group. In the full analysis set, 127 (33%) had Crohn's disease, 80 (21%) ulcerative colitis, 67 (18%) spondyloarthritis, 55 (15%) rheumatoid arthritis, 20 (5%) psoriatic arthritis and 31 (8%) chronic plaque psoriasis. RESULTS: Baseline characteristics were similar in the two groups at the time of switching (week 52). Disease worsening occurred in 32 (16.8%) patients in the maintenance group vs. 20 (11.6%) in the switch group (per-protocol set). Adjusted risk difference was 5.9% (95% CI -1.1 to 12.9). Frequency of adverse events, anti-drug antibodies, changes in generic disease variables and disease-specific composite measures were comparable between arms. The study was inadequately powered to detect noninferiority within individual diseases. CONCLUSION: The NOR-SWITCH extension showed no difference in safety and efficacy between patients who maintained CT-P13 and patients who switched from originator infliximab to CT-P13, supporting that switching from originator infliximab to CT-P13 is safe and efficacious.nb_NO
dc.description.sponsorshipMinistry of Health and Care services, Norwaynb_NO
dc.rightsNavngivelse 4.0 Internasjonal*
dc.subjectbiosimilar; chronic inflammatory disease; drug costs; health economics; infliximab; switchingnb_NO
dc.titleLong‐term efficacy and safety of biosimilar infliximab (CT‐P13) after switching from originator infliximab: Open‐label extension of the NOR‐SWITCH trialnb_NO
dc.typeJournal articlenb_NO
dc.typePeer reviewednb_NO
dc.rights.holder© 2019 The Authors. Journal of Internal Medicine published by John Wiley & Sons Ltd on behalf of Association for Publication of The Journal of Internal Medicine This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.nb_NO
dc.source.journalJournal of Internal Medicinenb_NO
cristin.unitnameDiv Gjøvik
cristin.unitnameDiv Lillehammer
cristin.unitnameDiv Elverum-Hamar

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Navngivelse 4.0 Internasjonal
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