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dc.contributor.authorJørgensen, Kristin Kaasen
dc.contributor.authorInge Christoffer, Olsen
dc.contributor.authorGoll, Guro Løvik
dc.contributor.authorLorentzen, Merete
dc.contributor.authorBolstad, Nils
dc.contributor.authorHaavardsholm, Espen A.
dc.contributor.authorLundin, Knut Erik Aslaksen
dc.contributor.authorMørk, Cato
dc.contributor.authorJahnsen, Jørgen
dc.contributor.authorKvien, Tore Kristian
dc.date.accessioned2019-01-18T11:47:17Z
dc.date.available2019-01-18T11:47:17Z
dc.date.created2017-10-03T12:09:33Z
dc.date.issued2017
dc.identifier.citationThe Lancet. 2017, 389 (10086), 2304-2316.nb_NO
dc.identifier.issn0140-6736
dc.identifier.urihttp://hdl.handle.net/11250/2581283
dc.description.abstractBackground TNF inhibitors have improved treatment of Crohn's disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, and chronic plaque psoriasis, but are expensive therapies. The aim of NOR-SWITCH was to examine switching from originator infliximab to the less expensive biosimilar CT-P13 regarding efficacy, safety, and immunogenicity. Methods The study is a randomised, non-inferiority, double-blind, phase 4 trial with 52 weeks of follow-up. Adult patients on stable treatment with infliximab originator treated in a hospital setting for at least 6 months were eligible for participation. Patients with informed consent were randomised in a 1:1 ratio to either continued infliximab originator or to switch to CT-P13 treatment, with unchanged dosing regimen. Data were collected at infusion visits in 40 Norwegian study centres. Patients, assessors, and patient care providers were masked to treatment allocation. The primary endpoint was disease worsening during 52-week follow-up. 394 patients in the primary per-protocol set were needed to show a non-inferiority margin of 15%, assuming 30% disease worsening in each group. This trial is registered with ClinicalTrials.gov, number NCT02148640. Findings Between Oct 24, 2014, and July 8, 2015, 482 patients were enrolled and randomised (241 to infliximab originator, 241 to CT-P13 group; one patient was excluded from the full analysis and safety set for CT-P13) and 408 were included in the per-protocol set (202 in the infliximab originator group and 206 in the CT-P13 group). 155 (32%) patients in the full analysis set had Crohn's disease, 93 (19%) had ulcerative colitis, 91 (19%) had spondyloarthritis, 77 (16%) had rheumatoid arthritis, 30 (6%) had psoriatic arthritis, and 35 (7%) had chronic plaque psoriasis. Disease worsening occurred in 53 (26%) patients in the infliximab originator group and 61 (30%) patients in the CT-P13 group (per-protocol set; adjusted treatment difference −4·4%, 95% CI −12·7 to 3·9). The frequency of adverse events was similar between groups (for serious adverse events, 24 [10%] for infliximab originator vs 21 [9%] for CT-P13; for overall adverse events, 168 [70%] vs 164 [68%]; and for adverse events leading to discontinuation, nine [4%] vs eight [3%], respectively). Interpretation The NOR-SWITCH trial showed that switching from infliximab originator to CT-P13 was not inferior to continued treatment with infliximab originator according to a prespecified non-inferiority margin of 15%. The study was not powered to show non-inferiority in individual diseases.nb_NO
dc.language.isoengnb_NO
dc.publisherElseviernb_NO
dc.titleSwitching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trialnb_NO
dc.typeJournal articlenb_NO
dc.typePeer reviewednb_NO
dc.description.versionpublishedVersionnb_NO
dc.source.pagenumber2304-2316nb_NO
dc.source.volume389nb_NO
dc.source.journalThe Lancetnb_NO
dc.source.issue10086nb_NO
dc.identifier.doi10.1016/S0140-6736(17)30068-5
dc.identifier.cristin1501789
dc.description.localcodeThis article will not be available due to copyright restrictions (c) 2017 by Elseviernb_NO
cristin.unitcode194,65,15,0
cristin.unitnameInstitutt for klinisk og molekylær medisin
cristin.ispublishedtrue
cristin.fulltextoriginal
cristin.qualitycode2A


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