Long‐term efficacy and safety of biosimilar infliximab (CT‐P13) after switching from originator infliximab: Open‐label extension of the NOR‐SWITCH trial
Goll, Guro Løvik; Jørgensen, Kristin Kaasen; Sexton, Joseph; Olsen, Inge Christoffer; Bolstad, Nils; Haavardsholm, Espen A.; Lundin, Knut Erik Aslaksen; Tveit, Kåre Steinar; Lorentzen, Merete; Berset, Ingrid Prytz; Fevang, Bjørg-Tilde Svanes; Kalstad, Synnøve; Ryggen, Kristin; Warren, David; Klaasen, Rolf; Asak, Øivind Wessel; Baigh, Somyeh; Blomgren, Ingrid; Brenna, Øystein; Bruun, Trude J; Dvergsnes, Katrine; Frigstad, Svein Oskar; Myrnes, Inger; Hatten, Ingvild Helgheim; Huppertz-Hauss, Gert; Henriksen, Magne; Hoie, Sunniva S.; Krogh, Jan Reidar; Midtgard, Irina P.; Mielnik, Pawel; Moum, Bjørn; Noraberg, Geir; Poyan, Armin; Prestegård, Ulf; Rashid, Haroon Ur; Strand, Eldri Kveine; Skjetne, Kristine; Seeberg, Kathrine; Torp, Roald; Ystrøm, Carl Magnus; Vold, Cecilia; Zettel, Camilla C.; Waksvik, Kenneth; Gulbrandsen, Bjørn; Hagfors, Jon; Mørk, Cato; Jahnsen, Jørgen; Kvien, Tore Kristian
Journal article, Peer reviewed
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Original versionJournal of Internal Medicine. 2019, 285 (6), 653-669. 10.1111/joim.12880
BACKGROUND 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.