• G L Goll, K K Jørgensen, J Sexton, I C Olsen, N Bolstad, E A Haavardsholm, K E A Lundin, K S Tveit, M Lorentzen, I P Berset, B T S Fevang, S Kalstad, K Ryggen, D J Warren, R A Klaasen, Ø Asak, S Baigh, I M Blomgren, Ø Brenna, T J Bruun, K Dvergsnes, S O Frigstad, I M Hansen, I S H Hatten, G Huppertz-Hauss, M Henriksen, S S Hoie, J Krogh, I P Midtgard, P Mielnik, B Moum, G Noraberg, A Poyan, U Prestegård, H U Rashid, E K Strand, K Skjetne, K A Seeberg, R Torp, C M Ystrøm, C Vold, C C Zettel, K Waksvik, B Gulbrandsen, J Hagfors, C Mørk, J Jahnsen, and T K Kvien.
• Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
• J. Intern. Med. 2019 Jun 1; 285 (6): 653-669.

Background And ObjectivesThe 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.MethodsPatients 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.ResultsBaseline 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.ConclusionThe 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.© 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.

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