Background The NOR-SWITCH study was a 52-week randomized, double-blind, non-inferiority, phase IV switch trial in patients with Crohn's disease (CD), ulcerative colitis (UC), spondyloarthritis (SpA), rheumatoid arthritis (RA), psoriatic arthritis (PsA) and plaque psoriasis (Ps) on stable treatment with originator infliximab (Remicade®, INX) and was funded by the Norwegian government. Previously, the primary analyses of the pooled indications have been published1.
Objectives To investigate efficacy, safety and immunogenicity in RA patients treated with continous INX vs patients switched to CT-P13 (biosimilar infliximab, Remsima®) in the NOR-SWITCH study (explorative analyses).
Methods Patients were randomized 1:1 to continued INX or switch to CT-P13. Serum drug levels were analysed in automated in-house assay. The primary endpoint was disease worsening according to disease-specific composite measures and/or consensus between investigator/patient leading to major treatment change. Exploratory subgroup analyses examined disease worsening and safety in RA. The primary endpoint was analysed using logistic regression, adjusted for diagnosis and disease duration.
Results Demographics, occurence of disease worsening, change in disease measures and treatment-emergent adverse events (TEAE) were similar (Table). Serum drug levels for INX and CT-P13 were similar throughout the study (Figure)
Conclusions Explorative analyses in the NOR-SWITCH study showed similar efficacy, serum drug levels and safety in RA patients switched to CT-P13 as those on continuous INX. The study was not powered to show non-inferiority within each diagnosis.
Jørgensen KK et al Switching from originator infliximab to biosimimlar CT-P13 compared to maintained treatment with originator infliximab (NOR-SWITCH): a 52-week randomized double-blind non-inferiority trial. The Lancet, in press.
Disclosure of Interest G. Goll Consultant for: Orion Pharma, Pfizer, Novartis, Boeringer Ingelheim, AbbVie, I. Olsen: None declared, N. Bolstad: None declared, K. Jørgensen Consultant for: Intercept, Celltrion, Tillot, M. Lorentzen: None declared, C. Mørk Consultant for: Cellgene, AbbVie, Novartis, LeoPharma, ACOhud, Galdena Nordic, J. Jahnsen Consultant for: OrionPharma, Celltrion, Pfizer, MSD, AbbVie, Takeda, NappPharma, AstroPharma, E. Haavardsholm Consultant for: AbbVie, UCB, Roche, MSD, Pfizer, T. Kvien Consultant for: Biogen, BMS, Boehringer Ingelheim, Celltrion, Eli Lily, Epirus, Hospira, Merck-serono, Novartis, Orion Pharma, Pfizer, Sandoz, UCB