Background The NOR-SWITCH study is 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), funded by the Norwegian government. Previously, primary analyses of the pooled indications have been published1.
Objectives To investigate efficacy, safety and immunogenicity in SpA patients treated with continuous 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 analyzed by automated in-house assay. The primary endpoint was disease worsening according to disease-specific composite measures and/or consensus between investigator/patient. Exploratory subgroup analyses examined disease worsening and safety in SpA. The primary endpoint was analysed by logistic regression, adjusted for diagnosis and disease duration.
Results Demographics, occurrence of disease worsening, change in disease measures and treatment-emergent adverse events (TEAE) were similar (Table), as were serum drug levels for INX and CT-P13 (Figure).
Conclusions Explorative analyses in the NOR-SWITCH study showed similar efficacy, drug levels and safety in SpA 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 biosimilar CT-P13 compared to maintained treatment with originator infliximab (NOR-SWITCH): a 52-week randomised double-blind non-inferiority trial. The Lancet, in press.
Disclosure of Interest G. Goll Consultant for: AbbVie, Boehringer Ingelheim, Orion Pharma, Novartis, Pfizer, I. Olsen: None declared, N. Bolstad: None declared, K. Jørgensen Consultant for: Celltrion, Intercept, AbbVie, Tillott, M. Lorentzen: None declared, C. Mørk Consultant for: Cellgene, AbbVie, Galderma Nordic, ACOhud, Novartis, LEOPharma, J. Jahnsen Consultant for: Celltrion, Orion Pharma, Pfizer, MSD, AbbVie, Takeda, Napp Pharma, AstroPharma, E. Haavardsholm Consultant for: AbbVie, UCB, Pfizer, MSD, Roche, T. Kvien Consultant for: Biogen, BMS, Boehringer Ingelheim, Celltrion, Eli Lily, Epirus, Hospira, Merck-Serono, Novartis, Orion Pharma, Pfizer, Sandoz, UCB