NOR-SWITCH was a randomised, double-blind, non-inferiority parallel-group study that compared the effect of switching from Remicade®† to Infelctra®/CT-P13* (infliximab) in 481 patients across all indications∏17.
Primary endpoints: Disease worsening across all indications at Week 5217.
Non inferiority‡ in disease worsening17
Disease worsening at Week 52#17
Stable patients switching to CT-P13* experienced a similar percentage of disease worsening when measured across all indications compared to those remaining on Remicade® therapy∏17.
†Remicade® is a registered trademark of MSD.
*CT-P13 is marketed under different brand names including INFLECTRA® and REMSIMA®.
∏Only single one-way switching from Remicade® to CT-P13* was examined in this study. The NOR-SWITCH trial included only patients on Remicade® and CT-P13*; its findings do not support that any other biosimilars of infliximab can achieve the same result.
‡According to a pre-specified margin of 15%. The study was not powered to show non-inferiority in individual diseases.
CI, Confidence interval; TNF, Tumour necrosis factor.
PP-IFA-GBR-0311. December 2018