This article is more than 5 years old. Information may no longer be current.
NOR-SWITCH: Switching from infliximab to CT-P13 biosimilar seen as non-inferior to maintained infliximab
Switching from infliximab to the CT-P13 biosimilar was non-inferior to continuing with infliximab, according to a recently published analysis.
Kristin K. Jorgensen, PhD, from Akershus University Hospital, and colleagues performed a phase 4 non-inferiority trial of 482 patients undergoing infliximab therapy and were randomized to either continue infliximab or receive the CT-P13 biosimilar for 52 weeks. The pre-specified non-inferiority margin was 15%.
Researchers found disease worsening occurred in 26% of patients in the infliximab group compared with 30% of the CT-P13 group, which was non-inferior. In addition, serious adverse events occurred in 10% for infliximab and 9% for CT-P13.
“There was no suggestion of differences in safety or immunogenicity between the two treatment groups,” the researchers wrote. “Consequently, the study results support that patients can be switched from originator to biosimilar infliximab. However, the study was not powered to show non-inferiority in individual diseases and the 15% margin might be too wide to exclude all clinically important differences. Moreover, we recommend caution in generalizing these findings to other biological agents. Further studies are needed to examine multiple-sequenced as well as back-and-forth switches.” – by Will A. Offit
Disclosures: Jorgensen reports fees from Tillott, Intercept and Celltrion. Please see the full study for a list of all other relevant financial disclosures.