1 research outputs found
Longâterm efficacy and safety of biosimilar infliximab (CTâP13) after switching from originator infliximab: Openâlabel extension of the NORâSWITCH trial
Background and objectives
The 52âweek, randomized, doubleâblind, noninferiority, governmentâfunded NORâSWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CTâP13 was not inferior to continued treatment with infliximab originator. The NORâSWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CTâP13 throughout the 78âweek study period (maintenance group) versus patients switched to CTâP13 at week 52 (switch group). The primary outcome was disease worsening during followâup based on diseaseâspecific composite measures.
Methods
Patients 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.
Results
Baseline 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 (perâprotocol set). Adjusted risk difference was 5.9% (95% CI â1.1 to 12.9). Frequency of adverse events, antiâdrug antibodies, changes in generic disease variables and diseaseâspecific composite measures were comparable between arms. The study was inadequately powered to detect noninferiority within individual diseases.
Conclusion
The NORâSWITCH extension showed no difference in safety and efficacy between patients who maintained CTâP13 and patients who switched from originator infliximab to CTâP13, supporting that switching from originator infliximab to CTâP13 is safe and efficacious