SAT0286 Retention rate and safety data of biosimilar ct-p13 in ankylosing spondylitis patients: data from the korean college of rheumatology biologics registry

Background CT-P13 is a biosimilar prescribed in a number of countries for indications approved for the reference infliximab (RINF), including ankylosing spondylitis (AS), rheumatoid arthritis, and inflammatory bowel diseases. Clinical data of CT-P13 have been analysed in previous clinical trials, demonstrating equivalence of efficacy and pharmacokinetic profile to RINF. However, there are few studies showing long-term data of its drug survival or safety. Objectives To investigate the drug retention rate and safety data of biosimilar CT-P13 in Korean AS patients. Methods Subjects were AS patients enrolled in the Korean College of Rheumatology biologics registry (KOBIO). Data from patients who received RINF and CT-P13 were included in the analysis Dec 2012 ~ . Dec 2017 Discontinuation was defined as switching or stopping the biologic agent. Kaplan-Meier curve and Cox proportional hazard model were used for further analysis. Reason for RINF or CT-P13 discontinuation was also assessed. Results Data from 399 AS patients (CT-P13; 256, RINF; 143) were analysed. The mean age of patients was 39.0 in the CT-P13 group, and 73% were males. The mean disease duration was 4.1 years. Eighty percent of patients were first-time biologic users. Discontinuation of CT-P13 occurred in 30.9% (switching in 17.6%) of patients during follow-up. The drug retention rate of first-line users of CT-P13 was marginally higher compared with second or more (≥2)-line users of CT-P13, first-line users of RINF, and ≥2 line users of CT-P13 in Korean AS patients (p=0.0518). The reason of discontinuation was inefficacy (42.7%), adverse events (20.2%), clinical improvement (7.9%), and others (18.0%) in the CT-P13 group. The incidence of adverse events of CT-P13, including infusion reaction (n=10), mycobacterial infection (n=2), and skin eruption (n=1) was comparable to that of RINF. Conclusions Our study demonstrates that the drug retention rate of CT-P13, especially in first-line users was relatively higher than that of RINF,[H1] and CT-P13 showed a reasonable long-term safety profile in Korean AS patients. Disclosure of Interest None declared