Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
CT-P13 is a biosimilar prescribed in a number of countries for indications approved for the reference infliximab (RINF) including rheumatoid arthritis (RA), ankylosing spondylitis (AS), and inflammatory bowel diseases. Clinical data of CT-P13 have been analyzed in previous clinical trials, demonstrating non-inferiority of efficacy and equivalence pharmacokinetic profile to RINF. However, there are few studies showing long-term data of its drug survival or safety. This study is to investigate the drug retention rate and safety data of biosimilar CT-P13 in Korean RA patients.
Methods: Subjects were RA 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 were used for further analysis. Reason for RINF or CT-P13 discontinuation was also assessed.
Results: Data from 199 RA patients (CT-P13; 147, RINF; 52) were analyzed. The mean age of patients was 51.3 years in the CT-P13 group, and 12% were males. The mean disease duration was 7.7 years. Eighty four percent of CT-P13 treated patients were first-time biologic users. The overall drug retention rate of CT-P13 versus RINF was comparable (p = 0.8382), as well as the retention rates of first-line (p = 0.6609) and second or more (≥2)-line users (p = 0.9552) of agents. The reasons for discontinuing were inefficacy (31.8% in CT-P13, 34.8% in RINF), adverse events (20.0% in CT-P13. 23.9% in RINF), clinical improvement (3.0% in CT-P13, 4.3% in RINF), and others (10.4% in CT-P13, 4.3% in RINF). The incidence of adverse events in CT-P13 treated patients leading to discontinuation was comparable to that of RINF; infusion reaction (10.2%), skin eruption (2.0%), and herpes zoster (0.68%).
Conclusion: Our study demonstrates that the drug retention rate of CT-P13 was similar to RINF, and CT-P13 showed a reasonable long-term safety profile comparable to RINF in Korean RA patients.
To cite this abstract in AMA style:Kim HA, Lee EY, Lee SK, Park YB, Lee YN, Kang H, Shin K. Retention Rate and Safety Data of Biosimilar CT-P13 in Patients with Rheumatoid Arthritis: Data from the Korean College of Rheumatology Biologics Registry [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/retention-rate-and-safety-data-of-biosimilar-ct-p13-in-patients-with-rheumatoid-arthritis-data-from-the-korean-college-of-rheumatology-biologics-registry/. Accessed September 16, 2019.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/retention-rate-and-safety-data-of-biosimilar-ct-p13-in-patients-with-rheumatoid-arthritis-data-from-the-korean-college-of-rheumatology-biologics-registry/