ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2543

Retention Rate and Safety Data of Biosimilar CT-P13 in Patients with Rheumatoid Arthritis: Data from the Korean College of Rheumatology Biologics Registry

Hyoun-Ah Kim1, Eun-Young Lee2, Sun Kyung Lee3, Yong-Beom Park4, Young Nam Lee5, HeeJung Kang6 and Kichul Shin7, 1Department of Rheumatology, Ajou University School of Medicine, Suwon, Korea, Republic of (South), 2Department of Medical Informatics, Ajou University School of Medicine, Suwon, Korea, Republic of (South), 3Division of Rheumatology, Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul, Korea, Republic of (South), 4Yonsei University College of Medicine, Seoul, Korea, Republic of (South), 5Celltrion Healthcare Co. Ltd, Incheon, Korea, Republic of (South), 6Celltrion Healthcare Co.Ltd, Incheon, Korea, Republic of (South), 7Kyungnam villa #102, Division of Rheumatology, Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul, Korea, Republic of (South)

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords:

Session Information

Date: Tuesday, October 23, 2018

Title: Rheumatoid Arthritis – Treatments Poster III: Biosimilars and New Compounds

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose:

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.

Disclosure: H. A. Kim, None; E. Y. Lee, None; S. K. Lee, None; Y. B. Park, None; Y. N. Lee, Celltrion Healthcare Co. Ltd, 3; H. Kang, Celltrion Healthcare Co. Ltd, 3; K. Shin, None.

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 9). 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 .

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