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BioDrugs. 2019 Nov 16. doi: 10.1007/s40259-019-00393-y. [Epub ahead of print]

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

Author information

1
Department of Rheumatology, Ajou University School of Medicine, Suwon, Republic of Korea.
2
Department of Biomedical Informatics, Ajou University School of Medicine, Suwon, Republic of Korea.
3
Office of Biostatistics, Ajou Research Institute for Innovative Medicine, Ajou University Medical Center, Suwon, Republic of Korea.
4
Division of Rheumatology, Seoul Metropolitan Government-Seoul National University Hospital Boramae Medical Center, Seoul, Republic of Korea.
5
Department of Internal Medicine (Division of Rheumatology), Yonsei University College of Medicine, Severance Hospital, Seoul, Republic of Korea.
6
Celltrion Healthcare Co. Ltd., Incheon, Republic of Korea.
7
Division of Rheumatology, Seoul Metropolitan Government-Seoul National University Hospital Boramae Medical Center, Seoul, Republic of Korea. kideb1@gmail.com.

Abstract

OBJECTIVE:

The aim was to evaluate long-term drug retention, discontinuation, efficacy and safety of CT-P13 and reference infliximab in patients with rheumatoid arthritis (RA) enrolled in the Korean College of Rheumatology Biologics (KOBIO) registry.

METHODS:

Patients included adults with RA who received CT-P13 or reference infliximab between December 2012 and December 2017. Drug retention, efficacy (Disease Activity Score in 28 joints [DAS28]-erythrocyte sedimentation rate [ESR] or DAS28-C-reactive protein [CRP] and American College of Rheumatology [ACR] core set measure), and adverse events (AEs) were assessed over 4-years' follow-up.

RESULTS:

Data from 199 RA patients (CT-P13: n = 147; reference infliximab: n = 52) were analyzed. Median treatment duration was 1.22 years for CT-P13 and 1.40 years for reference infliximab (p = 0.67). Overall, 82% of patients received first-line therapy. Drug retention of CT-P13 versus reference infliximab was comparable for the overall population (p = 0.84) and for first-line (p = 0.66) and subsequent treatment lines (p = 0.96). Treatment changes or discontinuations occurred in 65.2% of patients with CT-P13 and 69.6% with reference infliximab. The most common reason for treatment changes or discontinuing treatment was lack of efficacy (CT-P13: 31.9%; reference infliximab: 34.8%). CT-P13 demonstrated comparable improvements in DAS28-ESR, DAS28-CRP and ACR responses to reference infliximab. Overall, 19 grade 3 AEs were reported for CT-P13 and eight for reference infliximab.

CONCLUSION:

Long-term data from patients with RA treated in routine clinical practice in Korea showed that CT-P13 had a comparable drug retention rate to reference infliximab, with similar efficacy and an acceptable safety profile. CLINICALTRIALS.

GOV IDENTIFIER:

NCT01965132.

PMID:
31734899
DOI:
10.1007/s40259-019-00393-y

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