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Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101: an open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study

Cited 3 time in Web of Science Cited 3 time in Scopus
Authors
Park, Min-Chan; Matsuno, Hiroaki; Kim, Jinseok; Park, Sung-Hwan; Lee, Sang-Heon; Park, Yong-Beom; Lee, Yun Jong; Lee, Sang-Il; Park, Won; Sheen, Dong Hyuk; Choe, Jung-Yoon; Choi, Chan-Bum; Hong, Seung-Jae; Suh, Chang-Hee; Lee, Shin-Seok; Cha, Hoon-Suk; Yoo, Bin; Hur, Jin-Wuk; Kim, Geun-Tae; Yoo, Wan-Hee; Baek, Han Joo; Shin, Kichul; Shim, Seung Cheol; Yang, Hyung-In; Kim, Hyun Ah; Park, Kyung-Su; Choi, In Ah; Lee, Jisoo; Tomomitsu, Masato; Shin, Seonghye; Lee, Jiyoon; Song, Yeong Wook
Issue Date
2019-05-21
Publisher
BioMed Central
Citation
Arthritis Research & Therapy. 21(1):122
Keywords
EtanerceptLBEC0101Rheumatoid arthritisBiosimilarSwitch
Abstract
Background
To evaluate the long-term efficacy, safety and immunogenicity of continuing LBEC0101; the etanercept (ETN) biosimilar; or switching from the ETN reference product (RP) to LBEC0101 in patients with rheumatoid arthritis (RA).

Methods
This multicentre, single-arm, open-label extension study enrolled patients who had completed a 52-week randomised, double-blind, parallel phase III trial of LBEC0101 vs ETN-RP. Patients treated with ETN-RP during the randomised controlled trial switched to LBEC0101; those treated with LBEC0101 continued to receive LBEC0101 in this study. LBEC0101 (50 mg) was administered subcutaneously once per week for 48 weeks with a stable dose of methotrexate. Efficacy, safety and immunogenicity of LBEC0101 were assessed up to week 100.

Results
A total of 148 patients entered this extension study (70 in the maintenance group and 78 in the switch group). The 28-joint disease activity scores (DAS28)-erythrocyte sedimentation rate (ESR) were maintained in both groups from week 52 to week 100 (from 3.068 to 3.103 in the maintenance group vs. from 3.161 to 3.079 in the switch group). ACR response rates at week 100 for the maintenance vs. switch groups were 79.7% vs. 83.3% for ACR20, 65.2% vs. 66.7% for ACR50 and 44.9% vs. 42.3% for ACR70. The incidence of adverse events and the proportion of patients with newly developed antidrug antibodies were similar in the maintenance and switch groups (70.0% and 70.5%, 1.4% and 1.3%, respectively).

Conclusions
Administration of LBEC0101 showed sustained efficacy and acceptable safety in patients with RA after continued therapy or after switching from ETN-RP to LBEC0101.

Trial registration
ClinicalTrials.gov, NCT02715908. Registered 22 March 2016.
ISSN
1478-6362
Language
English
URI
http://hdl.handle.net/10371/156025
DOI
https://doi.org/10.1186/s13075-019-1910-2
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College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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