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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

 Min-Chan Park  ;  Hiroaki Matsuno  ;  Jinseok Kim  ;  Sung-Hwan Park  ;  Sang-Heon Lee  ;  Yong-Beom Park  ;  Yun Jong Lee  ;  Sang-Il Lee  ;  Won Park  ;  Dong Hyuk Sheen  ;  Jung-Yoon Choe  ;  Chan-Bum Choi  ;  Seung-Jae Hong  ;  Chang-Hee Suh  ;  Shin-Seok Lee  ;  Hoon-Suk Cha  ;  Bin Yoo  ;  Jin-Wuk Hur  ;  Geun-Tae Kim  ;  Wan-Hee Yoo  ;  Han Joo Baek  ;  Kichul Shin  ;  Seung Cheol Shim  ;  Hyung-In Yang  ;  Hyun Ah Kim  ;  Kyung-Su Park  ;  In Ah Choi  ;  Jisoo Lee  ;  Masato Tomomitsu  ;  Seonghye Shin  ;  Jiyoon Lee  ;  Yeong Wook Song 
 ARTHRITIS RESEARCH & THERAPY, Vol.21(1) : 122, 2019 
Journal Title
Issue Date
Biosimilar ;  Etanercept ;  LBEC0101 ;  Rheumatoid arthritis ; Switch
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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Park, Min Chan(박민찬) ORCID logo https://orcid.org/0000-0003-1189-7637
Park, Yong Beom(박용범)
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