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
- 주제(키워드) Etanercept , LBEC0101 , Rheumatoid arthritis , Biosimilar , Switch
- 주제(기타) Rheumatology
- 설명문(일반) [Park, Min-Chan] Yonsei Univ, Div Rheumatol, Coll Med, Seoul, South Korea; [Matsuno, Hiroaki] Tokyo Med Univ, Inst Med Sci, Tokyo, Japan; [Matsuno, Hiroaki] Matsuno Clin Rheumat Dis, Toyama, Japan; [Kim, Jinseok] Jeju Natl Univ Hosp, Div Rheumatol, Jeju, South Korea; [Park, Sung-Hwan] Catholic Univ Korea, Seoul St Marys Hosp, Div Rheumatol, Seoul, South Korea; [Lee, Sang-Heon] Konkuk Univ, Div Rheumatol, Med Ctr, Seoul, South Korea; [Park, Yong-Beom] Yonsei Univ, Div Rheumatol, Dept Internal Med, Coll Med, Seoul, South Korea; [Lee, Yun Jong] Seoul Natl Univ, Bundang Hosp, Dept Internal Med, Div Rheumatol, Gyeonggi Do, South Korea; [Lee, Sang-Il] Gyeongsang Natl Univ Hosp, Div Rheumatol, Jinju, South Korea; [Park, Won] Inha Univ, Div Rheumatol, Sch Med, Incheon, South Korea; [Sheen, Dong Hyuk] Eulji Univ, Div Rheumatol, Sch Med, Daejeon, South Korea; [Choe, Jung-Yoon] Daegu Catholic Univ, Dept Internal Med, Div Rheumatol, Sch Med, Daegu, South Korea; [Choi, Chan-Bum] Hanyang Univ Hosp, Div Rheumatol, Seoul, South Korea; [Hong, Seung-Jae] Kyung Hee Univ Hosp, Div Rheumatol, Seoul, South Korea; [Suh, Chang-Hee] Ajou Univ Hosp, Dept Rheumatol, Suwon, South Korea; [Lee, Shin-Seok] Chonnam Natl Univ, Div Rheumatol, Med Sch & Hosp, Gwangju, South Korea; [Cha, Hoon-Suk] Samsung Med Ctr, Dept Med, Seoul, South Korea; [Yoo, Bin] Asan Med Ctr, Div Rheumatol, Seoul, South Korea; [Hur, Jin-Wuk] Eulji Univ, Eulji Hosp, Dept Internal Med, Coll Med, Seoul, South Korea; [Kim, Geun-Tae] Kosin Univ, Div Rheumatol, Gospel Hosp, Busan, South Korea; [Yoo, Wan-Hee] Chonbuk Natl Univ Hosp, Div Rheumatol, Jeonju, South Korea; [Baek, Han Joo] Gachon Univ, Div Rheumatol, Dept Med, Gil Med Ctr, Incheon, South Korea; [Shin, Kichul] Seoul Natl Univ, Seoul Metropolitan Govt, Boramae Med Ctr, Div Rheumatol, Seoul, South Korea; [Shim, Seung Cheol] Chungnam Natl Univ Hosp, Div Rheumatol, Daejeon, South Korea; [Yang, Hyung-In] Kyung Hee Univ Hosp Gangdong, Oriental Hosp, Div Rheumatol, Seoul, South Korea; [Kim, Hyun Ah] Hallym Univ, Div Rheumatol, Sacred Heart Hosp, Kyunggi, South Korea; [Park, Kyung-Su] Catholic Univ Korea, St Vincents Hosp, Div Rheumatol, Seoul, South Korea; [Choi, In Ah] Chungbuk Natl Univ Hosp, Div Rheumatol, Cheongju, South Korea; [Lee, Jisoo] Ewha Womans Univ, Div Rheumatol, Mokdong Hosp, Seoul, South Korea; [Tomomitsu, Masato] Mochida Pharmaceut Co Ltd, Tokyo, Japan; [Shin, Seonghye; Lee, Jiyoon] LG Chem Ltd, Seoul, South Korea; [Song, Yeong Wook] Seoul Natl Univ Hosp, Dept Internal Med, Div Rheumatol, Seoul 03080, South Korea; [Song, Yeong Wook] Seoul Natl Univ, Grad Sch Convergence Sci & Technol, Dept Mol Med & Biopharmaceut Sci, Seoul, South Korea; [Song, Yeong Wook] Seoul Natl Univ, Coll Med, Med Res Ctr, Seoul, South Korea
- 등재 SCIE, SCOPUS
- OA유형 Green Published, gold
- 발행기관 BMC
- 발행년도 2019
- URI http://www.dcollection.net/handler/ewha/000000159851
- 본문언어 영어
- Published As http://dx.doi.org/10.1186/s13075-019-1910-2
- PubMed https://pubmed.ncbi.nlm.nih.gov/31113455
초록/요약
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.
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