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

Arthritis Research & Therapy

Yeong Wook Song¹  Seung-Jae Hong²  Hoon-Suk Cha³  Hiroaki Matsuno⁴  Seonghye Shin⁵  Jiyoon Lee⁵  Bin Yoo⁶  Won Park⁷  Sang-Heon Lee⁸  Sung-Hwan Park⁹  Yong-Beom Park^1,10  Min-Chan Park^1,11  Jin-Wuk Hur^1,12  Sang-Il Lee^1,13  Geun-Tae Kim^1,14  Wan-Hee Yoo^1,15  Seung Cheol Shim^1,16  Shin-Seok Lee^1,17  Han Joo Baek^1,18  Yun Jong Lee^1,19  Chan-Bum Choi^2,20  Kyung-Su Park^2,21  Chang-Hee Suh^2,22  In Ah Choi^2,23  Dong Hyuk Sheen^2,24  Masato Tomomitsu^2,25  Hyun Ah Kim^2,26  Jung-Yoon Choe^2,27  Jisoo Lee^2,28  Jinseok Kim^2,29  Kichul Shin^3,30  Hyung-In Yang^3,31 

[1] 0000 0001 0302 820X, grid.412484.f, Division of Rheumatology, Department of Internal Medicine, Seoul National University Hospital, Jongno-gu, 03080, Seoul, South Korea;0000 0004 0470 5905, grid.31501.36, Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology and College of Medicine, Medical Research Centre, Seoul National University, Seoul, South Korea;0000 0001 0357 1464, grid.411231.4, Division of Rheumatology, Kyung Hee University Hospital, Seoul, South Korea;0000 0001 0640 5613, grid.414964.a, Department of Medicine, Samsung Medical Center, Seoul, South Korea;0000 0001 0663 3325, grid.410793.8, Institute of Medical Science, Tokyo Medical University, Tokyo, Japan;Matsuno Clinic for Rheumatic Diseases, Toyama, Japan;0000 0001 0696 9566, grid.464630.3, LG Chem Ltd., Seoul, South Korea;0000 0001 0842 2126, grid.413967.e, Division of Rheumatology, Asan Medical Center, Seoul, South Korea;0000 0001 2364 8385, grid.202119.9, Division of Rheumatology, Inha University School of Medicine, Incheon, South Korea;0000 0004 0371 843X, grid.411120.7, Division of Rheumatology, Konkuk University Medical Center, Seoul, South Korea;0000 0004 0470 4224, grid.411947.e, Division of Rheumatology, The Catholic University of Korea, Seoul St. Mary’s Hospital, Seoul, South Korea;0000 0004 0470 5454, grid.15444.30, Division of Rheumatology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea;0000 0004 0470 5454, grid.15444.30, Division of Rheumatology, Yonsei University College of Medicine, Seoul, South Korea;0000 0004 0604 7715, grid.414642.1, Department of Internal Medicine, Eulji University College of Medicine, Eulji Hospital, Seoul, South Korea;0000 0004 0624 2502, grid.411899.c, Division of Rheumatology, Gyeongsang National University Hospital, Jinju, South Korea;0000 0004 0647 1110, grid.411145.4, Division of Rheumatology, Kosin University Gospel Hospital, Busan, South Korea;0000 0004 0647 1516, grid.411551.5, Division of Rheumatology, Chonbuk National University Hospital, Jeonju, South Korea;0000 0004 0647 2279, grid.411665.1, Division of Rheumatology, Chungnam National University Hospital, Daejeon, South Korea;0000 0004 0647 2471, grid.411597.f, Division of Rheumatology, Chonnam National University Medical School and Hospital, Gwangju, South Korea;0000 0004 0647 2885, grid.411653.4, Department of Medicine, Division of Rheumatology, Gachon University Gil Medical Center, Incheon, South Korea;0000 0004 0647 3378, grid.412480.b, Division of Rheumatology, Department of Internal Medicine, Seoul National University Bundang Hospital, Gyeonggi-do, South Korea;0000 0004 0647 539X, grid.412147.5, Division of Rheumatology, Hanyang University Hospital, Seoul, South Korea;0000 0004 0647 774X, grid.416965.9, Division of Rheumatology, The Catholic University of Korea, St. Vincent’s Hospital, Seoul, South Korea;0000 0004 0648 1036, grid.411261.1, Department of Rheumatology, Ajou University Hospital, Suwon, South Korea;0000 0004 1794 4809, grid.411725.4, Division of Rheumatology, Chungbuk National University Hospital, Cheongju, South Korea;0000 0004 1798 4296, grid.255588.7, Division of Rheumatology, Eulji University School of Medicine, Daejeon, South Korea;0000 0004 1800 5387, grid.467457.3, Mochida Pharmaceutical Co., Ltd, Tokyo, Japan;0000000404154154, grid.488421.3, Division of Rheumatology, Hallym University Sacred Heart Hospital, Kyunggi, South Korea;Division of Rheumatology, Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, South Korea;grid.411076.5, Division of Rheumatology, Ewha Womans University Mokdong Hospital, Seoul, South Korea;grid.411842.a, Division of Rheumatology, Jeju National University Hospital, Jeju, South Korea;grid.412479.d, Division of Rheumatology, Seoul Metropolitan Government-Seoul National University, Boramae Medical Center, Seoul, South Korea;grid.496794.1, Division of Rheumatology, Kyung Hee University Hospital at Gangdong, Oriental Hospital, Seoul, South Korea;

关键词: Etanercept;    LBEC0101;    Rheumatoid arthritis;    Biosimilar;    Switch;   

DOI  :  10.1186/s13075-019-1910-2

来源: publisher

【 摘 要 】

BackgroundTo 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).MethodsThis 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.ResultsA 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).ConclusionsAdministration of LBEC0101 showed sustained efficacy and acceptable safety in patients with RA after continued therapy or after switching from ETN-RP to LBEC0101.Trial registrationClinicalTrials.gov, NCT02715908. Registered 22 March 2016.

【 授权许可】

CC BY