SCI 발표논문

SCI 발표논문

← SCI 발표논문 목록

Arthritis Res Ther. 2019;21(1):122.

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.

, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

제1저자 박민찬 · 교신저자 송영욱

PMID 31113455 PMC6528252 DOI 10.1186/s13075-019-1910-2 IF 5.4 류마티스내과
소속 (33)
  1. Division of Rheumatology, Yonsei University College of Medicine, Seoul, South Korea.
  2. Institute of Medical Science, Tokyo Medical University, Tokyo, Japan.
  3. Matsuno Clinic for Rheumatic Diseases, Toyama, Japan.
  4. Division of Rheumatology, Jeju National University Hospital, Jeju, South Korea.
  5. Division of Rheumatology, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, South Korea.
  6. Division of Rheumatology, Konkuk University Medical Center, Seoul, South Korea.
  7. Division of Rheumatology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.
  8. Division of Rheumatology, Department of Internal Medicine, Seoul National University Bundang Hospital, Gyeonggi-do, South Korea.
  9. Division of Rheumatology, Gyeongsang National University Hospital, Jinju, South Korea.
  10. Division of Rheumatology, Inha University School of Medicine, Incheon, South Korea.
  11. Division of Rheumatology, Eulji University School of Medicine, Daejeon, South Korea.
  12. Division of Rheumatology, Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, South Korea.
  13. Division of Rheumatology, Hanyang University Hospital, Seoul, South Korea.
  14. Division of Rheumatology, Kyung Hee University Hospital, Seoul, South Korea.
  15. Department of Rheumatology, Ajou University Hospital, Suwon, South Korea.
  16. Division of Rheumatology, Chonnam National University Medical School and Hospital, Gwangju, South Korea.
  17. Department of Medicine, Samsung Medical Center, Seoul, South Korea.
  18. Division of Rheumatology, Asan Medical Center, Seoul, South Korea.
  19. Department of Internal Medicine, Eulji University College of Medicine, Eulji Hospital, Seoul, South Korea.
  20. Division of Rheumatology, Kosin University Gospel Hospital, Busan, South Korea.
  21. Division of Rheumatology, Chonbuk National University Hospital, Jeonju, South Korea.
  22. Department of Medicine, Division of Rheumatology, Gachon University Gil Medical Center, Incheon, South Korea.
  23. Division of Rheumatology, Seoul Metropolitan Government-Seoul National University, Boramae Medical Center, Seoul, South Korea.
  24. Division of Rheumatology, Chungnam National University Hospital, Daejeon, South Korea.
  25. Division of Rheumatology, Kyung Hee University Hospital at Gangdong, Oriental Hospital, Seoul, South Korea.
  26. Division of Rheumatology, Hallym University Sacred Heart Hospital, Kyunggi, South Korea.
  27. Division of Rheumatology, The Catholic University of Korea, St. Vincent's Hospital, Seoul, South Korea.
  28. Division of Rheumatology, Chungbuk National University Hospital, Cheongju, South Korea.
  29. Division of Rheumatology, Ewha Womans University Mokdong Hospital, Seoul, South Korea.
  30. Mochida Pharmaceutical Co., Ltd, Tokyo, Japan.
  31. LG Chem Ltd., Seoul, South Korea.
  32. Division of Rheumatology, Department of Internal Medicine, Seoul National University Hospital, Jongno-gu, Seoul, 03080, South Korea. ysong@snu.ac.kr.
  33. 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. ysong@snu.ac.kr.

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.

Keywords

BiosimilarEtanerceptLBEC0101Rheumatoid arthritisSwitch

Figures

Fig. 1
Fig. 1 Patient flow chart: Randomisation was carried out in the initial randomised trial only (1:1 ratio to LBEC0101 or ETN-RP), and no further randomisation was carried out in the extension study. *The number of patients enrolled in the extension study is different from the number finishing the phase III study because only Korean patients were enrolled in the extension study. ETN-RP, etanercept reference product
Fig. 2
Fig. 2 Disease activity score in 28 joints based on erythrocyte sedimentation rate (DAS28-ESR) (full-analysis set). DAS28-ESR mean values at weeks 0, 52, 76 and 100. SE, standard error
Fig. 3
Fig. 3 ACR response rates (full-analysis set). a ACR20, b ACR50 and c ACR70 response rates at weeks 52, 76 and 100. ACR, American College of Rheumatology; CI, confidence interval
Fig. 4
Fig. 4 EULAR response rates (full analysis set). EULAR response rates at weeks 52, 76 and 100. EULAR, European League Against Rheumatism

그림 출처: PubMed Central 공개 논문 (PMC6528252)

Conflict of interest statement

HM has received consulting fees for this study from Mochida Pharmaceutical Co., Ltd.; consulting fees from AYUMI Pharmaceutical Corporation and Nichi-Iko Pharmaceutical Co., Ltd.; and lecture fees from Daiichi Sankyo Co., Ltd., Chugai Pharmaceutical Co., Ltd. and Ono Pharmaceutical Co., Ltd., outside of this study. MT is an employee of Mochida Pharmaceutical Co., Ltd. SS and JY are employees of LG Chem, Ltd. All authors other than HM, MT, SS and JY received grants for this extension study from LG Chem, Ltd.

그 밖의 정보
출판 형태
Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
저널
Arthritis research & therapy · eISSN 1478-6362
전자 출판
2019-05-21
MeSH
Adult · Antirheumatic Agents / pharmacokinetics / therapeutic use · Arthritis, Rheumatoid / drug therapy · Biosimilar Pharmaceuticals / pharmacokinetics / therapeutic use · Double-Blind Method · Etanercept / pharmacokinetics / therapeutic use · Female · Humans · Immunoglobulin G / therapeutic use · Male · Middle Aged · Receptors, Tumor Necrosis Factor / therapeutic use · Therapeutic Equivalency · Time · Treatment Outcome
Substances
Antirheumatic Agents · Biosimilar Pharmaceuticals · Immunoglobulin G · LBEC0101 · Receptors, Tumor Necrosis Factor · Etanercept
데이터
ClinicalTrials.gov: NCT02715908
참고문헌
30편