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Clinical and epidemiological research
Extended report
Phase III, multicentre, double-blind, randomised, parallel-group study to evaluate the similarities between LBEC0101 and etanercept reference product in terms of efficacy and safety in patients with active rheumatoid arthritis inadequately responding to methotrexate
  1. Hiroaki Matsuno1,2,
  2. Masato Tomomitsu3,
  3. Atsushi Hagino3,
  4. Seonghye Shin4,
  5. Jiyoon Lee4,
  6. Yeong Wook Song5,6
  1. 1 Matsuno Clinic for Rheumatic Diseases, Toyama, Japan
  2. 2 Institute of Medical Science, Tokyo Medical University, Tokyo, Japan
  3. 3 Mochida Pharmaceutical, Tokyo, Japan
  4. 4 LG Chem, Seoul, Korea
  5. 5 Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, and College of Medicine, Medical Research Center, Seoul National University, Seoul, Korea
  6. 6 Division of Rheumatology, Department of Internal Medicine, Seoul National University Hospital, Jongno-gu, Seoul, Korea
  1. Correspondence to Dr Yeong Wook Song, Division of Rheumatology, Department of Internal Medicine, Seoul National University Hospital, Seoul 03080, Republic of Korea; ysong{at}snu.ac.kr

Abstract

Objective To evaluate the similarities between LBEC0101 (etanercept biosimilar) and the etanercept reference product (ETN-RP) in terms of efficacy and safety, including immunogenicity, in patients with active rheumatoid arthritis despite methotrexate treatment.

Methods This phase III, multicentre, randomised, double-blind, parallel-group, 54-week study was conducted in Japan and Korea. The primary efficacy endpoint was the change from baseline in the disease activity score in 28 joints based on erythrocyte sedimentation rate (DAS28-ESR) at week 24. American College of Rheumatology 20% (ACR20) response rate, adverse events (AEs), pharmacokinetics and development of antidrug antibodies (ADAs) were also evaluated.

Results In total, 374 patients were randomised to LBEC0101 (n=187) or ETN-RP (n=187). The least squares mean changes from baseline in DAS28-ESR at week 24 in the per-protocol set were −3.01 (95% CI −3.198 to −2.820) in the LBEC0101 group and −2.86 (95% CI −3.051 to −2.667) in the ETN-RP group. The estimated between-group difference was −0.15 and its 95% CI was −0.377 to 0.078, which was within the prespecified equivalence margin of −0.6 to 0.6. ACR20 response rates at week 24 were similar between the groups (LBEC0101 93.3% vs ETN-RP 86.7%). The incidence of AEs up to week 54 was comparable between the groups (LBEC0101 92.0% vs ETN-RP 92.5%), although fewer patients in the LBEC0101 group (1.6%) than the ETN-RP group (9.6%) developed ADAs.

Conclusion The clinical efficacy of LBEC0101 was equivalent to that of ETN-RP. LBEC0101 was well tolerated and had a comparable safety profile to ETN-RP.

Trial registration number NCT02357069.

  • Rheumatoid Arthritis
  • Methotrexate
  • Das28

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/annrheumdis-2017-212172

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    Footnotes

    • Handling editor Tore K Kvien

    • Contributors All authors (1) were involved in the conception and design of the study, or the acquisition, analysis and interpretation of data for the study, (2) were involved in drafting the manuscript and revising it critically for important intellectual content, (3) gave final approval of the version to be published, and (4) agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

    • Funding This study was funded by LG Chem (formerly LG Life Sciences), Mochida Pharmaceutical and Korea Health Industry Development Institute. Medical writing and editorial assistance, funded by Mochida Pharmaceutical, was provided by Michelle Belanger, MD, of Edanz Medical Writing.

    • Competing interests HM has received consulting fees for this study from Mochida Pharmaceutical, consulting fees unrelated to this study from AYUMI Pharmaceutical Corporation, Nichi-Iko Pharmaceutical and Meiji Seika Pharma, and lecture fees from Daiichi Sankyo, UCB Japan, Janssen Pharmaceutical KK, Chugai Pharmaceutical and Ono Pharmaceutical. MT and AH are employees of Mochida Pharmaceutical. SS and JL are employees of LG Chem. YWS received a grant for this study from LG Chem.

    • Patient consent Detail has been removed from this case description/these case descriptions to ensure anonymity. The editors and reviewers have seen the detailed information available and are satisfied that the information backs up the case the authors are making.

    • Ethics approval This study was conducted according to the Declaration of Helsinki, International Committee on Harmonization Good Clinical Practice guideline, and applicable local laws and regulations. The protocol was approved by the regulatory authorities in each country and by the ethics committees of each study site.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Presented at Part of this manuscript was presented at the 2017 ACR/ARHP Annual Meeting.