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  • A phase III, multicentre, randomised, double-blind, active-controlled, parallel-group trial comparing safety and efficacy of HD203, with innovator etanercept, in combination with methotrexate, in patients with rheumatoid arthritis: the HERA study

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Clinical and epidemiological research
Extended report
A phase III, multicentre, randomised, double-blind, active-controlled, parallel-group trial comparing safety and efficacy of HD203, with innovator etanercept, in combination with methotrexate, in patients with rheumatoid arthritis: the HERA study
  1. Sang-Cheol Bae1,
  2. Jinseok Kim2,
  3. Jung-Yoon Choe3,
  4. Won Park4,
  5. Sang-Heon Lee5,
  6. Yong-Beom Park6,
  7. Seung-Cheol Shim7,
  8. Shin-Seok Lee8,
  9. Yoon-Kyoung Sung1,
  10. Chan-Bum Choi1,
  11. So-Ra Lee9,
  12. HanYu Park9,
  13. Yongho Ahn10
  14. on behalf of the HERA Study Investigators
  1. 1Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea
  2. 2Jeju National University Hospital, Jeju, Republic of Korea
  3. 3Catholic University of Daegu School of Medicine, Daegu, Republic of Korea
  4. 4Inha University Hospital, Incheon, Republic of Korea
  5. 5Konkuk University School of Medicine, Seoul, Republic of Korea
  6. 6Yonsei University College of Medicine, Seoul, Republic of Korea
  7. 7Chungnam National University Hospital, Daejeon, Republic of Korea
  8. 8Chonnam National University Hospital, Gwangju, Republic of Korea
  9. 9Hanwha Chemical Biologics, Seoul, Republic of Korea
  10. 10Hanwha Chemical Biologics, Daejeon, Republic of Korea
  1. Correspondence to Professor Sang-Cheol Bae, Hanyang University Hospital for Rheumatic Diseases, 222 Wangsimni-ro, Seongdong-gu, Seoul 133-792, Republic of Korea; scbae{at}hanyang.ac.kr

Abstract

Objectives To evaluate equivalence in efficacy for rheumatoid arthritis (RA) and compare the safety of the biosimilar HD203 with innovator etanercept (ETN) plus methotrexate (MTX) (ClinicalTrials.gov NCT01270997).

Methods Patients with active RA received 25 mg HD203 or ETN subcutaneously twice-weekly with MTX for 48 weeks in a phase III, multicentre, randomised, double-blind, parallel-group design. The primary end point was the proportion of patients achieving the American College of Rheumatology 20% response (ACR20) at week 24 for per-protocol study completer set (PPS). Secondary end points included ACR response criteria, ACRn, European League against Rheumatism (EULAR) response, change in Disease Activity Score 28 (DAS28), patient-reported outcomes, safety and immunogenicity.

Results Of the 294 randomised patients (HD203, n=147; ETN, n=147), 233 comprised the 24-week PPS (n=115 and 118, respectively). ACR20 at week 24 was achieved by 83.48% and 81.36% of PPS patients, respectively, demonstrating equivalent efficacy within predefined margins of ±20% (treatment difference 2.12%, 95% CI −7.65% to 11.89%). Outcomes for secondary end points were consistent with the primary efficacy findings. Groups were comparable for overall incidences of treatment-emergent (all-causality) adverse events (AEs) (HD203 113 (76.9%) vs ETN 114 (78.1%) (p=0.804)), adverse drug reactions, serious AEs and discontinuations due to AEs. Few patients (HD203, n=8; ETN, n=3) tested positive for anti-drug antibodies.

Conclusion The study met the primary objective of demonstrating equivalent efficacy of HD203 and ETN. HD203 was well tolerated, with safety comparable with ETN in this population of patients with RA.

Trial registration number NCT01270997; Results.

  • Rheumatoid Arthritis
  • Anti-TNF
  • DMARDs (biologic)

https://doi.org/10.1136/annrheumdis-2015-207613

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    Footnotes

    • Handling editor Tore K Kvien

    • Contributors All authors meet the following conditions: (1) conception and design, acquisition of data or analysis and interpretation of data, (2) drafting the article or revising it critically for important intellectual content and (3) final approval of version submitted for publication.

    • Funding Hanwha Chemical Biologics Co., Seoul, Republic of Korea funded the HERA study.

    • Competing interests S-CB has acted as a consultant for Hanwha Chemical Co. and Ares Trading SA. At the time of writing, S-RL, YA, and HYP were employees of Hanwha Chemical Biologics, Seoul, Republic of Korea. At the time of submission, S-RL was an employee of AbbVie, Seoul, Republic of Korea.

    • Patient consent Obtained.

    • Ethics approval The study was conducted in accordance with the Declaration of Helsinki and was consistent with International Conference on Harmonisation Good Clinical Practice. The protocol and patients’ informed consent received institutional review board/independent ethics committee approval prior to initiation of the study.

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

    • Data sharing statement The FAS dataset for American College of Rheumatology response and ACRn is available on request for reviewer use only.

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