Sang-Cheol Bae1, Jinseok Kim2, Jung-Yoon Choe3, Won Park4, Sang-Heon Lee5, Yong-Beom Park6, Seung-Cheol Shim7, Shin-Seok Lee8, Yoon-Kyoung Sung1, Chan-Bum Choi1, So-Ra Lee9, HanYu Park9, Yongho Ahn10. 1. Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea. 2. Jeju National University Hospital, Jeju, Republic of Korea. 3. Catholic University of Daegu School of Medicine, Daegu, Republic of Korea. 4. Inha University Hospital, Incheon, Republic of Korea. 5. Konkuk University School of Medicine, Seoul, Republic of Korea. 6. Yonsei University College of Medicine, Seoul, Republic of Korea. 7. Chungnam National University Hospital, Daejeon, Republic of Korea. 8. Chonnam National University Hospital, Gwangju, Republic of Korea. 9. Hanwha Chemical Biologics, Seoul, Republic of Korea. 10. Hanwha Chemical Biologics, Daejeon, Republic of Korea.
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
RCT Entities:
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 PPSpatients, 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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Authors: Andreas Kerschbaumer; Alexandre Sepriano; Josef S Smolen; Désirée van der Heijde; Maxime Dougados; Ronald van Vollenhoven; Iain B McInnes; Johannes W J Bijlsma; Gerd R Burmester; Maarten de Wit; Louise Falzon; Robert Landewé Journal: Ann Rheum Dis Date: 2020-02-07 Impact factor: 19.103
Authors: Marco Matucci-Cerinic; Yannick Allanore; Arthur Kavanaugh; Maya H Buch; Hendrik Schulze-Koops; Eugeniusz J Kucharz; Heike Woehling; Goran Babic; Johann Poetzl; Adanna Davis; Arnd Schwebig Journal: RMD Open Date: 2018-11-14