PMID- 26905864
OWN - NLM
STAT- MEDLINE
DCOM- 20170606
LR  - 20220330
IS  - 1468-2060 (Electronic)
IS  - 0003-4967 (Linking)
VI  - 76
IP  - 1
DP  - 2017 Jan
TI  - 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.
PG  - 65-71
LID - 10.1136/annrheumdis-2015-207613 [doi]
AB  - 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.
CI  - 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/.
FAU - Bae, Sang-Cheol
AU  - Bae SC
AD  - Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea.
FAU - Kim, Jinseok
AU  - Kim J
AD  - Jeju National University Hospital, Jeju, Republic of Korea.
FAU - Choe, Jung-Yoon
AU  - Choe JY
AD  - Catholic University of Daegu School of Medicine, Daegu, Republic of Korea.
FAU - Park, Won
AU  - Park W
AD  - Inha University Hospital, Incheon, Republic of Korea.
FAU - Lee, Sang-Heon
AU  - Lee SH
AD  - Konkuk University School of Medicine, Seoul, Republic of Korea.
FAU - Park, Yong-Beom
AU  - Park YB
AD  - Yonsei University College of Medicine, Seoul, Republic of Korea.
FAU - Shim, Seung-Cheol
AU  - Shim SC
AD  - Chungnam National University Hospital, Daejeon, Republic of Korea.
FAU - Lee, Shin-Seok
AU  - Lee SS
AD  - Chonnam National University Hospital, Gwangju, Republic of Korea.
FAU - Sung, Yoon-Kyoung
AU  - Sung YK
AD  - Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea.
FAU - Choi, Chan-Bum
AU  - Choi CB
AD  - Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea.
FAU - Lee, So-Ra
AU  - Lee SR
AD  - Hanwha Chemical Biologics, Seoul, Republic of Korea.
FAU - Park, HanYu
AU  - Park H
AD  - Hanwha Chemical Biologics, Seoul, Republic of Korea.
FAU - Ahn, Yongho
AU  - Ahn Y
AD  - Hanwha Chemical Biologics, Daejeon, Republic of Korea.
CN  - HERA Study Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT01270997
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160223
PL  - England
TA  - Ann Rheum Dis
JT  - Annals of the rheumatic diseases
JID - 0372355
RN  - 0 (Antibodies)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - OP401G7OJC (Etanercept)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
CIN - Ann Rheum Dis. 2017 Jan;76(1):4-6. PMID: 27566795
MH  - Adult
MH  - Aged
MH  - Antibodies/blood
MH  - Antirheumatic Agents/adverse effects/immunology/*pharmacokinetics/*therapeutic 
      use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Biosimilar Pharmaceuticals/*pharmacokinetics/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Etanercept/adverse effects/immunology/*pharmacokinetics/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Methotrexate/therapeutic use
MH  - Middle Aged
MH  - Therapeutic Equivalency
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Anti-TNF
OT  - DMARDs (biologic)
OT  - Rheumatoid Arthritis
EDAT- 2016/02/26 06:00
MHDA- 2017/06/07 06:00
CRDT- 2016/02/25 06:00
PHST- 2015/03/17 00:00 [received]
PHST- 2016/02/04 00:00 [revised]
PHST- 2016/02/06 00:00 [accepted]
PHST- 2016/02/26 06:00 [pubmed]
PHST- 2017/06/07 06:00 [medline]
PHST- 2016/02/25 06:00 [entrez]
AID - annrheumdis-2015-207613 [pii]
AID - 10.1136/annrheumdis-2015-207613 [doi]
PST - ppublish
SO  - Ann Rheum Dis. 2017 Jan;76(1):65-71. doi: 10.1136/annrheumdis-2015-207613. Epub 
      2016 Feb 23.