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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

DC FieldValueLanguage
dc.contributor.author박용범-
dc.date.accessioned2018-07-20T08:29:33Z-
dc.date.available2018-07-20T08:29:33Z-
dc.date.issued2017-
dc.identifier.issn0003-4967-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/161237-
dc.description.abstractOBJECTIVES: 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.-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherBMJ-
dc.relation.isPartOfANNALS OF THE RHEUMATIC DISEASES-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHAdult-
dc.subject.MESHAged-
dc.subject.MESHAntibodies/blood-
dc.subject.MESHAntirheumatic Agents/adverse effects-
dc.subject.MESHAntirheumatic Agents/immunology-
dc.subject.MESHAntirheumatic Agents/pharmacokinetics*-
dc.subject.MESHAntirheumatic Agents/therapeutic use*-
dc.subject.MESHArthritis, Rheumatoid/drug therapy*-
dc.subject.MESHBiosimilar Pharmaceuticals/pharmacokinetics*-
dc.subject.MESHBiosimilar Pharmaceuticals/therapeutic use*-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHDrug Therapy, Combination-
dc.subject.MESHEtanercept/adverse effects-
dc.subject.MESHEtanercept/immunology-
dc.subject.MESHEtanercept/pharmacokinetics*-
dc.subject.MESHEtanercept/therapeutic use*-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHMale-
dc.subject.MESHMethotrexate/therapeutic use-
dc.subject.MESHMiddle Aged-
dc.subject.MESHTherapeutic Equivalency-
dc.subject.MESHTreatment Outcome-
dc.titleA 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-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Internal Medicine-
dc.contributor.googleauthorSang-Cheol Bae-
dc.contributor.googleauthorJinseok Kim-
dc.contributor.googleauthorJung-Yoon Choe-
dc.contributor.googleauthorWon Park-
dc.contributor.googleauthorSang-Heon Lee-
dc.contributor.googleauthorYong-Beom Park-
dc.contributor.googleauthorSeung-Cheol Shim-
dc.contributor.googleauthorShin-Seok Lee-
dc.contributor.googleauthorYoon-Kyoung Sung-
dc.contributor.googleauthorChan-Bum Choi-
dc.contributor.googleauthorSo-Ra Lee-
dc.contributor.googleauthorHanYu Park-
dc.contributor.googleauthorYongho Ahn-
dc.identifier.doi10.1136/annrheumdis-2015-207613-
dc.contributor.localIdA01579-
dc.relation.journalcodeJ00182-
dc.identifier.eissn1468-2060-
dc.identifier.pmid26905864-
dc.identifier.urlhttp://ard.bmj.com/content/76/1/65.long-
dc.subject.keywordAnti-TNF-
dc.subject.keywordDMARDs (biologic)-
dc.subject.keywordRheumatoid Arthritis-
dc.contributor.alternativeNamePark, Yong Beom-
dc.contributor.affiliatedAuthorPark, Yong Beom-
dc.citation.volume76-
dc.citation.number1-
dc.citation.startPage65-
dc.citation.endPage71-
dc.identifier.bibliographicCitationANNALS OF THE RHEUMATIC DISEASES, Vol.76(1) : 65-71, 2017-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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