A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Park, Won | - |
dc.contributor.author | Hrycaj, Pawel | - |
dc.contributor.author | Jeka, Slawomir | - |
dc.contributor.author | Kovalenko, Volodymyr | - |
dc.contributor.author | Lysenko, Grygorii | - |
dc.contributor.author | Miranda, Pedro | - |
dc.contributor.author | Mikazane, Helena | - |
dc.contributor.author | Gutierrez-Urena, Sergio | - |
dc.contributor.author | Lim, MieJin | - |
dc.contributor.author | Lee, Yeon-Ah | - |
dc.contributor.author | Lee, Sang Joon | - |
dc.contributor.author | Kim, HoUng | - |
dc.contributor.author | Yoo, Dae Hyun | - |
dc.contributor.author | Braun, Juergen | - |
dc.date.accessioned | 2022-07-16T07:59:53Z | - |
dc.date.available | 2022-07-16T07:59:53Z | - |
dc.date.created | 2021-05-12 | - |
dc.date.issued | 2013-10 | - |
dc.identifier.issn | 0003-4967 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/161810 | - |
dc.description.abstract | Objectives To compare the pharmacokinetics (PK), safety and efficacy of innovator infliximab (INX) and CT-P13, a biosimilar to INX, in patients with active ankylosing spondylitis (AS). Methods Phase 1 randomised, double-blind, multicentre, multinational, parallel-group study. Patients were randomised to receive 5mg/kg of CT-P13 (n=125) or INX (n=125). Primary endpoints were area under the concentration-time curve (AUC) at steady state and observed maximum steady state serum concentration (C-max,C-ss) between weeks 22 and 30. Additional PK, efficacy endpoints, including 20% and 40% improvement response according to Assessment in Ankylosing Spondylitis International Working Group criteria (ASAS20 and ASAS40), and safety outcomes were also assessed. Results Geometric mean AUC was 32765.8gh/ml for CT-P13 and 31359.3gh/ml for INX. Geometric mean C-max,C-ss was 147.0 g/ml for CT-P13 and 144.8g/ml for INX. The ratio of geometric means was 104.5% (90% CI 94% to 116%) for AUC and 101.5% (90% CI 95% to 109%) for C-max,C-ss. ASAS20 and ASAS40 responses at week 30 were 70.5% and 51.8% for CT-P13 and 72.4% and 47.4% for INX, respectively. In the CT-P13 and INX groups more than one adverse event occurred in 64.8% and 63.9% of patients, infusion reactions occurred in 3.9% and 4.9%, active tuberculosis occurred in 1.6% and 0.8%, and 27.4% and 22.5% of patients tested positive for anti-drug antibodies, respectively. Conclusions The PK profiles of CT-P13 and INX were equivalent in patients with active AS. CT-P13 was well tolerated, with an efficacy and safety profile comparable to that of INX up to week 30. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | BMJ PUBLISHING GROUP | - |
dc.title | A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Yoo, Dae Hyun | - |
dc.identifier.doi | 10.1136/annrheumdis-2012-203091 | - |
dc.identifier.scopusid | 2-s2.0-84883746909 | - |
dc.identifier.wosid | 000323906000005 | - |
dc.identifier.bibliographicCitation | ANNALS OF THE RHEUMATIC DISEASES, v.72, no.10, pp.1605 - 1612 | - |
dc.relation.isPartOf | ANNALS OF THE RHEUMATIC DISEASES | - |
dc.citation.title | ANNALS OF THE RHEUMATIC DISEASES | - |
dc.citation.volume | 72 | - |
dc.citation.number | 10 | - |
dc.citation.startPage | 1605 | - |
dc.citation.endPage | 1612 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.isOpenAccess | Y | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Rheumatology | - |
dc.relation.journalWebOfScienceCategory | Rheumatology | - |
dc.subject.keywordPlus | ALPHA MONOCLONAL-ANTIBODY | - |
dc.subject.keywordPlus | RHEUMATOID-ARTHRITIS | - |
dc.subject.keywordPlus | SPINAL INFLAMMATION | - |
dc.subject.keywordPlus | CLINICAL-RESPONSE | - |
dc.subject.keywordPlus | 2010 UPDATE | - |
dc.subject.keywordPlus | METHOTREXATE | - |
dc.subject.keywordPlus | PLACEBO | - |
dc.subject.keywordPlus | TRIAL | - |
dc.subject.keywordPlus | RECOMMENDATIONS | - |
dc.subject.keywordPlus | REDUCTION | - |
dc.identifier.url | https://ard.bmj.com/content/72/10/1605 | - |
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.
222, Wangsimni-ro, Seongdong-gu, Seoul, 04763, Korea+82-2-2220-1365
COPYRIGHT © 2021 HANYANG UNIVERSITY.
Certain data included herein are derived from the © Web of Science of Clarivate Analytics. All rights reserved.
You may not copy or re-distribute this material in whole or in part without the prior written consent of Clarivate Analytics.