Comparative efficacy of subcutaneous (CT-P13) and intravenous infliximab in adult patients with rheumatoid arthritis: a network meta-regression of individual patient data from two randomised trials
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Combe, Bernard | - |
dc.contributor.author | Allanore, Yannick | - |
dc.contributor.author | Alten, Rieke | - |
dc.contributor.author | Caporali, Roberto | - |
dc.contributor.author | Durez, Patrick | - |
dc.contributor.author | Iannone, Florenzo | - |
dc.contributor.author | Nurmohamed, Michael T. | - |
dc.contributor.author | Toumi, Mondher | - |
dc.contributor.author | Lee, Sang Joon | - |
dc.contributor.author | Kwon, Taek Sang | - |
dc.contributor.author | Noh, Jiwon | - |
dc.contributor.author | Park, Gahee | - |
dc.contributor.author | Yoo, Dae Hyun | - |
dc.date.accessioned | 2021-07-30T04:45:04Z | - |
dc.date.available | 2021-07-30T04:45:04Z | - |
dc.date.created | 2021-07-14 | - |
dc.date.issued | 2021-04 | - |
dc.identifier.issn | 1478-6354 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/1240 | - |
dc.description.abstract | BackgroundA subcutaneous (SC) formulation of infliximab biosimilar CT-P13 is approved in Europe for the treatment of adult patients with rheumatoid arthritis (RA). It may offer improved efficacy versus intravenous (IV) infliximab formulations.MethodsA network meta-regression was conducted using individual patient data from two randomised trials in patients with RA, which compared CT-P13 SC with CT-P13 IV, and CT-P13 IV with reference infliximab IV. In this analysis, CT-P13 SC was compared with CT-P13 IV, reference infliximab IV and pooled data for both reference infliximab IV and CT-P13 IV. Outcomes included changes from baseline in 28-joint Disease Activity Score based on C-reactive protein (DAS28-CRP), Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI), and rates of remission, low disease activity or clinically meaningful improvement in functional disability per Health Assessment Questionnaire-Disability Index (HAQ-DI).ResultsThe two studies enrolled 949 patients with RA; pooled data for 840 and 751 patients were evaluable at weeks 30 and 54, respectively. For the CT-P13 SC versus pooled IV treatment arm comparison, differences in changes from baseline in DAS28-CRP (-0.578; 95% confidence interval [CI] -0.831, -0.325; p<0.0001), CDAI (-3.502; 95% CI -5.715, -1.289; p=0.002) and SDAI (-4.031; 95% CI -6.385, -1.677; p=0.0008) scores at 30weeks were statistically significant in favour of CT-P13 SC. From weeks 30 to 54, the magnitude of the differences increased and remained statistically significant in favour of CT-P13 SC. Similar results were observed for the comparison of CT-P13 SC with CT-P13 IV and with reference infliximab IV. Statistically significant differences at week 30 favoured CT-P13 SC over the pooled IV treatment arms for the proportions of patients achieving EULAR-CRP good response, American College of Rheumatology (ACR) 50 and ACR70 responses, DAS28-CRP-defined remission, low disease activity (DAS28-CRP, CDAI and SDAI criteria) and clinically meaningful HAQ-DI improvement.ConclusionsCT-P13 SC was associated with greater improvements in DAS28-CRP, CDAI and SDAI scores and higher rates of clinical response, low disease activity and clinically meaningful improvement in functional disability, compared with CT-P13 IV and reference infliximab IV.Trial registrationEudraCT, 2016-002125-11, registered 1 July 2016; EudraCT 2010-018646-31, registered 23 June 2010. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | BMC | - |
dc.title | Comparative efficacy of subcutaneous (CT-P13) and intravenous infliximab in adult patients with rheumatoid arthritis: a network meta-regression of individual patient data from two randomised trials | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Yoo, Dae Hyun | - |
dc.identifier.doi | 10.1186/s13075-021-02487-x | - |
dc.identifier.scopusid | 2-s2.0-85104490306 | - |
dc.identifier.wosid | 000641651600003 | - |
dc.identifier.bibliographicCitation | ARTHRITIS RESEARCH & THERAPY, v.23, no.1, pp.1 - 11 | - |
dc.relation.isPartOf | ARTHRITIS RESEARCH & THERAPY | - |
dc.citation.title | ARTHRITIS RESEARCH & THERAPY | - |
dc.citation.volume | 23 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 1 | - |
dc.citation.endPage | 11 | - |
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 | DISEASE-ACTIVITY MEASURES | - |
dc.subject.keywordPlus | QUALITY-OF-LIFE | - |
dc.subject.keywordPlus | CLINICAL-RESPONSE | - |
dc.subject.keywordPlus | AMERICAN-COLLEGE | - |
dc.subject.keywordPlus | ACTIVITY SCORE | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | CORE SET | - |
dc.subject.keywordPlus | METHOTREXATE | - |
dc.subject.keywordPlus | SAFETY | - |
dc.subject.keywordPlus | RECOMMENDATIONS | - |
dc.subject.keywordAuthor | CT-P13 | - |
dc.subject.keywordAuthor | Disease activity | - |
dc.subject.keywordAuthor | Indirect treatment comparison | - |
dc.subject.keywordAuthor | Individual patient data | - |
dc.subject.keywordAuthor | Infliximab | - |
dc.subject.keywordAuthor | Intravenous | - |
dc.subject.keywordAuthor | Network meta-regression | - |
dc.subject.keywordAuthor | Rheumatoid arthritis | - |
dc.subject.keywordAuthor | Subcutaneous | - |
dc.subject.keywordAuthor | Tumour necrosis factor inhibitor | - |
dc.identifier.url | https://arthritis-research.biomedcentral.com/articles/10.1186/s13075-021-02487-x | - |
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.