Analysis of clinical trials of biosimilar infliximab (CT-P13) and comparison against historical clinical studies with the infliximab reference medicinal product
DC Field | Value | Language |
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dc.contributor.author | Yoo, Dae Hyun | - |
dc.contributor.author | Oh, Choongseob | - |
dc.contributor.author | Hong, SeungSuh | - |
dc.contributor.author | Park, Won | - |
dc.date.accessioned | 2022-07-15T21:06:32Z | - |
dc.date.available | 2022-07-15T21:06:32Z | - |
dc.date.created | 2021-05-12 | - |
dc.date.issued | 2015-09 | - |
dc.identifier.issn | 1744-666X | - |
dc.identifier.uri | https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/156428 | - |
dc.description.abstract | Objective: To examine whether efficacy, safety and pharmacokinetic (PK) data observed with CT-P13 (Remsima (R); Inflectra (R)), an infliximab biosimilar, are similar to those from published reports with the reference medicinal product (RMP; Remicade (R)) in patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS). Methods: Literature searches were performed to identify clinical studies with infliximab RMP. Efficacy, safety and PK data were indirectly compared with data from head-to-head clinical trials of CT-P13 and RMP. Results: CT-P13 and RMP produce similar efficacy in patients with RA and AS when compared across clinical studies. There are no substantial differences in the incidence of infusion-related reactions, infections, serious infections, malignancy or lymphoma. PK data in patients with RA are similar in direct comparisons and comparisons with historical data. Conclusion: Efficacy, safety and PK data are highly comparable between CT-P13 and RMP, both in head-to-head clinical studies, and indirect comparisons with historical clinical data for RMP. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | TAYLOR & FRANCIS LTD | - |
dc.title | Analysis of clinical trials of biosimilar infliximab (CT-P13) and comparison against historical clinical studies with the infliximab reference medicinal product | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Yoo, Dae Hyun | - |
dc.identifier.doi | 10.1586/1744666X.2015.1090314 | - |
dc.identifier.scopusid | 2-s2.0-84942259056 | - |
dc.identifier.wosid | 000369964700003 | - |
dc.identifier.bibliographicCitation | EXPERT REVIEW OF CLINICAL IMMUNOLOGY, v.11, pp.S15 - S24 | - |
dc.relation.isPartOf | EXPERT REVIEW OF CLINICAL IMMUNOLOGY | - |
dc.citation.title | EXPERT REVIEW OF CLINICAL IMMUNOLOGY | - |
dc.citation.volume | 11 | - |
dc.citation.startPage | S15 | - |
dc.citation.endPage | S24 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.isOpenAccess | N | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Immunology | - |
dc.relation.journalWebOfScienceCategory | Immunology | - |
dc.subject.keywordPlus | NECROSIS-FACTOR-ALPHA | - |
dc.subject.keywordPlus | ACTIVE ANKYLOSING-SPONDYLITIS | - |
dc.subject.keywordPlus | PLACEBO-CONTROLLED TRIAL | - |
dc.subject.keywordPlus | RHEUMATOID-ARTHRITIS | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | PARALLEL-GROUP | - |
dc.subject.keywordPlus | TNF-ALPHA | - |
dc.subject.keywordPlus | EULAR RECOMMENDATIONS | - |
dc.subject.keywordPlus | INNOVATOR INFLIXIMAB | - |
dc.subject.keywordPlus | MONOCLONAL-ANTIBODY | - |
dc.subject.keywordAuthor | ankylosing spondylitis | - |
dc.subject.keywordAuthor | biosimilar | - |
dc.subject.keywordAuthor | CT-P13 | - |
dc.subject.keywordAuthor | efficacy | - |
dc.subject.keywordAuthor | infliximab | - |
dc.subject.keywordAuthor | literature search | - |
dc.subject.keywordAuthor | pharmacokinetics | - |
dc.subject.keywordAuthor | rheumatoid arthritis | - |
dc.subject.keywordAuthor | safety | - |
dc.identifier.url | https://www.tandfonline.com/doi/full/10.1586/1744666X.2015.1090314 | - |
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