Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 유대현 | - |
dc.date.accessioned | 2017-08-08T02:43:12Z | - |
dc.date.available | 2017-08-08T02:43:12Z | - |
dc.date.issued | 2015-10 | - |
dc.identifier.citation | EXPERT REVIEW OF CLINICAL IMMUNOLOGY, v. 11, NO Special SI, Page. 15-24 | en_US |
dc.identifier.issn | 1744-666X | - |
dc.identifier.issn | 1744-8409 | - |
dc.identifier.uri | http://www.tandfonline.com/doi/full/10.1586/1744666X.2015.1090314 | - |
dc.identifier.uri | http://hdl.handle.net/20.500.11754/28355 | - |
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. | en_US |
dc.description.sponsorship | DH Yoo received research grants (not related to CT-P13) from Celltrion and is a consultant of Celltrion. W Park received research grants and consultancy fees from Celltrion. C Oh and S Hong are full-time employees of Celltrion. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. | en_US |
dc.language.iso | en | en_US |
dc.publisher | EXPERT REVIEWS | en_US |
dc.subject | ankylosing spondylitis | en_US |
dc.subject | biosimilar | en_US |
dc.subject | CT-P13 | en_US |
dc.subject | efficacy | en_US |
dc.subject | infliximab | en_US |
dc.subject | literature search | en_US |
dc.subject | pharmacokinetics | en_US |
dc.subject | rheumatoid arthritis | en_US |
dc.subject | safety | en_US |
dc.title | Analysis of clinical trials of biosimilar infliximab (CT-P13) and comparison against historical clinical studies with the infliximab reference medicinal product | en_US |
dc.type | Article | en_US |
dc.relation.no | Special SI | - |
dc.relation.volume | 11 | - |
dc.identifier.doi | 10.1586/1744666X.2015.1090314 | - |
dc.relation.page | 15-24 | - |
dc.relation.journal | EXPERT REVIEW OF CLINICAL IMMUNOLOGY | - |
dc.contributor.googleauthor | Yoo, Dae Hyun | - |
dc.contributor.googleauthor | Oh, Choongseob | - |
dc.contributor.googleauthor | Hong, SeungSuh | - |
dc.contributor.googleauthor | Park, Won | - |
dc.relation.code | 2015011356 | - |
dc.sector.campus | S | - |
dc.sector.daehak | COLLEGE OF MEDICINE[S] | - |
dc.sector.department | DEPARTMENT OF MEDICINE | - |
dc.identifier.pid | dhyoo | - |
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