A non-interventional, post-marketing surveillance study evaluating the safety and effectiveness of biosimilar rituximab (CT-P10) during routine clinical practice in the Republic of Korea
DC Field | Value | Language |
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dc.contributor.author | Jo, Jae-Cheol | - |
dc.contributor.author | Jeon, Youngwoo | - |
dc.contributor.author | Kim, DaJung | - |
dc.contributor.author | Yang, Deok-Hwan | - |
dc.contributor.author | Lee, Won Sik | - |
dc.contributor.author | Choi, Yoon Seok | - |
dc.contributor.author | Yi, Jun Ho | - |
dc.contributor.author | Yoon, Dok Hyun | - |
dc.contributor.author | Kong, Jee Hyun | - |
dc.contributor.author | Choe, Jung-Yoon | - |
dc.contributor.author | Kim, SungHyun | - |
dc.contributor.author | Ahn, KeumYoung | - |
dc.contributor.author | Park, TaeHong | - |
dc.contributor.author | Ju, Hana | - |
dc.contributor.author | Kwon, Soonbum | - |
dc.contributor.author | Cho, Seok-Goo | - |
dc.date.accessioned | 2023-11-22T07:46:21Z | - |
dc.date.available | 2023-11-22T07:46:21Z | - |
dc.date.issued | 2023-08 | - |
dc.identifier.issn | 1471-2598 | - |
dc.identifier.issn | 1744-7682 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/68633 | - |
dc.description.abstract | BackgroundCT-P10 was the first licensed rituximab biosimilar. This Korean post-marketing surveillance study evaluated CT-P10 safety and effectiveness in approved indications.Research design and methodsThis prospective, open-label, observational, phase 4 study collected routine clinical practice data across 27 centers in the Republic of Korea. Patients received their first CT-P10 treatment, per prescribing information, for non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), or microscopic polyangiitis (MPA) during the surveillance period (16 November 2016-15 November 2020). Safety (including adverse events [AEs] and adverse drug reactions [ADRs]) and disease-specific clinical response (by best overall response [NHL/CLL], Disease Activity Score in 28-joints [RA], or Birmingham Vasculitis Activity Score for Wegener's Granulomatosis [GPA/MPA]) were assessed for <= 1 year (NHL/CLL) or <= 24 weeks (RA/GPA/MPA).ResultsThe safety population comprised 677 patients (604 NHL, 16 CLL, 42 RA, 7 GPA, 8 MPA). AEs/ADRs were reported for 68.4%/27.7% (NHL/CLL), 31.0%/14.3% (RA), and 86.7%/13.3% (GPA/MPA) of patients. Serious AEs and unexpected ADRs did not raise new safety signals. Pneumonia was the most frequent serious ADR overall. Positive effectiveness outcomes were observed.ConclusionsFindings were consistent with the known CT-P10/reference rituximab safety profile, with high effectiveness observed in NHL/CLL and RA. | - |
dc.format.extent | 11 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | TAYLOR & FRANCIS LTD | - |
dc.title | A non-interventional, post-marketing surveillance study evaluating the safety and effectiveness of biosimilar rituximab (CT-P10) during routine clinical practice in the Republic of Korea | - |
dc.type | Article | - |
dc.identifier.doi | 10.1080/14712598.2023.2177101 | - |
dc.identifier.bibliographicCitation | EXPERT OPINION ON BIOLOGICAL THERAPY, v.23, no.8, pp 737 - 747 | - |
dc.description.isOpenAccess | Y | - |
dc.identifier.wosid | 000945879200001 | - |
dc.identifier.scopusid | 2-s2.0-85150501693 | - |
dc.citation.endPage | 747 | - |
dc.citation.number | 8 | - |
dc.citation.startPage | 737 | - |
dc.citation.title | EXPERT OPINION ON BIOLOGICAL THERAPY | - |
dc.citation.volume | 23 | - |
dc.type.docType | Article | - |
dc.publisher.location | 영국 | - |
dc.subject.keywordAuthor | Chronic lymphocytic leukemia | - |
dc.subject.keywordAuthor | CT-P10 | - |
dc.subject.keywordAuthor | granulomatosis with polyangiitis | - |
dc.subject.keywordAuthor | microscopic polyangiitis | - |
dc.subject.keywordAuthor | non-Hodgkin's lymphoma | - |
dc.subject.keywordAuthor | rheumatoid arthritis | - |
dc.subject.keywordAuthor | rituximab | - |
dc.subject.keywordPlus | BURDEN FOLLICULAR LYMPHOMA | - |
dc.subject.keywordPlus | BUDGET IMPACT ANALYSIS | - |
dc.subject.keywordPlus | RHEUMATOID-ARTHRITIS | - |
dc.subject.keywordPlus | PRACTICE GUIDELINES | - |
dc.subject.keywordPlus | PARALLEL-GROUP | - |
dc.subject.keywordPlus | CELL LYMPHOMA | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | EFFICACY | - |
dc.subject.keywordPlus | PHARMACOKINETICS | - |
dc.subject.keywordPlus | CANCER | - |
dc.relation.journalResearchArea | Biotechnology & Applied Microbiology | - |
dc.relation.journalResearchArea | Research & Experimental Medicine | - |
dc.relation.journalWebOfScienceCategory | Biotechnology & Applied Microbiology | - |
dc.relation.journalWebOfScienceCategory | Medicine, Research & Experimental | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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