Cited 12 times in
Retention Rate and Safety of Biosimilar CT-P13 in Rheumatoid Arthritis: Data from the Korean College of Rheumatology Biologics Registry
DC Field | Value | Language |
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dc.contributor.author | 박용범 | - |
dc.date.accessioned | 2022-09-06T06:35:35Z | - |
dc.date.available | 2022-09-06T06:35:35Z | - |
dc.date.issued | 2020-02 | - |
dc.identifier.issn | 1173-8804 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/190222 | - |
dc.description.abstract | Objective The aim was to evaluate long-term drug retention, discontinuation, efficacy and safety of CT-P13 and reference infliximab in patients with rheumatoid arthritis (RA) enrolled in the Korean College of Rheumatology Biologics (KOBIO) registry. Methods Patients included adults with RA who received CT-P13 or reference infliximab between December 2012 and December 2017. Drug retention, efficacy (Disease Activity Score in 28 joints [DAS28]-erythrocyte sedimentation rate [ESR] or DAS28-C-reactive protein [CRP] and American College of Rheumatology [ACR] core set measure), and adverse events (AEs) were assessed over 4-years' follow-up. Results Data from 199 RA patients (CT-P13: n = 147; reference infliximab: n = 52) were analyzed. Median treatment duration was 1.22 years for CT-P13 and 1.40 years for reference infliximab (p = 0.67). Overall, 82% of patients received first-line therapy. Drug retention of CT-P13 versus reference infliximab was comparable for the overall population (p = 0.84) and for first-line (p = 0.66) and subsequent treatment lines (p = 0.96). Treatment changes or discontinuations occurred in 65.2% of patients with CT-P13 and 69.6% with reference infliximab. The most common reason for treatment changes or discontinuing treatment was lack of efficacy (CT-P13: 31.9%; reference infliximab: 34.8%). CT-P13 demonstrated comparable improvements in DAS28-ESR, DAS28-CRP and ACR responses to reference infliximab. Overall, 19 grade 3 AEs were reported for CT-P13 and eight for reference infliximab. Conclusion Long-term data from patients with RA treated in routine clinical practice in Korea showed that CT-P13 had a comparable drug retention rate to reference infliximab, with similar efficacy and an acceptable safety profile. ClinicalTrials.gov identifier NCT01965132. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Adis, Springer International | - |
dc.relation.isPartOf | BIODRUGS | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antibodies, Monoclonal / therapeutic use* | - |
dc.subject.MESH | Antirheumatic Agents | - |
dc.subject.MESH | Arthritis, Rheumatoid / drug therapy* | - |
dc.subject.MESH | Biosimilar Pharmaceuticals / therapeutic use* | - |
dc.subject.MESH | Blood Sedimentation / drug effects | - |
dc.subject.MESH | Drug Substitution / methods | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Infliximab / therapeutic use | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Registries | - |
dc.subject.MESH | Republic of Korea | - |
dc.subject.MESH | Rheumatology / methods | - |
dc.subject.MESH | Severity of Illness Index | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | Retention Rate and Safety of Biosimilar CT-P13 in Rheumatoid Arthritis: Data from the Korean College of Rheumatology Biologics Registry | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Hyoun-Ah Kim | - |
dc.contributor.googleauthor | Eunyoung Lee | - |
dc.contributor.googleauthor | Sun-Kyung Lee | - |
dc.contributor.googleauthor | Yong-Beom Park | - |
dc.contributor.googleauthor | Young Nam Lee | - |
dc.contributor.googleauthor | Hee Jung Kang | - |
dc.contributor.googleauthor | Kichul Shin | - |
dc.identifier.doi | 10.1007/s40259-019-00393-y | - |
dc.contributor.localId | A01579 | - |
dc.relation.journalcode | J04063 | - |
dc.identifier.eissn | 1179-190X | - |
dc.identifier.pmid | 31734899 | - |
dc.contributor.alternativeName | Park, Yong Beom | - |
dc.contributor.affiliatedAuthor | 박용범 | - |
dc.citation.volume | 34 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 89 | - |
dc.citation.endPage | 98 | - |
dc.identifier.bibliographicCitation | BIODRUGS, Vol.34(1) : 89-98, 2020-02 | - |
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