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Retention Rate and Safety of Biosimilar CT-P13 in Rheumatoid Arthritis: Data from the Korean College of Rheumatology Biologics Registry

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dc.contributor.author박용범-
dc.date.accessioned2022-09-06T06:35:35Z-
dc.date.available2022-09-06T06:35:35Z-
dc.date.issued2020-02-
dc.identifier.issn1173-8804-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/190222-
dc.description.abstractObjective 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.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherAdis, Springer International-
dc.relation.isPartOfBIODRUGS-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAntibodies, Monoclonal / therapeutic use*-
dc.subject.MESHAntirheumatic Agents-
dc.subject.MESHArthritis, Rheumatoid / drug therapy*-
dc.subject.MESHBiosimilar Pharmaceuticals / therapeutic use*-
dc.subject.MESHBlood Sedimentation / drug effects-
dc.subject.MESHDrug Substitution / methods-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHInfliximab / therapeutic use-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHRegistries-
dc.subject.MESHRepublic of Korea-
dc.subject.MESHRheumatology / methods-
dc.subject.MESHSeverity of Illness Index-
dc.subject.MESHTreatment Outcome-
dc.titleRetention Rate and Safety of Biosimilar CT-P13 in Rheumatoid Arthritis: Data from the Korean College of Rheumatology Biologics Registry-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorHyoun-Ah Kim-
dc.contributor.googleauthorEunyoung Lee-
dc.contributor.googleauthorSun-Kyung Lee-
dc.contributor.googleauthorYong-Beom Park-
dc.contributor.googleauthorYoung Nam Lee-
dc.contributor.googleauthorHee Jung Kang-
dc.contributor.googleauthorKichul Shin-
dc.identifier.doi10.1007/s40259-019-00393-y-
dc.contributor.localIdA01579-
dc.relation.journalcodeJ04063-
dc.identifier.eissn1179-190X-
dc.identifier.pmid31734899-
dc.contributor.alternativeNamePark, Yong Beom-
dc.contributor.affiliatedAuthor박용범-
dc.citation.volume34-
dc.citation.number1-
dc.citation.startPage89-
dc.citation.endPage98-
dc.identifier.bibliographicCitationBIODRUGS, Vol.34(1) : 89-98, 2020-02-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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