Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial
DC Field | Value | Language |
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dc.contributor.author | Westhovens, Rene | - |
dc.contributor.author | Wiland, Piotr | - |
dc.contributor.author | Zawadzki, Marek | - |
dc.contributor.author | Ivanova, Delina | - |
dc.contributor.author | Kasay, Alfredo Berrocal | - |
dc.contributor.author | El-Khouri, Elias Chalouhi | - |
dc.contributor.author | Balazs, Eva | - |
dc.contributor.author | Shevchuk, Sergii | - |
dc.contributor.author | Eliseeva, Larisa | - |
dc.contributor.author | Stanislavchuk, Mykola | - |
dc.contributor.author | Yatsyshyn, Roman | - |
dc.contributor.author | Hrycaj, Pawel | - |
dc.contributor.author | Jaworski, Janusz | - |
dc.contributor.author | Zhdan, Vyacheslav | - |
dc.contributor.author | Trefler, Jakub | - |
dc.contributor.author | Shesternya, Pavel | - |
dc.contributor.author | Lee, Sang Joon | - |
dc.contributor.author | Kim, Sung Hyun | - |
dc.contributor.author | Suh, Jee Hye | - |
dc.contributor.author | Lee, Seul Gi | - |
dc.contributor.author | Han, Noo Ri | - |
dc.contributor.author | Yoo, Dae Hyun | - |
dc.date.accessioned | 2021-07-30T04:44:49Z | - |
dc.date.available | 2021-07-30T04:44:49Z | - |
dc.date.created | 2021-07-14 | - |
dc.date.issued | 2021-05 | - |
dc.identifier.issn | 1462-0324 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/1164 | - |
dc.description.abstract | Objective. To assess non-inferiority of s.c. to i.v. CT-P13 in RA. Methods. Patients with active RA and inadequate response to MTX participated in this phase I/III double-blind study at 76 sites. Patients received CT-P13 i.v. 3mg/kg [week (W) 0 and W2] before randomization (1:1) at W6 to CT-P13 s.c. via pre-filled syringe (PFS) 120mg biweekly until W28, or CT-P13 i.v. 3mg/kg every 8weeks until W22. Randomization was stratified by country, W2 serum CRP and W6 body weight. From W30, all patients received CT-P13 s.c. In a usability sub-study, patients received CT-P13 s.c. via auto-injector (W46-54) then PFS (W56-64). The primary endpoint was change (decrease) from baseline in disease activity score in 28 joints (DAS28)-CRP at W22 (non-inferiority margin: -0.6). Results. Of 357 patients enrolled, 343 were randomized to CT-P13 s.c. (n=167) or CT-P13 i.v. (n=176) at W6. The least-squares mean change (decrease) from baseline (standard error) in DAS28-CRP at W22 was 2.21 (0.22) for CT-P13 s.c. (n=162) and 1.94 (0.21) for CT-P13 i.v. [n=168; difference 0.27 (95% CI: 0.02, 0.52)], establishing non-inferiority. Efficacy findings were similar between arms at W54. Safety was similar between arms throughout: 92 (54.8%; CT-P13 s.c.) and 117 (66.9%; CT-P13 i.v.) patients experienced treatment-emergent adverse events (from W6). There were no treatment-related deaths or new safety findings. Usability was similar for CT-P13 s.c. via auto-injector or PFS. Conclusion. CT-P13 s.c. was non-inferior to CT-P13 i.v. in active RA. The convenience of s.c. administration could benefit patients. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | OXFORD UNIV PRESS | - |
dc.title | Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Yoo, Dae Hyun | - |
dc.identifier.doi | 10.1093/rheumatology/keaa580 | - |
dc.identifier.scopusid | 2-s2.0-85106889260 | - |
dc.identifier.wosid | 000807554700031 | - |
dc.identifier.bibliographicCitation | RHEUMATOLOGY, v.60, no.5, pp.2277 - 2287 | - |
dc.relation.isPartOf | RHEUMATOLOGY | - |
dc.citation.title | RHEUMATOLOGY | - |
dc.citation.volume | 60 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 2277 | - |
dc.citation.endPage | 2287 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.isOpenAccess | Y | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Rheumatology | - |
dc.relation.journalWebOfScienceCategory | Rheumatology | - |
dc.subject.keywordPlus | CLINICAL-RESPONSE | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | INNOVATOR INFLIXIMAB | - |
dc.subject.keywordPlus | PARALLEL-GROUP | - |
dc.subject.keywordPlus | METHOTREXATE | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | FORMULATION | - |
dc.subject.keywordAuthor | biosimilar | - |
dc.subject.keywordAuthor | non-inferiority | - |
dc.subject.keywordAuthor | CT-P13 | - |
dc.subject.keywordAuthor | subcutaneous | - |
dc.subject.keywordAuthor | rheumatoid arthritis | - |
dc.subject.keywordAuthor | infliximab | - |
dc.subject.keywordAuthor | switching | - |
dc.subject.keywordAuthor | pharmacokinetics | - |
dc.subject.keywordAuthor | immunogenicity | - |
dc.identifier.url | https://academic.oup.com/rheumatology/article/60/5/2277/5999127 | - |
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