Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial

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dc.contributor.authorWesthovens, Rene
dc.contributor.authorWiland, Piotr
dc.contributor.authorZawadzki, Marek
dc.contributor.authorIvanova, Delina
dc.contributor.authorKasay, Alfredo Berrocal
dc.contributor.authorEl-Khouri, Elias Chalouhi
dc.contributor.authorBalazs, Eva
dc.contributor.authorShevchuk, Sergii
dc.contributor.authorEliseeva, Larisa
dc.contributor.authorStanislavchuk, Mykola
dc.contributor.authorYatsyshyn, Roman
dc.contributor.authorHrycaj, Paweł
dc.contributor.authorJaworski, Janusz
dc.contributor.authorZhdan, Vyacheslav
dc.contributor.authorTrefler, Jakub
dc.contributor.authorShesternya, Pavel
dc.contributor.authorLee, Sang Joon
dc.contributor.authorKim, Sung Hyun
dc.contributor.authorSuh, Jee Hye
dc.contributor.authorLee, Seul Gi
dc.contributor.authorHan, Noo Ri
dc.contributor.authorYoo, Dae Hyun
dc.contributor.authorЖдан, Вячеслав Миколайович
dc.date.accessioned2020-12-03T06:57:10Z
dc.date.available2020-12-03T06:57:10Z
dc.date.issued2021
dc.description.abstractObjective. 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. 3 mg/kg [week (W) 0 and W2] before randomization (1:1) at W6 to CT-P13 s.c. via pre-filled syringe (PFS) 120 mg biweekly until W28, or CT-P13 i.v. 3 mg/kg every 8 weeks 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 ¼ 167) or CT-P13 i.v. (n ¼ 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 ¼ 162) and 1.94 (0.21) for CT-P13 i.v. [n ¼ 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.uk_UA
dc.identifier.citationEfficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial / R. Westhovens, P. Wiland, M. Zawadzki [et al.] // Rheumatology. – 2021. – Vol. 60, issue 5. – P. 2277–2287. doi: 10.1093/rheumatology/keaa580.uk_UA
dc.identifier.doi10.1093/rheumatology/keaa580
dc.identifier.urihttps://repository.pdmu.edu.ua/handle/123456789/14176
dc.language.isoenuk_UA
dc.publisherOxford University Pressuk_UA
dc.subjectbiosimilaruk_UA
dc.subjectnon-inferiorityuk_UA
dc.subjectCT-P13uk_UA
dc.subjectsubcutaneousuk_UA
dc.subjectrheumatoid arthritisuk_UA
dc.subjectinfliximabuk_UA
dc.subjectswitchinguk_UA
dc.subjectpharmacokineticsuk_UA
dc.subjectimmunogenicityuk_UA
dc.titleEfficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trialuk_UA
dc.typeArticleuk_UA

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