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http://repository.pdmu.edu.ua/handle/123456789/14176
Повний запис метаданих
Поле DC | Значення | Мова |
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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, Paweł | - |
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.contributor.author | Ждан, Вячеслав Миколайович | - |
dc.date.accessioned | 2020-12-03T06:57:10Z | - |
dc.date.available | 2020-12-03T06:57:10Z | - |
dc.date.issued | 2021 | - |
dc.identifier.citation | Efficacy, 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.uri | http://repository.pdmu.edu.ua/handle/123456789/14176 | - |
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. 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.language.iso | en | uk_UA |
dc.publisher | Oxford University Press | uk_UA |
dc.subject | biosimilar | uk_UA |
dc.subject | non-inferiority | uk_UA |
dc.subject | CT-P13 | uk_UA |
dc.subject | subcutaneous | uk_UA |
dc.subject | rheumatoid arthritis | uk_UA |
dc.subject | infliximab | uk_UA |
dc.subject | switching | uk_UA |
dc.subject | pharmacokinetics | uk_UA |
dc.subject | immunogenicity | uk_UA |
dc.title | Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial | uk_UA |
dc.type | Article | uk_UA |
dc.identifier.doi | 10.1093/rheumatology/keaa580 | - |
Розташовується у зібраннях: | Наукові праці. Кафедра сімейної медицини і терапії |
Файли цього матеріалу:
Файл | Опис | Розмір | Формат | |
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Efficacy_pharmacokinetics_and_safety_of_subcutaneous_versus.pdf | 768,07 kB | Adobe PDF | Переглянути/Відкрити |
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