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Title: | Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial |
Authors: | Westhovens, Rene Wiland, Piotr Zawadzki, Marek Ivanova, Delina Kasay, Alfredo Berrocal El-Khouri, Elias Chalouhi Balazs, Eva Shevchuk, Sergii Eliseeva, Larisa Stanislavchuk, Mykola Yatsyshyn, Roman Hrycaj, Paweł Jaworski, Janusz Zhdan, Vyacheslav Trefler, Jakub Shesternya, Pavel Lee, Sang Joon Kim, Sung Hyun Suh, Jee Hye Lee, Seul Gi Han, Noo Ri Yoo, Dae Hyun Ждан, Вячеслав Миколайович |
Issue Date: | 2021 |
Publisher: | Oxford University Press |
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. |
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. |
Keywords: | biosimilar non-inferiority CT-P13 subcutaneous rheumatoid arthritis infliximab switching pharmacokinetics immunogenicity |
DOI: | 10.1093/rheumatology/keaa580 |
URI: | http://repository.pdmu.edu.ua/handle/123456789/14176 |
Appears in Collections: | Наукові праці. Кафедра сімейної медицини і терапії |
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Efficacy_pharmacokinetics_and_safety_of_subcutaneous_versus.pdf | 768,07 kB | Adobe PDF | View/Open |
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