Перегляд за Автор "Jaworski, J."

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    Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial
    (Oxford University Press, 2021) Westhovens, R.; Wiland, P.; Zawadzki, M.; Ivanova, D.; Kasay, A. B.; El-Khouri, E. Ch.; Balazs, E.; Shevchuk, S.; Eliseeva, L.; Stanislavchuk, M.; Yatsyshyn, R.; Hrycaj, P.; Jaworski, J.; Zhdan, V.; Trefler, J.; Shesternya, P.; Lee, S. J.; Kim, S. H.; Suh, J. H.; Lee, S. G.; Han, N. R.; Yoo, D. H.; Ждан, Вячеслав Миколайович
    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.
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    Sustained Efficacy and Comparable Safety and Immunogenicity after Transition to SB5 (an Adalimumab Biosimilar) Vs. Continuation of SB5 or Reference Adalimumab (Humira®) in Patients with Rheumatoid Arthritis: Results of Phase III Study
    (American College of Rheumatology, 2016-11-13) Weinblat, M.; Baranauskaite, A.; Niebrzydowski, J.; Dokoupilova, E.; Zielinska, A.; Sitek-Ziolkowska, K.; Jaworski, J.; Racewicz, A.; Pileckyte, M.; Jedrychowicz-Rosiak, K.; Zhdan, V.; Cheong, SY.; Ghil, J.; Ждан, Вячеслав Миколайович