Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trialopen access
- 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, Pawel; 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
- Issue Date
- May-2021
- Publisher
- OXFORD UNIV PRESS
- Keywords
- biosimilar; non-inferiority; CT-P13; subcutaneous; rheumatoid arthritis; infliximab; switching; pharmacokinetics; immunogenicity
- Citation
- RHEUMATOLOGY, v.60, no.5, pp.2277 - 2287
- Indexed
- SCIE
SCOPUS
- Journal Title
- RHEUMATOLOGY
- Volume
- 60
- Number
- 5
- Start Page
- 2277
- End Page
- 2287
- URI
- https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/1164
- DOI
- 10.1093/rheumatology/keaa580
- ISSN
- 1462-0324
- 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.
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