Long-Term Efficacy and Safety of Biosimilar CT-P10 Versus Innovator Rituximab in Rheumatoid Arthritis: 48-Week Results from a Randomized Phase III Trialopen access
- Authors
- Suh, Chang-Hee; Yoo, Dae Hyun; Berrocal Kasay, Alfredo; Chalouhi El-Khouri, Elia; Cons Molina, Francisco Fidenci; Shesternya, Pavel; Miranda, Pedro; Medina-Rodriguez, Francisco G.; Wiland, Piotr; Jeka, Slawomir; Chavez-Corrales, Jose; Linde, Thomas; Hrycaj, Pawel; Abello-Banfi, Mauricio; Hospodarskyy, Ihor; Jaworski, Janusz; Piotrowski, Mariusz; Brzosko, Marek; Krogulec, Marek; Shevchuk, Sergii; Calvo, Armando; Andersone, Daina; Park, Won; Shim, Seung Cheol; Lee, Sang Joon; Lee, Sung Young
- Issue Date
- Feb-2019
- Publisher
- ADIS INT LTD
- Citation
- BIODRUGS, v.33, no.1, pp.79 - 91
- Indexed
- SCIE
SCOPUS
- Journal Title
- BIODRUGS
- Volume
- 33
- Number
- 1
- Start Page
- 79
- End Page
- 91
- URI
- https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/15063
- DOI
- 10.1007/s40259-018-00331-4
- ISSN
- 1173-8804
- Abstract
- The aim of this study was to investigate long-term clinical outcomes of extended treatment with CT-P10, a rituximab biosimilar, compared with rituximab reference products sourced from the USA and the EU (US-RTX and EU-RTX) in rheumatoid arthritis (RA) for up to 48 weeks. In this multinational, randomized, double-blind trial, adults with active RA received up to two courses of CT-P10, US-RTX, or EU-RTX alongside methotrexate. Efficacy endpoints included Disease Activity Score 28-joint count (DAS28) and American College of Rheumatology (ACR) response rates. Pharmacokinetics, pharmacodynamics, immunogenicity, and safety were also assessed. Of 372 patients randomized to the study drug, 330 (88.7%) completed the second treatment course. Mean change from baseline to week 48 in DAS28-C-reactive protein was comparable in the CT-P10 and combined rituximab (US-RTX and EU-RTX) groups (- 2.7 and - 2.6, respectively). ACR20, ACR50, and ACR70 response rates at week 48 indicated no differences between groups (80.6%, 55.4%, and 31.7% vs. 79.8%, 53.9%, and 33.7% in the CT-P10 and combined rituximab groups, respectively). Similar improvements in the Health Assessment Questionnaire Disability Index and all medical outcomes in the Short Form 36-Item Health Survey, including physical and mental health, were seen in all groups. At week 48, antidrug antibodies were detected in 4.9%, 9.4%, and 8.6% of patients in the CT-P10, US-RTX, and EU-RTX groups, respectively. CT-P10 and rituximab displayed similar pharmacokinetic, pharmacodynamic, and safety profiles. CT-P10 was similar to EU-RTX and US-RTX in terms of efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, and safety up to week 48. NCT02149121.
- Files in This Item
-
Go to Link
- Appears in
Collections - 서울 의과대학 > 서울 내과학교실 > 1. Journal Articles
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.