한빛사논문
- 조회1,220
Abstract
Dae Hyun Yoo1, Chang-Hee Suh2, Seung Cheol Shim3, Slawomir Jeka4, Francisco Fidencio Cons-Molina5, Pawel Hrycaj6, Piotr Wiland7, Eun Young Lee8, Francisco G Medina-Rodriguez9, Pavel Shesternya10, Sebastiao Radominski11, Marina Stanislav12, Volodymyr Kovalenko13, Dong Hyuk Sheen14, Leysan Myasoutova15, Mie Jin Lim16, Jung-Yoon Choe17, Sang Joon Lee18, Sung Young Lee18, Taek Sang Kwon18, Won Park16,*
1Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea
2Ajou University Hospital, Suwon, Korea
3Chungnam National University Hospital, Daejeon, Korea
4University Hospital No. 2, Collegium Medicum in Bydgoszcz, UMK in Toruń, Poland
5Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico
6Poznań University of Medical Sciences, Poznań, Poland
7Medical University of Wrocław, Wrocław, Poland
8Seoul National University College of Medicine, Seoul, Korea
9LaSalle University, Philadelphia, Pennsylvania, USA
10Krasnoyarsk State Medical University, Krasnoyarsk, Russia
11Universidade Federal do Parana, Curitiba, Brazil
12Research Rheumatology Institute n. a. V.A. Nassonova, Moscow, Russia
13National Scientific Center, Kiev, Ukraine
14Eulji University Hospital, Daejeon, Korea
15Research Medical Complex Vashe Zdorovie, Kazan, Russia
16IN-HA University, School of Medicine, Incheon, Korea
17Catholic University of Daegu, School of Medicine, Daegu, Korea
18CELLTRION, Incheon, Korea
*Correspondence to
Professor Won Park, IN-HA University, School of Medicine, Medicine/Rheumatology, 366 Seohae-daero, Jung-Gu, Incheon 22332, Korea
Abstract
Objective To demonstrate pharmacokinetic equivalence of CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA) with inadequate responses or intolerances to antitumour necrosis factor agents.
Methods In this randomised phase I trial, patients with active RA were randomly assigned (2:1) to receive 1000?mg CT-P10 or RTX at weeks 0 and 2 (alongside continued methotrexate therapy). Primary endpoints were area under the serum concentration-time curve from time zero to last quantifiable concentration (AUC0-last) and maximum serum concentration after second infusion (Cmax). Additional pharmacokinetic parameters, efficacy, pharmacodynamics, immunogenicity and safety were also assessed. Data are reported up to week 24.
Results 103 patients were assigned to CT-P10 and 51 to RTX. The 90% CIs for the ratio of geometric means (CT-P10/RTX) for both primary endpoints were within the bioequivalence range of 80%-125% (AUC0-last: 97.7% (90% CI 89.2% to 107.0%); Cmax: 97.6% (90% CI 92.0% to 103.5%)). Pharmacodynamics and efficacy were comparable between groups. Antidrug antibodies were detected in 17.6% of patients in each group at week 24. CT-P10 and RTX displayed similar safety profiles.
Conclusions CT-P10 and RTX demonstrated equivalent pharmacokinetics and comparable efficacy, pharmacodynamics, immunogenicity and safety.
Trial registration number NCT01534884.
논문정보
- Research article
- 2016년 09월 (BRIC 등록일 2016-09-22)
- 국내(교신)+국외 연구진
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