Article Text

Download PDFPDF

Concise report
A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis
  1. Dae Hyun Yoo1,
  2. Chang-Hee Suh2,
  3. Seung Cheol Shim3,
  4. Slawomir Jeka4,
  5. Francisco Fidencio Cons-Molina5,
  6. Pawel Hrycaj6,
  7. Piotr Wiland7,
  8. Eun Young Lee8,
  9. Francisco G Medina-Rodriguez9,
  10. Pavel Shesternya10,
  11. Sebastiao Radominski11,
  12. Marina Stanislav12,
  13. Volodymyr Kovalenko13,
  14. Dong Hyuk Sheen14,
  15. Leysan Myasoutova15,
  16. Mie Jin Lim16,
  17. Jung-Yoon Choe17,
  18. Sang Joon Lee18,
  19. Sung Young Lee18,
  20. Taek Sang Kwon18,
  21. Won Park16
  1. 1Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea
  2. 2Ajou University Hospital, Suwon, Korea
  3. 3Chungnam National University Hospital, Daejeon, Korea
  4. 4University Hospital No. 2, Collegium Medicum in Bydgoszcz, UMK in Toruń, Poland
  5. 5Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico
  6. 6Poznań University of Medical Sciences, Poznań, Poland
  7. 7Medical University of Wrocław, Wrocław, Poland
  8. 8Seoul National University College of Medicine, Seoul, Korea
  9. 9LaSalle University, Philadelphia, Pennsylvania, USA
  10. 10Krasnoyarsk State Medical University, Krasnoyarsk, Russia
  11. 11Universidade Federal do Parana, Curitiba, Brazil
  12. 12Research Rheumatology Institute n. a. V.A. Nassonova, Moscow, Russia
  13. 13National Scientific Center, Kiev, Ukraine
  14. 14Eulji University Hospital, Daejeon, Korea
  15. 15Research Medical Complex Vashe Zdorovie, Kazan, Russia
  16. 16IN-HA University, School of Medicine, Incheon, Korea
  17. 17Catholic University of Daegu, School of Medicine, Daegu, Korea
  18. 18CELLTRION, Incheon, Korea
  1. Correspondence to Professor Won Park, IN-HA University, School of Medicine, Medicine/Rheumatology, 366 Seohae-daero, Jung-Gu, Incheon 22332, Korea; parkwon{at}inha.ac.kr

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.

  • Rheumatoid Arthritis
  • Pharmacokinetics
  • DMARDs (biologic)
  • B cells
  • Treatment

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

View Full Text

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.