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SAT0146 Randomised double-blind study shows comparable long-term efficacy and safety between rituximab biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: 48-week results
  1. C-H Suh1,
  2. E Chalouhi El Khouri2,
  3. P Miranda3,
  4. F F Cons Molina4,
  5. P Shesternya5,
  6. F Medina-Rodriguez6,
  7. P Wiland7,
  8. S Jeka8,
  9. J Chavez-Corrales9,
  10. T Linde10,
  11. P Hrycaj11,
  12. I Hospodarskyy12,
  13. M Abello-Banfi13,
  14. J Jaworski14,
  15. M Piotrowski15,
  16. W Park16,
  17. SC Shim17,
  18. SJ Lee18,
  19. SY Lee18,
  20. DH Yoo19
  1. 1Ajou University School of Medicine, Suwon, Korea, Republic Of
  2. 2Clinica Internacional, Lima, Peru
  3. 3Centro de Estudios Reumatolόgicos, Santiago, Chile
  4. 4Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico
  5. 5KrasSMU, Krasnoyarsk, Russian Federation
  6. 6Biologics Especializados SA, Mexico City, Mexico
  7. 7Medical University, Wroclaw
  8. 82nd University Hospital, CM UMK, Bydgoszcz, Poland
  9. 9Clinica San Borja, Lima, Peru
  10. 10Rheumatology Medical Center, Halle/Saale, Germany
  11. 11Poznañ University of Medical Sciences, Poznañ, Poland
  12. 12Ternopil Medical University, Ternopil, Ukraine
  13. 13Centro Integral de Reumatologia del Caribe, Barranquilla, Colombia
  14. 14Reumatika - Centrum Reumatologii, Warszawa
  15. 15Medical University of Lublin, Lublin, Poland
  16. 16IN-HA University, School of Medicine, Incheon
  17. 17Chungnam National University Hospital, Daejeon
  18. 18Celltrion, Inc., Incheon
  19. 19Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic Of

Abstract

Background In phase 1 trials (NCT01534884 and NCT01873443), pharmacokinetic equivalence of CT-P10, biosimilar of rituximab, to innovator rituximab (RTX) was demonstrated. In the phase 3 study, equivalence of PK and efficacy up to week 24 were achieved between CT-P10 and RTX (US and EU sourced)1,2.

Objectives To investigate the long-term efficacy, pharmacodynamics, immunogenicity and safety of CT-P10 up to week 48.

Methods Patients with rheumatoid arthritis were randomly assigned to CT-P10, US-RTX or EU-RTX, in combination with MTX. The patients received 2 treatment courses at Week 0 and 24, each consisting of 2 infusions of 1000mg study drug at 2-week interval.

Results A total of 372 patients were randomised, and 330 patients completed the 2nd course treatment. DAS28 scores through Week 48 were comparable between CT-P10 and US/EU-RTX (Figure), as well as the proportion of ACR responses at Week 48 between the CT-P10 and combined rituximab groups; 81.3% and 79.8% for ACR 20, 55.4% and 53.9% for ACR50, and 31.7% and 33.7% for ACR 70, respectively.

Figure 1.

Efficacy Results – DAS28.

B-cell depletion was comparable from after the 1st infusion and up to Week 48.

Number (%) of patients with positive anti-drug antibodies in the CT-P10, US-RTX, and EU-RTX was 7 (4.9), 13 (9.4), and 5 (8.6), respectively at Week 48.

The safety profile was also similar across groups (Table).

Table 1.

Summary of Safety Profile [n (%)]

Conclusions This phase 3 randomised controlled trial demonstrated the comparability of CT-P10 with two rituximab in terms of efficacy, pharmacodynamics, immunogenicity and safety for 1 year.

References

  1. Suh CH, et al. 2016 ACR Abstract No. 1634.

  2. Yoo DH, et al. 2016 ACR Abstract No. 1635.

References

Disclosure of Interest C.-H. Suh Consultant for: Celltrion, Inc., E. Chalouhi El Khouri Grant/research support from: Celltrion, Inc., P. Miranda Grant/research support from: Celltrion, Inc., F. F Cons Molina Grant/research support from: Celltrion, Inc., P. Shesternya Grant/research support from: Celltrion, Inc., F. Medina-Rodriguez Grant/research support from: Celltrion, Inc., P. Wiland Grant/research support from: Celltrion, Inc., S. Jeka Grant/research support from: Celltrion, Inc., J. Chavez-Corrales Grant/research support from: Celltrion, Inc., T. Linde Grant/research support from: Celltrion, Inc., P. Hrycaj Grant/research support from: Celltrion, Inc., I. Hospodarskyy Grant/research support from: Celltrion, Inc., M. Abello-Banfi Grant/research support from: Celltrion, Inc., J. Jaworski Grant/research support from: Celltrion, Inc., M. Piotrowski Grant/research support from: Celltrion, Inc., W. Park Consultant for: Celltrion, Inc., S. C. Shim Consultant for: Celltrion, Inc., S. J. Lee Employee of: Celltrion, Inc., S. Y. Lee Employee of: Celltrion, Inc., D. H. Yoo Consultant for: Celltrion, Inc.

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