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FRI0143 A randomized, double-blind, phase 3 study demonstrates clinical equivalence of CT-P13 to infliximab when co-administered with methotrexate in patients with active rheumatoid arthritis
  1. D. Yoo1,
  2. P. Miranda2,
  3. M. Piotrowski3,
  4. E. Ramiterre4,
  5. V. Kovalenko5,
  6. N. Prodanovic6,
  7. M. Tee7,
  8. S. Gutierrez-Ureña8,
  9. R. Jimenez9,
  10. O. Zamani10,
  11. S. Lee11,
  12. H. Kim12,
  13. W. Park13,
  14. U. Müller-Ladner14
  1. 1Hanyang University Medical Center, Seoul, Korea, Republic Of
  2. 2Centro de Estudios Reumatologicos, Santiago, Chile
  3. 3Reumed, Lubin, Poland
  4. 4Brokenshire Memorial Hospital, Davao City, Philippines
  5. 5National Scientific Center, Kiev, Ukraine
  6. 6Clinical Center Banja Luka, Banja Luka, Bosnia and Herzegovina
  7. 7Medical Center Manila, Manila, Philippines
  8. 8Antiguo Hospital Civil de Guadalajara, Guadalajara, Mexico
  9. 9Centro de Estudios Investigaciones Clinicas, Viña del Mar, Chile
  10. 10Rheuma Zentrum Favoriten, Vienna, Austria
  11. 11University of New Mexico, Albuquerque, United States
  12. 12Celltrion
  13. 13Inha University Hospital, Incheon, Korea, Republic Of
  14. 14Kerchoff-Klinik GmbH, Bad Nauheim, Germany

Abstract

Background CT-P13 was developed as a biosimilar product to infliximab (Remicade®), a chimeric monoclonal antibody approved in the European Union in 1999 for the treatment of rheumatoid arthritis (RA), ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriasis, and psoriatic arthritis.

Objectives To compare the clinical efficacy and overall safety of CT-P13 with those of infliximab in patients with active RA.

Methods Six hundred six patients with active RA despite previous treatment with disease-modifying anti-rheumatic drugs including methotrexate were randomized 1:1 to receive either CT-P13 or infliximab (3 mg/kg, 2-hour IV infusion per dose) plus methotrexate and folic acid. The treatment period consisted of a dose-loading phase (weeks 0, 2, and 6) and a maintenance phase (weeks 14, 22, and 30). The primary endpoint was the proportion of patients achieving 20% improvement in ACR20 at week 30. The exact binomial test with 95% confidence intervals (CIs) for ACR20 within a margin of ±15% was used to define equivalence between the 2 treatments. Secondary efficacy and safety endpoints (including ACR50/70; frequency of adverse events [AEs]) were also evaluated. This report presents results up to study week 30 (as approved by the European Medicines Agency).

Results At week 30, ACR20 response rates were 60.9% for CT-P13 vs 58.6% for infliximab (2% difference; 95% CI -6% to 10%) in the intent-to-treat population, and 73.4% vs 69.7% (4% difference; 95% CI: -4% to 12%) in the per-protocol population. Outcomes for the secondary efficacy and safety endpoints were also comparable as follows. ACR50 rates in the per-protocol population were 42.3% vs 40.6% (2% difference; 95% CI -7% to 10%), and ACR70 rates were 20.2% vs 17.9% (2% difference; 95% CI -5% to 9%) in the CT-P13 and infliximab arms, respectively, all indicating equivalence in clinical efficacy at week 30. AEs considered by the investigators to be related to study treatment were reported for 106 (35.2%) patients and 108 (35.9%) patients in the CT-P13 and infliximab arms, respectively. Related AEs due to infection were reported in 46 (15.3%) patients and 51 (16.9%) patients in the CT-P13 and infliximab arms, respectively. 15 (5%) CT-P13-treated and 17 (6%) infliximab-treated patients experienced at least 1 infusion reaction. Tuberculosis was reported in 3 patients in the CT-P13 arm and in 1 patient in the infliximab arm.

Conclusions CT-P13 and infliximab are equivalent in terms of ACR20 in patients with RA. In addition, CT-P13 was well tolerated, with an efficacy and safety profile comparable to that of infliximab up to week 30.

Disclosure of Interest D. Yoo: None Declared, P. Miranda: None Declared, M. Piotrowski: None Declared, E. Ramiterre: None Declared, V. Kovalenko: None Declared, N. Prodanovic: None Declared, M. Tee: None Declared, S. Gutierrez-Ureña: None Declared, R. Jimenez: None Declared, O. Zamani: None Declared, S. Lee: None Declared, H. Kim Employee of: Celltrion, W. Park: None Declared, U. Müller-Ladner: None Declared

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