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A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study
  1. Dae Hyun Yoo1,
  2. Pawel Hrycaj2,
  3. Pedro Miranda3,
  4. Edgar Ramiterre4,
  5. Mariusz Piotrowski5,
  6. Sergii Shevchuk6,
  7. Volodymyr Kovalenko7,
  8. Nenad Prodanovic8,
  9. Mauricio Abello-Banfi9,
  10. Sergio Gutierrez-Ureña10,
  11. Luis Morales-Olazabal11,
  12. Michael Tee12,
  13. Renato Jimenez13,
  14. Omid Zamani14,
  15. Sang Joon Lee15,
  16. HoUng Kim16,
  17. Won Park17,
  18. Ulf Müller-Ladner18
  1. 1Division of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea
  2. 2Department of Rheumatology and Clinical Immunology, Poznan University of Medical Sciences, Poznan, Poland
  3. 3Rheumatology Department, Centro de Estudios Reumatologicos, Santiago, Chile
  4. 4Department of Internal Medicine, Brokenshire Memorial Hospital, Davao City, Philippines
  5. 5Reumed, Lublin, Poland
  6. 6Scientific and Research Institute of Invalid Rehabilitation of MoH of Ukraine, Kiev, Ukraine
  7. 7Section of Non-coronarogenic Myocardial Diseases and Clinical Rheumatology, National Scientific Center, Kiev, Ukraine
  8. 8Department of Rheumatology and Clinical Immunology, Clinic of Internal Diseases, Clinical Center Banja Luka, Banja Luka, Bosnia and Herzegovina
  9. 9Centro Integral de Reumatologia del Caribe, Barranquilla, Colombia
  10. 10Rheumatology Department, Antiguo Hospital Civil de Guadalajara, Guadalajara, Mexico
  11. 11Rheumatology Department, Hospital Maria Auxiliadora, Lima, Peru
  12. 12Department of Medicine, Medical Center Manila, Manila, Philippines
  13. 13Rheumatology Department, Centro de Estudios Investigaciones Clinicas, Viña del Mar, Chile
  14. 14Rheuma Zentrum Favoriten, Vienna, Austria
  15. 15Division of Biostatistics, Department of Internal Medicine, University of New Mexico, Albuquerque, New Mexico, USA
  16. 16Clinical Planning and Medical Affairs Department, CELLTRION Inc, Incheon, Republic of Korea
  17. 17Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, Republic of Korea
  18. 18Department of Rheumatology and Clinical Immunology, Justus-Liebig University Giessen, Kerchoff-Klinik GmbH, Bad Nauheim, Germany
  1. Correspondence to Professor Dae Hyun Yoo, Division of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, 220 Wangsimni-Ro, Seongdong-Gu, Seoul 133-792, Republic of Korea; dhyoo{at}hanyang.ac.kr; Professor Ulf Müller-Ladner, Department of Rheumatology and Clinical Immunology, Justus Liebig University Giessen, Kerckhoff-Klinik GmbH, Benekestrasse 2–8, 61231 Bad Nauheim, Germany; u.mueller-ladner{at}kerckhoff-klinik.de

Abstract

Objectives To compare the efficacy and safety of innovator infliximab (INX) and CT-P13, an INX biosimilar, in active rheumatoid arthritis patients with inadequate response to methotrexate (MTX) treatment.

Methods Phase III randomised, double-blind, multicentre, multinational, parallel-group study. Patients with active disease despite MTX (12.5–25 mg/week) were randomised to receive 3 mg/kg of CT-P13 (n=302) or INX (n=304) with MTX and folic acid. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 30. Therapeutic equivalence of clinical response according to ACR20 criteria was concluded if the 95% CI for the treatment difference was within ±15%. Secondary endpoints included ACR response criteria, European League Against Rheumatism (EULAR) response criteria, change in Disease Activity Score 28 (DAS28), Medical Outcomes Study Short-Form Health Survey (SF-36), Simplified Disease Activity Index, Clinical Disease Activity Index, as well as pharmacokinetic (PK) and pharmacodynamic (PD) parameters, safety and immunogenicity.

Results At week 30, ACR20 responses were 60.9% for CT-P13 and 58.6% for INX (95% CI −6% to 10%) in the intention-to-treat population. The proportions in CT-P13 and INX groups achieving good or moderate EULAR responses (C reactive protein (CRP)) at week 30 were 85.8% and 87.1%, respectively. Low disease activity or remission according to DAS28–CRP, ACR–EULAR remission rates, ACR50/ACR70 responses and all other PK and PD endpoints were highly similar at week 30. Incidence of drug-related adverse events (35.2% vs 35.9%) and detection of antidrug antibodies (48.4% vs 48.2%) were highly similar for CT-P13 and INX, respectively.

Conclusions CT-P13 demonstrated equivalent efficacy to INX at week 30, with a comparable PK profile and immunogenicity. CT-P13 was well tolerated, with a safety profile comparable with that of INX.

ClinicalTrials.gov Identifier NCT01217086

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