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A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study
  1. Won Park1,
  2. Pawel Hrycaj2,
  3. Slawomir Jeka3,
  4. Volodymyr Kovalenko4,
  5. Grygorii Lysenko5,
  6. Pedro Miranda6,
  7. Helena Mikazane7,
  8. Sergio Gutierrez-Ureña8,
  9. MieJin Lim1,
  10. Yeon-Ah Lee9,
  11. Sang Joon Lee10,
  12. HoUng Kim11,
  13. Dae Hyun Yoo12,
  14. Jürgen Braun13
  1. 1Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, Republic of Korea
  2. 2Department of Rheumatology and Clinical Immunology, Poznan University of Medical Sciences, Poznań, Poland
  3. 3Department of Rheumatology and Connective Tissue Diseases, "NASZ LEKARZ" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia, Toruń, Poland
  4. 4Section of Non-coronarogenic Myocardial Diseases and Clinical Rheumatology, National Scientific Center, Kiev, Ukraine
  5. 5Department of Family Medicine, Kyiv Regional Clinical Hospital, Kiev, Ukraine
  6. 6Rheumatology Department, Centro de Estudios Reumatológicos, Santiago, Chile
  7. 7Outpatient Clinic ORTO, Riga, Latvia
  8. 8Rheumatology Department, Antiguo Hospital Civil de Guadalajara, Guadalajara, Mexico
  9. 9Division of Rheumatology, Department of Internal Medicine, Kyung Hee University Hospital, Seoul, Republic of Korea
  10. 10Division of Biostatistics, Department of Internal Medicine, University of New Mexico, Albuquerque, New Mexico, USA
  11. 11Clinical Planning and Medical Affairs Department, CELLTRION, Inc, Incheon, Republic of Korea
  12. 12Division of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea
  13. 13Medical Director of Rheumazentrum Ruhrgebiet, a Medical Center specialised for rheumatic diseases, Rheumazentrum Ruhrgebiet, Herne, Germany
  1. Correspondence to Dr W Park, Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Center for Rheumatism. 27, InhangRo, JungGu, Incheon 400-711, Republic of Korea; parkwon@inha.ac.kr and Professor J Braun, Rheumazentrum Ruhrgebiet, Landgrafenstraße 15, Herne 44652, Germany; j.braun@rheumazentrum-ruhrgebiet.de

Abstract

Objectives To compare the pharmacokinetics (PK), safety and efficacy of innovator infliximab (INX) and CT-P13, a biosimilar to INX, in patients with active ankylosing spondylitis (AS).

Methods Phase 1 randomised, double-blind, multicentre, multinational, parallel-group study. Patients were randomised to receive 5 mg/kg of CT-P13 (n=125) or INX (n=125). Primary endpoints were area under the concentration-time curve (AUC) at steady state and observed maximum steady state serum concentration (Cmax,ss) between weeks 22 and 30. Additional PK, efficacy endpoints, including 20% and 40% improvement response according to Assessment in Ankylosing Spondylitis International Working Group criteria (ASAS20 and ASAS40), and safety outcomes were also assessed.

Results Geometric mean AUC was 32 765.8 μgh/ml for CT-P13 and 31 359.3 μgh/ml for INX. Geometric mean Cmax,ss was 147.0  μg/ml for CT-P13 and 144.8 μg/ml for INX. The ratio of geometric means was 104.5% (90% CI 94% to 116%) for AUC and 101.5% (90% CI 95% to 109%) for Cmax,ss. ASAS20 and ASAS40 responses at week 30 were 70.5% and 51.8% for CT-P13 and 72.4% and 47.4% for INX, respectively. In the CT-P13 and INX groups more than one adverse event occurred in 64.8% and 63.9% of patients, infusion reactions occurred in 3.9% and 4.9%, active tuberculosis occurred in 1.6% and 0.8%, and 27.4% and 22.5% of patients tested positive for anti-drug antibodies, respectively.

Conclusions The PK profiles of CT-P13 and INX were equivalent in patients with active AS. CT-P13 was well tolerated, with an efficacy and safety profile comparable to that of INX up to week 30.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) 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/3.0/

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