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FRI0421 A randomised, double-blind, parallel-group, phase 1 study comparing the pharmacokinetics, safety and efficacy of ct-p13 and infliximab in patients with active ankylosing spondylitis: 54 week results from the planetas study
  1. W. Park1,
  2. J. Jaworski2,
  3. J. Brzezicki3,
  4. A. Gnylorybov4,
  5. V. Kadinov5,
  6. I. Goecke Sariego6,
  7. C. Abud-Mendoza7,
  8. W. J. Otero Escalante8,
  9. S. W. Kang9,
  10. D. Andersone10,
  11. F. Blanco11,
  12. D. H. Yoo12,
  13. C. Ahn13,
  14. H. U. Kim14,
  15. J. Braun15
  1. 1Inha Univ. Hospital, Incheon, Korea, Republic Of
  2. 2Linea Corporis, Warszawa
  3. 3Wojewodzki Szpital Zespolony w Elblagu, Elbląg, Poland
  4. 4Institute of Urgent and Recovery Surgery, Donetsk, Ukraine
  5. 5Univ. Hospital St. Marina, Varna, Bulgaria
  6. 6Prosalud y cia Ltda, Santiago, Chile
  7. 7Hospital Central Dr. Ignacio Morones Prieto, San Luis Potosí, Mexico
  8. 8Servimed Empresa Unipersonal, Bucaramanga, Colombia
  9. 9Chungnam National Univ. Hospital, Daejeon, Korea, Republic Of
  10. 10P. Stradina Clinical Univ. Hospital, Riga, Latvia
  11. 11Hospital Universitario a Coruña, A Coruña, Spain
  12. 12Hanyang Univ. Hospital, Seoul, Korea, Republic Of
  13. 13UT Southwestern Medical Center, Dallas, United States
  14. 14CELLTRION, Incheon, Korea, Republic Of
  15. 15Rheumazentrum Ruhrgebiet, Herne, Germany

Abstract

Background CT-P13 is a biosimilar product of infliximab (INX). Data up to week 30 has been reported at EULAR 2012.1

Objectives To assess the PK, efficacy and safety of CT-P13 in patients with active AS up to week 54 and to compare this with INX, also in relation to the formation of anti-drug antibodies (ADAs).

Methods Patients with active AS (1984 modified NY criteria) were randomised (1:1) to receive either CT-P13 (5mg/kg) or INX (5mg/kg) at weeks 0, 2, 6 and then every 8 weeks up to week 54.

Results Of 250 patients randomised at baseline, 213 patients were treated up to week 54. Cmax of CT-P13 and INX were shown to be equivalent, since 90% CIs for the ratio of geometric means were within 80–125% at all doses (CT-P13, 128.1µg/mL–172.2µg/mL; INX, 123.0µg/mL–176.7µg/mL). At week 54, the proportion of patients testing positive for ADAs was comparable between CT-P13 and INX (22.9% [25/109] vs 26.7% [28/105]). ADAs had similar effects on PKs in both groups. Patients with negative ADA results had higher Cmax values (CT-P13, 134.5µg/mL–177.2µg/mL; INX, 131.9µg/mL–177.4µg/mL) compared with patients with positive results (CT-P13, 101.8µg/mL–160.4µg/mL; INX, 104.0µg/mL–175.2µg/mL). At week 54, ASAS40 and ASAS partial remission were comparable between groups (CT-P13, 54.7% and 19.8%; INX, 49.1% and 17.6%, respectively). More patients with negative ADA results achieved ASAS40 responses (CT-P13, 61.0%; IFX, 54.7%) compared with patients with positive results (CT-P13, 37.9%; IFX, 36.4%). The safety profiles of CT-P13 and INX were also comparable (table). Active tuberculosis (TB) was reported in 3 patients (CT-P13, 2; INX, 1) and there were no malignancies.

Conclusions CT-P13 has similar PK values and a clinical efficacy comparable to INX up to week 54. CT-P13 was well tolerated with a safety profile comparable to that of INX up to 54 weeks. ADAs seem to diminish the clinical response to both agents in some patients.

References

  1. Park W et al. A randomised, double-blind, phase 1 study demonstrates equivalence in pharmacokinetics, safety and efficacy of CT-P13 and infliximab in patients with ankylosing spondylitis. Ann Rheum Dis 2012;71(Suppl 3):111.

Disclosure of Interest W. Park Consultant for: CELLTRION Inc., J. Jaworski Grant/research support from: CELLTRION Inc., J. Brzezicki Grant/research support from: CELLTRION Inc., A. Gnylorybov Grant/research support from: CELLTRION Inc., V. Kadinov Grant/research support from: CELLTRION Inc., I. Goecke Sariego Grant/research support from: CELLTRION Inc., C. Abud-Mendoza Grant/research support from: CELLTRION Inc., W. J. Otero Escalante Grant/research support from: CELLTRION Inc., S. W. Kang Grant/research support from: CELLTRION Inc., D. Andersone Grant/research support from: CELLTRION Inc., F. Blanco Grant/research support from: CELLTRION Inc., D. H. Yoo Consultant for: CELLTRION Inc., C. Ahn Consultant for: CELLTRION Inc., Speakers bureau: CELLTRION Inc., H. U. Kim Employee of: CELLTRION Inc., J. Braun Consultant for: CELLTRION Inc., Speakers bureau: CELLTRION Inc.

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