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OP0068 A Phase 3 Randomised Controlled Trial to Compare CT-P13 with Infliximab in Patients with Active Rheumatoid Arthritis: 54 Week Results from the Planetra Study
  1. D. H. Yoo1,
  2. A. Racewicz2,
  3. J. Brzezicki3,
  4. R. Yatsyshyn4,
  5. E. Tobias Arteaga5,
  6. A. Baranauskaite6,
  7. C. Abud-Mendoza7,
  8. S. Navarra8,
  9. R. Eullaran9,
  10. V. Kadinov10,
  11. I. Goecke Sariego11,
  12. P. Byrne12,
  13. W. Park13,
  14. S. J. Lee14,15,
  15. H. U. Kim14,
  16. U. Müller-Ladner16
  1. 1Hanyang Univ. Hospital, Seoul, Korea, Republic of Korea
  2. 2NZOZ Osteo-Medic, Bialystok
  3. 3Wojewodzki Szpital Zespolony, Elbląg, Poland
  4. 4Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine
  5. 5Hospital Militar Central, Bogota, Colombia
  6. 6Kaunas Medical Univ. Hospital, Kaunas, Lithuania
  7. 7Hospital Central Dr. Ignacio Morones Prieto, San Luis Potosi, Mexico
  8. 8St. Luke’s Medical Center, Quezon City
  9. 9Chong Hua Hospital, Cebu City, Philippines
  10. 10Univ. Hospital St. Marina, Varna, Bulgaria
  11. 11Prosalud y cia Ltda, Santiago, Chile
  12. 12Colchester General Hospital, Colchester, United Kingdom
  13. 13Inha Univ. Hospital
  14. 14CELLTRION, Incheon, Korea, Republic Of
  15. 15Univ. of New Mexico, Albuquerque, United States
  16. 16Justus-Liebig Univ. Giessen, Bad Nauheim, 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 compare the efficacy and safety of CT-P13 and INX in active rheumatoid arthritis (RA) patients up to week 54.

Methods Patients with active RA (1987 ACR criteria) and inadequate response to methotrexate (MTX) were randomised (1:1) to receive either CT-P13 (3mg/kg) or INX (3mg/kg) at weeks 0, 2, 6 and then every 8 weeks up to week 54 in combination with MTX (12.5–25mg/week).

Results Of 606 patients randomised at baseline, 457 patients were treated up to week 54. At week 54, ACR20 was highly similar between groups (CT-P13, 57.0% [172/302]; INX, 52.0% [158/304]; 95% CI: -0.03–0.13). ACR50 and ACR70 scores were also comparable between groups (CT-P13, 33.1% and 16.2%; INX, 31.6% and 15.1%, respectively). In the CT-P13 and INX groups respectively, 26.4% and 27.8% of patients reached remission with DAS28-CRP; additionally, 14.3% and 14.8% reached low disease activity compared to approximately 80% high disease activity in both groups at baseline. The proportion of patients testing positive for anti-drug antibodies (ADAs) was comparable between CT-P13 (52.3%) and INX (49.5%). More patients with negative ADA results achieved ACR20 responses (CT-P13, 73.9%; INX, 67.2%) compared with patients with positive results (CT-P13, 53.2%; INX, 48.1%). Total Sharp scores at baseline and week 54 were comparable (CT-P13, 104.6 and 70.4; INX, 103.6 and 73.0). Cmax of CT-P13 or INX at all doses ranged from 66.1µg/mL–112.2µg/mL and 60.3µg/mL–104.5µg/mL, respectively. The safety profiles of CT-P13 and INX were also comparable (table).

Conclusions CT-P13 showed comparable efficacy and PKs to those of INX up to week 54. CT-P13 was well tolerated with a safety profile comparable to that of INX up to week 54.

References

  1. Yoo D et al. 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. Ann Rheum Dis 2012;71(Suppl 3):359.

References

Disclosure of Interest D. H. Yoo Consultant for: CELLTRION Inc., A. Racewicz Grant/research support from: CELLTRION Inc., J. Brzezicki Grant/research support from: CELLTRION Inc., R. Yatsyshyn Grant/research support from: CELLTRION Inc., E. Tobias Arteaga Grant/research support from: CELLTRION Inc., A. Baranauskaite Grant/research support from: CELLTRION Inc., C. Abud-Mendoza Grant/research support from: CELLTRION Inc., S. Navarra Grant/research support from: CELLTRION Inc., Consultant for: Pfizer Ltd., Speakers bureau: CELLTRION Inc., R. Eullaran Grant/research support from: CELLTRION Inc., V. Kadinov Grant/research support from: CELLTRION Inc., I. Goecke Sariego Grant/research support from: CELLTRION Inc., P. Byrne Grant/research support from: CELLTRION Inc., W. Park Consultant for: CELLTRION Inc., S. J. Lee Consultant for: CELLTRION Inc., Employee of: CELLTRION Inc., H. U. Kim Employee of: CELLTRION Inc., U. Müller-Ladner Speakers bureau: CELLTRION Inc.

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