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AB0392 Safety and effectiveness of CT-P13 in patients with rheumatoid arthritis: results from 24 months nationwide registry in korea
  1. SH Park1,
  2. SS Nah2,
  3. SH Chang2,
  4. KJ Kim3,
  5. KS Park3,
  6. SS Lee4,
  7. SR Kwon5,
  8. SI Lee6,
  9. CH Suh7,
  10. SH Kim8,
  11. CN Son8,
  12. JK Min9,
  13. HR Kim10,
  14. HJ Beak11,
  15. HS Kim12,
  16. JY Choe13,
  17. HI Yang14,
  18. MK Lim15,
  19. SJ Hong16,
  20. YS Kim17,
  21. JH Lee18,
  22. J Suh19,
  23. S Lee19
  1. 1The Catholic University of Korea Seoul St.Mary's Hospital, Seoul
  2. 2Soonchunhyang University Cheonan Hospital, Cheonan
  3. 3The Catholic University of Korea St. Vincent's Hospital, Suwon
  4. 4Chonnam National University Hospital, Gwangju
  5. 5Inha University Hospital, Incheon
  6. 6Gyeongsang National University School of Medicine, Jinju
  7. 7Ajou University School of Medicine, Suwon
  8. 8Keimyung University Dongsan Medial Center, Daegu
  9. 9Bucheon St.Mary's Hospital, Bucheon
  10. 10Konkuk University School of Medicine, Seoul
  11. 11Gachon University Gil Medical Center, Incheon
  12. 12The Soonchunhyang University Seoul Hospital, Seoul
  13. 13Daegu Catholic University Medical Center, Daegu
  14. 14Kyung Hee University Hospital at Gang Dong, Seoul
  15. 15Eulji University School of Medicine, Daejeon
  16. 16Kyung Hee University Medical Center, Seoul
  17. 17Chosun University Hospital, Gwangju
  18. 18Inje University Ilsan Paik Hospital, Goyang
  19. 19Celltrion, Inc, Incheon, Korea, Republic Of

Abstract

Background CT-P13 is approved in both European Union and United States, and licensed for use in 79 countries around the world as a biosimilar to innovator infliximab (INX). The independent registries of CT-P13 have been conducted in a number of European countries and Korea [1].

Objectives To evaluate safety and effectiveness of CT-P13 when administered in a real-life setting in active RA patients.

Methods This study collected data of patients who were treated with CT-P13 from 2013 December to 2016 June. Efficacy was assessed at baseline and every 6 months thereafter using DAS28 (ESR) and/or DAS28 (CRP) and collection of adverse events (AEs) was performed. Immunogenicity was assessed at baseline, Week 30 and every year during CT-P13 treatment period.

Results Total 125 patients were enrolled; 104 patients started treatment with CT-P13 (Naïve group) and 21 patients (8 from INX, 13 from other anti-TNFs) switched treatment to CT-P13 (Switching group). The mean (SD) duration since RA diagnosis was 6.5 (±6.85) years for all patients.

Of all patients treated with CT-P13, only 4.8% (6/125) of patients changed to other anti-TNFs. Two of six patients changed treatment within 8 month after starting CT-P13.

The proportion of patients achieving clinical remission by DAS28 (ESR/CRP) increased gradually (Figure 1). DAS28 (ESR/CRP) value decreased from baseline at 6 months and it maintained thereafter (Table 1). Switching group also showed similar results that remission rate by DAS28 (CRP) was 42.9% (3/7) and mean actual value was 2.85 at 12 months.

For Naïve group, 50% (52/104) of patients had at least one positive anti-drug antibody result and it is consistent to other published study [2].

Overall safety summarized as the percentage of patients with at least one treatment emergent AE (TEAE) was similar or lower after switching to CT-P13 (Table 2). No cases of active tuberculosis were reported.

Table 1.

DAS28 in CT-P13 Naïve group over 24 months

Table 2.

Safety results in CT-P13 Naïve and Switching group

Conclusions The overall safety profile revealed that CT-P13 is well-tolerated in patients with RA and remission rate for 24 months also showed that CT-P13 is efficacious under real world practice.

References

  1. Glintborg et al. ACR 2016.

  2. Krintel et al. Rheumatology 2013.

References

Disclosure of Interest None declared

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