Rheumatology International

, Volume 34, Issue 11, pp 1519–1527

A randomized, double-blind, and placebo-controlled multicenter clinical trial of a novel cytotoxic T-lymphocyte antigen-4 fusion protein, Leining, in Chinese active rheumatoid arthritis patients with an inadequate response to methotrexate

  • Wei Fan
  • Dong-bao Zhao
  • Shao-Xian Hu
  • Hu-ji Xu
  • Xiao Zhang
  • Miu-jia Zhang
  • Zhi-wei Chen
  • Feng-xiao Zhang
  • Ping Zhu
  • Xin-fu Li
  • Li-qi Bi
  • Bin Zhou
  • Chun-de Bao
Original Article

DOI: 10.1007/s00296-014-2989-z

Cite this article as:
Fan, W., Zhao, D., Hu, SX. et al. Rheumatol Int (2014) 34: 1519. doi:10.1007/s00296-014-2989-z

Abstract

To assess the clinical efficacy as well as safety profiles of Leining, a novel cytotoxic T-lymphocyte antigen-4 fusion protein, versus placebo in the treatment of Chinese active rheumatoid arthritis (RA) patients with an inadequate clinical response to methotrexate (MTX). In this 24-week, randomized, double-blind, placebo-controlled multicenter study, a total of 440 Chinese patients with active RA with an inadequate response to MTX were randomly assigned to receive Leining (10 mg/kg) or placebo. Clinical response was assessed using the American College of Rheumatology 20 % improvement criteria ACR20, ACR50, and ACR70, with ACR20 as the primary major endpoints. Disease activity scores in 28 joints with erythrocyte sedimentation rate assessment (DAS28-ESR) were used to evaluate disease activity. After 24 weeks of treatment, significantly more patients in Leining group achieved ACR20 response than those in placebo group (70.61 vs. 46.36 %; p < 0.001). Similarly, ACR50 and ACR70 responses of Leining group were significantly higher than those of placebo group (40.30 vs. 22.73 %; p < 0.001 and 16.67 vs. 7.27 %; p < 0.05, respectively). DAS28-ESR in Leining group was significantly reduced compared to that in placebo group, with greater clinically meaningful (>1.2 unit) improvement (54.85 vs. 29.09 %, p < 0.05). Both the rates of remission (DAS28-ESR < 2.6) and low disease activity (DAS28-ESR < 3.2) were greater in the Leining group than those in the placebo group (12.42 vs. 2.73 %; p < 0.05 and 15.45 vs. 2.73 %; p < 0.05 respectively). The overall incidence of adverse events was similar in both Leining and placebo groups. No neutralizing antibodies were detected. Leining demonstrated clinically meaningful efficacy compared with placebo in Chinese patients with active RA despite MTX therapy. Administration of Leining in combination with MTX for 24 weeks was well tolerated.

Keywords

Leining Abatacept Rheumatoid arthritis Methotrexate 

Copyright information

© Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • Wei Fan
    • 1
  • Dong-bao Zhao
    • 2
  • Shao-Xian Hu
    • 3
  • Hu-ji Xu
    • 4
  • Xiao Zhang
    • 5
  • Miu-jia Zhang
    • 6
  • Zhi-wei Chen
    • 7
  • Feng-xiao Zhang
    • 8
  • Ping Zhu
    • 9
  • Xin-fu Li
    • 10
  • Li-qi Bi
    • 11
  • Bin Zhou
    • 12
  • Chun-de Bao
    • 1
  1. 1.Department of Rheumatology, Ren Ji Hospital, School of MedicineShanghai Jiao Tong UniversityShanghaiChina
  2. 2.Changhai HospitalAffiliated to Second Military Medical UniversityShanghaiChina
  3. 3.Tongji HospitalAffiliated to Tongji UniversityWuhanChina
  4. 4.Changzheng HospitalAffiliated to Second Military Medical UniversityShanghaiChina
  5. 5.Guangdong General HospitalGuangzhouChina
  6. 6.Jiangsu Province HospitalNanjingChina
  7. 7.Suzhou First People’s HospitalThe First Affiliated Hospital of Soochow UniversitySuzhouChina
  8. 8.Hebei General HospitalShijiazhuangChina
  9. 9.Xijing HospitalAffiliated to Fouth Military Medical UniversityXi’anChina
  10. 10.Qilu Hospital of Shandong UniversityShandongChina
  11. 11.China-Japan Union Hospital of Jilin UniversityChangchunChina
  12. 12.Sichuan Academy of Medical Sciences and Sichuan Provincial People’s HospitalChengduChina

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