Clinical Rheumatology

, Volume 32, Issue 1, pp 99–108

A multicenter, randomized, double-blind clinical trial of combination therapy with Anbainuo, a novel recombinant human TNFRII:Fc fusion protein, plus methotrexate versus methotrexate alone or Anbainuo alone in Chinese patients with moderate to severe rheumatoid arthritis

  • Xiao-Xiang Chen
  • Qing Dai
  • An-Bin Huang
  • Hua-Xiang Wu
  • Dong-Bao Zhao
  • Xing-Fu Li
  • Shao-Xian Hu
  • Nan-Ping Yang
  • Yi Tao
  • Jian-Hua Xu
  • Lin-Di Jiang
  • Chun-De Bao
Original Article

DOI: 10.1007/s10067-012-2096-z

Cite this article as:
Chen, X., Dai, Q., Huang, A. et al. Clin Rheumatol (2013) 32: 99. doi:10.1007/s10067-012-2096-z

Abstract

This study aims to evaluate the clinical and radiological efficacy as well as safety profiles of Anbainuo, a recombinant human TNFRII:Fc fusion protein, combined with methotrexate (MTX) versus MTX alone or Anbainuo alone in the treatment of Chinese patients with moderate to severe rheumatoid arthritis (RA). In this 24-week, multicenter, double-blind, active comparator-controlled study, 396 RA patients were randomized into combination therapy group (Anbainuo plus MTX), Anbainuo group, or MTX group. Clinical response was assessed using the American College of Rheumatology (ACR)-N, ACR20, ACR50, ACR70, and van der Heijde modification of Sharp score, among which ACR-N and ACR20 were defined as primary major endpoints. After 24 weeks of treatment, the ACR-N in the combination therapy group (12.79 ± 9.24 %) was significantly higher than that in Anbainuo group (9.56 ± 11.16 %) and in MTX group (5.08 ± 11.1 %) (p = 0.00 and p = 0.00, respectively). Patients in Anbainuo group had significantly higher ACR-N than those in MTX group (p = 0.02). More patients in the combination therapy group (53.6 %) achieved ACR50 improvement response than those in the MTX group (30.8 %). ACR70 of combination therapy group (27.7 %) was significantly higher than that of Anbainuo group (15.8 %) and MTX group (7.70 %), with no significant difference between Anbainuo group and MTX group. DAS28-ESR in the combination therapy group was significantly reduced compared to either monotherapy groups. Moreover, DAS28-ESR was significantly lower in Anbainou group than in MTX group. The combination therapy group also showed significantly less radiographic progression than the MTX group (p = 0.03). The total adverse events (AE) in the combination group (40.9 %) was significantly higher than those in the MTX group (28.8 %) (p < 0.05). Anbainuo combined with MTX therapy can effectively control the disease activity and radiographic progression of RA, while the incidence of AE also increased compared to either Anbainuo or MTX.

Keywords

MethotrexateRheumatoid arthritisTNF receptor II: Fc fusion protein

Copyright information

© Clinical Rheumatology 2012

Authors and Affiliations

  • Xiao-Xiang Chen
    • 1
  • Qing Dai
    • 1
  • An-Bin Huang
    • 2
  • Hua-Xiang Wu
    • 3
  • Dong-Bao Zhao
    • 4
  • Xing-Fu Li
    • 5
  • Shao-Xian Hu
    • 6
  • Nan-Ping Yang
    • 7
  • Yi Tao
    • 8
  • Jian-Hua Xu
    • 9
  • Lin-Di Jiang
    • 10
  • Chun-De Bao
    • 1
  1. 1.Renji Hospital, School of MedicineAffiliated to Shanghai JiaoTong UniversityShanghaiChina
  2. 2.The Union HospitalAffiliated to Tongji UniversityHubei ProvinceChina
  3. 3.Second HospitalAffiliated to Zhejiang UniversityZhejiang ProvinceChina
  4. 4.Changhai HospitalAffiliated to Second Military Medical UniversityShanghaiChina
  5. 5.Qilu HospitalAffiliated to Shandong UniversityShandong ProvinceChina
  6. 6.Tongji HospitalAffiliated to Tongji UniversityHubei ProvinceChina
  7. 7.Huaxi HospitalAffiliated to Sichuan UniversitySichuan ProvinceChina
  8. 8.The Third HospitalAffiliated to Zhongshan Medical UniversityGuangdong ProvinceChina
  9. 9.The First HospitalAffiliated to Anhui medical UniversityAnhui ProvinceChina
  10. 10.Zhongshan HospitalAffiliated to Fudan UniversityShanghaiChina