title: [An open-label, multicentric clinical trial to evaluate the efficacy and impact on bone metabolism of recombinant human tumor necrosis factor-α receptor II IgG Fc fusion protein with methotrexate in active rheumatoid arthritis: 24-week clinical and radiographic results from ReABLE study].
abstract: OBJECTIVE
  To evaluate the efficacy, radiographic changes and safety of the combination of recombinant human tumor necrosis factor-α receptor II IgG Fc fusion protein (rhTNFR:Fc) and methotrexate (MTX) in patients with rheumatoid arthritis (RA).
  
  
  METHODS
  30 RA patients were treated with rhTNFR:Fc (25 mg subcutaneously twice weekly) and oral MTX (up to 15 mg weekly) in an open-label manner. Clinical response was assessed by American College of Rheumatology (ACR) criteria and Disease Activity Score in 28 joints (DAS28). Radiographs of hands and wrist were assessed by the modified Sharp score.
  
  
  RESULTS
  At Week 24, ACR20, ACR50 and ACR70 responses were achieved by 90%, 76.67% and 46.67% respectively. At Week 24, the mean DAS28 was 3.65 ± 1.26 versus 6.41 ± 0.61 at baseline (P < 0.001). And 20% patients achieved remission and 16.67% patients had a low disease activity. At week 24, EULAR good and moderate responses were attained by 36.67% and 60% respectively. Similarly, Health Assessment Questionnaire (HAQ) improved significantly, declining from 1.12 at baseline to 0.36 at week 24 (P < 0.001). No radiographic progression (based on change of total Sharp score) was found in 27 cases. Adverse events were mild.
  
  
  CONCLUSIONS
  rhTNFR:Fc in combination with MTX shows an excellent efficacy of reduced disease activity, improved function and slowed radiographic progression through 24 weeks. A combination therapy for 24 weeks can lead to disease remission and an inhibition of radiographic progression. Further study is warranted.
authors.affiliation: Department of Clinical Immunology & Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China.
authors.forename: Qing-jun
authors.initials: QJ
authors.lastname: Wu
authors.forename: Zhuo-li
authors.initials: ZL
authors.lastname: Zhang
authors.forename: Zhen-bin
authors.initials: ZB
authors.lastname: Li
authors.forename: Dong
authors.initials: D
authors.lastname: Xu
authors.forename: Guang-tao
authors.initials: GT
authors.lastname: Li
authors.forename: Li-fen
authors.initials: LF
authors.lastname: Geng
authors.forename: Meng-tao
authors.initials: MT
authors.lastname: Li
authors.forename: Yu
authors.initials: Y
authors.lastname: Wang
authors.forename: Jian-jun
authors.initials: JJ
authors.lastname: Zhu
authors.forename: Yan-jie
authors.initials: YJ
authors.lastname: Hao
authors.forename: Nai-ling
authors.initials: NL
authors.lastname: Hui
authors.forename: Jing
authors.initials: J
authors.lastname: Yang
authors.forename: Xiao-qing
authors.initials: XQ
authors.lastname: Cui
authors.forename: Xiao-gang
authors.initials: XG
authors.lastname: Zhang
authors.forename: Yan
authors.initials: Y
authors.lastname: Zhao
mesh_terms: D000328:Adult; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000378:metabolism; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D047889:Receptors, Tumor Necrosis Factor, Type II / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D047889:Receptors, Tumor Necrosis Factor, Type II; D011993:Recombinant Fusion Proteins; D008727:Methotrexate