title: Efficacy and safety of adalimumab in Chinese adults with active ankylosing spondylitis: results of a randomised, controlled trial.
abstract: OBJECTIVE
  Efficacy of adalimumab for ankylosing spondylitis (AS) has been established for Western populations but not in the Chinese population. This study is the first to evaluate the efficacy and safety of adalimumab in Chinese patients with AS.
  
  
  METHODS
  Chinese adults with active AS who had an inadequate response or were intolerant to ≥1 non-steroidal anti-inflammatory drugs were randomised to adalimumab 40 mg (N=229) or matching placebo (N=115) subcutaneously every other week (EOW) for 12 weeks, followed by a 12-week open-label adalimumab 40 mg EOW phase. The primary efficacy endpoint was the percentage of patients meeting the Assessment in Spondyloarthritis International Society (ASAS20) response criteria at week 12. The recently developed AS Disease Activity Score (ASDAS), as well as efficacy measures of spinal mobility, disease activity, physical function and quality of life were evaluated.
  
  
  RESULTS
  At week 12, adalimumab treatment resulted in a significantly greater percentage of ASAS20 responders than placebo (67.2% versus 30.4%, respectively; p<0.001). Differences in ASAS20 were observed as early as week 2 (42.8% vs 6.1%, respectively; p<0.001). The percentages of patients achieving ASAS40, ASAS 5/6 and ASDAS inactive disease were significantly greater with adalimumab than placebo at week 12 (all p<0.001). Tuberculosis was reported in one patient. No cases of malignancy, lymphoma, demyelinating disease or lupus-like syndrome were reported during the study.
  
  
  CONCLUSIONS
  Adalimumab significantly reduced the signs and symptoms, improved physical function and quality of life of Chinese patients with active AS, and was generally safe and well tolerated in this population.
authors.affiliation: Department of Rheumatology, Chinese PLA General Hospital, , Beijing, People's Republic of China.
authors.forename: Feng
authors.initials: F
authors.lastname: Huang
authors.forename: Jieruo
authors.initials: J
authors.lastname: Gu
authors.forename: Ping
authors.initials: P
authors.lastname: Zhu
authors.forename: Chunde
authors.initials: C
authors.lastname: Bao
authors.forename: Jianhua
authors.initials: J
authors.lastname: Xu
authors.forename: Huji
authors.initials: H
authors.lastname: Xu
authors.forename: Huaxiang
authors.initials: H
authors.lastname: Wu
authors.forename: Guochun
authors.initials: G
authors.lastname: Wang
authors.forename: Qun
authors.initials: Q
authors.lastname: Shi
authors.forename: Nupun
authors.initials: N
authors.lastname: Andhivarothai
authors.forename: Jaclyn
authors.initials: J
authors.lastname: Anderson
authors.forename: Aileen L
authors.initials: AL
authors.lastname: Pangan
mesh_terms: D000068879:Adalimumab; D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012720:Severity of Illness Index; D013167:Spondylitis, Ankylosing / Q000188:drug therapy* / Q000503:physiopathology / Q000534:rehabilitation; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha; D000068879:Adalimumab
keywords: Ankylosing Spondylitis; Anti-TNF; Disease Activity; Treatment