title: Safety and efficacy of golimumab in Chinese patients with active ankylosing spondylitis: 1-year results of a multicentre, randomized, double-blind, placebo-controlled phase III trial.
abstract: OBJECTIVE
  The aim of this study was to assess the efficacy and safety of golimumab in Chinese patients with active AS.
  
  
  METHODS
  Two hundred and thirteen patients were randomized in a 1:1 ratio to receive either s.c. injections of placebo from weeks 0 to 20 followed by golimumab 50 mg from weeks 24 to 48 (group 1, n = 105) or golimumab 50 mg from weeks 0 to 48 (group 2, n = 108), both every 4 weeks. Placebo crossover occurred at week 24, while early escape was at week 16. The primary endpoint was an improvement of at least 20% in the Assessment of SpondyloArthritis international Society (ASAS20) criteria at week 14. Major secondary endpoints included week 24 ASAS20 response and week 14 change scores for BASFI and BASMI.
  
  
  RESULTS
  Golimumab treatment elicited significantly better responses than placebo in week 14 ASAS20 response [49.1% (53/108) vs 24.8% (26/105), respectively, P < 0.001], week 24 ASAS20 response (50.0% vs 22.9%, P < 0.001) and mean improvements in BASFI (-1.26 vs 0.11, P < 0.001) and BASMI (-0.42 vs -0.19, P = 0.021) scores at week 14. Additionally, golimumab treatment led to significant improvements in the mental and physical components of health-related quality of life (HRQoL) and sleep problems at week 24, all of which were further improved through week 52. During the 16-week placebo-controlled study period, 31.4% and 30.6% of patients had adverse events (AEs) in groups 1 and 2, respectively; similar AE reporting rates were observed through week 24 (34.3% and 32.0%) and among the golimumab-treated patients through week 56 (41.2%).
  
  
  CONCLUSIONS
  Golimumab significantly reduced clinical symptoms/signs and improved physical function, range of motion and HRQoL in Chinese patients with active AS without unexpected safety concerns.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT01248793.
authors.affiliation: Shanghai Renji Hospital, Shanghai, Chinese PLA General Hospital, Beijing, China, Case Western Reserve University, Cleveland, OH, Janssen Research & Development, LLC, Spring House, PA and University of Pennsylvania School of Medicine, Philadelphia, PA, USA. hap//contradistinctionst2/show/NCT01248793 baochunde_1678@126.com.
authors.forename: Chunde
authors.initials: C
authors.lastname: Bao
authors.affiliation: Shanghai Renji Hospital, Shanghai, Chinese PLA General Hospital, Beijing, China, Case Western Reserve University, Cleveland, OH, Janssen Research & Development, LLC, Spring House, PA and University of Pennsylvania School of Medicine, Philadelphia, PA, USA. hap//contradistinctionst2/show/NCT01248793.
authors.forename: Feng
authors.initials: F
authors.lastname: Huang
authors.affiliation: Shanghai Renji Hospital, Shanghai, Chinese PLA General Hospital, Beijing, China, Case Western Reserve University, Cleveland, OH, Janssen Research & Development, LLC, Spring House, PA and University of Pennsylvania School of Medicine, Philadelphia, PA, USA. hap//contradistinctionst2/show/NCT01248793.
authors.forename: Muhammad Asim
authors.initials: MA
authors.lastname: Khan
authors.affiliation: Shanghai Renji Hospital, Shanghai, Chinese PLA General Hospital, Beijing, China, Case Western Reserve University, Cleveland, OH, Janssen Research & Development, LLC, Spring House, PA and University of Pennsylvania School of Medicine, Philadelphia, PA, USA. hap//contradistinctionst2/show/NCT01248793.
authors.forename: Kaiyin
authors.initials: K
authors.lastname: Fei
authors.affiliation: Shanghai Renji Hospital, Shanghai, Chinese PLA General Hospital, Beijing, China, Case Western Reserve University, Cleveland, OH, Janssen Research & Development, LLC, Spring House, PA and University of Pennsylvania School of Medicine, Philadelphia, PA, USA. hap//contradistinctionst2/show/NCT01248793.
authors.forename: Zhong
authors.initials: Z
authors.lastname: Wu
authors.affiliation: Shanghai Renji Hospital, Shanghai, Chinese PLA General Hospital, Beijing, China, Case Western Reserve University, Cleveland, OH, Janssen Research & Development, LLC, Spring House, PA and University of Pennsylvania School of Medicine, Philadelphia, PA, USA. hap//contradistinctionst2/show/NCT01248793.
authors.forename: Chenglong
authors.initials: C
authors.lastname: Han
authors.affiliation: Shanghai Renji Hospital, Shanghai, Chinese PLA General Hospital, Beijing, China, Case Western Reserve University, Cleveland, OH, Janssen Research & Development, LLC, Spring House, PA and University of Pennsylvania School of Medicine, Philadelphia, PA, USA. hap//contradistinctionst2/show/NCT01248793Shanghai Renji Hospital, Shanghai, Chinese PLA General Hospital, Beijing, China, Case Western Reserve University, Cleveland, OH, Janssen Research & Development, LLC, Spring House, PA and University of Pennsylvania School of Medicine, Philadelphia, PA, USA. hap//contradistinctionst2/show/NCT01248793.
authors.forename: Elizabeth C
authors.initials: EC
authors.lastname: Hsia
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D011788:Quality of Life; D012720:Severity of Illness Index; D013167:Spondylitis, Ankylosing / Q000097:blood / Q000188:drug therapy* / Q000534:rehabilitation; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; C529000:golimumab
keywords: Asia; China; ankylosing spondylitis; biologic; spondyloarthritis; spondyloarthropathy; tumour necrosis factor