title: The effects of golimumab on subclinical  atherosclerosis and arterial stiffness in ankylosing  spondylitis—a randomized, placebo-controlled  pilot trial.
abstract: OBJECTIVE
  Our aim was to ascertain the efficacy of golimumab compared with placebo in the prevention of atherosclerosis and arterial stiffness in AS.
  
  
  METHODS
  A randomized, double-blind, placebo-controlled pilot study was performed in which AS patients were treated with golimumab (n = 20) and placebo (n = 21) for 12 months. Patients from the placebo group who failed to achieve a 20% response to Assessment of SpondyloArthritis international Society criteria (ASAS20) at 6 months received open-label golimumab. Intima-media thickness (IMT), pulse wave velocity (PWV) and augmentation index (AIx) were measured at baseline, 6 and 12 months.
  
  
  RESULTS
  At 6 months, 11/20 (55%) and 3/21 (14%) patients from the golimumab and placebo groups achieved an ASAS20 response, respectively (P = 0.006). There was no significant difference in the change of the vascular parameters between the two groups. In the placebo group, significantly greater progression of the mean IMT [from 0.51 mm (S.D. 0.07) at baseline to 0.53 mm (S.D. 0.08) at 6 months, P = 0.044] and PWV (from 12.2 m/s (S.D. 1.6) at baseline to 12.6 m/s (S.D. 1.3), P = 0.028] were observed. There was a trend towards progression of the mean IMT in the golimumab group (P = 0.099) but the maximum IMT, PWV and AIx remained unchanged. At 12 months the changes in vascular parameters were similar between the early and delayed (or no) golimumab groups.
  
  
  CONCLUSIONS
  Uncontrolled inflammation may result in a significant progression in IMT and PWV in patients with AS. Arterial dysfunction may be prevented by golimumab over a period of 6 months, probably because of effective suppression of inflammation.
  
  
  BACKGROUND
  clinicaltrials.gov (NCT01212653)
authors: Lai-Shan
authors: LS
authors: Tam
authors: Qing
authors: Q
authors: Shang
authors: Emily W
authors: EW
authors: Kun
authors: Ka-Lai
authors: KL
authors: Lee
authors: Man-Lung
authors: ML
authors: Yip
authors: Martin
authors: M
authors: Li
authors: Tena K
authors: TK
authors: Li
authors: Tracy Y
authors: TY
authors: Zhu
authors: Michelle O
authors: MO
authors: Pui
authors: Edmund K
authors: EK
authors: Li
authors: Cheuk-Man
authors: CM
authors: Yu
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D050197:Atherosclerosis / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D059168:Carotid Intima-Media Thickness; D018450:Disease Progression; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D018836:Inflammation Mediators / Q000097:blood; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D063177:Pulse Wave Analysis; D012307:Risk Factors; D012720:Severity of Illness Index; D013167:Spondylitis, Ankylosing / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D059289:Vascular Stiffness / Q000187:drug effects*; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D018836:Inflammation Mediators; C529000:golimumab