title: Effect of golimumab on carotid atherosclerotic disease measures and cardiovascular events in inflammatory arthritides.
abstract: OBJECTIVE
  The objective of this study was to assess the effect of golimumab on carotid ultrasound measures and cardiovascular serious adverse events (SAEs) in patients with inflammatory arthritides.
  
  
  METHODS
  An exploratory carotid artery ultrasound substudy was performed in the GO-BEFORE study of methotrexate (MTX)-naive rheumatoid arthritis patients, with ultrasounds performed at weeks 0, 24, and 52 to measure common carotid artery intima-media thickness, distensibility coefficient, interadventitial diameter, and plaque count. Cardiovascular SAEs reported over 2 years of follow-up were assessed in 5 golimumab phase 3 clinical trials of patients with rheumatoid arthritis (GO-BEFORE, GO-FORWARD, and GO-AFTER), psoriatic arthritis (GO-REVEAL), and ankylosing spondylitis (GO-RAISE). In GO-BEFORE and GO-FORWARD, patients received placebo + MTX, golimumab 50 mg + MTX, or golimumab 100 mg +/- MTX at baseline and every 4 weeks; in the other 3 trials, patients received placebo or golimumab 50 or 100 mg.
  
  
  RESULTS
  The carotid ultrasound substudy showed inconsistent changes in common carotid artery intima-media thickness in the golimumab + MTX groups over time, and there was large variability in the measurements. Increases in interadventitial diameter were observed in the golimumab 100 mg + placebo group, but not in the golimumab + MTX groups. There were no significant differences in the distensibility coefficient and plaque count between the golimumab and placebo groups. Very few patients overall experienced a cardiovascular SAE, and the incidence of cardiovascular SAEs was not statistically different between the golimumab and placebo groups.
  
  
  CONCLUSIONS
  The results of the carotid ultrasound substudy were inconclusive, and no increase or decrease in cardiovascular SAEs was observed following 2 years of treatment with golimumab with or without MTX.
authors.affiliation: From the *Allegheny Singer Research Institute, West Penn Allegheny Health System; †Temple University School of Medicine-Pittsburgh Campus, Pittsburgh, PA; ‡Janssen Research & Development, LLC, Spring House, PA; §University of Pennsylvania School of Medicine, Philadelphia, PA; ∥Guy's & St Thomas' NHS Foundation Trust, London, United Kingdom; ¶Department of Neurology and Stroke Center, Hôpital Bichat, Paris, France; #Metroplex Clinical Research Center, Dallas, TX; **Stanford University, Palo Alto, CA; and ††Mayo Clinic College of Medicine, Rochester, MN.
authors.forename: Mary Chester
authors.initials: MC
authors.lastname: Wasko
authors.forename: Elizabeth C
authors.initials: EC
authors.lastname: Hsia
authors.forename: Bruce
authors.initials: B
authors.lastname: Kirkham
authors.forename: Pierre-Jean
authors.initials: PJ
authors.lastname: Touboul
authors.forename: Roy
authors.initials: R
authors.lastname: Fleischmann
authors.forename: Mark C
authors.initials: MC
authors.lastname: Genovese
authors.forename: Eric L
authors.initials: EL
authors.lastname: Matteson
authors.forename: Jiandong
authors.initials: J
authors.lastname: Lu
authors.forename: Weichun
authors.initials: W
authors.lastname: Xu
authors.forename: Mahboob U
authors.initials: MU
authors.lastname: Rahman
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use; D001168:Arthritis / Q000188:drug therapy*; D002318:Cardiovascular Diseases / Q000000981:diagnostic imaging / Q000453:epidemiology*; D002339:Carotid Arteries / Q000000981:diagnostic imaging / Q000187:drug effects*; D002340:Carotid Artery Diseases / Q000000981:diagnostic imaging / Q000453:epidemiology*; D059168:Carotid Intima-Media Thickness; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D012307:Risk Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; C529000:golimumab; D008727:Methotrexate