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JCR: Journal of Clinical Rheumatology:
doi: 10.1097/RHU.0000000000000053
Original Articles

Effect of Golimumab on Carotid Atherosclerotic Disease Measures and Cardiovascular Events in Inflammatory Arthritides

Wasko, Mary Chester MD, MSc*†; Hsia, Elizabeth C. MD‡§; Kirkham, Bruce MD; Touboul, Pierre-Jean MD; Fleischmann, Roy MD#; Genovese, Mark C. MD**; Matteson, Eric L. MD, MPH††; Lu, Jiandong PhD; Xu, Weichun PhD; Rahman, Mahboob U. MD, PhD‡§

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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.

© 2014 by Lippincott Williams & Wilkins, Inc.

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