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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‡§

Journal of Clinical Rheumatology: January 2014 - Volume 20 - Issue 1 - p 1–10
doi: 10.1097/RHU.0000000000000053
Original Articles

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.

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.

The Cardiovascular Steering Committee (Drs Joan Bathon of Johns Hopkins Medical Institutes, Baltimore, MD [currently at Columbia University, New York, NY], E.C.H., B.K., M.U.R., and M.C.W.) for the Golimumab Rheumatology Program led the development of the protocol and interpretation of the results of the study.

This study was funded by Janssen Research & Development, LLC, and Merck/Schering-Plough.

Author contribution: M.C.W., E.C.H., B.K., P.-J.T., R.F., M.C.G., E.L.M., and M.U.R. designed the study. E.C.H., P.-J.T., J.L., W.X., and M.U.R. analyzed the data. All authors interpreted the data, critically revised the manuscript, and approved the final draft for submission.

M.C.W. has received consulting fees for Janssen Research & Development, LLC, and is an investigator for Astra-Zeneca. B.K. conducts clinical trials and sits on speaker panels for Abbott, Janssen Research & Development, LLC; Merck, Bristol-Meyers-Squibb, and Amgen. M.C.G. has received grant support from, and served as a consultant to, Janssen Research & Development, LLC. R.F. has received consulting fees and/or research grants from Abbott Laboratories, Amgen, Inc, Bristol-Myers Squibb, Centocor/Janssen, F Hoffmann-LaRoche, Ltd, GlaxoSmithKline, Novartis Pharmaceuticals Corporation, Pfizer Pharmaceuticals, UCB, Genentech, Lexicon, Lily, and Wyeth Pharmaceuticals. E.L.M. has been a paid consultant and advisory board member and is an investigator for Johnson & Johnson/Janssen Research & Development, LLC. P.-J.T. has received honoraria from Centocor/Janssen as a consultant and receives royalties from M’Ath software as an inventor. E.C.H., J.L., and W.X. are employees of the study sponsor and own stock in Johnson & Johnson. M.U.R. was an employee of Janssen Research & Development, LLC, at the time this study was conducted and is currently employed by and owns stock in Pfizer.

Correspondence: Mary Chester Wasko, MD, MSc, West Penn Allegheny Health System, 4800 Friendship Ave, North Tower 2600, Pittsburgh, PA 15224. E-mail:

© 2014 by Lippincott Williams & Wilkins, Inc.