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: email@example.com.