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Golimumab did not affect cardiovascular SAEs in RA patients
Patients with rheumatoid arthritis did not experience a significant change in serious cardiovascular adverse events after 2 years of golimumab therapy with or without methotrexate, according to recent study results.
Researcher Eric L. Matteson, MD, MPH, chair of the division of rheumatology at Mayo Clinic in Rochester, Minn., and colleagues conducted an exploratory carotid artery substudy on 392 patients with rheumatoid arthritis (RA) who were methotrexate (MTX)-naive. Ultrasound at 0, 24 and 52 weeks was used to measure common carotid artery intima-media thickness (CCA-IMT), distensibility coefficient, interadventitial diameter and plaque count.
Eric L. Matteson
Researchers also assessed cardiovascular serious adverse events (SAEs) reported during 2 years of follow-up for five phase 3 trials of golimumab in 2,303 patients with RA (GO-BEFORE, n=637; GO-FORWARD, n=444; and GO-AFTER, n=461), psoriatic arthritis (GO-REVEAL, n=405) and ankylosing spondylitis (GO-RAISE, n=356).
Patients were assigned placebo plus MTX, 50 mg golimumab plus MTX or 100 mg golimumab with MTX or placebo at baseline and every 4 weeks in the GO-BEFORE and GO-FORWARD trials. GO-AFTER, GO-REVEAL and GO-RAISE trial patients received placebo, 50 mg golimumab or 100 mg golimumab.
In golimumab/MTX patients, the substudy using ultrasound resulted in inconsistent changes in CCA-IMT and substantial variability in measurements.
Among patients treated with 100 mg golimumab/placebo, increases in interadventitial diameter were seen, but not in patients assigned golimumab/MTX. Distensibility coefficient and plaque count displayed no significant differences between golimumab- and placebo-treated patients.
“Very few patients overall experienced a cardiovascular SAE, and the incidence of cardiovascular SAEs was not statistically different between the golimumab and placebo groups,” the researchers concluded. “We found no consistent evidence that treatment with golimumab was associated with changes in carotid artery ultrasound indicators of atherosclerosis in MTX-naive patients with RA.
“Additional work is needed to fully elucidate the relationship between anti-[tumor necrosis factor] therapy and atherosclerosis.”
Disclosure: See the study for a full list of relevant financial disclosures.