Stewart Tepper, MD, Professor of Neurology, Geisel School of Medicine at Dartmouth, Hanover, NH, discusses the cardiovascular and cerebrovascular adverse events of erenumab in patients with migraine with or without a history of aura. This interview was recorded during an online conference call with The Video Journal of Neurology (VJNeurology).
We presented at the european academy neurology meeting a pooled analysis of 2443 patients to evaluate cardiovascular and cerebrovascular safety virenumab over time the evaluation included four large studies first a trial of arenamab for episodic migraine which was a which included a 12 week double pline treatment phase and then five years of open label treatment
So this is the longest study that has ever been done with a monoclonal antibody for one of the anti-cgrp monoclonal antibodies trial two was a randomized controlled trial of a renumbab for episodic migraine with a six-month double-blind treatment phase and then a seven month open label treatment phase trial three was also for episodic migraine and it was a
Three-month double-blind randomized control trial followed by a 28-week open label treatment phase and trial four was the regulatory trial varenimab for chronic migraine with a three-month double-blind treatment phase and a one-year open label treatment phase and we also evaluated a rhetomab in these evaluations for those we evaluated the migraine patients
Who were exposed to a renumbab with those who had no history of aura and those who had a history of aura because of concern that aura might generate a greater risk for cerebral vascular cardiovascular safety and we evaluated that in both the double-blind treatment phase patients and the open label treatment phase so this was quite an extensive evaluation and
A variety of ischemic and central nervous system and heart disease outcomes were included the analysis the first part of this was to evaluate the incident rates of adverse events at baseline in the patients with and without aura and there was a slight increase across all of the patients with a history of aura for most of the risk factors diabetes was slightly
Higher in the aura patients hypertension slightly higher in the in the aura patients hyperlipidemia was slightly higher in the aura patients a higher body mass index was present in the oro patients current cigarette use was actually higher in the aura patients when one looked at patients with multiple vascular risk factors that is at least two risk factors again
That group was higher in the aura patients it did look like going into this data evaluation that the aura patients were at greater risk they appeared to have a greater number of risk factors the total number of patients was not that far apart we had 1 303 patients with no history of aura and 1 140 patients with a history of aura then we evaluated the rates of
Adverse events during the double-blind treatment phase of the episodic migraine trials and the chronic migraine trial evaluating for serious adverse events fatal adverse events cardiovascular and cerebral vascular disorder adverse events central venous thrombosis hypertension related adverse events and then hypertension alone and diastolic hypertension alone
And we found that essentially the patients with and without aura had adverse events at the same rate as placebo and it didn’t matter whether the patients had a history of aura or no history of aura they were essentially equivalent in when one included any adverse event then there was a a rate of adverse events that was pretty much the same between aura non-aura
And placebo and then all of the other adverse events that i described were pretty much the same as placebo we then evaluated the exposure adjusted incidence rates of adverse events in the open label treatment phase in the patients with and without aura and remember this went out as long as five years and once again very interestingly the patients with a history
Of aura and the patients without a history of aura were essentially identical there was no increased incidence of adverse events in the patients who had aura despite having had a few more risk factors at baseline and we looked pretty extensively so we evaluated cardiovascular and cerebral vascular disorder adverse events in total separated out cerebrovascular
Disorders cerebral venous thrombosis transient ischemic attacks myocardial ischemia reynolds angina atherosclerotic coronary artery disease blood mb increase hypertension related adverse events that included hypertension diastolic hypertension and hypertensive heart disease in not one of these did it look like the aura conferred any additional risk and the
Arenamab and the renomab rates of adverse events were extremely low the only one that even registered slightly was hypertension so in conclusion the frequency of cardiovascular and cerebrovascular adverse events with long-term arenamap treatment was similar in patients with and without aura and then very importantly as one looked across time in these patients
There was no increased emergence of adverse events over over time so these were very reassuring data suggesting number one that erenimab appeared safe and tolerable across time number two that the cardiovascular and cerebrovascular adverse events were extremely low across time and number three there was no new emergence of risks over time with a random app
Transcribed from video
Erenumab in migraine with or without aura: cardiovascular safety By VJNeurology
