#10 Immunologics for Migraine Prophylaxis 

Overview

Your head is throbbing, you’re nauseous, and even the dimmest light from across the room feels like you’re staring directly into the sun. You haven’t moved for hours, were forced to call off work, and have canceled your evening plans. You have another migraine – and it’s your fifth this month.

A migraine is more than the occasional pressure headache. It’s a neurovascular disorder associated with dysfunction of the cerebral nerve cells and blood vessels that affects more than 38 million people in the US – an estimated 12% of the adult population. In short, migraines are dysfunctional reactions in the brain, causing excessive relaxation or dilation of cranial blood vessels. These dilated blood vessels then mechanically activate sensory fibers from the trigeminal nerve located in the vessel wall, which convey pain impulses to the brainstem and other higher brain centers. Migraines are most likely to occur in women between the ages of 15 and 55, but the impact on quality of life is universal to those who suffer. Roughly 90% of individuals with migraine difficulties report missing work or failing to function normally during a migraine attack. For a third or more of those with migraine, financial security is a concern, and about a quarter worry they will lose their job due to their symptoms. The Migraine Research Foundation estimates that US employees take 113 million sick days per year due to migraines, creating an annual loss of $13 B. The cost to patients is great as well, incurring 70% higher healthcare-related costs than those without the disease.

For pain relief at the first sign of an oncoming migraine, there are several types of medication. Over-the-counter pain relievers are popular, as are ergot alkaloids, triptans, and, to a lesser extent, prescription opioids. While effective at treating individual headaches, they do not provide preventative treatment and are not considered a cure. Additionally, the drugs don’t work for everyone and share the unpleasant side effect of increasing headache frequency and severity with use. Prevention of migraines is the more current area of research. For some time, multi-purpose drugs like blood pressure medications, antidepressants, anti-seizure drugs, and botox injections have been used to prevent attacks. Not developed specifically for migraine, these methods are met with mixed results.

In 2018, new medications arrived on the scene to help head off migraine pain. Known as calcitonin gene-related peptide monoclonal antibodies, a type of immunologic, these compounds were designed specifically for migraine prophylaxis. The class of drugs works by blocking the activity of a molecule called calcitonin gene-related peptide (CGRP), which spikes when pain impulses are sent from the trigeminal nerve to the brain. When CGRP is released, it causes intense inflammation in the meninges, the membrane coverings of the brain, and causes the pain of a migraine attack. The first three medications in this class approved for the prevention of both chronic and episodic migraines are erenumab, galcanezumab, and fremanezumab. Either acting as agonists for the CGRP receptor or GCRP protein, these medications were approved by the FDA in May and September of 2018, respectively. The treatments are given as once-monthly injections and are extremely well-tolerated. For most people, there are few adverse reactions aside from some pain at the injection site.
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For a report published in July 2018, the Institute for Clinical and Economic Review (ICER) reviewed nearly 20 clinical trials of CGRP inhibitors for preventing both chronic and episodic migraines. The ICER found that, overall, migraine patients who took CGRP inhibitors had greater reductions in headache days per month versus other preventive medications. Higher odds of 50% response and greater reductions in days using acute medication per month were reported for all the interventions versus placebo. In short, all three FDA-approved CGRP inhibitors, as well as eptinezumab, the first-ever intravenous migraine prophylactic approved in February 2020, have earned an important spot in the arsenal of medications that prevent migraines.

Actively prescribed in 2020 with no signs of slowing adoption in 2021, this new FDA-approved class of medication for migraine sufferers is helping countless individuals reclaim their personal and professional lives.

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