New drug uses antibodies to stop chronic migraines, without side effects

Authored by nbcnews.com and submitted by drewiepoodle

More than 37 million Americans suffer from migraine attacks, according to the American Headache Society. Of these, about 4 million have chronic migraine and suffer headaches for 10 to 14 days a month.

While some people are helped by low cost, over-the-counter drugs such as ibuprofen, others need stronger prescription medications, such as sumatriptan and ergotamine, which constrict the blood vessels in the brain and can cause dizziness or nausea. Botox injections are also used to help ease migraines in some people.

But a large percentage of sufferers are not helped by anything.

“"This is the first-ever mechanism specific migraine drug designed for prevention," said lead study author Dr. Peter Goadsby, professor of neurology at Kings College London, UK and University of California, San Francisco. "This will change migraine treatment for those who don’t respond to conventional treatments.”

To participate in the study — the results were released ahead of the annual meeting of the American Academy of Neurology — adults ages 18 or over, had to report between four and 14 disabling episodic migraines, or 15 or more chronic migraines per month, and to have failed two or more preventative treatments, such as topiramate, propranolol, or amitriptyline.

Researchers found that the drug reduced the average number of monthly migraine headaches by more than 50 percent for nearly a third of study participants. After three months, patients treated with the human antibody were nearly three times more likely to have reduced their migraine days by 50 percent or more, than those treated with placebo.

They also had a greater average reduction in the number of days with headaches and the number of days they needed to take drugs to stop the migraines.

No patients taking erenumab stopped treatment due to adverse side effects, but the scientists noted that more research will needed to investigate if the benefits continue.

Malden, Massachusetts native Denise Desjardins, 58, with niece Madeline Salvitella suffered from migraine headaches for over 10 years, but found great relief after taking erenumab, a fully human monoclonal antibody drug that is showing great promise in migraine prevention. Denise Dejardins

Malden, Massachusetts native Denise Desjardins, 58, coped with migraine headaches for over 10 years, particularly around her menstrual cycle.

“I would land in bed for two to three days, four to five times a year,” said Desjardins. “These were in-your-bed, no-matter-what headaches.”

Her migraines became a daily misery after a bilateral mastectomy following a diagnosis of breast cancer. She was put on Imitrex, a popular migraine drug that helps to quiet overactive pain nerves in the brain, but it didn't help.

For about four years, Desjardins has been taking an erenumab injection once a month, without any side effects, as part of the study.

"I don't even think I get migraines anymore," said Desjardins.

The drug is expected to receive Food and Drug Administration approval on May 17. If approved, it could be available for prescription, and insurance coverage, later this year. The drug's cost has been estimated at $10,000 a year.

Because other migraine medications were not developed for headache, their side effects limited how well patients could tolerate them, said Kudrow.

"This class of drug is a real game changer," said Kudrow. "One, because it’s effective and two, the side effect profile is really favorable."

alkali112 on April 19th, 2018 at 05:34 UTC »

Former cluster headache sufferer here: I would consider this to be a potentially lifesaving treatment. When you’re having a headache fit, it’s like being tortured without knowing what your torturer wants from you, and suicide briefly seems very reasonable. I had immunotherapy for 3 years, and my doctor was skeptical that it would work at all. Surprisingly, it worked for me, and I no longer have cluster headaches at all. If this treatment is effective, it could save people from living in a state of constant fear that they will go into a fit.

Edit: typo

spicypanda97 on April 19th, 2018 at 05:25 UTC »

Really hoping my insurance covers this injection. My neurologist told me about it in December after she informed me I'm out of treatment options. I've had chronic migraines for over 20 years. I get Botox every 10 weeks, occipital nerve blocks every 4 weeks, I'm on Topomax and Effexor, and I take Imatrex and Sumavil to abort the migraine. Even so, I still have around 12 migraines a month with a trip to the ER about every 6 weeks. I recently started using medicinal marijuana and that has reduced the intensity of most of my migraines, which is good. I'm not suicidal anymore. Yay me. But even if my insurance doesn't cover it, I'd still like to thank the scientists who created this drug. It's going to help give people back their lives. The magnitude of that can't be overstated.

catullus48108 on April 19th, 2018 at 00:40 UTC »

Edit: The trial had two sections, both chronic and 4>x<15, which I missed, so I deleted my original comment and put some of my research here.

I have been following this for a while. Here is the research behind CGRP receptors and why they were targeted by the drug company

Basically the drug, Erenumab is a monoclonal antibody that inhibits the CGRP receptor which is a vasodilator. Research has shown an increased concentration of CGRP in people undergoing migraine attacks. This drug inhibits CGRP which, as the studies have shown, prevent a migraine from occurring roughly 50% of the time.

Sources: Clinical trial: ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. https://www.ncbi.nlm.nih.gov/pubmed/29471679

Original Trial: A Controlled Trial of Erenumab for Episodic Migraine. https://www.ncbi.nlm.nih.gov/pubmed/29171821

Vasoactive peptide release in the extracerebral circulation of humans during migraine headache. https://www.ncbi.nlm.nih.gov/pubmed/1699472

Neuronal signal substances as biomarkers of migraine. https://www.ncbi.nlm.nih.gov/pubmed/16866713

CGRP may play a causative role in migraine. https://www.ncbi.nlm.nih.gov/pubmed/11993614

Calcitonin gene-related peptide (CGRP) and migraine. https://www.ncbi.nlm.nih.gov/pubmed/16927957