{"id":16876,"date":"2018-07-03T10:05:19","date_gmt":"2018-07-03T16:05:19","guid":{"rendered":"https:\/\/www.uchealth.org\/today\/?p=16876"},"modified":"2023-05-15T15:36:11","modified_gmt":"2023-05-15T21:36:11","slug":"new-medication-aims-to-throw-a-block-on-migraine","status":"publish","type":"post","link":"https:\/\/www.uchealth.org\/today\/new-medication-aims-to-throw-a-block-on-migraine\/","title":{"rendered":"New medication aims to throw a block on migraine"},"content":{"rendered":"<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div><figure id=\"attachment_16879\" aria-describedby=\"caption-attachment-16879\" style=\"width: 640px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-16879 size-large\" src=\"https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2018\/07\/03100226\/EXT_061318_Kaitlyn-Key.jpgeee.webp\" alt=\"a photo of Kaitlyn, who suffers from migraines.\" width=\"640\" height=\"360\" srcset=\"https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2018\/07\/03100226\/EXT_061318_Kaitlyn-Key.jpgeee.webp 1200w, https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2018\/07\/03100226\/EXT_061318_Kaitlyn-Key.jpgeee-300x169.webp 300w, https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2018\/07\/03100226\/EXT_061318_Kaitlyn-Key.jpgeee-1024x576.webp 1024w, https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2018\/07\/03100226\/EXT_061318_Kaitlyn-Key.jpgeee-768x432.webp 768w, https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2018\/07\/03100226\/EXT_061318_Kaitlyn-Key.jpgeee-150x84.webp 150w, https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2018\/07\/03100226\/EXT_061318_Kaitlyn-Key.jpgeee-200x113.webp 200w\" sizes=\"auto, (max-width: 640px) 100vw, 640px\" \/><figcaption id=\"caption-attachment-16879\" class=\"wp-caption-text\">Kaitlyn, who suffers from chronic migraines, hopes a recently approved medication will help her enjoy more afternoons like this one near Cherry Creek State Park.<\/figcaption><\/figure>\n<p>Kaitlyn was 10 years old when she had her first migraine.<\/p>\n<p>At the time, she had no name for it. She only knew that the lights suddenly became too bright in the room in the church where her mother led a Girl Scout troop. Kaitlyn ran to the bathroom \u2013 also harshly lighted \u2013 and threw up. The experience was as mysterious as it was traumatic.<\/p>\n<p>\u201cI remember it clearly. I didn\u2019t understand what it was. We wrote it off as something weird,\u201d said Kaitlyn, who prefers not to use her last name.<\/p>\n<p>It wasn\u2019t long before Kaitlyn, now 29, and her parents couldn\u2019t write it off. She suffered through more episodes like the first one, and they became more frequent. After about a year and a half, she was struggling through the attacks more often than not. A pediatrician finally diagnosed the problem as migraine \u2013 a neurologic disease frequently misidentified as severe headache. <a id=\"\" href=\"https:\/\/americanmigrainefoundation.org\/living-with-migraine\/\" target=\"_blank\" rel=\"noopener\">It affects nearly 40 million people in the United States alone<\/a>; about 10 percent of those are chronic sufferers (at least 15 episodes a month).<\/p>\n<p>Kaitlyn had identified her childhood foe but finding the weapons to battle it proved elusive. Nearly two decades later, migraine remains a defining feature of her life. She hasn\u2019t worked in nearly a year and a half. Pain, fatigue, and cognitive difficulties are nearly constant, unwelcome companions. Because of migraine, Kaitlyn is frequently homebound, unable to get outside or hang out with friends.<\/p>\n<p>\u201cIt limits a lot of what is possible,\u201d she said.<\/p>\n<h3><strong>New option<\/strong><\/h3>\n<p>In May, Kaitlyn, and millions of other people who suffer from episodic (between four and 14 episodes a month) and chronic migraine received a note of hope. <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-novel-preventive-treatment-migraine\">The Food and Drug Administration approved Aimovig<\/a>, the first medication developed specifically for migraine prevention. It\u2019s a once-a-month treatment that patients self-administer through an autoinjector that looks like an EpiPen with the aim of preventing, rather than treating, migraine attacks.<\/p>\n<p>\u201cIt\u2019s a new option for patients,\u201d said <a href=\"https:\/\/www.uchealth.org\/provider\/marius-birlea-md-neurology\/\">Marius Birlea, MD<\/a>, a neurologist and medical director of the <a href=\"http:\/\/www.ucdenver.edu\/academics\/colleges\/medicalschool\/departments\/neurology\/clinical\/Pages\/Headache-Clinic.aspx\">Headache Clinic<\/a> at <a href=\"https:\/\/www.uchealth.org\/locations\/uchealth-university-of-colorado-hospital-uch\/\">UCHealth University of Colorado Hospital\u00a0on\u00a0the\u00a0Anschutz Medical\u00a0Campus.<\/a><\/p>\n<p>Aimovig targets the neuro pathway for calcitonin gene related peptide (CGRP), a protein specifically implicated in causing migraine. The pathway has been studied for over two decades, Birlea said. Early work used small molecules to successfully block the CGRP\u2019s receptor. However, the effort was shelved because the molecules caused liver damage. Aimovig skirts this issue with a monoclonal antibody \u2013 one designed to bind specifically to the CGRP receptor \u2013 that doesn\u2019t require clearance through the liver or kidneys, Birlea explained.<\/p>\n<figure id=\"attachment_16880\" aria-describedby=\"caption-attachment-16880\" style=\"width: 225px\" class=\"wp-caption alignleft\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-16880 size-medium\" src=\"https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2018\/07\/03100301\/EXT_061318_Marius-Birlea.jpgeee.webp\" alt=\"A photo of Dr. Marius Birlea\" width=\"225\" height=\"300\" srcset=\"https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2018\/07\/03100301\/EXT_061318_Marius-Birlea.jpgeee.webp 750w, https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2018\/07\/03100301\/EXT_061318_Marius-Birlea.jpgeee-225x300.webp 225w, https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2018\/07\/03100301\/EXT_061318_Marius-Birlea.jpgeee-113x150.webp 113w, https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2018\/07\/03100301\/EXT_061318_Marius-Birlea.jpgeee-200x267.webp 200w\" sizes=\"auto, (max-width: 225px) 100vw, 225px\" \/><figcaption id=\"caption-attachment-16880\" class=\"wp-caption-text\">Marius Birlea, MD, a neurologist and migraine specialist at UCHealth University of Colorado Hospital, holds the device that delivers a once-monthly dose of Aimovig, the first treatment approved by the FDA specifically to prevent migraines.<\/figcaption><\/figure>\n<p>Aimovig \u201cis not a panacea,\u201d Birlea emphasized, and it will not supplant an array of treatments he prescribes for migraine. But the clinical trial results were promising: for chronic sufferers, more than two fewer days of migraine a month versus a placebo. In a separate study of migraine patients who had not gotten relief from other treatments, those who received Aimovig were about twice as likely to see a 50 percent reduction in their migraine days as those who received a placebo. The drug was also free of side effects frequently produced by other migraine medications, such as fatigue, concentration problems and weight gain.<\/p>\n<p>The findings as a whole are significant, Birlea said. \u201cThe study showed that for patients who received Aimovig, migraines were less frequent and less disabling,\u201d he noted. \u201cAnd our goal with preventive treatment is to decrease the burden of migraine by at least 50 percent.\u201d<\/p>\n<h3><strong>Only a first step<\/strong><\/h3>\n<p>Aimovig\u2019s minimal side effects and the need to administer it just once a month should encourage patients to adhere to their treatment regimen, Birlea added. While there are no contraindications in the label, experts are looking for more data before determining if these medications will be offered to pregnant women, those who are breastfeeding or plan to, and people at high risk for cardiovascular disease and stroke, he said. As part of its approval, the <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/appletter\/2018\/761077Orig1s000ltr.pdf\">FDA also \u201crequested\u201d<\/a> that Amgen, the manufacturer of Aimovig, conduct \u201cpost-marketing surveillance\u201d of patients for these potential issues and for liver toxicity.<\/p>\n<p>\u201cThere are some unknowns about the potential side effects of Aimovig, although no concerning signals came out of studies involving about 2,500 subjects,\u201d Birlea said.<\/p>\n<p>As might be expected, the cost of the drug also generated discussion. Amgen listed it at $6,900 a year, or $575 a monthly dose. To begin, patients may receive their first two doses free, and Amgen announced a copay program that would allow some patients to pay as little as $5 a month for the medication. Birlea also pointed to a <a href=\"https:\/\/www.tandfonline.com\/doi\/full\/10.1080\/13696998.2018.1457533\">recent study<\/a> that argues that erenumab, the antibody in Aimovig that blocks the CGRP receptor, will reduce the direct and indirect costs of migraine while increasing the number of \u201cquality-adjusted life years,\u201d a measure of the cost-effectiveness of medical treatment.<\/p>\n<p>Birlea didn\u2019t participate in the erenumab (Aimovig) trials, but he\u2019ll be an active observer in evaluating its effectiveness going forward. One day after the FDA gave the go-ahead for writing Aimovig prescriptions in late May, Birlea said he\u2019d already written three \u2013 one of them for Kaitlyn. He estimated that the drug could benefit as many as 2,000 patients the Headache Clinic treats for migraine.<\/p>\n<p>\u201cWe see the most severe cases,\u201d Birlea said.<\/p>\n<h3><strong>Beyond neuro<\/strong><\/h3>\n<p>Aimovig offers promise for specialists outside of neurology. For example, <a href=\"https:\/\/www.uchealth.org\/provider\/rachael-rzasa-lynn-md-pain-medicine\/\">Rachael Rzasa Lynn, MD<\/a>, medical director of the <a href=\"https:\/\/www.uchealth.org\/locations\/uchealth-interventional-pain-management-anschutz\/\">Pain Management Clinic<\/a> at UCH, treats migraine sufferers with a variety of techniques, including Botox injections, nerve blocks and medications. She said she called Birlea after hearing news of the FDA approval to discuss adding Aimovig to her array of migraine treatment options.<\/p>\n<p>\u201cIt\u2019s not a magic bullet,\u201d Rzasa Lynn said, \u201cbut it\u2019s impressive how few major exclusions it has. It could be useful for a broad spectrum of patients.\u201d<\/p>\n<p>She emphasized that Botox is established as an effective, FDA-approved preventive treatment for chronic migraine, and she expects \u201cthe vast majority\u201d of patients will continue with it. \u201cBotox does a very good job of relieving the debilitating pain and vomiting that migraine causes while allowing people to stay fully functional. We\u2019ll see if Aimovig can do the same.\u201d<\/p>\n<p>If it does, Aimovig could be an important alternative to patients who haven\u2019t responded to Botox, Rzasa Lynn said. Others could find self-administering their treatment once a month with Aimovig preferable to Botox, which requires injections at 31 different sites in the face and neck every three months, she added.<\/p>\n<h3><strong>Migraine shuts down the show<\/strong><\/h3>\n<p>Kaitlyn\u2019s experience with migraine illuminates the excitement news of the Aimovig approval generated. The chronic migraines she endured through middle school and her early high school years gradually abated and were nearly gone by the time she entered NYU as a theater major. Other than a couple of episodes exacerbated by what she later learned was an allergy to triptans, a widely prescribed group of migraine medications, she was mostly migraine-free and worked steadily for several years, shuttling between Washington, D.C. and California as a stage and production manager for theater groups.<\/p>\n<p>In 2015, however, Kaitlyn began experiencing persistent pain she thought were sinus headaches. To get through long hours on both coasts, she took what she now acknowledges were excessive doses of over-the-counter medications. \u201cI tried to push through the pain,\u201d she said. \u201cIt was seven or eight months before I started taking it seriously.\u201d<\/p>\n<p>At that point she had no choice. While she was working in California that summer, Kaitlyn began passing out. Her hair fell out in chunks, and she battled a bout of hives. She encountered severe digestive problems. She chalked it up to stress and decided to find another job, but an otolaryngologist in the District who heard her history concluded that her migraines had returned and sent her to a neurologist. She spent three or four days in the hospital for rest and to cleanse her system of the over-the-counter medications that she now knows can cause migraines to rebound. She worked with neurologists in the District to find relief from the disease that so disrupted her life.<\/p>\n<figure id=\"attachment_16881\" aria-describedby=\"caption-attachment-16881\" style=\"width: 225px\" class=\"wp-caption alignright\"><img loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-16881\" src=\"https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2018\/07\/03100336\/EXT_061318_Aimovig-injection-site.jpgeee.webp\" alt=\"A photo of a doctor injecting Aimovig into the thigh of a patient.\" width=\"225\" height=\"300\" srcset=\"https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2018\/07\/03100336\/EXT_061318_Aimovig-injection-site.jpgeee.webp 750w, https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2018\/07\/03100336\/EXT_061318_Aimovig-injection-site.jpgeee-225x300.webp 225w, https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2018\/07\/03100336\/EXT_061318_Aimovig-injection-site.jpgeee-113x150.webp 113w, https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2018\/07\/03100336\/EXT_061318_Aimovig-injection-site.jpgeee-200x267.webp 200w\" sizes=\"auto, (max-width: 225px) 100vw, 225px\" \/><figcaption id=\"caption-attachment-16881\" class=\"wp-caption-text\">Birlea demonstrates how a patient would self-administer Aimovig.<\/figcaption><\/figure>\n<p>The ordeal, however, continues, and migraines are a nearly constant presence for her. \u201cI have good days and bad days,\u201d Kaitlyn said. Bad weather is a trigger, as is bright light, dehydration and fatigue. She describes the pain from her migraines as intense sinus pressure that starts deep in her ears and spreads.<\/p>\n<p>She wants people to understand that a migraine is not simply a severe headache. \u201cMigraines are a neurologic disorder; headaches are not,\u201d she said. \u201cFor the most part, people who have headaches have the ability to push it to the side and continue to do their work. A migraine for me is a true breakdown of my body. It\u2019s like the computer chips start to break down in my head.\u201d<\/p>\n<h3><strong>Search for relief<\/strong><\/h3>\n<p>Kaitlyn began seeing Birlea for her migraines after moving to Colorado with her boyfriend last November. She credits Birlea for a number of treatments that have improved her symptoms. They include tweaking her medications; prescribing an SPG (sphenopalatine ganglion) block, which delivers pain-numbing lidocaine to nerves implicated in migraine via nasal injections; and ordering two procedures that use her own blood to patch a cerebrospinal fluid leak that may exacerbate her migraine symptoms.<\/p>\n<p>The first of those procedures produced two weeks of pain-free mornings, Kaitlyn said, something she hadn\u2019t experienced in more than two years. The second was less successful, but it still helped to keep her more functional during the day.<\/p>\n<p>\u201cI\u2019d seen multiple neurologists and none of them considered a cerebrospinal fluid leak,\u201d she said.<\/p>\n<p>Birlea also keeps Kaitlyn\u2019s prescribed mix of medications in the Epic electronic health record, allowing her to get relief from a severe attack quickly by visiting the Infusion Center at UCH. Without that option in the District, her migraine attacks forced her to the emergency department, where she often sat for hours under bright fluorescent lights before getting medications of \u201cwhatever they had on hand.\u201d<\/p>\n<p>\u201cI can also talk to Dr. Birlea about changing my medications when something isn\u2019t working as well as I\u2019d like,\u201d Kaitlyn said. \u201cThe back-and-forth is incredible. The last six months of treatment I\u2019ve gotten more care and options than I\u2019ve gotten the past three years.\u201d<\/p>\n<p>As for Aimovig, Kaitlyn was well aware of the trials and was elated when she heard of its approval. \u201cI\u2019ve had my eye on it, she said. \u201cI\u2019m pretty excited about it.\u201d Her treatment goals are basic: more opportunities to get outside to camp and hike, travel, meet with friends and, most of all, work.<\/p>\n<p>\u201cI tied my identity to being able to work,\u201d she said. \u201cNot being able to work removes a lot of feelings of self-worth in my life.\u201d<\/p>\n<p>Birlea sees the Aimovig approval as an important first step in expanding the range of migraine treatments for both providers and patients. He anticipates more options coming online soon. Three other preventive treatments that block CGRP itself, rather than the receptor, have been developed, he noted.<\/p>\n<p>\u201cIt\u2019s extremely exciting,\u201d he said. \u201cWe will be able to develop guidelines for how to choose these medications for patients and how to use them in combinations.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Kaitlyn was 10 years old when she had her first migraine. At the time, she had no name for it. She only knew that the lights suddenly became too bright in the room in the church where her mother led a Girl Scout troop. Kaitlyn ran to the bathroom \u2013 also harshly lighted \u2013 and [&hellip;]<\/p>\n","protected":false},"author":2143,"featured_media":16879,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[5],"tags":[184],"class_list":["post-16876","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-innovative-care","tag-neurology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.7 (Yoast SEO v27.7) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>New medication aims to throw a block on migraine - 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