Managing Migraine Headaches: Aimovig & Ubrevly are Changing the Game!
by Sharon Reynolds and Dr. C.H. Weaver M.Dl updated 11/2020
Living with migraine means managing lifestyle and symptoms every day. A whole person approach is necessary for optimal migraine management and the approvals of Aimovig and Ubrevly augment this strategy by providing new options for the prevention and treatment of migraines respectively. (3,4)
Susan McDermott has lived with migraine, a complex neurologic disorder, since her late thirties, after the birth of her second daughter. “When my kids were little, I had headaches and other symptoms that were really debilitating,” she says. “My parents or my sister would have to come watch the kids during the day, and my husband would take care of them in the evenings. I couldn’t do anything; I would just go lie down in a dark room and try to sleep, which seemed impossible.”
Now 54, Susan, a reading specialist in the Chicago area, experiences at least two episodes of migraine each month, which can each last two to three days; in addition to these acute episodes, she has more-minor symptoms most days: “I have some kind of headache over half the days of the month. I’m constantly evaluating how to manage them, engaging in an ongoing conversation with myself about what medication to take, what lifestyle factors I should moderate, and wondering if the headache I have at the moment will spiral out of control.”
Susan is one of 28 million American women who, according to the Migraine Research Foundation, live with migraine, a neurologic syndrome or collection of symptoms that can include a throbbing headache, blurred vision, nausea, and sensitivity to light, sound, and smell.
Getting good care is essential for women living with migraine. The path to effective treatment begins with understanding migraine; empowering yourself with information about the disorder and seeking expert, whole-person care can help you manage migraine and enjoy the best quality of life.
What Causes Migraine?
On the most basic level, migraine is a reaction to stimulation that the brain perceives as a potential threat and which activates a protective response. The “triggers” that evoke the brain’s response might be environmental—like light, sound, or smell—or internal, like hormonal shifts (rising and dropping around menstruation and ovulation) or internalized stress.
People who experience migraine are more sensitive to these changes; whether they are because of a genetic mutation or other causes is still the subject of research. “There are several genes that we know are connected to migraine, but we haven’t discovered the most common—that’s an area for future discovery,” says Soma Sahai-Srivastava, MD, an associate professor of neurology at the Keck School of Medicine of the University of Southern California (USC) and the director of the USC Headache and Neuralgia Center at Keck Medicine of USC.
When the protective response is initiated, in the brain stem, “the migraine generator flips on,” says Dr. Sahai-Srivastava, “which communicates directly to the fifth nerve, also referred to as the migraine nerve, which is basically the freeway of pain on the face and head. Once this is flipped on, it spills toxic, inflammatory chemicals on the roadmap of the brain. Then the blood vessels start acting out, which produces throbbing; it’s like an orchestra on the surface of the brain.”
The pain that follows, or the headache stage of a migraine, can be accompanied by other symptoms, such as nausea, dizziness, confusion, neck and sinus pain, and gastrointestinal issues. “It’s not just a headache,” says Merle Diamond, MD, president and managing director of the Diamond Headache Clinic in Chicago and a board member of the National Headache Foundation. “It’s a disabling neurologic disorder, and each person will experience it differently.”
For some the headache stage follows two earlier stages of a migraine episode: the prodrome, which can include physical changes like fatigue or excitability, yawning, frequent urination, and mood changes, and aura, a sensory response that can include visual changes (pulsing, waving light, or blind spots are common) and tingling and numbness. About 15 to 20 percent of migraneurs experience aura, according to the National Headache Foundation. (1) The headache stage of a migraine episode may then be followed by a stage of “migraine hangover,” called postdrome, during which some pain, sensitivity, and nausea might remain.
Getting an Accurate Diagnosis: Headache or Migraine—What’s the Difference?
“One in four Americans has migraine,” says Dr. Sahai-Srivastava, “but less than half of those who have it even know that they have migraine.” Often migraine is misdiagnosed as a sinus headache or a tension headache, she notes.
The International Headache Society has developed diagnostic criteria for three different types of migraine, updated most recently in 2013: migraine with aura, migraine without aura, and chronic migraine. (2) For women living with symptoms that they think may be those of migraine, it’s important to get an accurate diagnosis, which can lead to effective clinical care and lifestyle modification to help mitigate symptoms and improve quality of life.
“Migraine is actually a very simple diagnosis,” says Dr. Sahai-Srivastava. While the official criteria developed by the International Headache Society for migraine with aura include five criteria (available at ichd-3.org), she notes that a patient need meet only two of those criteria to be diagnosed with migraine. In fact, migraine can be as basic as “moderate headaches that keep you from participating in even the pleasurable activities of daily life,” she adds. “These are disabling headaches that make life miserable.”
Dr. Diamond says that this disruptive aspect of migraine is key in making a diagnosis. “Migraine is a time robber: it robs people of the ability to make plans, to be counted on, to know consistently what their day might look like because they are always considering the potential disruption from migraine.”
While migraine can be diagnosed and treated by primary care physicians and other clinicians, women seeking care should be aware that there is a board-certified specialty in headache medicine. “A headache specialist spends a year after their residency (generally in neurology) working with doctors who see only [patients with] headaches or nerve pain, allowing for the development of empathy, expertise, and a unique understanding of the stigma and disability of migraine,” Dr. Sahai-Srivastava says.
Whether you see a headache specialist or another provider, establishing a diagnosis will involve extensive discussion of the patterns and symptoms of your unique migraine experience, as well as of your lifestyle, to establish triggers and develop the best plan of care. Often your physician will have you record information about your migraine experiences ahead of your appointment, which might include keeping a headache diary to track your symptoms and identify triggers. “If you don’t understand where your headaches are coming from and why you’re having them, you won’t be able to make effective changes. Knowledge is power.”
Whole-Person Care for Migraine
Once a diagnosis of migraine has been made, a treatment plan can be developed that can include lifestyle modifications to reduce potential triggers, medication to manage acute attacks, and, if necessary, preventive medications to reduce the number of attacks. Patients may also take anti-nausea medications and many find relief through complementary therapies such as acupuncture.
“Treating migraine is a challenge because it involves not only triggers that are easy to control, like different foods and hydration, but also other, internal triggers (stress, pulse rate) and external triggers (light, sound, pacing),” says Dr. Sahai-Srivastava. Ultimately, she says, effective treatment means really taking time to get to know the patient—to understand her lifestyle and personality. From there an integrated plan can be developed to address all the aspects of a patient’s life and symptoms, which might include implementing healthy-living strategies and working with a variety of providers, from physical therapists to pain specialists to complementary therapy practitioners.
When Susan McDermott sought care with a headache specialist at the Diamond Clinic, she initially wanted to try to treat her migraine symptoms through lifestyle modification alone, focusing on avoiding triggers and being vigilant about diet and hydration. “I really didn’t want to go to prescription medicines at first; I worried about side effects,” she says. When symptoms continued to disrupt her life, however, she decided to try medication. “My doctor was really supportive of my desire to try everything else first, but during a really bad string of headaches, she said, ‘You know, there are medicines that can help you.’”
Susan decided to start taking prescription medication. Since that time she has been taking a preventive medication (in her case, a beta blocker) and also using a triptan via injection when she has a migraine. If she has an especially bad string of headaches, she will use a backup NSAID (nonsteroidal anti-inflammatory drug) or, occasionally, take a five-day course of steroids. (For description of common migraine medications, see sidebar “Migraine Medication 101.”) Though Susan wasn’t eager to take medications, she says she trusts her doctor’s advice and feels grateful for the relief the drugs have provided: “The fact that they help me live a normal life makes me feel I made the right choice; now when I feel a migraine coming on, I have a way to deal with it. It doesn’t interrupt my life like it did 15 years ago.”
Working with your physician to develop a plan that takes your unique experience with migraine into account is essential. “Each person needs an individual approach,” says Dr. Sahai-Srivastava. “To treat your headache, I have to understand you.”
Living with Migraine
For Susan living with migraine is a constant process of evaluating symptoms, managing the lifestyle factors that she can control, and striving to embrace any period of respite. “I feel truly grateful when I feel well. I try to really appreciate those days,” she says.
For other women living with migraine, Susan encourages self-care—get sleep, exercise regularly, eat well, and try to avoid stress—and seeking treatment from a headache specialist. “If your headaches are in any way frequent, seeing a specialist, someone who treats only headaches and has empathy for what you’re going through, can make a big difference.”
Migraine Medication 101
FDA Approves Aimovig, A Novel Preventive Treatment for Migraine Headaches
According to Dr. Jessica Ailani, MD, associate professor of neurology at MedStar’s Georgetown University Hospital and director of the MedStar Georgetown Headache Center, migraines affect over 36 million people in the U.S. yet they are still a poorly recognized and under-diagnosed disease. In 2018, the number of migraine-specific treatments available in the US will double compared to what was available 2 decades ago.
The U.S. Food and Drug Administration has now approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks. According to Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research “We need new treatments for this painful and often debilitating condition, and Aimovig provides patients with a novel option for reducing the number of days with migraine.”
The effectiveness of Aimovig for the preventive treatment of migraine was evaluated in three clinical trials. The first study included 955 participants with a history of episodic migraine. Over the course of six months Aimovig-treated patients experienced, on average, one to two fewer monthly migraine days than those on placebo. The second study included 577 patients with a history of episodic migraine and compared Aimovig to placebo. Over the course of three months, Aimovig-treated patients experienced, on average, one fewer migraine day per month than those on placebo. The third study evaluated 667 patients with a history of chronic migraine and compared Aimovig to placebo. In that study, over the course of three months, patients treated with Aimovig experienced, on average, 2 ½ fewer monthly migraine days than those receiving placebo.
Aimovig Compared to Trokendi in Head-to-Head Migraine Prevention Study
The HER-MES directly compared Aimovig to Trokendi (topiramate) in 777 adult patients with episodic and chronic migraine suffering from at least 4 migraine days/month and who were naïve to, not suitable for, or had previously failed up to 3 prophylactic treatments. Patients were treated for 24 weeks then evaluated.
The study showed a higher proportion of patients remained on treatment with Aimovig compared with topiramate, demonstrating superior tolerability. Additionally, a greater proportion of erenumab-treated patients achieved at least a 50% reduction in monthly migraine days vs those who received topiramate. (5)
Overall Aimovig was very well tolerated and the most common side effects that patients in the clinical trials reported were injection site reactions and constipation.
Acute medications are taken once symptoms of a migraine present and these drugs, also referred to as abortive medications. They can sometimes stop the migraine in its tracks or at least shorten its duration. “Currently, we’re treating migraine most commonly with triptans—drugs developed 20 to 25 years ago—which weren’t even developed to treat migraine. Ubrevly is the first new drugs to target the inflammation that takes place; they will be a game-changer for patients.”
Ubrevly™ Approved for the Acute Treatment of Migraine with or without Aura in Adults
The U.S. Food and Drug Administration (FDA) approved Ubrelvy™ (ubrogepant) for the treatment of migraine headaches with or without aura in adults in December 2019. Migraine suffers have needed an on-demand oral relief for a very long time to better manage their migraine attacks. With just one dose, Ubrelvy™ can quickly eliminate patients' migraine pain and their most bothersome migraine symptoms. (4)
UBRELVY™ (ubrogepant) is a novel, highly potent, orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) approved for the acute treatment of migraine headaches with or without aura in adults. It works in a new way by blocking CGRP, a protein released during a migraine attack, from binding to its receptors. It works without constricting blood vessels, which some older treatments are known to do. CGRP receptor antagonism is a completely new mechanism of action for the treatment of migraines. The most common side effects reported were nausea, tiredness and dry mouth. Ubrelvy is contraindicated for co-administration with strong CYP3A4 inhibitors.
According to the National Headache Foundation common acute or abortive medications include the following:(3)
- Ergot based: Cafergot (caffeine and ergotamine)
- Phenothiazines/nausea medications: Motilium™(domperidone), prochlorperazine, and Reglan®(metoclopramide)
- Dihydroergotamines: DHE-45® and Migranal®
- Anti-inflammatories: aspirin, ibuprofen, naproxen sodium, and meclofenamate
- Analgesic combinations: Excedrin® Migraine (acetaminophen, aspirin, and caffeine) and Midrin®(acetaminophen, dichloralphenazone, and isometheptene)
- Triptans: Amerge® (naratriptan), Maxalt® (rizatriptan). Imitrex® (sumatriptan), Zomig® (zolmitriptan), Axert®(almotriptan), Frova® (frovatriptan), and Relpax® (eletriptan)
Other Preventive medications are taken daily, with the goal of reducing the number of episodes a patient has each month. According to the National Headache Foundation,1 most preventive medications prescribed today for migraine were initially developed to treat other conditions, including seizures, depression, and hypertension. Common preventive medications include the following:
- Anti-epileptic (anticonvulsant) medications
- Beta blockers
- Calcium channel blockers
In the Pipeline
Dr. Sahai-Srivastava says that in addition to CGRP, migraine patients will continue to benefit from nonpharmacologic innovation, specifically in the realm of devices. Handheld single-pulse transcranial magnetic stimulation (sTMS) devices, which deliver magnetic pulses to the brain, have shown promise in relieving pain in patients with migraine with aura, and other devices, both surgical and noninvasive, are being studied. “We’re doing a cluster headache trial now, where a surgeon puts a little device like a hairpin into a ganglion nerve, which stops cluster pain,” she says. “I think we’ll see a lot of innovation in the field of neurostimulation devices moving forward.”
- National Headache Foundation, headaches.org
- Migraine Research Foundation, migraineresearchfoundation.org
- American Headache Society, americanheadachesociety.org
- Headache FAQ. National Headache Foundation website. Available at: headaches.org/headache-faq/. Accessed November 12, 2016.
- IHS Classification ICHD-3 Beta. International Headache Society website. Available here. Accessed November 12, 2016.
- Abortive Drugs for Migraine. National Headache Foundation website. Available here.
- FDA approves new treatment for adults with migraine
- Novartis announces positive results from a Phase IV study showing superior tolerability and efficacy of Aimovig® (erenumab) compared with topiramate in migraine prevention. [press release]. Basel, Switzerland: Novartis; November 2, 2020.