If you are looking for a way to prevent migraine attacks, you've probably heard of Aimovig. Aimovig (erenumab) was the first of the anti-CGRP drugs for migraine approved by the U.S. Food and Drug Administration (FDA). In addition to Aimovig, the current anti-CGRP drugs available for the prevention of migraine attacks include fremanezumab (Ajovy), galcanezumab (Emgality), rimegepant (Nurtec), and eptinezumab-jjmr (Vyepti).
It can be tricky to figure out what migraine treatment may be best for you. Knowing the right questions to ask your healthcare provider before starting a new medication can help.
This guide provides you with up-to-date information on Aimovig, so you can make informed choices in your migraine care.
1 - Aimovig Is Proven to Prevent Migraine
FDA approves novel preventive treatment for migraine. (2018, May 17).
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In trials, Aimovig showed a significant decrease in migraine days compared to placebo in patients with both chronic (15 or more migraine days per month) and episodic (4-14 migraine days per month) migraine. This is the kind of news that offers hope to people who have been unresponsive to other preventive treatments.
Three key studies compared Aimovig to placebo. Two looked at episodic migraine and one evaluated chronic migraine.
Aimovig for Episodic Migraine
- The STRIVE study for episodic migraine showed that when compared to placebo, Aimovig reduced monthly migraine days by one to two days, on average, over a 6-month study period
- (-3.2 and -3.7 days with 70-mg and 140-mg of Aimovig, respectively, vs. -1.8 days for placebo).Migraine Again Verified SourceView Source
Goadsby, P., Reuter, O., Hallström, Y et al. (2017, November 30). A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med 2017; 377:2123-2132. DOI: 10.1056/NEJMoa1705848.
- (-3.2 and -3.7 days with 70-mg and 140-mg of Aimovig, respectively, vs. -1.8 days for placebo)
- The ARISE study for episodic migraine showed a decrease of one migraine day per month, on average, when compared to placebo over a period of 3 months
- (-2.9 days vs. -1.8 for placebo).Migraine Again Verified SourceView Source
Dodick, D. W., Ashina, M., Brandes, J. L., Kudrow, D., Lanteri-Minet, M., Osipova, V., … Lenz, R. A. (2018). ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia, 38(6), 1026–1037.
- (-2.9 days vs. -1.8 for placebo)
Aimovig for Chronic Migraine
- Aimovig vs. placebo in those with chronic migraine showed an average decrease of 2.5 monthly migraine days
- (-6.6 days vs. -4.2 for placebo)Migraine Again Verified SourceView Source
Aimovig: Highlights of Prescribing Information. (2019, March).
.Migraine Again Verified SourceView SourceStewart Tepper, Messoud Ashina, Uwe Reuter,et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. The Lancet Neurology, Volume 16, Issue 6. 2017: Pages 425-434.
- (-6.6 days vs. -4.2 for placebo)
Goadsby, P., Reuter, O., Hallström, Y et al. (2017, November 30). A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med 2017; 377:2123-2132. DOI: 10.1056/NEJMoa1705848
What did physicians and patients say about trying Aimovig?
However, these results improved with continued treatment over time, and many patients reported decreases in average migraine days by the sixth month. This indicates that it may take time before some people experience the full benefit.
We asked Dr. Rebecca Burch, Assistant Professor at Harvard Medical School and headache specialist at Brigham and Women's Hospital to tell us about her patients' experiences. "We are seeing that Aimovig is effective in most of our patients who try it. Early results from our clinic's survey of patients who used Aimovig show that around 60-65% of patients experienced at least some benefit," she said.
"What's particularly impressive about this finding is that we are mostly prescribing Aimovig to patients who have tried and failed a number of other treatments. There are several unanswered questions, however, including whether this treatment response will be sustained over time," said Dr. Burch. "We are seeing some patients for whom the benefit wears off, so we'll have to study efficacy again after a period of time."
Dr. Christopher Gottschalk, Director of Yale Headache Medicine and Chief of General Neurology, has seen "a full range of responses, from phenomenal to no change, but clearly, the majority of patients benefit. I have seen people stop all other medications as a result, people improve who had little to no relief from anything else, and others who are finally functional as a result of adding one of these to prior treatments," he told us.
A five-year open-label study showed that about 70% of the people participating said that Aimovig was still effective in reducing their monthly migraine days and need for acute treatments. Since so many people with migraine disease have struggled with preventive treatments wearing off after a few months, this is good news.
2 - Fewer Migraine Days Means Less 'Anticipatory Anxiety' and Better Quality of Life
DiGrande, S. Patient-Reported Outcomes Trial Concludes Erenumab Improves QOL, Disability. (2019, May 21). Patient-Reported Outcomes Trial Concludes Erenumab Improves QOL, Disability.
"This finding isn't surprising," says Dr. Burch. "Pain is not the only driver of decreased quality of life in patients with migraine, so just knowing that something can help is often a big driver of improved quality of life in our patients with refractory migraine. We also see a decrease in anticipatory anxiety when the headache frequency goes down, which then improves the quality of life between attacks."
"I don't think we are seeing an effect from Aimovig that's different from what we see with other effective treatments, however," said Dr. Burch. "Lots of patients report similar quality of life benefits from onabotulinum toxin (Botox) treatment. This finding is very likely related to the efficacy of treatment, not which specific treatment is being studied."
With that, Dr. Gottschalk explains, "Some of the most remarkable responses are in the category of 'sensorium,' people who say almost immediately, 'it's like the fog has lifted!' Many are saying, 'I can finally think about going back to work or school'."
3 - Aimovig Stops Migraine Attacks by Blocking CGRP
FDA approves novel preventive treatment for migraine. (2018, May 17).
What is CGRP?
During a migraine attack, the trigeminal nerves in the face and head are abnormally activated, causing the release of peptides like substance P and CGRP.
Durham P. L. (2006). Calcitonin gene-related peptide (CGRP) and migraine. Headache, 46 Suppl 1(Suppl 1), S3–S8.
4 - Aimovig Isn't Right for Everyone
While you may be eager to start Aimovig to prevent migraine attacks, it is not recommended for everyone who has migraine.
Aimovig is recommended for:
- Adults (18 years and older) with...
- episodic or chronic migraine who...
- Have tried and did not respond to first-line treatments
Aimovig: Highlights of Prescribing Information. (2019, March).
Avoid using Aimovig:
- Children
- Pregnant or breastfeeding women
- Women or men planning to conceive
- Hypersensitivity to erenumab or its ingredients (acetate, polysorbate 80, sucrose)
Proceed with caution if:
- History of allergies to latex
- Over the age of 65
Aimovig: Highlights of Prescribing Information. (2019, March).
Aimovig is considered after trying other first-line treatments
"Aimovig is a new treatment, and there are still many unanswered questions about safety," explains Dr. Burch. "Given this, we are offering Aimovig to patients who have failed or who have contraindications to three other preventive treatments. We usually try oral preventives with high levels of evidence for efficacy in the preventive treatment guidelines. Amitriptyline, topiramate, and propranolol are often used as first-line treatments. These criteria are also what we typically use when we consider onabotulinum toxin (Botox) in patients with chronic migraine. Aimovig wasn't studied in children, or in older adults, so we use more caution in those populations."
The American Headache Society Position Statement On Integrating New Migraine Treatments Into Clinical Practice. (2018, December 10). Headache.59(1), 1-18.
Talk with your healthcare provider to determine if it's a good fit for you.
5 - Aimovig Has Side Effects
Overall, Aimovig's low side effect profile is part of its appeal to people with migraine who have suffered through trials of many preventative medications including beta-blockers, anticonvulsants, and antidepressants. But after more than two years on the U.S. market, there are reports of a small number of patients who had more severe side effects.
For most people who try Aimovig, the commonly reported side effects tend to be mild to moderate, most commonly injection site reactions (pain, swelling, or redness). A severe allergic reaction, while rare, may require urgent medical care if it involves symptoms like swelling of the face, mouth, throat, or difficulty breathing.
Constipation was another side effect reported in the Aimovig trials, although this occurred infrequently (up to 3%) and was typically mild. With real-world use of Aimovig, the rates of constipation have been much higher; in some studies, up to 20% of patients report constipation. And there have been some cases of more severe constipation, even requiring hospitalization and surgery. This has prompted the FDA to update the warnings and precautions label of Aimovig to reflect the risk of more severe constipation.
In January 2021, experts published an analysis of 61 cases of severe hypertension in people who used Aimovig. Of 61 hypertension cases reported to the FDA Adverse Events Reporting System (FAERS), 41 cases reported "serious outcomes," including some hospitalizations (but no deaths). Some of the people had high blood pressure before starting treatment with Aimovig, but others did not. About half of the people had this adverse effect within a week of taking their first dose of Aimovig.
Although this side effect appears to be rare, it is now listed in the Warnings and Precautions section of the prescribing and patient information for Aimovig. We don't know yet if this is a possible side effect for the other CGRP monoclonal antibody treatments. The good news is that migraine experts are aware of this news and can help patients like us make better decisions about treatment options.
Dr. Andrew Charles, Director of Headache Research and Treatment and Professor of Neurology at the David Geffen School of Medicine at UCLA, states, "The bottom line is that the evidence regarding the vascular safety of the treatments targeting CGRP is very reassuring. But given what we know about how CGRP works in the body, we need to continue to be cautious, consider the risks and benefits of the treatments for individual patients on a case by case basis, and be vigilant about monitoring for any adverse effects as our experience with these treatments continues (we hope) to increase our confidence that they are safe in those with existing vascular disease."
Aimovig's makers, Amgen and Novartis, said about the updated information: On April 30, 2020, the FDA approved a revision to the Aimovig® U.S. PI Warnings and Precautions section to include new language on hypertension. Amgen and Novartis are confident in the safety profile and patient benefit of Aimovig®, the first FDA-approved preventive migraine treatment that targets the calcitonin gene-related peptide (CGRP) receptor. The extensive clinical database for Aimovig® includes long-term data up to 5 years for episodic migraine and the largest exposure from real-world experience. Clinical study results have established the efficacy and safety profile of Aimovig across a spectrum of people living with both episodic and chronic migraine.
Another potential side effect to be aware of is Raynaud's syndrome, a condition in which parts of your body (often fingers and toes) can get cold and numb easily in cold weather or stressful situations. Raynaud's makes the blood vessels spasm, making you more susceptible to numbness, pain, or even frostbite. Because CGRP helps blood vessels open wide, blocking CGRP can trigger or worsen Raynaud's syndrome.
Aimovig may even worsen headache. "One side effect I haven't seen described well elsewhere is a severe worsening of headache. Our clinic has seen at least five cases of patients whose migraines get much, much worse after using Aimovig, even provoking status migrainosus," Dr. Burch said.
For some people, Aimovig may cause the body's immune system to react to the medication. In this case, the body will see Aimovig as an invader, similar to a bacteria or virus, and create a protein called an antibody to fight back. Although only around 6% of those receiving the 70 mg dose and almost 3% of those receiving the 140 mg dose, developed antibodies to the drug, the long-term antibody development risk is unclear at this point. It is also not well understood whether the presence of these antibodies is actually clinically significant. It's possible that even if someone has these antibodies, Aimovig may still be effective for migraine.
Real-world experience with Aimovig has certainly revealed new side effects that did not show up in the original clinical trials. And overall, people seem to be reporting side effects from Aimovig at higher rates compared to the trials. "Our clinic survey, which included all patients who had taken Aimovig and had a 70% response rate, found that around 60% of patients reported at least one side effect," said Dr. Burch. "The majority of our patients who had been prescribed Aimovig ended up feeling that the benefits outweighed the side effects, but our experience has been that the side effect burden is much higher than seen in the clinical trials."
6 - Aimovig Doesn't Interact with Other Medications
Many drugs are processed or metabolized in the liver or kidneys, but not Aimovig.
Why is this important?
The American Headache Society Position Statement On Integrating New Migraine Treatments Into Clinical Practice. (2018, December 10). Headache.59(1), 1-18.
Despite this, it is always important to talk about any medications or supplements you are taking with your healthcare provider and pharmacist.
7 - Two Doses (70mg and 140mg) are Available
Aimovig is currently available in two prescription doses, 70 mg or 140 mg syringes. While the trials did not show significant differences between the two doses, certain patients may do better with the lower or higher dose as determined by their doctor.
The American Headache Society Position Statement On Integrating New Migraine Treatments Into Clinical Practice. (2018, December 10). Headache.59(1), 1-18.
The American Headache Society Position Statement On Integrating New Migraine Treatments Into Clinical Practice. (2018, December 10). Headache.59(1), 1-18.
8 - We Still Don't Know Everything About Blocking CGRP
The American Headache Society Position Statement On Integrating New Migraine Treatments Into Clinical Practice. (2018, December 10). Headache.59(1), 1-18.
When asked if patients will have to take Aimovig forever, Dr. Gottschalk said, "Probably not. I have enough experience that says once someone is doing very well for a long time (a year or two)—once they are stably desensitized—they can stop or reduce preventive therapy."
Dr. Burch further explains, "When a preventive treatment is effective, it's always hard to know what's happening to the underlying headache disease. If a patient is truly headache-free for a period of 3 to 6 months, it's reasonable to try stretching out the time between Aimovig injections and see if the migraine pattern remains quiescent."
9 - Aimovig Is Available by Prescription in a Handful of Countries
Access varies and depends on insurance or agency coverage (see below).
In March of 2021, the United Kingdom's National Institute of Health and Care Excellence (NICE) reversed an earlier decision not to cover Aimovig since it was still in early use and ruled that erenumab is recommended for preventing migraine in adults who have at least 4 migraine days per month, and its cost-effectiveness estimates are within what NICE usually considers an acceptable use of National Health Service resources.
10 - Aimovig Can Be Expensive, but It's Often Covered by Insurance
Like with many drugs, consumers rarely see the true price tag. Instead, we tend to think of the cost as what we pay out of pocket for a co-pay at the pharmacy.
Ducharme, J. A Year After Approval, Migraine Drugs Are Changing Lives. But Insurance Battles Are Creating a Whole New Headache. (2019, June 24).
If your insurance plan does not cover Aimovig, you have the option of filing an appeal, also known as a formulary exemption. If your appeal is granted, your insurance provider will cover a portion of the cost.
It's worth reading the fine print for your plan, however. Some plans cover only 50% of the total cost until you meet your deductible, which still leaves you on the hook for ~$300 per month for Aimovig. Check out the Patient Advocate Foundation for helpful info on filing formulary exemptions.
Amgen, the manufacturer of Aimovig, offers programs to offset the cost of the medication. For more information on the programs available, visit the official Aimovig website.
11 - New Treatments Are More Difficult to Get
Due to issues with insurance approvals, the need for step therapy, and the potentially high out-of-pocket costs, access to Aimovig may be limited.
"Aimovig is still quite an expensive treatment," explained Dr. Burch. "Some patients with insurance coverage still have high copays. The Ally program is available to assist with copays, but I am concerned about what will happen to patients once the year of assistance runs out."
Mississippians Struggle for Medication Access, Again. (2019, July 2).
12 – There are Other CGRP Treatment Options Available – or Coming Soon
If Aimovig doesn't work, does it mean you're a lost cause? Hardly. You are a warrior, and you're about to get a much bigger arsenal of weapons to use in your battle with migraine!
Just because one treatment is not effective, that does not mean another may not work. If Aimovig does not work as you had hoped in preventing migraine, there are other anti-CGRPs that are available by prescription. Ajovy, Emgality, Nurtec and Vyepti have all been proven effective in migraine prevention.
These drugs work a little differently from Aimovig. While Aimovig works by blocking the CGRP receptor, Ajovy, Emgality, and Vyepti block the actual CGRP molecule. Ajovy and Emgality come in auto-injectors that you can use at home. To use Vyepti, you have to see your clinician for an IV infusion once every three months.
There are also new kinds of acute medications for you to try. Gepants are small-molecule medications that work on CGRP, like Aimovig. They're designed to take for migraine attacks. Ubrelvy and Nurtec are available by prescription now, and they are taken by mouth. On May 27, 2021, Nurtec ODT became the first oral CGRP antagonist approved by the FDA for both the preventive and acute treatment of migraine.
13 – Aimovig is One of Many Treatments for Migraine Prevention
There is no one-size-fits-all migraine treatment. Other commonly used medications for migraine prevention include onabotulinumtoxinA (Botox) and topiramate (Topamax).
How Aimovig Compares to Other Migraine Treatments
Uwe R, Ehrlich M, Gendolla A, et al. Erenumab versus topiramate for the prevention of migraine - a randomised, double-blind, active-controlled phase 4 trial. Cephalalgia. November 2021
However, most healthcare providers and insurance companies want patients to try topiramate and other first-line drugs such as nortriptyline before the newer medications. These first-line prevention meds are less costly than Aimovig. Accessing Aimovig – and any treatment – may require a fight with insurance. Insurance providers are less likely to include brand-name treatments like Aimovig on their formularies.
Compared to Botox, Aimovig is similar in price. Both Botox and Aimovig are second-line treatments, meaning your doctor will probably only recommend them after you have tried something else first. Botox and Aimovig may be safely used at the same time, but insurance companies are reluctant to pay for both. Many people with migraine are being forced to choose between Botox or Aimovig.
In addition to new medications, there are devices worth considering to help migraine pain like Nerivio, Cefaly, Gammacore, and SpringTMS (This device is currently not available, but the company hopes it will be back on the market soon.) as well as natural migraine remedies to help manage symptoms.
Final Thoughts
If you are considering Aimovig to prevent migraine, having accurate, up-to-date information on the medication is key. Approaching your healthcare provider armed with information is powerful and will help you and your team decide how to best approach treatment.
Aimovig isn't right for everyone but it may be right for you or a loved one with migraine. No matter what course of treatment you choose, there is hope.
With this knowledge comes the power to find treatment options that will help give you the relief to live your life to its fullest.
Dr. Gottschalk disclosed that he serves as an advisor to and speaker for Amgen/Novartis, maker of Aimovig. He also consults with Lilly, the maker of Emgality, and companies making other treatments mentioned in this article.
Dr. Burch has no relevant disclosures.
