Teshamae Monteith, MD, associate professor of clinical neurology and chief of the headache division at the University of Miami Miller School of Medicine, talks about new therapies and treatments for migraines.
Doctor Monteith, how many people in the U.S. suffer from migraines?
Dr. Monteith: Migraines by epidemiological studies, is about 12% percent of the population. It’s very common in people that are in their most productive years of life so 20s, 30s, 40s. It could be up to one-third of women that are suffering from migraines. It’s one of the leading causes of disability worldwide.
Worldwide?
Dr. Monteith: Yes, the biggest problem with migraines is– well, there are multiple problems with migraines, but one of the problems is that people don’t always know that they have migraines. It’s usually under-diagnosed, under-treated because if you don’t know you have it, you’re not getting the appropriate treatments and again, associated with tremendous disability.
Did you also mention that more women suffer from migraines than men?
Dr. Monteith: Yes, there seems to be a hormonal component to migraines. There may be more than just a hormonal component to migraines, but it’s definitely one of the conditions associated with gender differences.
Can you give us the definition, so we understand, what exactly is a migraine?
Dr. Monteith: So, migraine is a primary headache disorder, it’s a recurring condition so it’s chronic. Patients oftentimes have a background of migraines, so they may be more light-sensitive or sound-sensitive than their peers without migraines. But then they have these acute attacks and migraine is fundamentally defined by the pain of the disorder. Moderate to severe pain, but they’re also associate symptoms with migraines like sensitivity to light and sound, nausea, vomiting, smell-sensitivity, and those are just parts of the diagnostic criteria. There are a number of other symptoms, concentration, impairment, speech problems, vertigo. There are a number of other symptoms that patients have. Fatigue, for example, is a very common one. Processing disorders being able to not quite get that word out. Focusing problems, there are a number of conditions that are a part of migraine that really makes you recognize it as a brain disorder.
Wow, and even, paralysis?
Dr. Monteith: Yes, so migraine can be further subdivided. There are chronic migraines, meaning migraine happening almost all the time. There’s also migraine with aura, migraine without aura. Patients that have migraine with aura – the most common type of migraine is actually the visual disturbances, which sometimes can be prolonged. But patients may also have speech impairment so they can become acutely aphasic. They can look like a stroke patient or they can have weakness on one side. I’ve had patients that have actually been admitted to rehab and diagnosed with a stroke when they were actually having migraines with aura. So, they were going through different treatments when they really should have been going through migraine treatments to get that weakness, that paralysis under control.
How many episodes do people normally have? I mean, do they have a certain number a month? And what did they do? How long do they last?
Dr. Monteith: By definition, migraine lasts four hours to three days, but there are patients that could go on to have migraines for three weeks at a time. The frequency is going to vary with individual, it’s also going to vary within an individual depending on the different times of their life. Let’s say they started a new job, they have changes in sleep, or some patients are having hormonal changes and they’re having more migraines around their menstrual period. Perimenopause is also a time where patients are having more active migraines for some individuals. So, it varies completely. As you know the frequency and the severity is tightly correlated with what their presentation is.
This is a debilitating condition, there are triggers, and different people have different triggers. So, what up until this point, what have been the treatments for migraine? Why are we so excited about what’s new?
Dr. Monteith: So, there are behavioral interventions. If you can find a trigger that is causing someone’s migraines, then that’s wonderful– avoid that trigger, but this can have its own problems because, for some people, they can’t avoid that trigger. So, those are behavioral interventions. Then there are non-pharmacological interventions that could be tried like biofeedback, cognitive behavioral therapy, mindfulness, getting regular sleep, not skipping meals, maintaining hydration, etc. Then there are the pharmacological treatments, which are divided by acute treatments and preventive therapies. So, depending on the number of migraines or the disability associate with migraines, someone may or may not need to be on a preventive therapy, which up until now had been, generally speaking, oral medications that are taken daily. These were non-specific treatments, medications for blood pressure or anti-depressants or anti-seizure drugs were used. So, borrowed therapies from other disorders that we found were also helpful for migraines. Botox injections are another treatment but indicated for chronic migraines. Then there’s acute therapy. So, these are the non-specific things, like nostrils anti-inflammatory, but then there is a class of specific things like the triptans are the mainstay of acute migraine management. Depending on what migraines look like, the treatment is really where you’re going to place the patient in terms of their management plan. We’re excited now because that’s been the standard of care– no cure for migraines. Some patients respond beautifully to these things and there are vitamin approaches and other things that we’ve not mentioned. In supplements, some patients respond beautifully and when they do, everyone is happy. It’s an episodic condition, so patients can go into remission on their own at times but when they’re missing a lot of work or school or social interactions, then it’s really a point where they may want to consider being on preventive therapy. What we’re excited about now is, for the first time ever, there are migraine-specific treatments for migraine prevention.
Talk about the treatments and what they’re called and how they work.
Dr. Monteith: So, when we say migraines specific treatments, we’re talking about a way to target migraines based on the pathophysiology, more directly than some of the treatments we’ve used in the past. Calcitonin gene-related peptide has been known to be implicated with migraine, acute migraine attacks, as well as silent migraines for decades. So, more recently, in 2018, three drugs were FDA approved for the prevention of migraines by targeting the CGRP pathway. Why the CGRP, calcitonin gene-related peptide? It’s a signaling molecule essentially signaling your brain to have or experience migraine pain. We know that the levels are acutely elevated and acute migraine attacks, seem to be persistently elevated and people that are having migraines all the time are chronic migraines. So, if you target that pathway, that communication between the peptide, the protein, and the receptor which receives that signal or once the protein connects to the receptor, there’s is a whole activation path that happens that further perpetuates the whole migraines process. So, if you’re able to block that either by targeting the protein itself or the receptor, then you can potentially prevent migraines.
Can you tell me more about monoclonal antibodies?
Dr. Monteith: So, they’re monoclonal antibodies. Our bodies actually make monoclonal antibodies to fight off things, like, infections, viruses, and so it’s a very specific way of targeting a particular protein, for example. The nice thing about this is targeted therapy.
So, Dr. Monteith, how do you describe this? Like, if you’re describing it to a patient?
Dr. Monteith: Well, I try and pull up the graphs and show them what’s going on with the binding– and there are some beautiful graphs out there. If that doesn’t work, I really try and just put it in kind of a very coordinated way of doing it. I like to think of it like, if you think about someone trying to get into let’s say a VIP club or something like that and if you think about the person trying to get in and you think about the door, you think about the door as the receptor. And you think of the person as the CGRP. Then the bouncer is either going to get to the person or block the door. Either way, that person is not coming in. OK, so there’s a blockage and communication or entry and activation.
So, the bouncer is really the drug?
Dr. Monteith: Yes, and it has two mechanisms of blocking that pathway.
Right, So to clarify, there are three kinds?
Dr. Monteith: Absolutely. So, there are three on the market currently. A random MAB was the first to come out, which blocks the CGRP receptor. There is one that’s coming out that is in process or evaluation by the FDA that’s called (inaudible) and that drug is also one that blocks the peptide but interestingly is administered through the IV.
Now, talk to us about how these injectables work, and then let’s talk about Cherise and what happened in her case.
Dr. Monteith: First of all, they’re administered subcutaneously, slowly, so the patient injects once a month and has an option for once every three months. But generally, once a month, patients are injecting. They have long half-life, so they stick around for a long enough time that you only need to inject once a month. They also seem to work better over time. Generally speaking, what we like about these treatments is that there’s no issue with trying to increase drugs, the dose up. It’s generally speaking one dose and so, there’s a quicker onset of action that patients can generally start seeing benefits within one month. However, over time, patients can continue to inject and see cumulative benefits and they may also see a great benefit in the reduction of their migraines.
This is in your studies and experience in using this with patients. So, this is preventing migraines from happening?
Dr. Monteith: Yes, preventing migraines from happening. However, many patients will still have migraine attacks, but the goal is to have less painful migrant attacks, less frequent migraine attacks and easier to treat migraines attacks as well as to reduce the acute medication use. So, we know that patients that have frequent migraines or even chronic migraines about half of the patients with chronic migraines are overusing acute treatment. So, using acute treatments to stop a migraine more than they should be, which is associated with tons of side effects. So, the nice thing about being on a preventive such as this one is that you may also reduce the frequency of acute medication use.
Right, because they’re not waiting until they start to feel the effects of the migraine when the migraine’s coming in?
Dr. Monteith: Well, yes, but they’re also having fewer migraines, so they need to treat less often.
Which is really good, but this is not a cure?
Not a cure.
But what you’re seeing in your experience is patients are experiencing fewer migraine attacks?
Dr. Monteith: Absolutely. It’s just one additional tool or set of tools to provide to our patients. Many patients have tried multiple preventive therapies and have not done well. I’ve seen patients that have had chronic migraines literally for decades. One started having chronic migraines the year I was born, and this was the first time he’s only had one or two migraines per month. If you look at his preventive medication list, his acute medication, the number of hospitalizations he’s had, the number of doctors he’s seen it’s absolutely shocking, mind-blowing. So, it’s very rewarding to have new treatment options for patients.
Absolutely and any side effects?
Dr. Monteith: So, on the major side effects across all the CGRP monoclonal antibodies, is the injection site reaction. So, the place that you inject, you may see some redness, you may see some swelling and it could be more severe. If you look at the clinical trials, it’s rarely a reason that a patient would stop the injection. So, despite having some discomfort in the thigh or the stomach, that’s usually not a reason to stop. In some cases, we do see allergies, if there’s about a 2% risk of constipation in patients, you stop. But 2% is generally low and I would say it’s not unique to some of the other migraine medications that we’re using. So, these are what we know as the side effects. However, these drugs were newly approved in 2018. They’re ongoing open-label studies. So, we’re still collecting, or the companies are still collecting, post-marketing data.
That makes sense. But very exciting, right?
Dr. Monteith: Absolutely. This is a phenomenal time to treat migraines has a neurologist, as a primary care doctor. This is a phenomenal time to come and see a headache specialist and have new treatment options that may actually change your life.
And in the case of Cherise?
Dr. Monteith: Absolutely shocking. I learned from my patients. I learned from their experiences and the courage that they have to be an advocate for themselves and to get the care that they need and to see what life can bring when you get your migraines under control.
Because her whole life changed, Dr. Monteith. She was suffering very severe symptoms?
Dr. Monteith: Not only did she have the migraine pain, that was disabling, but she also had the persistent, weakness down one side. She was initially diagnosed as having a TIA stroke spectrum. So, it’s visual disturbances while driving, and for some patients, it’s just absolutely disabling as we mentioned.
So, she’s really counting the days that she’s been migraine free?
Dr. Monteith: Absolutely. Absolutely.
Lastly, it’s life-changing for patients as you’ve seen this in your experience, and is it covered by most insurance companies?
Dr. Monteith: Most insurances are starting to pick up the cost of these things and recognizing the data that supports their use. So it’s nice as a provider to prescribe these things with the correct documentation. Documenting the diagnosis, the frequency, the impact, whether there’s work loss, school loss, symptoms like anxiety and depression that might be associated with having chronic migraines or very frequent migraines, the medication overuse, and so far I’m getting patients on these treatments without a lot of back and forth.
That’s good news. You’re getting calls from patients all over the country and all over the world?
Dr. Monteith: Absolutely, this is just, again, a great time to practice migraine treatment. Not only these news therapeutic options, the seizure of monoclonal antibodies, but we now have our first oral CGRP antagonists also known as gepants. So, there are other ways to treat CGRP. These are newer treatments. We have our first triptan, lasmiditan, which is similar to other triptans but doesn’t cause basal constriction. So helpful for patients that have suffered from heart attacks or strokes or at risk for that. So, we have a number of new treatments for patients. We have now four FDA approved devices for migraines. This is a great time for different options for our patients.
So, would you say that people need to reach out if they’re suffering?
Dr. Monteith: Absolutely.
And that injection drug, you just show the patient how to do it at home?
Dr. Monteith: Yes.
Is it like an epi-pen?
Dr. Monteith: It is like an epi-pen. All of them now have an epi-pen-like device available that is usually pretty easy for most patients to be able to maneuver.
Interview conducted by Ivanhoe Broadcast News.
END OF INTERVIEW
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