In Part 1 of this interview, Amaal Starling, MD, assistant professor of neurology at Mayo Clinic Scottsdale, shared her experiences with a number of new migraine drugs and devices and the impact that more options will have on clinical practice.
Amaal Starling, MD
Over the last 18 months, the arsenal of available treatment options for migraine and headache have multiplied, providing hope for a number of patients who previously had inadequate control over their headaches. Now, exploration of novel pathways has opened the door to the development of therapies that act on the biological anchors of migraine, and as some specialists have put it, have begun to blur the lines of acute and preventive treatment.
Amaal Starling, MD, an assistant professor of neurology in the divisions of concussion and headache at Mayo Clinic Scottsdale, has felt the impact of these new developments as much as any physician in the space. In a conversation with NeurologyLive
, she noted that she has one line of patients waiting for the arrival of a number of therapies in the pipeline and another who are already reaping the benefits of those that have arrived.
Starling shared her experiences with these new devices, therapies, and developments as well as what she is looking forward to seeing come down the pike in the future.
NeurologyLive: How would you describe the current therapeutic landscape for headache and migraine care?
Amaal Starling, MD:
Right now is a very, very exciting time to be a healthcare provider in headache medicine, in migraine, and in neurology. I think it's also a very exciting time for our patients because, finally, there is an explosion of different therapeutics, both for acute use and prevention, as well as neuromodulation devices that can often be used for both acute as well as preventive therapy. And the coolest thing is these things are designed based on what is happening in the brain in migraine—they're being designed for migraine. So, we're finally entering an era of disease-specific, mechanism-based targeted treatment options for migraines.
We also are recognizing that migraine is not ever going to be a one-size-fits-all disease because of the multitude of genes that are involved in contributing to migraine susceptibility. Everyone has a little bit of different migraine disease, and that's why we need to have a plethora of options available so that we can figure out which ones will be effective for which patients.
What do you anticipate the impact of new medicines, such as the gepants and ditans, will be in the headache space? Do you anticipate being able to treat even more patients?
We’ve already started doing that since May of 2018 when the first CGRP monoclonal antibody for prevention was FDA-approved. We've been able to help so many more patients and even before that, when we started getting FDA clearance on the multiple neuromodulation devices, we have been able to address migraine disease for individuals who have found other medications ineffective, as well as those patients who have poorly tolerated other preventive treatment options and acute treatment options, or even if they found them to be effective but they were unable to tolerate it due to adverse effects from a tolerability perspective.
As well as exploring new mechanisms that may be underlying different migraine, also being able to have devices and oral treatment options that are really blurring the lines between acute and preventive treatment is really exciting. It's kind of confusing for patients to be like, “Okay, this is what we use for prevention. And this is what we use for as needed.” I really like, with some of the neuromodulation devices, that we can use one device for both acute and preventive treatment. I believe that that is going to be the direction that these CGRP antagonists are also going to go. The gepants, not in the immediate future but in the next couple years, should have FDA approval for prevention as well as acute treatment, so those may be medications that can be recommended to use it as needed. If you need to use it daily in the beginning, that's okay. It'll work from a preventive perspective. And then it'll also work as needed when you have to take it like that.
Have any particular therapies in acute or preventive treatment stood out to you as particularly promising?
Several of them. All 3 of the currently FDA-approved CGRP monoclonal antibodies have been wonderfully useful in our headache practice. Mayo Clinic Scottsdale is a tertiary coronary center and the realist in me didn't expect that the medications would work as well in our very medically complicated and very refractory population as it did in the clinical trials. But we've actually had excellent results where it really mimics the clinical trials, where regardless of which monoclonal antibody it is, about 50% of patients will be responders. That's kind of what we told patients were the results in the clinical trials—about 50% of patients plus or minus a couple of percentage points, depending on the clinical trial and depending on the monoclonal antibody—and that's what we've seen even in our very complicated patient population.
We’ve also had great tolerability with all of those monoclonal antibodies. It's been beautiful to see that, to really kind of change the lives of some of these patients, especially the ones that were super responders and had greater than 75% remission of their migraine attack. That was awesome. I'm also excited about the upcoming FDA approval of eptinezumab, which will be the first CGRP monoclonal antibody infusion, especially given some of the onset of efficacy data that has been suggested in the different abstracts presented at the different meetings.
And then, of course, the recent FDA approval of lasmiditan is going to be very helpful when we finally have that clinically available because it will help us address that patient population that has not responded to triptans. I mean, 30% to 40% of patients who received triptan medications do not get a good response, whether it be inefficacy or poor tolerability. Hopefully, this will be an option for them as well as for that patient population for whom we are unable to use triptan medications because they have a history of heart attacks or strokes or significant peripheral cardiovascular or cerebrovascular disease. Those are individuals for who we are hesitant to using triptans because of the vasoconstrictive effects. Once lasmiditan becomes clinically available, it is something that we will be able to use for those patients. I have a list of patients who I will be calling once I can write the prescription for a limited time, because I'm hoping that this is going to be an as-needed treatment option that they can tolerate. Also, hopefully, ubrogepant should be coming down the pipeline very quickly, with FDA approval for acute treatment. I'm hoping that maybe we'll see that in November, or prior to the end of this year.
And then, the neuromodulation devices. We already have been using the Cefaly and the STMS Mini, the noninvasive vagal nerve stimulation device—we've been using all of those devices. For this patient population, usually, when we're using the nerve modulation devices, we use them in combination with other either injectables or oral medications. There are some patients who would rather not use any type of medication, whether it be injectable or oral, and for them, we’re able to kind of work with the different neuromodulation devices and find one that works for them.
The lovely thing about the neuromodulation devices is that there are very few contraindications. In fact, some of the devices such as the STMS Mini has recently received label extension to include the adolescent population, and the STMS Mini has some case reports already published in the literature in patients who are pregnant. So, these are options that we can use in our population that is medically vulnerable because of a variety of reasons. I mean, on a personal note, I just had a baby 5 months ago. I have migraine and I used the STMS Mini for prevention as well as acute relief for treatment during the time I was pregnant because of the safety. Then there's the recent FDA clearance of the remote electrical stimulation patch that would be used on the arm. We haven't yet been able to clinically prescribe that, but I've been talking to patients about it and patients are super excited about it. I also have a list of patients once I can actually write the prescription for it and get them the device. I have a lot of patients that are waiting for that.
Transcript edited for clarity