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Episode 28: Patient Experiences with CGRP Medications

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Voice-over: Welcome to Spotlight on Migraine, a podcast series hosted by the Association of Migraine Disorders. Through personal stories and interviews with experts, we expose the true scope of migraine by exploring symptoms, treatments, research topics, and more. This episode is brought to you in part by our generous sponsors, Amgen, Novartis, and Alder BioPharmaceuticals.

In this episode, Shoshana Lipson shares anecdotal reports about using CGRP medications for migraine, compiled by surveying the 6,000-plus-member Facebook group CGRP and Migraine Community, which she founded. She details the findings in four areas: efficacy and expectations, adverse side effects, accessibility, and information flow. Most importantly, her studies include a broader range of patients than those permitted in clinical trials, allowing for a potentially more realistic look into the implications and outcomes of using CGRP antagonists.

Since 2015, Amgen and Novartis have been working together to develop pioneering therapies in Alzheimer’s disease and migraine. Together, Amgen and Novartis share in a mission to fight migraine and the stereotypes and misconceptions surrounding this debilitating disease.

 

Shoshana Lipson: I am privileged to lead and to have founded a support group on Facebook called CGRP and Migraine Community. We just recently changed the name to “Community” from “Support Group” because that is really what we have become. We’ve been around for 9 months. We currently have almost 6,500 members, and not only do we have that many members, which is fast growing, but in the past month, over 6,000 of those people have actually been active. So just to give you an idea, for those who aren’t familiar with Facebook, a lot of people join support groups and then just kind of forget about it. But in this support group, that is not the case.

 

So my talk this morning is based on patient perspectives towards the CGRP inhibitor medications that were just released in 2018, and it’s a really exciting time for us. I’m going to start with a quote from the American Headache Society paper — the consensus statement that was published in October 2018: “Because the severity, frequency, and characteristics of migraine vary among persons and often individuals over time, optimizing treatment for particular patients remains challenging. Determining the efficacy and tolerability of preventive treatment is a patient-driven decision that may not exactly mirror the end points used in clinical trials.” 

 

So I’m just going to give you a caveat that my conversation today is based on observations within the CGRP and Migraine Community. It is not based on anything scientific. We do not have evidence-based trials in my group. It is patient anecdotal reports from 6,500 people who are either on these medications, been on the medications, or are considering trying them.

 

So obviously, this is a new frontier. Any new frontier is real exciting but also presents challenges. So the challenges are communication — there has been a lack of effective two-way communication since the release of these medications. Information — it’s been an information explosion, and I often describe it as a maze. It’s like you’re trying to find your way through this maze of information. It is confusing. Sometimes, it is contradictory because it’s not only evidence-based information, but also a lot of people’s opinions — sometimes, those opinions from people who do not know anything about migraine or headache disorders and do not have migraine or a headache disorder. The clinical trial results — there are concerns about some of them because of the — what we would describe as a lack of representative portion from the migraine community, if that makes sense, because of the limitations and exclusions from the trial. It doesn’t mean that the trial results were incorrect; it just means that there was concern for the high percentage of people who were excluded from the trials. It’s shown the importance of patient-centricity, and right now, as many doctors have said, there are simply more unknowns than knowns, and it’s really important to remember that.

 

So I’m going to cover four key areas today: efficacy and expectations; side effects, adverse events; accessibility; and information flow. So I heard it said, actually, on a Migraine World Summit a couple of days ago that there is kind of a law of thirds that applies here. So roughly speaking — again, this is not clinical evidence — one-third of the people have a fabulous response to these medications, one-third will have a so-so response, and one-third will have no response at all. Many headache specialists have put it in just 50/50, so 50% of people will get about 50% relief. And bear in mind, a 50% relief does not mean that your headache will necessarily go away — your migraine will go away. It’s 50% relief.

 

We’ve seen a huge range of responses within my group, so ranging from people saying, “It has been life-changing. I have got my life back. I have gone back to school. I’ve gone back to work. It has transformed my family, my marriage, my job.” One person wrote to me and said, “I did a math problem in my head for the first time in years.” A lot of people don’t realize that with migraine, it’s not just a headache, as Dr. Gordon says. It affects so many other aspects of your life and of your functioning, including the cognitive aspects.

 

There are other people who say, “I’ve got a new normal.” You may think that that’s exciting, and in many ways it is exciting. If you have chronic migraine like I do, then the thought of having instead of, let’s say, 22 migraine days a month, having 11 migraine days a month — you would die for that. You’re going to think, “Wow, I’m going to have 11 more days.” But it’s kind of like childbirth, for those of you who’ve been through childbirth. You forget the pain. So once you’re down to that 11 days, it’s not long before you think, “You know what? This is still not normal. 11 days a month I’m devastated. I’m in bed. I’m incapacitated. I still can’t make plans.” So that new normal is not normal still.

 

So these are not wonder drugs. I know that no one in the pharmaceutical company or the headache specialists are claiming that they are, but because of the hype and because of the discouragement until now with people who have migraine, there is a tendency to grasp onto it and think, “This is going to be a miracle drug. This is my salvation.” And it’s not as easy as that.

 

So that leads me to unrealistic expectations, and you see the little roller coaster there. It really has been a roller coaster the past few months. There have been a lack of answers and communication, which has been really challenging frequently. Not surprisingly, the hottest topic online is side effects. So I hear it said from a lot of people on social media that they don’t want to get on social media or they discount what patients are saying on social media because, again, the hype happens there, but it kind of goes the other way. So one person gets on and says, “My eyelids started twitching. My legs stopped working.” And another person says, “Oh, my legs aren’t working either, and I can’t even open my eyes.” And it kind of escalates up. However, that is not to discount everything that is said on social media, and the advantage of having a group as big as mine is that we are starting to see some general trends within the group, which are very interesting. 

 

There is definitely a concern about the restrictions for the clinical trials. We understand that there is definitely a high desire to get these medications to the FDA and to get them approved; however, the challenge is that the majority — the vast majority of people who have migraine disease have comorbid conditions that made them excluded from these trials, such as fibromyalgia, any other kind of pain condition, and a whole ton of other conditions I don’t have the time to go into. People were also excluded for other reasons, sometimes because the medications they’ve been on or because they’ve failed not 2 to 4 medications but 20, 30 medications. All submit that they were excluded from the trials. 

 

Unfortunately, the consequence of that is that we did not actually know what the real-world results were going to look like once these were approved by the FDA and out in the general public. I was told yesterday by Dr. Silverstein that there are now hundreds of thousands of people on these prescription medications, and that is a lot more than the clinical trials, and that includes people with comorbid conditions and all the other exclusions. So it is not exactly mirroring what was seen in the clinical trials. 

 

Bearing in mind, however, that because of the complexity of migraine and how it varies not only person to person but sometimes day to day, month to month, year to year within one individual, it’s very, very challenging to know the difference between causation and correlation. So if you started a medication, let’s just say, in the summer 2018, and suddenly it got hot and humid where you live, and your migraine attacks became more severe or more frequent, was it the medication that caused that, or was it the fact that suddenly it was hot and humid? That’s just one example. Obviously, there are so many triggers for migraine attacks that it becomes very, very complex, and we can only start to tell this over time as people keep migraine diaries and as we hear from thousands of people.

 

People aren’t sure how to report side effects they get. Should they report them? Are they making it up? Is it real? Why is their doctor not hearing them? Who do they report them to? It’s complicated, and as one other person actually said on a Migraine World Summit this past week, there is a tendency to catastrophize among people who have migraine attacks because it is such a disabling order, and so there is a tendency to panic. I understand that. I have a tendency to panic, and so some days, we had to take a breath, take a step back, and say, “Okay, I’m just going to give this the best try that I can and monitor and keep my diary.”

 

Very quickly, also, the other issue is, of course, medication switching, which did not happen in the clinical trials. A lot of people are switching from one of these inhibitors to the other, and there is not an awareness right now and a lot of disagreement between doctors about should there be a washout period between these medications. If so, how long should it be, and should that depend on whether you had to stop one of — the first medication because of side effects or because of lack of efficacy?

 

So the general trends that we are seeing — again, this is just in my group, not necessarily reported by headache specialists, although I’ve heard from at least three certified headache specialists who are saying that they are seeing some of these trends in their practice. Hair loss, GI issues, fatigue, severe constipation that is sometimes sending people to the emergency room, allergic reactions, worse migraine attacks, body aches like the flu, muscle cramps, spasm, arthralgia. People are specifically saying that sometimes their triptans are less effective, while other people say that they’re more effective. Sleep changes, dizziness, vertigo. Obviously, that’s a huge list. 

 

I’m aware that this chart is way too small for you really to see much on it. I did that on purpose [laughter]. But the general idea is this is kind of the range of things that we’re seeing reported in the group. We see some really weird things. I did not include that, but I included the things that we’re getting a significant number of comments and reports back, especially people who say, “I had to go to the emergency room,” “I had to go on a medication from my doctor,” or, “I was hospitalized.” So these are things that I would consider serious, and I’m hearing what these people are saying. 

 

So what I do find interesting is that there is a difference between the medications. Now, I’m not calling one medication out over against the other, because we really don’t know why there’s a difference at this point. We don’t know if that one was first out the gate, if it’s a different population using it, if that there was a big panic to begin with when they first came out and now there’s less of a panic. We just really don’t know.

 

So this chart you can see — these charts are based on a survey that I did for each of the medications, asking, “Did you have side effects, and if so, what was your experience?” And some of them were very specific questions. So it was interesting. We got almost 500 people that responded who had taken Aimovig. There was about 226 from Ajovy and 164 from Emgality right now. So what I find interesting is that there is a lot of people who are saying, “Yes, I’m having side effects,” but just because you have a side effect — just like an injection-site reaction, which is really generally not significant, or mild to moderate constipation, which most of the time you can easily take care of and is definitely better than having a migraine attack — doesn’t necessarily mean you’re going to stop the medication. But if you look at the second chart, if you’re looking at the people who stopped due to these side effects, again, there’s a difference between the medications in the people who are stopping. And again, we don’t know why that happened.

 

Next subject: accessibility. So there are multiple challenges causing some issues in accessibility. We all know there was a somewhat chaotic rollout at the beginning. To the large part, that’s just been resolved now. We’re very, very appreciative, actually, that the first medication out made this medication available to everybody except, unfortunately, I think the people in Massachusetts [laughter], so sorry about that. I have nothing to do with that. But the programs are complex. That’s not a criticism of the pharmaceutical companies. We’re really grateful, but people with migraine have a hard time taking all this information, trying to figure out where they fit in, trying to talk about it with their physician and figure out which program that they are eligible for. And the programs keep changing, sometimes for the better, but it’s confusing, to be sure. 

 

There are insurance obstacles. This is, like, one of the biggest frustrations. I’m not even sure that I know what to say about that other than, really, in my personal belief as a migraine patient, I think that the decisions for medications should be a decision between the physician and the patient, and the insurance company should not have the right to say, “You got to take something else, or you have to stop taking this medication.” I know that’s kind of simplified, but from my perspective as someone who is disabled by migraine, that’s how I feel.

 

Doctor access — this is a huge issue. I have to wait 3 months just to get an appointment with a regular neurologist, and there are no certified headache specialists on my insurance plan, even though there are many in my area. Other people who are able to get to certified headache specialists can wait 3 months, 6 months, sometimes longer. It’s very discouraging, and there are some states where there are simply no certified headache specialists. And again, from the patient’s perspective, just because a doctor calls themself a headache specialist does not necessarily mean that they actually are a headache specialist. There is a big difference between a certified headache specialist and someone who just wants to start treating people who have migraine. A lot of patients do not know that, do not know the difference, and are not aware of the lack of education of so many doctors about migraine and other headache disorders, which is so sad.

 

And then, of course, there’s the cost issue, the cost to the medication, the co-pays. And especially for people who are on government-funded insurance, we do not have access to most of the access programs for patients, and so that often leaves those who are most disabled and most in need of these medications simply unable to get them.

 

And my last topic: information flow. So the journey towards a more patient-centric healthcare system is not always smooth. It is so important to have two-way communication. It is important to see what is going on in social media, and I’m really excited at what organizations like the American Migraine Foundation are doing with having headache specialists on Facebook and doing live chats. So instead of reaching the ones and the twos or the tens, now you’re reaching the hundreds and the thousands and getting accurate information out to people who desperately need it. 

 

And then, of course, the insurance companies again have complex and lengthy processes, and patients do not know their rights. I was actually reading some comments this morning in my group about people who are staring to panic because they got the first medication out the gate in May, June, July; the 12-month program where they had access to it is got a sunset, which is coming up rapidly; and they’re starting to get denials from their insurance company. And for those people who’ve responded, they are panicking, and they don’t know what to do. So advocacy is crucial. We really need doctors to listen to us. It’s time to have a two-way conversation. The time for a parental model is very different than a partnership model, and we are asking for a partnership model.

 

And finally, in conclusion, because my time is up [laughter] — so as a person with migraine, I would personally like to make a callout for the clinical trials, which are so important — but that there is less of an emphasis on speeding them to FDA approval and more of an emphasis on bringing a representative portion of the migraine patient population into those trials so at the point where they become FDA-approved, we have a better idea of real-world outcomes, and that is so important. Thank you so much for your time today. It’s been a pleasure.

 

[applause]

 

[music]

 

Voice-over: Thank you for tuning in to Spotlight on Migraine. For more information on migraine disease, please visit MigraineDisorders.org.

 

This podcast is sponsored in part by Amgen/Novartis and Alder BioPharmaceuticals.

*The contents of this podcast/video are intended for general informational purposes only and do not constitute medical or legal advice; the content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition. The speaker does not recommend or endorse any specific course of treatment, products, procedures, opinions, or other information that may be mentioned. Reliance on any information provided by this content is solely at your own risk.

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