Reclassification From Chronic to Episodic Migraine

Transcript:

Peter Salgo, MD: Patients with migraine, who have chronic migraine, now get put on 1 of these new drugs. And they work—half of them, perhaps more. They no longer make that 15-episodes-per-month [criterion]. Do you reclassify them, now they don’t have chronic migraine?

Stephen Silberstein, MD: No.

Peter Salgo, MD: Why?

Stephen Silberstein, MD: Because their biologically based disposition is chronic migraine, and they’ve regressed to episodic undertreatment. The problem we now have is the fact that I tend to get and give them 2 diagnoses: chronic and episodic migraine. Here’s what’s even more important. One of my friends, who is in a population-based study, looked at the number of headache days per month in a large number of individual patients. What he shows is [that] it’s like this—up and down. Many patients [in] 1 month will have 17 headache days, [and] the next month they’ll have 6. What do you call them? What we tend to do is take the words, call it chronic migraine, and give them 2 diagnoses. Or you could call it chronic migraine in remission. But you have the biological predisposition to chronic migraine, that should be the overwhelming diagnosis.

Peter Salgo, MD: I suppose that makes sense, in that other diseases do that. Someone with hypertension has hypertension.

Stephen Silberstein, MD: We call it controlled hypertension.

Peter Salgo, MD: Controlled, because you give them meds and their blood pressure is normal.

Stephen Silberstein, MD: Yes, that’s what we do. If somebody had a myocardial infarction angina and you have a medication that’s taken their symptoms away, does that mean they no longer have angina or heart disease?

Peter Salgo, MD: They don’t have angina symptoms, but they certainly have the disease.

Stephen Silberstein, MD: That’s the why we look at it.

Peter Salgo, MD: Fair enough. Do you have personal experience now with patients—in whom you’ve given this medicine, who have had the diagnosis established of chronic migraine, who now have chronic migraines in remission, if you will? [They have] fewer than 15 per month.

Stephen Silberstein, MD: Yes, tons of them.

Peter Salgo, MD: Tons of them?

Stephen Silberstein, MD: Tons of them.

Peter Salgo, MD: Why aren’t you smiling?

Stephen Silberstein, MD: What?

Peter Salgo, MD: You’re not smiling.

Stephen Silberstein, MD: Well, it’s a miracle. I have patients. As I said, we’ll give them a shot. They come back 2 months later, [and] they haven’t had a headache. It’s all over the spectrum, but we’ve had people who have 50% relief, 75% relief, and even 98% relief. It’s across the spectrum.

Peter Salgo, MD: What are you seeing from your friends?

Shoshana Lipson: That’s interesting. It’s not uncommon to see someone who’s new to my group [will] come on, [and] their first post is, “I’m a little different [from] the rest of you. I have all these comorbid conditions. I’ve tried all these medications. I have a migraine day almost every day of the month. Is there any hope for me?” First of all, they’re discovering that they’re not different. There’s so many of us. That there are so many, who actually are like this and are responding to the medications, is—in laymen’s terms, it’s mind-blowing. People who have lost all hope can have hope now. It’s huge.

Peter Salgo, MD: From your perspective, the 2 of you, does it make a difference? Do you change the classification from chronic migraine? Now that the migraines are fewer than 15 a month, do you call them something else?

Wayne N. Burton, MD: From the employer’s standpoint, we rely on the physician [who is] taking care of the patient. So the employer is not going to change the diagnosis.

Peter Salgo, MD: OK.

Maria Lopes, MD, MS: No. It’s a sign of success, right? So, no, I think.

Stephen Silberstein, MD: But in Europe—listen to this—…

Peter Salgo, MD: I’m listening.

Stephen Silberstein, MD: My friends tell me [that] if you go from chronic to episodic headache, they stop paying for your drugs.

Peter Salgo, MD: That’s where I was going.

Stephen Silberstein, MD: Yes. In Europe, that’s what happens.

Peter Salgo, MD: Because that, it seems to me, is cruel to do that, no? I mean, “Look, this drug worked, it made you better, we’re stopping the drug.”

Shoshana Lipson: Wouldn’t that also be true in America with Botox as well? Because you’re classified as chronic in order to get Botox?

Stephen Silberstein, MD: I would beg to differ. I did all the clinical trials and did the first Botox study. We clearly showed at the beginning that Botox did not work in episodic migraine, and that’s the reason why. There’s a subset of migraine patients, [who are] high-frequency episodic—in whom it may work, and it probably does work, who haven’t been studied—and we don’t know the reason why. Therefore, that’s where the separation between episodic and chronic began. Before that, all migraine drugs were approved for migraine. When we had the trials for Botox, we got the approval for chronic migraine because those are the only studies that separated from placebo.

Shoshana Lipson: Also, my understanding is that the difference between chronic and episodic isn’t entirely just picking a number. But from a teaching I recently heard from the Mayo Clinic is that the cortex in your brain actually changes.

Stephen Silberstein, MD: Do you know where that came from? Richard Lipton and I sat down and had a few drinks and came up with it.

Peter Salgo, MD: How many is a few drinks?

Stephen Silberstein, MD: Let me tell you, there’s a major problem in headache. In most disorders, a chronic disorder is something that’s been present for a finite period. In the headache world, cluster-headache becomes chronic when it’s 11 or more months. In the migraine world, it has to do with monthly frequency. Our original term wasn’t chronic migraine; it was transformed migraine. But people didn’t like the term because chronic is not what we’re talking about. We’re talking about somebody who’s gone from low-frequency headache to transformed migraine [for] most of the time. And the problem we have is [that] chronic is used in so many ways, in so many disorders. That’s the problem.

Shoshana Lipson: Right. Even if you’re episodic—if you have episodic migraine—you have a chronic disease.

Stephen Silberstein, MD: That’s the problem: You have a chronic disorder with episodic manifestation. It’s a difficult use of language. So I’m starting to use the little c and the big C.

Peter Salgo, MD: What I’m hearing from everybody here—disagreements notwithstanding—is that, as with so many other diseases, the introduction of these new biologics has changed everything. Everything.

Stephen Silberstein, MD: That is correct.

Peter Salgo, MD: We’re not even on the edge of the verge of the precipice.

Stephen Silberstein, MD: That is correct.

Peter Salgo, MD: We’re just seeing little nibbles of things. This is a new era.

Stephen Silberstein, MD: That is correct.

Peter Salgo, MD: This is new medicine.