Stephen Silberstein, MD: Andy, tell us about the onabotulinumtoxin type A.
Andrew Blumenfeld, MD: Well, this a treatment that was found by serendipity. Initially, it was being used as a cosmetic treatment, and predominantly in women in their 20s to 60s, which is a very common age to find patients with migraine. It was found indirectly by William Binder, MD, FACS, in Beverly Hills, an ear, nose, and throat surgeon, to work very well in preventing migraine in this population in an open-label setting. It was not a controlled trial. He reported on that data in the mid-90s. I was running a headache center and tried using it on some of my more-refractory patients, using his paradigm, and I was very surprised at the time to find that it actually helped. We were able to reduce things like triptan costs and emergency department visits. This gradually led to a much wider use across the community.
I know that you started using it around that time, Steve, and we collaborated and worked with Allergan to help them improve the injection technique. It turned out be key, where you placed the injections had a big impact on the outcome, and the type of patients who were treated was also important. The patients with more frequent headaches did better, and this eventually led to the categorization of chronic migraine. It stemmed in part from the development of Botox through the pivotal trial, which was referred to as the PREEMPT protocol, the PREEMPT trial. This led to an FDA approval specifically for chronic migraine in 2010.
Stewart J. Tepper, MD: I think it’s a very important part of our armamentarium, and it’s extremely effective in patients with chronic migraine, and over the last decade it’s been transforming for many patients’ lives. The advent of the new monoclonal antibodies gives patients with chronic migraine a choice. And the questions we’ve already alluded to, whether we leave onabotulinum in place and then add monoclonal antibodies or subtract, and how payers are going to rule on these issues, are some of the big battles ahead. In my practice, I try in a very dispassionate way to present both options to patients with chronic migraine and let them choose. Many of them, as Deb and I were talking earlier, will choose onabotulinum, because of its history of utility, safety, and effectiveness over the last decade in chronic migraine.
Deborah Friedman, MD, MPH: I think it also has a lot of great advantages for patients who have a lot of serious medical problems and different co-existing conditions that make it very difficult for us to prescribe oral preventives. That’s one of the situations where I definitely encourage people to try onabotulinumtoxin.
Stewart J. Tepper, MD: One other point I’d make about it—if we had been smart, we would have realized that onabotulinum was probably telling us that it is possible to prevent migraine with a peripherally acting medication. One of the great things about it is, it doesn’t go into the brain, and it doesn’t cause those kinds of adverse effects, it’s a peripherally acting medication. It predicted what was to happen subsequently, as we think that the monoclonal antibodies, for the most part, don’t go into the brain and have primarily peripheral action, which is marvelous from a patient standpoint in terms of adverse effects.
Deborah Friedman, MD, MPH: You know your previous comment was very apropos to what we were just talking about with oral preventives, where we all said in unison that none of us would stop an oral preventive to start a second one, right? And now we’re being asked to do that with Botox and the monoclonal antibodies. Frankly, I think it’s sort of a cruel and unusual punishment for the patient, to take them off something that might be partially effective for them but not effective enough.
Stephen Silberstein, MD: We should talk about that when we talk about the antibodies and how we introduce them. Any final comments?
Stephanie J. Nahas, MD, MSEd, FAHS, FAAN: We’ve talked about a lot of different types of treatments, and this dovetails into something that has really kept me involved in headache medicines. There are lots of reasons to practice in this field, but primarily, I’m a neurologist because I’m fascinated with how the brain works—knowing that all these different medications with such disparate mechanisms of action are starting to unlock the secrets of the brain and what happens during migraine. It becomes more and more fascinating, year after year, and I just can’t wait to see what’s next.