Michael Racke, M.D., a professor of neurology and neuroscience at The Ohio State University, talks about a new FDA approved drug that is making a difference for patients who have multiple sclerosis.
Interview conducted by Ivanhoe Broadcast News in April 2017.
Could you give an overview of what MS does to the system?
Dr. Racke: Multiple Sclerosis is what we think of as an autoimmune disease. That’s when your own immune system attacks your brain and spinal cord and specifically the myelin. The myelin is the part that allows you to send messages quickly so that you can move quickly or respond to the environment quickly. What happens is that MS patients can experience symptoms where they like have loss of vision, numbness, in-coordination and eventually weakness and difficulty walking and eventually difficulty in thinking.
Is this a progressive type of disease?
Dr. Racke: Initially MS patients have attacks so you could loose vision in your eye and that might last for a few weeks and it would typically get better on its own. Maybe not completely but what happens is that as you have more of these attacks you begin to recover less well. Eventually you get into the progressive form of the disease. That’s where patients just slowly get worse; accumulate disability while not really have any of these attacks.
Is this a fatal disease?
Dr. Racke: We usually say that now, multiple sclerosis is a disease that you die with rather than from. There can be rare incidences where somebody has a very aggressive case of MS but I would say the issues are much more related to the fact that it’s a disease of younger adults. Women are affected more than men and then eventually you accumulate neurologic disability.
What are the treatments?
Dr. Racke: The first MS treatment was approved in the mid-nineties and that was beta interferon. There have been subsequent many treatments but there’s never been a treatment for the progressive forms of MS. Primary progressive MS in particular. The ocalizamab really represents the first positive trial and FDA approved treatment for patients with primary progressive MS. That probably represents about ten to fifteen percent of all MS patients.
Tell me a little bit about what this drug does, how it works in the system and what its doing.
Dr. Racke: Most of the medications that we have for MS now have some sort of effect on the immune response, trying to prevent the immune system from attacking the nervous system. Ocrelizumab in particular is a monoclonal antibody that depletes B cells. By doing that we see important effects in terms of not only reduce disease progression but other things like reduced relapses in the patients with the relapsing form of disease and a dramatic reduction in MRI lesions.
MRI lesions are the lesions—
Dr. Racke: Probably only about ten percent of the lesions that occur in the brain does that actually cause clinical signs and symptoms, right? If you have a lesion on the optic nerve you can’t see out of your eye or if you have a lesion in your spinal cord you might be numb or weak below the level of that lesion. The MRI has actually given us additional incite in to the disease and told us that it was much more active than we originally thought. One of the things that I think is important that we’ve learned is that if you stop the MRI lesions particularly in the cerebral hemispheres, that really has a profound effect later on, on subsequent disability and also effects on your ability to think.
I want to ask you a question again about the drug itself, in your mind is this a game changer?
Dr. Racke: Yes, there have been several monoclonal antibodies approved. I think one of the things that’s very exciting about this one is that patients receive it every six months so it’s certainly a little bit more convenient perhaps than a monthly infusion or injection. The other thing that I think is important to recognize is that its safety profile seems to be quite good. There was a lot of concern with a drug nanalizumab although I think we’ve improved somewhat in our safety monitoring of that drug. There have been several hundred patients who developed a disorder called progressive multifocal leukoencephalopathy or PML, which is a disorder that before I used to only see in patients that had AID’s or that were on immunosuppression because they had received an organ transplant. That has not happened with anybody that’s received ocrelizumab yet. The other thing that’s important to recognize there was a term that was initially used by rheumatologists called NEDA or no evidence of disease activity. Before we would never have used as an outcome measure but we’re now using it as a secondary outcome measure in MS Clinical Trials. The NEDA over the two years with ocrelizumab was forty eight percent meaning that almost half the patients had no evidence of disease activity in terms of their MS. That’s much higher than we’ve seen with any other MS treatment.
This is a disease that you mentioned strikes young people and strikes women. Would you call this a particularly cruel disease in the way it strikes them?
Dr. Racke: I guess you could say that it’s cruel because of that fact. If you had a glioblastoma or amyotrophic lateral sclerosis that probably would be worse. I look at it a little bit differently in that I’ve been taking care of MS patients for about twenty five years. It used to be that we really didn’t have much that we could say for these patients. And I would say that it’s not atypical now to have a clinic where basically everyone you saw in that clinic looked normal. What is now happening is that we continue to make progress in being able to slow down the disease even more and doing it in a way that’s even safer for our patients with MS.
You heard about the FDA approval, just on a personal note can you put me inside your head, what did you think when you heard about this?
Dr. Racke: I was obviously very excited about it mostly for the patients with primary progressive MS who didn’t have anything else really for us to offer them. We’ve been involved in several of the ocrelizumab trials, we have currently about seventy patients receiving the drug right now. When you see those patients it’s like you ask them like how are they doing, the fact they have this big smile on their face and say, I’m doing great. That makes you feel great as well.
When you said you have seventy patients do you know how many other institutions are involved?
Dr. Racke: Probably in the United States and Europe could be as much as a hundred centers right. In the OBO trial which is a by-marker trial we are the leading enrolling site and we’re one of the leading enrolling sites in the trial where you’re giving ocrelizumab to patients who have essentially failed another MS medication. That’s the other thing that’s exciting is that we’ve gone from where we were approving drugs because you had like a thirty percent reduction in relapse to now we’re approving drugs that really put a significant break on the disease.
Do you know if this is covered by insurance for patients yet?
Dr. Racke: I wasn’t awake when I got the first e-mail at one thirty a.m., I got a phone call driving in this morning from one of the top people at Jen and Tec to let me know that the drug had been approved. They anticipate charging sixty five thousand dollars a year which is actually less than several current MS medications. Which I think is interesting from the perspective that we’re finally seeing a drug that’s coming in at a little bit lower price as opposed to a higher price. I was just on Capitol Hill last week advocating to members of Congress not only about increased NIH funding for MS but also about that we need more transparency in terms of drug pricing. In answer to your question, one of the things about transparency is that there still is quite a difference in drug cost depending on how you get it. Does your insurance company negotiate a price? Those are all things that on the day of approval I don’t really know yet.
But all things we need to watch—
Dr. Racke: There’s thousands of patient with primary progressive MS who haven’t had a treatment available for them. They’re going to be looking to try to get access for this medication. It’s going to be interesting to see how we handle that. We’ll do a better job than what happened back when betaseron or interferon Beta 1B was first approved the drug company wasn’t actually ready for the huge demand. There was a lottery that would determine who was the first one to get the drug. There were some patients that didn’t get it until several months later. I don’t think that’s going to be an issue with this drug, I think they’re prepared. This is I believe the fifteenth approved medication for multiple sclerosis. Now we have a lot of options for our patients with MS.
Is there anything I didn’t ask you that you would want people to know?
Dr. Racke: The other thing that’s going to be very interesting we were involved with this because we first gave a drug called rituximab to patients with multiple sclerosis. There are other anti CD 20 monoclonals, ublaeuxtumab and ofatumumab to name a couple. It’s going to be interesting that probably within a couple of years we’re going to have many different options in terms of monoclonal antibodies. We’re also very involved in the hematopoietic stem cell transplants for patients with multiple sclerosis. You’re seeing a real explosion in the options that patients with MS are going to have and that the efficacy of these treatments just keeps getting better and better.
How many people in the United States have the primary progressive form of MS?
Dr. Racke: About ten to fifteen percent. The funny part is one of the things I was on Capitol Hill for was lobbying for the neurologic disease surveillance program. The last time they counted the MS patients in the United States was nineteen seventy five. The number sort of magically went from three hundred thousand to four hundred thousand. I suspect it’s even higher than that. That would put the number of people with primary progressive MS somewhere in the forty to sixty thousand range.
END OF INTERVIEW
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