Michael:
So the next session is an update on clinical trials. And we have a couple of ways to convey all the exciting progress that’s been going on. The first is through what we call the Clinical Trial Medscape, that by the way, each of you can do for yourselves from your home online. And it focuses on the clinicaltrials.gov website. So let me just bring you up to date on the clinical trials that are registered on the clinicaltrials.gov website. If you would have looked at this kind of a table 10 years ago, there would have been two or three trials listed. Now, when you press return on the search that has neuromyelitis optica in it, there are 42 clinical trials registered. Now some of those have been completed. Some of those are in a standby status, but there are a bunch that are active, and there are a bunch that are just beginning recruitment. And really this information is to help you assess the information, your options, considering whether you want to take part in a trial, et cetera.
Michael:
I’ll just give you one piece of information for you to consider. You’ve heard that there are three late stage phase three clinical trials, and we’re going to hear from two of those representatives in just a moment. Of those three trials, if you add all the patients up that are necessary for those trials, the number is about 500, 500 patients. If all goes well, those 500 patients will lead to drugs that are approved for NMO that might help 500,000 patients. That is profound. Folks who enter clinical trials and do it out of an altruistic motive are really heroes, and we want to just pay a debt of gratitude for those of you who have considered clinical trials, those of you who have participated in them, and those who might be considering them. So thank you everyone who has helped us with that.
Michael:
So, if you look at the table here, and there’s another page to this that I’ll show you that’s even just as exciting. But you can see on the left side, it talks about the intervention, a bunch of molecules that end in M-A-B. Whenever you see a molecule that ends in M-A-B, that’s a monoclonal antibody. If it ends with U-M-A-B, UMAB, that means it’s a humanized monoclonal antibody. Rituximab, I-M-A-B, means it’s a chimeric antibody that’s partly human, and partly from some other organisms. Anyways, you can get a lot of information just from the name.
Michael:
But look at the second column, the targets. CD20B cells, veg FA, C1Q Estrace, the overall immune system through bone marrow transplant, autoreactive T and B cells, a potassium channel called the KV 1.4 channel. CD19 positive B cells complement C five, the isle six receptor. An FCR neonatal receptor, a different potassium channel, a different way to target CD20 cells with OFA Tuma map, [inaudible 00:03:56] MIB, which targets Proteus Soma processing of proteins in B cells.
Michael:
The slides are a little bit funky because of a formatting issue, but there are now six or seven new trials that have just shown up on the radar screen in the last year and a half or so that target even newer targets. You’ve heard about B-cell activating factor or bliss. That’s one of them. There are some drugs that are being tested for pain specific to NMO. The point is there’s a ton of progress in clinical trials. And while some of the pioneers in clinical trials are here with us today, there’s a lot going on in addition to those studies.
Michael:
This is what the world map looks like today, if you think about where and how many clinical trials are being done on NMO. This map just a couple of years ago was largely colorless. And now it is filled every continent except Antarctica. And maybe there’s some people there who have been treated in a clinical trial, but it’s a huge number. It is a global initiative. And as I say, every person counts. It’s really the power of rare, and we appreciate all you do and all that has been invested in these clinical trials. With that. I want to invite Dr. William Marshall, dr. Bill Marshall, to come up and tell us a little bit about one of the clinical trials that’s focused on NMO. That’s progressing nicely. Bill.
Dr. William Marshall:
Thanks. Is that better? Can people hear me? Great. So I was just thanking the Guthy Jackson foundation for inviting us here. This is my third year here at patient day. It’s always very inspiring. And what I’ll talk with you for the next five minutes about is the prevent study, which is a study of the drug Eculizumab in the treatment of Aquaporin four positive NMO spectrum disorder. So the reason that we’ll go through this relatively quickly is that our trial has actually ended recruitment. Recruitment stopped in October of 2017. And we’re expecting that we’ll have results in this year, and can’t wait for those results to come out. So what I’ll take you through in the next few slides is the scientific basis for why we think that Eculizumab, which blocks the compliment C5 as Dr. Damon was just talking about will be effective in blocking the destruction of nerve cells that causes NMOSD and the symptoms of NMOSD. And then also through the phase two clinical study that’s already completed.
Dr. William Marshall:
So our study goal is to study the ability of Eculizumab to prevent NMOSD, particularly in patients, or only in patients actually, who are Aquaporin four positive. The medication Eculizumab is a MAB. So we know that that’s a monoclonal antibody that blocks the immune system’s ability to attack healthy cells by way of a compliment pathway. Which can in turn, if we block this pathway, prevent relapses. Eculizumab is not approved by the FDA or any other regulatory agency for the treatment of NMO, but it is approved for two other diseases, PNH and HAUS, and was just approved for a third disease, which is a neurologic disease, the disease Mayasthenia gravis. So that’s the disease of the peripheral nervous system. And if Eculizumab is effective against NMO, it would be the first time that had been shown to be effective in a disease of the central nervous system.
Dr. William Marshall:
So this is our artist’s conception of the science behind why we think Eculizumab will work. NMO appears to be a compliment mediated disease. We all know that for patients who were Aquaporin four positive or NMOIGG positive, that that inverted Y that Dr. Rose was talking about before can bind to cells and not shown there on the middle of slide with those inverted Ys attacking the yellow cell, which has green Aquaporin four on its surface. What kills this, although isn’t the antibody binding. It’s the binding of complement to the antibody that then punches holes in those cells that mediates the cell death, that then results in neuronal cell death and side effects such as transverse myelitis or optic neuritis. So because of this compliment mediated effect where it forms a membrane attack complex, and basically punches holes in the cell walls of the Aquaporin 4 positive cell, which you can see at the very, very top it’s that pink cell with those yellow circles represent the Aquaporin four water channel that’s targeted individuals for reasons that we don’t know.
Dr. William Marshall:
But we don’t need to know the reason why Aquaporin four antibodies developing people, in order to develop a therapy for it. What we need are mechanisms to block the death of cells. So one of these is Eculizumab. The bottom slide just shows that individuals with NMO have high levels of Aquaporin four antibody, the bottom panel. So where are we in terms of clinical trials? Right now, what we’re talking about is a phase three trials. So as we had heard this morning, there’s a special type of clinical trial that’s done in order to get a drug approved so that people can actually use it in therapy and it can be reimbursed. And that’s a pivotal registrational trial. And that trial that we’re talking about today, the prevent trial, is a study that’s a pivotal registrational phase, three trial, just like the study you’ll hear about in a little while from my colleagues for MedImmune.
Dr. William Marshall:
Before the phase three trial was done, however, there was a phase two study done by an investigator, Dr. Sean Piddock at the Mayo clinic, along with his colleagues who recruited 14 patients, gave them Eculizumab for an entire year. Everyone knew they were getting the drug and the patients did great. Only two of them had relapses during that entire year, and before entry into the trial, the average relapse rate for each patient was two to three relapses per patient. So very dramatic results from that study. And that’s the basis for our thinking the phase three study will be will have good results, but we don’t know yet. So let me just take you through the results that we do have since we’re waiting for results from our phase three study later in this year.
Dr. William Marshall:
So the phase two study was published in Lancet neurology in 2013, here we are five years later, still waiting for a result, which we hope to get this year. So these studies take a long time. Point out that the patient’s had multiple relapses in the last year and all were Aquaporin four serial positive. Of these 12 of 14 patients were relapse free. The number of attacks went from three per year per patient to zero, when you look at the median number of attacks. no patient worsened in terms of their EDSS score. Two patients had possible relapses in the year after treatment with Eculizumab. When you looked at patients who had been treated, and now were off the drug, five of those patients had eight relapses. So the disease returned in many of the patients off with Eculizumab.
Dr. William Marshall:
So from a last slide, I’ll just go over the risks and side effects. As we talked about, and as was mentioned in the film you just saw, no drug is without its side effects and Eculizumab side effects are well known because it’s been studied for over 10 years in those patient populations I was talking with you about. Things such as headache, nausea, dizziness, coughing, diarrhea, abdominal pain, and rash, but the critical side effect that people need to be aware of is infection. Infection with meningococcal in particular. So there was one patient in the phase, two trial, 19 year old woman who developed a meningococcal infection. She was treated successfully and then restarted the Eculizumab and finished the trial without a relapse. In all the patients in our study and all the patients in the phase two study as well, meningococcal vaccines required for entry into the study.
Dr. William Marshall:
So let me just conclude by saying that we’re very optimistic for the results that we’ll get later this year because of the science behind Eculizumab therapy, but also because of the phase two study. And we’d like to thank both the patients who enrolled in this study, but also the investigators for their tireless efforts over the past several years in the prevent study. Thanks very much.
Michael:
And now we’d like to ask Dr. Jack Ratchford to provide comments on a different trial that’s being conducted in NMO, Jack.
Dr. Jack Ratchford:
Thank you, Michael. So yes, I’m Jack Ratchford on, I’m a doctor working for a company that’s called Viela Bio, and we’re working together with another company that’s called MedImmune. And we’re both two biotech companies located outside of Washington DC. And we’re working to advance a therapy specifically for NMO.
Dr. Jack Ratchford:
So a little talk about what’s the kind of vision is for Viela Bio. It’s a relatively small company. And currently the NMO drug that is in development is the lead drug and development for the company. So the company is very focused on NMO. We hope to bring a proven medication for NMOSD to patients, and along the way also develop meaningful relationships with neurologists who treat this condition and also collaborate with the foundations like the Guthy Jackson foundation, which advocates on behalf of these patients. And part of how we do that is through helping to organize symposia.
Dr. Jack Ratchford:
This are pictures from a number of different activities that were done in North America, Europe, Asia, even Africa, where our company supported educational conferences to advance and improve knowledge of NMO. So the disease that… I’m sorry, the, the trial that we’re doing is called the N-MOmentum trial. And basically it is testing a drug that I’ll explain a little bit here. So we’ve heard a lot about Aquaporin four and how that antibody can bind to cells and lead to damage to cells in the central nervous system. Now, this antibody, which has present in about 80%, but we believe that there’s other antibodies that are present in other individuals like MOG was discussed. But these antibodies are created by the B cells. So what this drug does is it knocks out the B cells. So Rituximab was mentioned earlier. It has some similarities to Rituximab, but also some important differences, but both of those drugs act on the B cells.
Dr. Jack Ratchford:
So this one hits a target called CD19. The name of the drug is Inebilizumab. Just rolls off the tongue, doesn’t it. You got to love drug names. But it has name called MEDI-551. And this Y shaped thing we’ve been talking about, it binds to something called CD 19 on the B cell. It recruits these other cells called macrophages and K cells. They come in and they knock out the B cell. And we hope that that reduces the bad antibody levels and also reduces some of the other things that B cells do that can contribute to NMO attacks. So this clinical trial that we’re… it is ongoing currently. It is about 75% of the way through recruitment. And the way this trial works is patients go through a screening process and then they are randomized to either receive the drug or a placebo. Now, 75% of the patients get the active drug and 25% get a placebo at the beginning of the study.
Dr. Jack Ratchford:
The drug is given by infusion on the first day and two weeks later. And then you don’t have to receive it again for another six months. And it’s given every six months after that. Now the length of the randomized period where there’s a placebo arm is only six and a half months. So once that period is over, everybody rolls into what’s called the open label period. And that means everybody is getting the active drug. That rent open label period could last a minimum of a year for the individual might be several years that they might elect to stay in that open label period and receive the drug.
Dr. Jack Ratchford:
So a couple important eligibility criteria. This study is for adults with NMO or NMOSD. There has to be some recent activity of the disease. So they have to have at least one act one attack in the past year or two attacks in the past two years. So this is generally for people who are breaking through on their current treatments or newly diagnosed. It’s typically not going to be a study for people who are very well controlled on whatever they’re doing currently. There are some other criteria, but those are the key ones.
Dr. Jack Ratchford:
Now the study is enrolling 252 patients. That’s our goal, but we do have to… Because of the relative rarity of this condition, we do have to go fairly wide to get those patients. So we are on a spread throughout the world, North, South America, Europe, Asia, and Africa and Australia we have sites enrolling. We’re about 75% of the way through, as I mentioned. So we still are enrolling patients in the study. They’re… In LA we actually have not successfully been able to have a site. So for local people here, we don’t have a site in LA, but we have 23 sites around the United States. So for folks who might be interested in information about whether there is a site in, near where you live, I’d be happy to just fly me down. And I can kind of give you information on that if you’re interested. And I want to thank the Guthy Jackson foundation for asking us to come here and talk a little bit about our study. And we’re looking forward to taking questions to, from the group on clinical trials in general. Thanks. Thanks Jack.
Michael:
So we thought we’d give those of you here. A chance to have some Q and A with the industry partners. Again, if you have a question, just raise your hand and we can, we can start the process. There’s a question right in the center of the room there. Thank you. Right behind you.
Matthew:
Hi, my name is Matthew. I applied to be in the MEDI-551 study. So if anybody has any questions you can ask me. And I turned out not to be eligible. My transverse myelitis wasn’t sufficiently transverse, but I’m looking forward to hearing about the three new studies. So if you guys have any info on that… I guess that’s not really your specialty, but…
Dr. Jack Ratchford:
Yeah. So you had to kind of ask you about the other studies that we didn’t discuss today. You’re asking me? Yeah. So I mean, I could… Yeah it is not my specialty, but as Michael mentioned, there’s one other study being done by a company called [inaudible 00:18:57] for a drug they call SA237. I don’t have a lot of details about that, except I know that it involves something called Interleukin 6, a another way to kind of dampen down the immune response. And they’re making good progress, I believe through their study, but I think that’s all the information I have about it.
Michael:
If you want to come to the simplifying the science of NMO session, we’ll talk all about the targets and drug alignments with that. Thanks Jack. A question over please.
Audience Question:
I was one of the 14 in the phase two study, and I went from not walking to walking miles and it lasted for a whole year. And then for the next four years, I never had another attack. And then, since then they’ve come back like crazy. If you were in the two study, would you be eligible for the third study?
Dr. William Marshall:
Right. So, as I was mentioning, the third study is now close to enrollment as of October 2017. Hopefully we’ll have results out this year. And if they’re favorable, then you may be able to get the drug through your insurer a year or two from now. But again, that requires data that’s considered adequate to the regulators. But I’m, I’m glad to hear about your response. I’m sorry that your relapses have come back.
Michael:
Do we have a microphone we could bring over here, please? Thank you.
Audience Question:
Hi. I’m from Houston and I have just been selected for the MEDI-551 study. Can you tell me what I can expect? Kind of, sort of?
Dr. Jack Ratchford:
Yeah, sure. So great news. Glad to hear it. So basically you’ll be, if you’re in the screening process, now you’ll be assigned to one of those two groups randomly, as was said in the video. You don’t select which group you’re go into, but there’s a 75% chance you’ll get the study drug from the beginning and have 25% chance you’d be assigned a placebo. Now you’ll… If you go through the screening process and it looks like you’re eligible, then on the first day you go in, there’s a number of tests on some questionnaires that you fill out, EKG, blood test and check out by an ophthalmologist. A neurologist will examine you, and then you’ll also have an MRI done. And then you’ll get the study drug given to you on that day, or if they decide to do it the next day, they might do it that way.
Dr. Jack Ratchford:
And the infusion lasts a couple hours and then you go on your way, come back day four, day eight, and then you come back again on day 15 that you get your second infusion then, and then you come back periodically after that, kind of at month one, two, three, and then kind of spreads out a little bit more. The visits spread out a little bit more. Typical visits involve asking you how you’re doing. Maybe asking you those questionnaires again, asking you if you’ve had any side effects, taking a blood sample, and periodically getting tests by the eye doctor and the neurologist.
Dr. Jack Ratchford:
And then at the end of the six month trial, you’ll get another MRI and then you’ll be given the option, okay, you can now go into the open label period, so you’d get another infusion. You know, at that point, you’re 100% you’re getting the actual drug. If along the way, you have an attack, we’ll ask you to come in to be checked out by your neurologist. They’ll do those same things, eye doctor, neurologist check you out, MRI will be done. And then the doctor has a chance to give you any of the typical treatments they would use, whether it’s steroids or plasma exchange or something like that to manage the attack, if that were to happen.
Dr. Jack Ratchford:
Also, if you, if an attack does happen during that randomized period, that six month period, and you can go straight into the open label period from then. So say you’re a couple months in, and there’s an attack. You could go straight into open label period. That means that no patient would have more than one potential attack during that period. It could leap right into the open label period. So that’s a little bit of information about it. I’m sure they gave you a consent form. Unfortunately, it’s kind of a bit of a book, which is unfortunate. You’ve got in your hand yet. But yeah, that has a little bit more details, but I’m happy to answer any other questions later if you have any more.
Michael:
Jack, thank you. Other questions? We have a question in the back, back here, guys.
Audience Question:
Hi. I was recently diagnosed in December with NMO. I’m not positive on… I just heard about MOG today. But any of these drugs that you’re focusing on, there’s a lot of cognitive issues that I’ve been experiencing before I had the episode and was diagnosed in December. It goes back to 2012. And I’m high functioning with cognitive. So there’s not a lot of treatment for that. And I’m wondering with any of these drugs, focusing on that type of problems we’re experiencing?
Dr. William Marshall:
the end point for the trials, what we’re trying to affect are relapses. So cognitive relapses would be unusual. I mean the usual relapses are a transverse myelitis followed by optic neuritis, followed by area [inaudible 00:24:07] syndrome. So hiccups, nausea, vomiting. So cognitive effects, at least in adults are relatively unusual. Did you say that you were Aquaporin four antibody positive?
Audience Question:
No, I’m negative.
Dr. William Marshall:
Okay. So then the study that we’re doing wouldn’t apply to you, unfortunately. I know that MedImmune study actually does include people who are Aquaporin four antibody negative. So Jack might have some advice for you,
Dr. Jack Ratchford:
Right, so yes, our study does enroll both positive and negative people. So that includes… There was a question earlier about studies with MOG, we couldn’t enroll patients who have MOG antibodies also. So that’s… That would… So potentially you would be eligible for a study like this, like the one I was discussing. But as Bill said, it’s not specifically aimed at cognitive effects. All these studies are trying to reduce the chance of attacks, because it’s really the, the mantra is if we reduce attacks, we reduce the risk of disability. Mostly those are spinal cord or eye attacks, but also cognitive effects also could potentially be prevented, but it’s not necessarily… I wouldn’t have a real expectation to be honest, that it’s going to give you a drug and you’ll feel an immediate improvement in cognition. Really the goal is try to prevent attacks that to keep you as good as you are at this point.
Audience Question:
Do you know of any clinical trials that will be studying a drug for a cognitive issues? I know you University of Miami has one person working on a drug that would help people with cognitive issues. Are you aware of any clinical studies for that outside of new drugs?
Dr. Jack Ratchford:
I am not. And these experts here might chime in if they know of any others, but I don’t know of any others.
Michael:
I think the thinking at this point is, stop the relapse and that will benefit cognitive issues. But you know, for those who do have cognitive effects already, then both pain and cognition are two areas that are being looked at more and more carefully. But I don’t know that there’s one that’s registered to focus on cognitive changes yet, but stay tuned. Okay. Thanks. A question oh you first please.
Angela:
Hi, I’m Angela. A question for you. Would the MEDI-551, would… If you’re accepted into the trial, would you be taken off of whatever preventative treatment you’re… Like I’m on Ritoxin. so if I was to apply and be accepted into it, what I then stopped my Ritoxin infusions?
Dr. Jack Ratchford:
So basically, yeah. So certain medications, generally medications that will, are other potential treatments for NMO can’t be taken while in the study. So if you were on Ritoxin, you’d have to be off for that for at least six months before you could enter the study. So generally that’s generally what’s done for patients in that scenario. They wait six months and then see potentially if their B cells are coming back. And if so, then they might go into the, this… They potentially go into this study. If patients are stable on Ritoxin, they probably would not go into the study, because they probably, I mean, they probably have not had that one attack in the last year or two attacks in the last two years. So that patient’s probably not going to end up in the study. But yes, generally you would have to go off Ritoxin to enter a study like this.
Angela:
Thank you.
Dr. Jack Ratchford:
Sure.
Michael:
Thanks Jack. There’s a question right near the middle. Please go ahead.
Sheila:
Hi. My name is Sheila. I live in Michigan and I was just wondering for the trial that still accepting patients. Do you have a place close to Michigan or in Michigan?
Dr. Jack Ratchford:
Yes. We have a site, I believe it’s at Wayne State. I can double check that in Detroit, I believe.
Sheila:
Okay. Thank you.
Michael:
Other questions? Matt? Sorry, please. Up in the front up here.
Avery:
Hi, I’m Avery. And I just had a question about the MEDI trial. So I was originally enrolling for this study, but I was denied because I was MOG positive. So I just want to know if you’re now accepting MOG positive patients in that study.
Dr. Jack Ratchford:
So this is for the MedImmune MEDI-511.
Avery:
Yeah.
Dr. Jack Ratchford:
Yeah, so being MOG positive does not in itself exclude. Generally what we find though, with some patients who are, if you’re MOG positive, that kind of falls in this zero negative group, meaning they’re negative for at least the Aquaporin four antibody, which is kind of the main one. So MOG itself, there hasn’t been a change in the study. MOG itself is not an exclusion, but generally to get into, to be zero negative and make it into this study, you have to meet the full diagnostic criteria that have been in place since 2006. They have been updated more recently, but the trial started before then. So that means that you have to have had optic neuritis and a spinal cord attack. And that spinal cord attack has to be long, meaning three segments of the vertebrae or more. So my hunch would be that if maybe you didn’t qualify, it might’ve been that you didn’t have all those criteria. But I don’t think it was the MOG itself that would stop you, but happy to kind of talk to you more about your individual situation and we can maybe figure out what happened.
Nancy:
Hi, I’m Nancy, and I want to thank you for what you’re for all that you’re doing for us. My question is, does Eculizumab work with the T cells? Is that the… Is that what their target is?
Dr. William Marshall:
So Eculizumab blocks a protein that basically sticks to the end of antibodies and serves to punch holes in cells. So it’s part of the immune response, the innate immune response, the very basic immune response that people have, and it works with antibodies. Antibodies are made by B cells. So it really doesn’t involve the T cells to any great extent.
Nancy:
Wonderful. I’m happy about that. And then, this is like a really basic question, but I understand when you’re doing the trials and you have to be very specific. I’m negative, so I’m not eligible for any, but once the FDA approves this and I’m being very optimistic here, a negative person would still be eligible for that if they’ve been diagnosed with NMO, right? I mean, if your doctor is going to do it and your other treatments aren’t working, I mean, I get that there’s a whole hierarchy of things. But it’s not going to be excluded for NMO patients that are negative because we’ve not been able to be a part of the trial? That’s my question.
Dr. William Marshall:
Yeah. So doctors in the U S are allowed to prescribe drugs off label, but I can’t imagine that the label would include people who are Aquaporin for NMOIGG negative in its indication. And the problem with the labeling in that regards is that if it were ever approved, it would be approved just for people who are anti Aquaporin four positive. That might not be true for some of the other studies that you’ve just heard about. And insurers tend to follow the label very, very strictly. So while your a physician, could certainly prescribe it. As you said, getting reimbursement might be a challenge. But again, this, this all depends upon any of these drugs getting approved and that’s optimistic.
Nancy:
Thank you for being very sensible about that.
Michael:
Thanks for the great questions and answers. We’ve got time for maybe one or two more quick questions, please.
Alida:
Hi, my name is Alida. I have a question. Can maybe you speak to any drug studies that promote remyelination?
Michael:
Right. So putting out the fire of inflammation that leads to the attacks is the first step toward allowing the system to repair. Now, the question is whether the system will repair itself or whether we’re going to need to do more to stimulate repair, remyelination. There are studies being done by a number of other groups that look at a spinal cord repair remyelination and restoring function of nerve tissue. So our focus is on stopping the relapses. Others are working on repairing the damage. Great question. Thank you. Any other last question?
Michael:
It’s pretty unusual to have industry talking so openly about their work. So we really appreciate both Jack and Bill as well as Athos, you probably have met before, and others. One last question, please.
Audience Question:
Hey, there’ll be a question for both of you. For the [inaudible] , what is the protocol? How many infusions does it… Do you do it every 15 days, every six months every 12 month?
Dr. Jack Ratchford:
Right. So the way the Eculizumab was dosed in the trial and the way it’s dosed in other indications on is every two weeks during the maintenance phase and shorter durations, like a week approximately during the induction phase, which is about a month.
Audience Question:
Okay. And regarding your protocols, I noticed that there are some trials in Peru and Colombia. We support many patients in South America. Can do we get in contact with you so we can let them know they can participate in that?
Dr. Jack Ratchford:
Yeah. Terrific. Yeah. Thank you.
Audience Question:
Okay.
Michael:
Okay. Bill, Jack, thank you very much for your time. And [inaudible 00:33:34]. Guys, if we could just bring the… Yes, thank you very much. The, the second of the NMO pro surveys, we wanted to remind you are in your package. This one focuses on treatment and vaccination history.
Michael:
Clearly you’ve heard that patients can experience a different sort of history in their treatment. Some individuals beginning with one drug and changing to another, others beginning with yet a different drug and eventually changing to something else. We’re really interested in your views of your experience. Yes, we can ask the docs. Yes, we can have them go to the charts and say, okay, what happened? We would like your perceptions. Patient reported outcomes. It’ll really help us understand what kind of treatment patterns there are in the case of the vaccine experience, if there are potential relationships that might be of interest to consider. So if you could, please, if you’ve been a patient that’s been treated for NMO, if you could please help us by completing this survey, we’d very much appreciate it.
Michael:
And we just remind you about the other survey as well, the relapse survey. At the top of both of those surveys, it asks for [inaudible 00:35:07] status. Are you NMOIGG positive, MOG positive don’t know, zero negative. From all the questions we’ve heard today, we know that there’s a great interest in serostatus as it relates to disease, as it relates to treatment. So you can see why there are these kinds of questions in relation to relapse experience. What you sense as coming before a relapse occurs. Did you have ringing in your ears? Were you unable to sleep? Did your left foot feel funny? And with respect to the treatment history, the more we can know about your experience with treatment, the better we can understand relationships between treatment and effect.
Michael:
So thank you very much for those of you who would like to participate in those surveys. And as I said, there will be others online in the future. So thank you so much for that. We just want to take a moment now to move to a topic that really focuses on the concept that we don’t get to choose necessarily what happens to us in life or in NMO, although we can choose what we do in response to it. And it’s really that concept and seeing through the dark, into the light, that we’d like you to consider with this next video.
