You talk a lot about and reference like AGA guidelines for managing or introducing therapy for EOE. For something that's new, like a biologic, when would you expect that there could be new guidelines updated to include a biologic introduction? I don't know if there's an update. Nimi, do you know when there's going to be an update? So I mean, this just came out in 2020. So the answer to that is I don't know. And again, in terms of what you're going to be dealing with, the fact that it's not in the guideline, well, when this was published in 2020, the work was done before the approval came in May of 2022. So I mean, I think that's the reality. And again, other questions may come up. There are obviously going to be a lot of issues as far as dupilumab prescription and usage by patients moving forward. I ask people if they have something to take out of their day. You know, like, this is awesome. We're super excited. The data looks incredible. However, we're wanting to see like what our peers and experts release in terms of appropriate use guidelines. So I don't know if that's only an official journal or if that could be... So I think that's an excellent question as well. You know, physicians come in all flavors. You have early adopters and you have people who are late adopters and you have things in between. So early adopters will take anything and everything. And that's just how they're wired. And part of that may be for marketing of their own practices. But I think it's one size doesn't fit all here. I think that if you're someone like me, if I wasn't in the EOE disease space, my first response would be, I'm waiting for that phase three trial to be published. So there's one peer-reviewed article on dupilumab as a randomized controlled trial and it's a phase two study. So if you're going to take a conservative approach, you're going to say, show me the data. And you're going to show that the FDA has approved that. But I'm going to turn back to you and say, I'd like to see the peer-reviewed article that goes along with this. And right now, you only have one peer-reviewed article to go with dupilumab for the time being. And that's not to say that this is a bad compound. We're really excited. We're all jumping for joy that we have something and that I was able to change that slide and put that line through it. Go ahead. Go ahead. So I have a, the question's a little complex. So let's say some doctors that I've spoke to in the field, they've mentioned, oh, the patient, you know, we dilate. I haven't had to dilate in a couple of years, right? But let's say there's worse patients or we're multiple dilations in and the patient tears. What's the next steps? Like obviously, that needs to be repaired. And then post-repair, what's the patient lifestyle going to look like? How much impact does a tear or, you know, getting to that point in the disease impact the patient's life? Well, there's RENT, which is what you're supposed to see with a dilation, which is you're basically tearing slightly the fibrosis. And then there's a through and through tear, which is free perforation to the mediastinum, which becomes life-threatening. That can be treated conservatively. That could be treated sometimes with surgery. That could be done through a scope by surgeons. It can result in open surgery. So one size doesn't fit all. These are extremely rare cases. And you know, anecdotally, the patients that I've seen for the most part have done quite well. There's one person anecdotally in particular that I think of who's had perforations twice before his diagnosis was even made. So he's perforated twice, and this individual was an investment banker in New York, and he fit all the criteria for hypervigilance and anxiety. And it really changed his life in a big way. So it affects quality of life. But again, you know, if you have a through and through perforation, there is not one necessary. It depends. It all depends on the severity of the perforation, whether it's contained or not, things like that. Okay. Question here in the middle. Yeah. I had a provider mention that she treats with H2 blockers and that there was better information on that. Do you know anything about that? Well, I think there's very good information. There is no information on H2 blockers in EOE. H2 blockers as anti-secretory therapy, you know, those date back to the 1980s. There are not many people in the room, remember, other than me, when this was first prescribed and when these were first developed. It was a big change for peptic ulcer disease. You know, famotidine is really the only one. Raniridine was taken off the market and may have been reintroduced. But its role in EOE, I'm not aware of any role in NIMI. It's really, it's not the case. And again, there is this entire cottage industry of PPI adverse events and it's more so among the primary care doctors and the family doctors, the non-gastroenterologists. Our literature makes it very clear. There's clear best evidence in this. There's clear level one evidence with this randomized control trials that these drugs are safe. Can there be idiosyncratic issues? Yes, very rarely. Are there real side effects of PPIs? The things that people don't talk about are things like headache, diarrhea can occur, things like microscopic colitis. Those can occur, but all these horrible things, dementia, metabolic bone disease, cirrhosis, you name it. I think the data for that are iffy at best. So H2 blockers are not part of the portfolio of EOE management. Other questions in the far part of the room? Hi. So mine is about the shared decision making. So when you're having that conversation with the patient that's come in, I'm more... Now we have a biologic, right? So the conversation is going to look a little bit different. And I guess I'm wondering what that might sound like if you're sitting across from a patient. Would the biologic conversation come in later down or is it like this is the new shiny toy? Let's have this discussion, diet, dilation, drugs, biologic in there. So I think that's a great question. And the answer to that is we're just kind of taking this all out for test drive right now. And it is part of the shared decision making for me. And I'll be curious what Dr. Gonsalves has to say about it. But it will be something I discuss. I'll tell them that it has a response rate of between 60 and 80%. It has the advantage of being an injectable once a month instead of taking something twice a day. However, and the big asterisk is that what's this going to cost? Is your insurance company going to pay for it? And that's the big, that's the elephant in the room with this. I think where I think the sweet spot for dupilumab is right now is for people who are not responsive to standard non-FDA approved therapy, for people with multiple atopic issues. Those are people that I'm going to go to the mat for to fight for the drug. But in terms of individuals who have not tried simpler, less expensive therapy, again, at the risk of insulting the people who invited me here, I mean, I think it's a complex thing because of the cost factor. And quite frankly, in the physician factor, there's going to be the paperwork factor. And again, we are here to be advocates for our patients. And I take a very firm view that not only we're advocates for our patients, but we're advocates for appropriate and optimal use of health care dollars to really optimize things for society benefit. And I think it's a very nuanced thing because if you're going to have a bill of what we think this might be, as a physician, I don't want to put someone into poverty, number one. And patients are proud. And I have yet to see a patient, or I shouldn't say that. We didn't used to see patients who would tell us, I can't afford the medicine. They would just kind of take the prescription in the old days when we write it out and they just kind of roll it up. Now patients, especially for things like SIBO, make it very clear to us they can't afford the compound. Nibi, how are you handling this discussion right now? Oh, OK. So I'm handling it very similarly to Dr. Falk in terms of having discussions with patients and really thinking about which patient we would have. Oh, sorry. Take the mask. So I'm having a similar discussion to Dr. Falk in terms of which patients we're talking this through. We approach our clinic where we go through all the pros and cons of each individual therapy with our patients and then make a combined decision with them. When we think about biologics, I mean, it's really our patients who are very atopic, who've been refractory, who may have some other added benefits. It's hard to think about a conversation with a brand new patient who's never tried anything. And I think the other thing you need to think about is patients are always a little bit scared when they get this diagnosis in terms of jumping into something kind of new. So we'll see how this plays out in the next month or so, but I approach it very similarly to you. And the other issue with a biologic or patients who are hearing biologic, what is it going to do to my immune system? People think of the anti-TNF experience. It's not an anti-TNF. Is it going to affect my immune system? I'm going to be using this for many, many years. Is it going to increase my risk of X, Y, or Z? And the answer is we don't know. So I think the key thing here is that there is enormous excitement. That refractory patient group, it's really throwing darts. The appeal of multimodal therapy is not very high. The appeal of elemental diet is not very high. So this is the sweet spot for this biologic and other biologics right now until the cost issue shakes itself out is going to be in multiple atopic issues in refractory patients. I think the issue of not compliance with a drug, but esophageal compliance is a real signal that's going to be very interesting to follow over time. And the other big advantage of this and other biologics is the frequency of dosing. That's a great advantage, but it really comes down to when you go to checkout what it's going to cost. And I think that's, we just don't know how that whole thing is going to shake out. Let me make one other comment. You know, I've listened to my IBD colleagues for years moaning about prior authorization. I mean, it's a real, the prior authorization thing is the bane of the IBD physician's existence. And I can tell you that we were talking at lunch about the Sisyphus of Epic and Outlook and Every Day. And then if you're dealing with prior authorizations as well, you just throw your hands up and say there's only so many hours a day and what can we do? And that's where we're going to need to partner with you and going to need your help because that's going to be a huge deal. Esophagologists are not used to dealing with prior authorizations. By the way, there's another group that's important, people who were in the phase two trial. So the first patient I put on dupilumab last week flew through for a very simple reason. Number one, they were in the phase two trial. Number two, they're an employee of Regeneron. So they got the drug immediately. Right here. So this is to piggyback what you're saying about cost and paperwork. You mentioned that the PPIs and topical steroids are not FDA approved. Can you help me understand, do you not have to do prior authorizations for those? Well, PPIs you can get over the counter. So PPIs you can just, you can go to the drugstore and get over the counter X, Y, or Z without a prescription. The topical steroids, it's variable. I think that, you know, there is some resistance because again, those are not inexpensive. They're very expensive if your insurance plan doesn't cover it. So there are a lot of hurdles put up with that. And for the issue of it's not FDA approved, we have a form letter that we send out with all, with references and the best practice guidance that basically says, yeah, it may not be FDA approved, but this is what our professional guidelines say. So are prior authorizations needed for the topical steroids? Yes, but infrequently. For the PPIs, not really at all. Okay, over here. Just a question around costs. So a lot of times, so for example, with Dupixent, we have a, you know, a comprehensive program for patients to get it at a discounted price. And you know, we allocate resources to those patients. We try to help them where we alleviate costs or pressure of costs at least. What's the best way in a practice to deliver that to the practice? I feel like what ends up happening is, yes, IBD hits a lot of PAs, a lot of prior authorization problems and step edits, but part of it is that we can't get those resources to the accounts, the proper resources, or, you know, what's the best way that you would want a rep to come in and introduce those type of resources where you know that there's help for commercially covered patients, there's potential help for Medicare patients, you know, or there's assistance along the way. How do we deliver a more impactful message? I think that's a great question. That's an important reason that everyone's here today, and the partnership is going to be really, really important. I think I can only think about my own shop where, you know, pharmaceutical reps are not allowed in the hospital. But at the same time, if I write a prescription for Dupilumab and send it off, that's when all hell starts breaking loose. Where the partnership is going to have to take place is behind the scenes, and probably with our clinical pharmacologists and the people who do that, that's how we're sorting out our pathway at Penn, is that we're utilizing for right now, until they get sick of us, the people who do the IBD work. And I think the best way is that each site, you're going to have to individualize it either on the phone or, you know, or on Outlook to see what's going to work best. One size doesn't fit all. Namie, how are you handling it at Northwestern? Yeah, so this is a great question. So this just happened as soon as we got back from DDW. We started rolling in our patients who were in the clinical trial. And we're going through our specialty pharmacy to put in the prescriptions. We put in like nine, I think. All of them have been rejected off the bat. So now they're going through the appeals process. Your field reimbursement agent has met with me, has met with our staff, has met with our specialty pharmacy. So there's a lot of work on the back end. It sounds like there's a lot of opportunity and the jupixent way and lots of ways that our patients can get it. It's just a matter of getting through these hurdles and learning from this in the next month. I would say, while this sounds all a little daunting as we're talking about the practicalities of this, I just want to share like a happy story. The patients, and I'm sure yours as well, Gary, who went through the initial trial, were, you know, obviously prioritizing them. They were tending to be the more refractory patients. They are so very appreciative of all of this. And I think this is what makes our kind of job so much easier and rewarding is to watch all this bench to bedside research and see patients through this clinical trial and have this medication approved. I mean, they were just, some of them were crying just hearing about this approval. So I mean, I think we're going to learn a lot in the next month on how to push this through. And just to expand upon that, tomorrow morning we're going to have a session on the day and the life of a gastroenterologist similar to our panel session this morning, except it's going to be more focused on EOE. And as you know, we've got an IBD specialized faculty member who is really expert in how to deal with the flow of that information and trying to get the structure of the staffing situation proper. One more question and then we're going to take a break right here. Yes, thank you. You mentioned that you can't treat based on symptoms, but I've encountered some physicians who say that they can't get approval to do a repeat scope. How have you guys navigated that and been able to do repeat scopes after new treatments? Well, you know, as far as clinical trials, that's easy. As far as other, for some reason it hasn't been a problem. There's an occasional person who tells me they got a bill, but in our place it hasn't been a problem. It's been like a Northwestern, but again, we hear that too. And again, we use endoscopy, but even at the ASG headquarters, I, where is a huge need for alternatives to endoscopy and that's being investigated. Same for me, I mean, I think we've never had someone come back and said, Hey, I have a bill. How do I navigate this? But the thing that we have in our back pocket is there are all these guidelines that suggest the use of endoscopy to follow disease because there is a big symptom histology disconnect. So a lot of times if that happens, we appeal and we do that, but it does take some effort, but we do it on behalf of our patients. Look, I just make one last closing comment here is that I think that I think one of the messages of both talks is that that is where there's this, the two major disconnects between town and gown is the concept of treat to target the need for repeat endoscopy. And the fact that symptoms alone really cannot inform your treatment decisions. It's just not enough. You're just tricking yourself. So I think that's really important. There's resistance to that. But I think it's part of a conversation. Great. Please join me in thanking both Dr. Falk and Dr. Don Galbraith.

biologics

Eosinophilic Esophagitis

treatment

guidelines

research