#86 Biologics in Food Allergy Care: A New Era with Dr. Brian Vickery
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This transcript was generated using AI software from the original podcast audio and may contain errors, omissions, or minor inaccuracies. It has been lightly edited for readability. Please refer to the full podcast episode for the most accurate representation of the conversation.
Brian Vickery, MD
Biologic is a type of medicine that, usually is injected and is a, a, an antibody based medicine. So antibodies are, are proteins that our own immune system makes naturally. It's kind of what helps us fight off infection and perform other important functions naturally inside of our immune system. The clinical development field broadly have learned how to turn antibodies into medicines over the last 20, 25 years. These medicines have become very useful in the treatment of lots of kinds of conditions, skin conditions, digestive conditions, cancer autoimmunity, and now more recently, allergy. And the reason that we like to use antibodies as medicines or biologics as medicines is because they're very, very specific. They can only act on what they can see as a target.
Amanda Whitehouse, PhD
Welcome to the Don't Feed the Fear podcast, where we dive into the complex world of food allergy anxiety. I'm your host, Dr. Amanda Whitehouse, food allergy anxiety psychologist and food allergy mom. Whether you're dealing with allergies yourself or supporting someone who is, join us for an empathetic and informative journey toward food allergy calm and confidence. This season of the podcast is all about exploring the expanding landscape of food allergy treatment, and I'm trying to walk through it with you step by step to explore all the options and better understand them.
Today's conversation moves us into one of the most significant shifts in recent years biologics. I'm joined by Dr. Brian Vickery, a leading allergist and researcher at Emory University, whose work has shaped how we think about immunotherapy, immune modulation, and patient-centered outcomes in food allergy care. Dr. Vickery brings both scientific rigor and clinical insight into today's discussion. We talk about biologics as standalone treatments, how they might be used in combination with other therapies, and what this means for families navigating risk, safety, quality of life, and practical factors like cost.
Dr. Vickery and I are hoping that this conversation will bring some clarity to you if you've been wondering what biologics could mean for both your medical outcomes and your emotional burden.
Dr. Vickery, thank you so much for being here on the Don't Feed The Fear Podcast. I'm so excited to have you. Well, Amanda, thanks for the invitation. We're gonna talk about a lot of things. You have a lot of experience all across the world of food allergy. We're hoping today to have a conversation focusing on biologics, but share with the audience a little bit about what you're doing.
Brian Vickery, MD
Yeah, so I'm at Emory University in Children's Healthcare of Atlanta, and I've had three main jobs since the time I've been here, and just recently kind of took on a fourth. so my, my three main jobs are I, I see patients as an allergy provider is a pediatric allergy provider. So I'm in clinic two half days a week, and see children primarily up to age, about 21, at our facility with all kinds of problems, to and including food allergy, eczema, asthma, the whole gamut. I run a research program devoted to food allergy and also asthma. And then I'm the chief of the Division of Allergy Immunology here at Emory, which means I'm responsible for for clinical operations and faculty development and other administrative things. and then most recently I was offered the opportunity to become the vice chair of clinical research here for the Department of Pediatrics where I'll have a role kind of overseeing how clinical trials and other studies are done, including but not limited to allergy across our department.
Amanda Whitehouse, PhD
That's a lot of hats to wear.
Brian Vickery, MD
It seems like it sometimes, but, but it's all good. Every day is fun and challenging.
Amanda Whitehouse, PhD
Just for context, when I first met you I learned how involved you are in the mental health side of working with food allergies and food allergy treatments. So can you touch on that and your perspective on that a little bit for us?
Brian Vickery, MD
Yeah, I'm happy to see that there's more and more awareness of the psychosocial behavioral mental health impact of food allergy on not only the patient, but the caregivers and the, the larger family. This is a condition that touches everybody, and I think we've always sort of understood that in taking care of patients one-on-one and trying to understand what their needs are. But I think that increasingly as a field we're more and more aware there is more and more, research going on in this area, more and more publications coming out, more and more practitioners in the space providing mental and behavioral health support for these patients.
And so, there's been a lot of progress over the last five or 10 years, which is remarkable and good. We still have a long way to go. But it's been fun to see that really starting to take hold because, on a day-to-day basis these impacts are, are considerable on patients and families. As a physician, as a clinician allergist, I feel like a lot of what affects people's day-to-day lives and their functioning is, is not something I'm really trained to take care of as much. We talk about the, the medical parts and the treatments and the diagnoses and all that kind of thing, but the day-to-day impact really is, is largely felt in that behavioral psychosocial space. We see that and we're kind of powerless to do a lot about it. So we really depend on partners and, I'm glad to see that there's more and more partnership
Amanda Whitehouse, PhD
Well, thanks for being a part of that. I think obviously it has to come from all directions for it to continue to grow. I enjoyed talking with you and your enthusiasm about it. It's so important. While I was preparing and going back through all of your publications, I found the article with the PEACH tool. Can you tell me about that tool and, and what we should know about it?
Brian Vickery, MD
Yeah, so it's, it's still in development and we're actually recruiting for a validation study right now. So this, this is being led by Kait Proctor at our place. Kait is a pediatric psychologist with a PhD who works with our group clinically and on a research capacity. Very strong collaborator of mine. Kait is really leading this project. Where this sort of originated from was a realization that although we do have validated PROs patient reported outcome instruments for quality of life and food allergy and quality of life is a broad cross-cutting set of measures to the point that the large sort of full measure, contains many, many items and takes up to 30 minutes or more to actually fill out. So it's not really a, a, a tool that's used in everyday clinical practice and it measures quality of life. It can be measured by the patient, him or herself, depending on their sort of age and developmental status. Or it can be measured by the caregiver as a proxy report on behalf of the patient. But it really focuses on quality of life.
Now, this is, I should say, this is not the only tool. There are others measuring anxiety and other things. But, but most of them relate to the experience of the patient, either reported by him or herself, or by their caregiver, as a proxy. What PEACH was developed and the gap we're attempting to fill is the recognition again that food allergy affects not just the patient but the entire family. It affects the way they travel, it affects the way they shop. It affects sometimes like the decisions are made about where the child goes to school, maybe even the parent's occupation and how much time they can or can't spend at home. And so. These impacts are not really captured in a quality of life tool. And so the, the idea of the PEACH is really to develop a tool that in a more kind of 360 fashion measures how the patient's food allergy is affecting the functioning of the entire family unit. And so we're, we're hopeful to move that forward.
Amanda Whitehouse, PhD
I'll have to have her on the show to talk about it more down the road.
You have vast experience with research and clinical aspects and perspectives within food allergy. But the thing that I've heard you talk the most recently about that I'm excited to have you share with my audience is what is going on with biologics. And all of a sudden we have all these options. Why don't you start by telling us maybe in the way that you would sit down with a patient who was in the clinic, considering whether these medications are right for them.
Brian Vickery, MD
Yeah, so this is part of our shared decision making conversation with individual families about kind of understanding where they are in their journey, and what their needs, goals, preferences are, what the, what the patient's specific allergies are and so on. And, and if they're ready to have a treatment conversation, then what treatments might we consider? Right? And so biologics are now part of that discussion. And that sometimes starts with the discussion about what a biologic is.
Biologic is, is a type of medicine that, usually is injected and is a, a, an antibody based medicine. So antibodies are, are proteins that our own immune system makes naturally. It's kind of what helps us fight off infection and, you know, and, and perform other important functions naturally inside of our immune system. And we've learned. You know, we, the, the, the clinical development field broadly have learned how to turn antibodies into medicines over the last 20, 25 years. so it's really hard these days to be able to watch you know, a primetime show or a sporting event without seeing ads for multiple biologics.
These medicines have become very useful in the treatment of lots of kinds of conditions, skin conditions, you know, digestive conditions, cancer autoimmunity. And now more recently, allergy. And the reason that we like to use antibodies as medicines or biologics as medicines is because they're very, very specific. They can only act on what they can see as a target. And, and antibodies can be very precisely targeted to certain. Things in the body. So, you know, the, they can have unintended, you know, adverse events related to their function, but compared to, you know, small molecule drugs like take a, you know, a steroid medicine. you can, you take a steroid medicine that goes into the target you intend it to, but then all kinds of other target, it goes throughout the body. It, it creates all kinds of unintended problems.
And, you know, biologics are very, very specific. They, they target one thing, it's like a, like a rifle shot instead of a, a shotgun. Right? And, and that's, that can be useful for, for precision when you have a patient with a condition that affects one of those pathways and, you know, you can, you can precisely target that. So that's kind of oftentimes we have a level setting conversation about like what biologics are. You know, what we know about them what their safety profiles are, look, you know, look like what they're useful for. And one of the things that's important in the conversation about biologics is many of them are approved for more than one condition. Many of my patients in the clinic have more than one condition. In fact, rarely do I have a patient that has. A single condition. You know, even the ones where food allergy is the only problem, often have more than one food allergy. but certainly we know that eczema is very common. In patients with food allergy, many patients also have wheezing or asthma, allergic rhinitis and so on. So conditions clustered together and some of these biologics can be useful for more than one condition. We sort of fit all that into a puzzle to start to then distill it down to what might be useful in this particular situation. And, that's kind of how the conversation starts. I think we have a few choices of specific medicines that I'm happy to talk about and what, what they might be able to do for a patient with different kinds of allergies.
And then, that's kind of current state, what's available out there right now in terms of biologics. There's a lot of research in this area. In future state, we may have more and more biologics coming available as, as is the case in other fields.
Amanda Whitehouse, PhD
That would be a great point to start, if you don't mind. I have a big food allergy audience, so specifically they're the most familiar with Xolair, I think. But why don't you tell us about what the options are now and what specifically each of those can target.
Brian Vickery, MD
That's a good place to start for an audience that's mostly interested in food allergy is is with Xolair Omalizumab, which became approved by the FDA for the treatment of food allergy in February, 2024. It was the first biologic to receive an indication for food allergy. Xolair or Omalizumab has been on the market for about 20 years. First approved for asthma in adults, and then down to adolescents and grade school kids down to age six for asthma, and then secondarily later approved for the treatment of chronic urticaria or hives. And then food allergy became the third indication following the completion of a large pivotal phase three trial called the OUTMATCH trial in which my site participated with nine other sites around the country.
And we were able to show that that about four months of treatment with omalizumab was able to produce quite a robust desensitization. So it's not a cure for food allergy, but it takes somebody who's quite sensitive, meaning reacting to small amounts of a food after four months of Xolair injections when the challenges to measure their sensitivity level are repeated, there is often 30, 50, a hundred fold improvement in their threshold levels, which would have the effect of protecting them from accidental exposure.
And what we see when we use omalizumab and where this might be a particular advantage, is that benefit occurs across foods. So in other words, it's not specific to one particular food. It's not just for peanut allergy or just for egg allergy. for theoretically any allergy. And especially in those patients who have multiple allergies which we, we understand is about 30 to 40% of the food allergic population. And that's important because we really had not had an intervention that would be helpful in the multi food allergy situation in somebody who had a more unusual allergy. And, and I'll say here, not even necessarily all that unusual, like sesame, for example. There hasn't been a ton of work in sesame, even though it's a dominant allergen. So omalizumab could be useful in these kinds of clinical scenarios. And the other thing that was sort of novel about it is the age distribution. So it became approved down to age one. And at the time we didn't have an FDA approved therapy for food allergy for kids as young as one. And then it extended into adulthood. And by the same token there was a product approved for patients age four to 17, but nothing beyond that. We didn't have a solution for the millions of adult patients who have adult food allergy and, and now, omalizumab is a potential option for them to discuss with their allergists.
So you know, that really sort of reshuffled the deck and changed the game when this became FDA approved back in, in, in early 2024. And the latest estimates I've heard are that somewhere around 80 to a hundred thousand food allergic patients have now used omalizumab for the treatment of their food allergy across the US as of sort of January, 2026, Xolair is a, is an option that really has, has changed the game and can be useful as a solo desensitization strategy by itself. Sometimes it's used in combination with. With other treatments like oral immunotherapy, and if you wanted to talk about kind of a combination approach, we could, we could talk about that too. But that's kind of taken a front row seat there in, in terms of the biologics conversation. And it remains to this day, the only one that's approved and, and shown to be effective in, in treating food allergy. And so that's, that's something you can have a conversation about a treatment for you or your child with an allergist you know, today?
There are, there are investigational biologics that are being studied in research that are, are not yet available, and, and I'll talk about those in a minute. I think the other main kind of clinical option. That's important to know for this audience is Dupilumab or Dupixent is the commercial name. And this has been a game changing biologic medication for, for patients with moderate to severe eczema or atopic dermatitis, which we know is very common among patients that have food allergy. So somewhere like 90, 95% of patients with food allergy have eczema to some degree. Now, not all of those are moderate to severe. But we see lots of patients where they've got extensive eczema that's hard to control, that really affects their daily quality of life when they're itchy all the time, breaking out, having trouble sleeping, and the topical approaches aren't, aren't helping.
In some of those patients dupilumab or Dupixent can really get the eczema under control and bring a lot of relief. Dupixent is also approved for asthma. which we know also know is, is highly comorbid in patients with food allergy. So in patients where their, maybe their food allergy is, is relatively easy to manage with avoidance, but some of these other problems are really popping up and difficult to control, then Dupixent is an option.
One of the questions that does come up from time to time is that the way that Dupixent works is to silence a part of the allergic inflammation mechanism that does many things. Which is why Dupixent is now approved for many allergic conditions. But one of the things that it does is it, it that signal goes to the antibody secreting cells called the B cells. And. D when Dupixent blocks that signal, then B cells don't receive the information they need to make IgE anymore.
And so patients on Dupixent experience dramatic decreases in their in their IgE levels over time. And those are the levels that we often measure in patients who have food allergy. And so what we see is in somebody who has food allergy, who goes on Dupixent, say for their eczema or their asthma, if you measure their food specific IgE levels over time. They can decrease by half, two thirds, three quarters dramatic decreases in their levels. Which, if that were happening outside of the Dupixent context, we'd say, oh, this is great news. The food allergy looks like it's getting better. But what we've seen is that despite the fact that those levels can, can drop quite a lot, those patients end up being still just as reactive to their foods as they were before. So that's really kind of an artifact of the treatment. And it means that we can't measure levels and know what they're doing in patients receiving Dupixent for one of these other indications.
There was one study that looked at Dupixent in terms of treating peanut allergy, and that was several years ago. At this point, we were hopeful, we were optimistic that maybe it would actually do something to cause desensitization. It doesn't. This was a study in peanut allergic children who were on average about 11 years old, although the treatment for six months was able to dramatically decrease their IgE levels to peanut when they were challenged, that 50% reduction in IgE levels did not translate into clinical protection.
So we don't think that Dupixent alone in the older patient who has established allergy works as a food allergy treatment, although I, I, retain some hope that it might work in different populations, like really young children, but that hasn't been shown yet. So I think those are kind of the two main biologics to be aware of in terms of having conversations with your allergist. then I guess kind of in a related way, one of the things that the other conversations that sometimes comes up is, can you be on both at the same time? So, Xolair treats food allergy and asthma, but not eczema. Dupixent treats eczema and asthma, but not food allergy.
If you have some combination there, can you, can you stay on both treatments to treat all three of those conditions? and, and the answer is there's no contraindication to doing that. It's not like they interact with each other or it would be unsafe to do it. There are, you know, patients who can take both, really becomes more of an insurance issue and, and a coverage reimbursement issue than it is sort of a, a, a clinical decision. But, but there are not, you know, not tons of patients that take both.
Amanda Whitehouse, PhD
Okay, thank you. Because yes, that does come up often. So that's helpful to, to know. And it is unfortunate that we always run into these financial and insurance barriers when there are things available to us, but that's the reality of it, unfortunately.
Brian Vickery, MD
Well, it's a real issue, right? I mean, these medicines can be life changing. As I said, they're very specific in their action. They, they target very specific parts of the immune system. And by the way, I should put it in note here, that whether it's Xolair, which binds to IgE in the circulation and kind of sequesters it and thereby kind of calms the allergic immune system down, or whether it's Dupixent that blocks the signal required for IgE in the first place, these medicines have an effect on the allergic parts of the immune system, and they leave the rest of the immune system alone. So they're not really thought to be or, likely to have long-term significant side effects with respect to being susceptible to infection which some other biologics in some other classes are.
You could take a biologic for, for say, Crohn's disease or colitis and there. Based on the mechanism, then there, there could be some more serious infection related side effects that you need to know about. That's not really the case with Xolair and Dupixent as far as we know. They've been shown to be useful for several allergic conditions. They're generally pretty safe and well tolerated. But they are expensive and, and that's an issue. They can be out of reach depending on your coverage plan. That is the one of the downsides about, about biologics. In addition to the fact that they're injectable which a lot of kids obviously don't like but they, they you know, the, the price leaves a lot to be desired. Especially if, if your coverage is somewhat limited.
Amanda Whitehouse, PhD
Well, and especially when, as far as I'm aware, these are medications that you stay on. Right? When you stop taking the medication, you lose the benefit, right?
Brian Vickery, MD
That that's right. Yeah. Because they're not curative. You know, they can be helpful. But, but when you stop 'em, like any other medicine, they kind of wash out of your system and then and then the condition comes back, right? If you're on a medicine for your blood pressure or your cholesterol or something and it's controlling it as long as you take the medicine, but when you stop it, it comes back.
And that's the same kind of thing here with your allergy. And so, yeah. So there's not a really clear off ramp. And we, and we talk about that with, with patients that often comes up when we make that point. The next obvious question, which makes total sense is, wait, so you're saying I gotta take this the rest of my life? and, and the answer there is, well, maybe, you have to have that mentality in mind and know that this is not something that we just use for 18 months and then stop and then there's like a, a permanent effect. If you stop it, the effect usually goes away. but I, but I encourage people like, don't necessarily think about it with like a 40 or 20, or even 10 year time horizon, because the field is, is changing so fast and so much that it's very likely that there will be other options available to you by then. And then the decision will be, do I wanna stay on this or shift to something else, which I guess is a good segue to talk about sort of other biologics that might be coming, things that are being studied right now.
And what you're seeing is that there are three or four versions of what I would call sort of next generation anti IgE treatment. What Xolair was able to show in terms of desensitization, Xolair requires one, two, or three injections given, every two or every four weeks. So that can be kind of burdensome. And as good as it was, there were some patients that that didn't seem to respond that well to Xolair. And so there are still some limitations with it. And you've got additional antibodies that are being studied in clinical trials that would have a similar mechanism to bind IgE but have different characteristics because they've been engineered to have different characteristics. So maybe they bind IgE, a little better or at a different place on the molecule or they've been engineered so that you don't have to give them as frequently. Maybe you could give them a few times a year and get the same benefit instead of every two weeks. so there are these kind of what I call next generation anti IgE medicines that would sort of build on the success of Xolair and, and hopefully improve it in some important way.
The other thing you're seeing in that anti IgE space is biosimilars may start to come out. They're not really available now, but biosimilars is sort of like the generic of a biologic. You could think of it that way. We still don't really understand what biosimilars are going do to the field. Because that sort of, again, depends on how insurers and other stakeholders view them. That's not currently an option but maybe down the road. And then I think you're going see some other kinds of biologics as well outside the anti IgE space. And so. One interesting approach that's being studied now is a biologic. And again, it's an antibody treatment. The antibody is the medicine, except the antibody is not recognizing the immune system. The antibody is recognizing the allergen, right? So there's a medicine that's a couple medicines being developed for peanut allergy, where the antibodies that are given are antibodies against peanut. One of the thoughts about how immunotherapy works is that by taking sort of micro doses of your allergen, your body starts to make a lot of antibodies against that food. And those antibodies are not IgE, they're IgG. The idea is that then those IgG antibodies kind of hang around and protect you from the accidental exposures if you ever take peanut by mistake. Those antibodies are now are ready to react and sort of to trap the peanut before it causes a problem. so there are some companies that are saying, well, if that's the case, we can just give people a whole bunch of IgG antibodies against peanut straight away. We could just tank 'em up so that they have high levels of these anti peanut antibodies all the time, kind of on defense so that if they, if that patient were to encounter the allergen, those antibodies would be there and just sort of trap it and keep it away from the immune system. And so that's an interesting idea where you might get the benefit of immunotherapy without having to, to take the daily dose of allergen over and over and over and over again to get the antibody. Go in and get the antibodies straight away. That's an example of a, of a novel biologic approach that's being studied.
And there are several others that are, that are being studied to target other parts of the immune system. So, it's an exciting time where these companies that do this, some of them are small companies, but many of them are bigger companies that again, have developed biologics for lots of other conditions. Sort of like, I would say big pharma companies with a lot of resources that are now kind of increasingly interested in meeting the needs of patients with food allergy and ultimately that's really a good thing for the field and for the patients to have interest in this condition from kind of deep pocketed companies that know how to make these medicines.
Amanda Whitehouse, PhD
Yeah, it's exciting. There's so many, so many things on the horizon. I want you to go back and touch on something that you mentioned and tell us more about what this can look like in conjunction with some form of immunotherapy.
Brian Vickery, MD
Yeah. So I mean, I think again, in that shared decision making conversation, we kind of talk through what the options are and depending on your age and your food and your goals, you may have multiple options now, and it can actually be a little bit even overwhelming. So remember that avoidance is a perfectly reasonable strategy for one or more foods in a multi food situation. You may desire to tackle one or a couple of them, and then leave others for avoidance. You may have a desire, especially if it's a staple food allergen and the child's kind of young to actually over time, try to incorporate that into the diet if possible. Whereas, your average older adolescent or young adult with say, a tree nut allergy, I'm generalizing here, may have no interest in ever consuming the food, just wants to know they're protected.
So it depends on a lot of things, the age the food, the goals as, as you walk through that shared decision making conversation. And then we talk about kind of what those options are. So, patients are drawn to immunotherapy if they decide to treat it because it's like a natural way to do it. It's like you're, you can explain the concept to a young child and they get it, it's like you're going take small amounts of this stuff, your immune system's going to get stronger and learn how to tolerate it. And it'll protect you if you come into contact with it again.
But there are some drawbacks with it. You gotta swallow the thing you're allergic to. A lot of kids hate the taste or texture and you can have reactions to it, and it's kind of gotta be daily on an ongoing basis. With biologics, you can get a lot of the same protection as you get with immunotherapy, but instead of it being daily, it's given every two or every, maybe, even every four weeks. It's not daily. It doesn't have allergen in it, so you don't react to it in the same way. You don't have to swallow your allergen to get that protection. It's kind of like an alternative that gets you to the same place. but then there are patients who desire both, right? Who want to have the protection that the, the biologic gives them, which happens, you know, rapidly and, and with multiple foods. But ultimately doesn't really change the, the immune system because there's no, there's no allergen in the treatment.
The analogy I sometimes make for patients with Xolair is it's like a, you know, an enhanced safety system in your car. The cameras and automatic braking and airbags and stuff that, that protect you in case of accident. And that's kind of what the, the protection is like when you're on Xolair. But it's not doing anything to the underlying immune system issue. It's not changing that. when you give immunotherapy, the immune response to that food changes, the body actually adjusts to small doses of the allergen.
And so there are patients who desire to have both. They want the protection. But then they also want to work to change their body's immune system's response to that food. And so, you can use immunotherapy and Xolair together. They're not mutually exclusive. But if people are interested, like, is that an option for me? You know, these are all contextual kind of case by case decisions and, and I would refer people to have those conversations with their own provider. But recognize that they're not mutually exclusive. It can be either or, or both.
Amanda Whitehouse, PhD
That's helpful to know, especially like those people that you mentioned might not want to be on it forever, that sounds like a good middle ground that some people might want to explore with their own doctors. I'm willing to try it if it gets me through immunotherapy, but then to I can maintain the immunotherapy and then in the future consider stopping the medication once I've belt up the safety and the tolerance.
Brian Vickery, MD
That's right. I mean, in fact that's, that's kind of the original way in which Xolair was studied for food allergy was conjunction with OIT, and there's probably 30, 40 papers published in the literature of using it that way for with different foods, milk, peanut, multiple foods because OIT can be kind of a bumpy experience that's associated with some allergic side effects.
The idea was, well, let's put people on Xolair first. Calm the immune system down. Once things are calmed down, then we'll start the OIT. We'll use them both together during the period of the OIT treatment when the dose is changing. And that's where the reactions tend to happen. And then once they get to their target dose and things are smooth sailing, then we'll pull the, the Xolair off and then they'll just sort of sail on their daily maintenance OIT dose. And that has been shown to work.
And again, many previous academic studies that have been published now. I think one of the, the major insights of the Outmatch study was to sort of tease that apart and realize that actually, so there was always been this question like how much of the benefit came from the Xolair and how much of the benefit came from the OIT when you use them together. And Outmatch clearly showed that actually there's tons of benefit in just using OIT by itself, right? They are alternatives to one another, but they can be used together. And again, for those, for those families that are more motivated, like you know, maybe I want to use Xolair for a short term basis, but I want to have an exit strategy to be able to get off of it eventually. Then, going on it for a little while and then starting to work some allergen into the diet in the form of OIT allows you to then stop it and continue the natural protection afterwards, and that's a framework that appeals to certain people.
Amanda Whitehouse, PhD
Yeah, just more options that people can customize to what works best for them. And like you said, the whole family. It affects everybody, not just the person who's getting the treatment. Can you give us an idea who might not be a good match or a good fit for using biologics and if they are, what they might be able to expect for side effects and how likely those are to happen.
Brian Vickery, MD
Yeah, so I, I mean, I think that again, part of the shared decision making is all those kind of clinical factors that I talked about before, age, food, goal, preference, you know, those kinds of things. Presence of, of comorbidities, so patient that's also struggling to control their asthma and has multiple food allergies might want to think about Xolair because you get kind of the benefit of both. Where would you have concern about maybe, maybe this is not the right choice. So again, I think the fact that it's injectable is just a reality that we have to kind of get out in front of and recognize that's going be a limitation for a lot of patients, the idea of a subcutaneous injection. Maybe multiple again, one, two, or three to deliver the dose. Because with, with Xolair the dose, the effective dose in food allergy ranges from 75 milligrams to 600 milligrams, and there's only three dosage strengths. There's 75, 1 50, and 300. So, you may have to use a combination of available dose strengths to get to your dose. and so that could be one, two, or three injections given every two or every four weeks. On top of the fact this medicine especially kind of hurts when it's given. It's just, it's uncomfortable. The solution is kind of thick or viscous, and it takes, it takes a minute to go in and really, patients sometimes feel that it's, it can be uncomfortable. And so I think we get out in front of that right away. Like if, if we think that either just substantial needle phobia or just kind of, well, I, I can, I can get through the nerves, but really just don't, don't like injections. Don't think that we'll be able to tolerate that. And we try, you know, all kinds of things with, with mindfulness, with cold spray, with little vibration devices you know, other kinds of topical approaches to, to sort of distract the nerves. But you can't, you can't ever make the discomfort go completely away. And I think that's a key thing to understand that, that it's likely that it's going to be sort of uncomfortable.
And then, I think the, the concept of like, what's the off ramp? Is this something that we could reasonably, consider continuing for 3, 4, 5, 10 years if it goes well. Is this something that we, we could feasibly continue for the near term future? That's always sort of a conversation because ultimately with, with Xolair, the first three doses are given in the clinic for safety reasons. Because when we talk about safety with Xolair, the biggest issue is there's a, there's a what's called a black box warning on it, which is a way that the FDA has to identify potentially unforeseen risks and inform the public about it. So there is a black box warning on Xolair about anaphylaxis, to the treatment itself which was reported in post-marketing studies, but not in the clinical trials themselves. The rate is estimated to be about one in a thousand patients. If it's going happen, it tends to happen in the first few doses. So it's rare. I, I really haven't seen a case of a convincing dose related anaphylactic reaction to Xolair in 17 years of practice. But they have been reported. So we do those first three doses in the clinic, and then once people do that, then they start giving it at home. So we train either the patient or the caregiver about how to give the injection when they're in the clinic with us, because then they transition to where the pharmacy just ships it to them at home and they're used to giving it. So that's another actually important factor when we talk about is this a good choice for you? Is could you see yourself given this to yourself? In an age appropriate way, or, you know, more likely the parent, the caregiver, learning how to give this injection to their child. And is that something that they're going to ultimately feel comfortable with?
And then I, I think the, the, the final piece is what we touched on earlier, which is cost, right? I mean, unfortunately, the reality is that these medications, the retail price is expensive. There are patient assistance programs, some people's coverage makes it so that their prescription drug plan takes most of the sting out of it and the part that they're responsible for is manageable. But that's certainly not the case for everybody. Those first three doses in the clinic are associated with clinic charges. And so we, at our place, we work really hard if somebody's considering Xolair to, you know, we provide them with the codes upfront, the billing codes that we're going to use. We encourage them to call their insurance company and make sure they understand, you know, what they're going to be charged and what, like, literally what that number is going to be. So that they're not surprised and they can make an informed decision about this is something that, would, provide a substantial out of pocket for us that, you know, we can either manage or we can't manage. And then knowing what that number is, then they can start to think about moving forward with some of these patient assistance programs or other ways to try to defray the cost.
Unfortunately, it's, it's uncomfortable to have to talk about this, but it's a reality of our system that even when drugs are FDA approved for the condition and even when your insurance company decides to cover them, that doesn't necessarily translate into them being affordable for each family. And that's a sad reality of, of kind of the system we work in. But, but it is a reality and it's important to have those conversations upfront so people aren't surprised by big bills.
Amanda Whitehouse, PhD
It is. Thank you for explaining that. It is so important. So many people are struggling just to pay for their epinephrine still. So it's certainly is a privilege and it's unfortunate that our system is that way, but we're all thankful for all the research that you and so many others are doing to at least get the options out there and, and to go from there. So this is so much information. Thank you so much for sharing it all with us.
Brian Vickery, MD
Well I, I hope it was helpful. I know it's probably a lot to take in all at once. And in a way this is like kind of our, our daily challenge and also a, a real benefit, right? I tell people my clinical practice nowadays is completely different than it was two years ago. The conversations we're having, the things we can do depending on the foods, depending on the ages, having multiple choices available. The field is really starting to, to move quickly and evolve. We can really start to change the course of the condition and, and the outcomes that we previously weren't able to think about and make that a reality for many patients which is exciting. And there's, there's more to come. I think the landscape will continue to evolve. But what, what that also means is that we've moved from a framework where we really didn't have many options, if at all, to now pretty, pretty rapidly we have multiple options and maybe even more to come. And it can be kind of overwhelming frankly, to try to figure out what is the right thing for me and or my child, and how do I figure that out even and that that conversation will continue to evolve. So. I appreciate you sort of shining a light on this, bringing some attention to it. Hope it was useful to kind of talk through this. If you have me back in, you know, a year or 18 months, we'll probably have a completely different conversation. This will continue to evolve. So I think it's important for content creators and experts like you to, to really start to try to break this down for people. Because on a day-to-day basis, you know, again, it could be a lot to take in. It, it is and thank you. It is so helpful. That's why I'm doing this, and I will take you up on that and we'll have you back when there's even more to excite and overwhelm us, but it's a great, it's a great and overwhelming time to be in the food allergy world. Absolutely. You know, the progress can't come fast enough for sure, for families. We're working towards our ultimate goal of trying to be able to move even past desensitization and, and try to limit the progress of this condition or even try to reverse it. We're not quite there yet, but still, a lot is happening. And again even in the behavioral mental health space as we talked about at, at the beginning, and appreciate your, your engagement there. So, you know, it, it feels, it feels better to be able to support families with more options, but we know we still have a long way to go. Yeah. Well, thank you for being a part of that, and thank you for being here. Well, thanks for having me and let's talk again soon. Absolutely.
Amanda Whitehouse, PhD
Thank you to Dr. Vickery for joining us, and thank you to everybody for listening. Here are three action steps to follow up on today's episode:
First follow of Dr. Brian Vickery's work through Emory University and his research publications to stay updated on developments in biologics and patient-centered allergy research. Patients seeking consultation can also learn more about services and I'll put links in the show notes.
Second. If you are curious and you haven't had a conversation with your own allergist about whether biologics would be helpful for you alone or in combination with other treatments, schedule an appointment and make a list of questions that you want to bring to them. Remember that treatment decisions are deeply individual. I'm not promoting any specific treatment here on the podcast, but I do think it's important for you to know your options.
And third, if you would like more support navigating the emotional and psychological layers of food allergy treatment options, I wrote a workbook for you called From Fear to Freedom with practical tools and activities to help you think clearly about risk, regulation, and resilience as you evaluate your options and move through them. The link for that is in the show notes as well. You can find it anywhere you buy your books, but consider bookshop.org to support local bookstores. Thank you for joining me, and I will be back next week.
The content of this podcast is for informational and educational purposes only, and is not a substitute for professional medical or mental health advice, diagnosis, or treatment. If you have any questions about your own medical experience or mental health needs, please consult a professional. I'm Dr. Amanda Whitehouse. Thanks for joining me. And until we chat again, remember don't feed the fear.