Can SLIT induce remission in babies and littles with peanut allergies?

Dr. Alice Hoyt interviews Dr. Edwin Kim about his research in sublingual immunotherapy in children with peanut allergies.

Guest Dr. Edwin Kim
Dr. Kim is a renowned pediatric allergist and immunologist who has extensive experience in treating children with food allergies. In this episode, he shares his research on sublingual immunotherapy, a method of allergy treatment that is gaining popularity among allergists and parents of children with food allergies.

SLIT
Sublingual immunotherapy, also known as "SLIT," is a form of food allergy treatment in which diluted allergen is placed under the tongue daily. The concentration is increased until the patient reaches a maintenance dose. The maintenance dose is continued for years. The goal of SLIT is to desensitize the patient's immune system to specific allergens, reducing the allergic response and decreasing the risk of a severe allergic reaction when he allergen is accidentally ingested.

Take-Aways

1. SLIT is safe for children.
2. SLIT is effective in children.

References

• Dr. Kim's article in JACI

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Transcript

Alice Hoyt, MD: 0:10

Hello and welcome to Food Allergy and your kiddo. I am your host, dr Alice Hoyt, excited, very excited to be joined today by Dr Edwin Kim. Some of you may know him as the food allergist who is really, really pioneering slit. When I talk about slit sublingual immunotherapy, evidence-based approach you all know you're coming to this podcast, so this show. You're looking for family-focused, evidence-based information and that is what we're providing here today. Dr Kim, thank you so much for coming on to the show.

Edwin Kim, MD: 0:45

Yeah, happy to be here.

Alice Hoyt, MD: 0:48

Awesome. The first question I really want to ask, and what our listeners are probably wondering, is really how did you find yourself researching food allergy? Tell us about your journey.

Edwin Kim, MD: 0:59

Yeah, I mean I think it started in the home growing up. I didn't realize it at the time, but we had lots of allergy in the house, whether it's seasonal allergies, food allergy, eczema, asthma. We had a lot of that floating between my parents, my brother, myself, and I think that probably planted the seeds that I didn't realize Fast forward all the way into college and then I was starting to head down the med school route and immunology in particular really stood out to me, the idea that your immune system is perfectly tuned to be able to fight off any possible infection that could be out there, and so that was fascinating to me. But then as I started to learn about allergy and autoimmune disease and starting to realize, wait, the immune system is not perfect and there are ways that it can overreact in the case of allergy or even attack itself, and autoimmunity really stood out.

Edwin Kim, MD: 1:48

So I got into our field, really initially focused more on the actual basic science immunology side, but then, just by pure chance, I happened to do a rotation at Duke University Medical Center, where Dr Wesley Birx was the allergy program director as well as the chief of allergy and one of the pioneers of the food allergy research that we've been doing, and so I was fortunate enough to work with him for a month, hear him talk and to just understand sort of the scope of the food allergy problem and again, this idea of how the immune system, which is supposed to be so perfect, is not so perfect when it comes to food allergy really really wrong, true to me. And so I ended up staying on and training under him, getting exposure to these different treatments oral immunotherapy and then the sublingual, and then fast forward to this is where I am, that's amazing and for our moms and dads listening and grandparents who are listening to the podcast.

Alice Hoyt, MD: 2:48

I know that whenever you're looking for good articles, good journal articles, you're sometimes you're wondering well, how do I know it's a good article. If the name Wes Birx is an article, it's a good article.

Edwin Kim, MD: 3:00

Here's your Libystein. That's exactly right.

Alice Hoyt, MD: 3:03

So, dr Kim, awesome that you've been able to train under him and work with him and collaborate with him, and also, I mean just that whole area is just so filled with amazing food allergy focused docs. So that's, that's awesome. And I'm not surprised that such cool research is coming out of of y'all's labs and has been for decades at this point. But what I, what I really want to talk about today is your amazing paper desensitization and remission after peanut sublingual immunotherapy in one to four year old peanut allergic children. A randomized placebo controlled trial. So that's a mouthful, but every single word in there is so critical. So let's and you have some real rock stars on this paper too Drew Bird, karin Keat, wes Birx I mean it's a real deal y'all so. So let's talk through just breaking down the title, because also the term remission has started really floating around on the interwebs and the title is desensitization and remission after peanut slit. So let's first talk about that. How did you guys define desensitization and how did you define remission?

Edwin Kim, MD: 4:34

Yeah. So that's probably the most important question here and I think as a field we've been trying to figure, figure this out. What are the proper definitions for these? And I think where our field has really come back to now, with the word desensitization at least, is the idea that while you're actively being treated and that could be whether it's going to be oral, sublingual or other treatments that are out there that we are able to make someone either non-reactive or less reactive, so increase the amount of food that it takes to actually have an outward allergic reaction. Now again, depending on sort of what study you see that threshold like, you'll see differences. Some of them might just say the maximum that we gave during that food challenge and nothing happened. Others will just say above a certain amount that we think would be the likely exposure you would have, you know, in cross-contamination or something else like that. So I do think that it's important for us as allergists and patients and families, all of us to be careful to understand, when that word is being used, what they're actually referring to.

Edwin Kim, MD: 5:34

For this particular study. What we try to do is we, in assessing whether the actual treatment was working, we gave kids up to 4,443 milligrams. What in the world does that mean? We estimate that to be pretty close to about a serving size of peanuts for these kids, and it's equivalent of probably about 15 peanuts, and so we wanted to make sure can the kids eat that much peanut with no sort of symptoms at all? Now, again, going back to that point of like, how much does it take to get sick? What we have seen we don't have great data on this, but what we've seen is most kids, if they're going to get sick from eating a little bit of peanut cross-contamination, it takes only about a third to one peanut. It's about 100 to 300 milligrams. So in this case we push the envelope. We wanted to make sure you know, way over 4,000 plus milligrams that nothing would happen at all, and so that's how we define desensitization here. Now the next part, though is pretty amazing yeah it's really cool.

Edwin Kim, MD: 6:30

It's really cool just and especially I mean I'm jumping the gun here but the idea that our treatment is only giving four milligrams, a tiny little amount of peanut every day, and then we're getting a thousand times that in benefit, like over 4,000 milligrams, which is just. It's kind of mind-boggling in a good way.

Alice Hoyt, MD: 6:46

Yeah, we'll talk about the protocol in a minute because I know our listeners are wondering wait, how? How do they go from?

Edwin Kim, MD: 6:52

4,000, and then 100, and then 4,000, like what.

Edwin Kim, MD: 6:57

Yep, and then jumping to that remission, and so this is another problem we've had in our field of. Of course, the goal we're looking for is we want to cure the kids. We want the kids to be able to eat whatever they want whenever they want. We're trying to get there. We're not there yet, unfortunately, we're probably not close, but in the process of getting there.

Edwin Kim, MD: 7:16

One of the things that I think we're all thinking about is how do we even know, like we, when we think about what we're eating on an everyday basis, we don't say, oh, I haven't had a trip today, like it's been a couple of weeks. I need to go eat it, like when you're not allergic, you just eat it whenever you want to and whatever you want to do. But in a research study you kind of can't do it that way, and so we've been trying to figure out in a research study, how can we fairly confidently say, okay, you're not reactive and that's okay. And so the earliest kind of ways we tried to do this was we would treat someone, show that they were not reactive, desensitized, and then take the treatment away for a couple of weeks, maybe up to a month, and then come back and try that again, and if you were again, we're not reactive. That looked pretty good, but then you could easily say well, how do we know? Like a month, in a day or two months, then suddenly you're allergic again. So then we started pushing it out a little further, and so so we have found that a group of kids, especially when they start young, seem to be able to get to this point where there's some lasting change in the immune system again we're nervous to say permanent, but at least some lasting change that even a few months later they're still not reactive.

Edwin Kim, MD: 8:26

And so the impact study which was published last year looked at the oral immunotherapy, the OIT for peanut, and found that it wasn't a large number, but about a fifth of those patient 20% of them, even six months after stopping the peanuts, still stayed not reactive at all, and so, for lack of a better term, we decided that that might be the best. The best way to describe that would be remission, so that disease is there, but it's sort of in hiding, it's not doing anything, and could they eventually have a relapse where the symptoms come back? Possibly we hope not, but possibly. And so that's kind of where the remission word has started to pop into our food allergy world, and and so for our particular treatment, we didn't. This was planned. This study started probably six, seven years ago, so we didn't know the impact results. We had arbitrarily decided three months seem like a really long time, and so in our minds we thought well, again, this seems pretty good and it seems to suggest that the immune system has some lasting benefits. So that's how we've used that word here.

Alice Hoyt, MD: 9:27

Well, also because if you're listening, you're probably thinking well, if it worked, why would you stop it?

Alice Hoyt, MD: 10:23

yes, that's right, that's right if you get to where a kid who has desensitized, why would you stop it? And we stop it because, in the world of oral immunotherapy, participating in oral immunotherapy is is a big commitment, specifically of time and having a kiddo avoid strenuous activities during, during what's called their safety window being an hour before, two hours, after their dose, they really need to not participate in anything that's going to raise their heart rate, raise their body temperature, because those things can lower the threshold to have an allergic reaction. So undergoing oral immunotherapy is is a big commitment and so when you can get to a sense of normalcy and start to step away of that gazelle intensity essentially for for dosing, and you do have a negative ingestion challenge after being on oral immunotherapy, it is really an art at this time to figure out okay, how much do they need to keep in the diet?

Alice Hoyt, MD: 11:20

that's right do they still need a safety window? Do they need to carry epi? Usually we are on the side of yes for that, at least for the through, the time being. And what's so amazing about SLIT, as we'll talk about, is that that safety window is is much looser, and that is because of the low side effect risk but, I'm getting ahead of myself.

Alice Hoyt, MD: 11:47

I do want to talk about, I do want to talk about the protocol that you guys used. And how did you? Can you just sort of talk us through what it would look like for a family to come in and participate? Of course they were blinded, you guys were blinded, so you didn't know if they were getting the actual peanuts slit or a placebo slit. But talk us through what that looked like. How many up doses, really up dosing at home, all of those things.

Edwin Kim, MD: 12:18

Yeah. So if it's okay, I'm going to take one like a few seconds just to kind of tell, explain how we got to where we got to. And so I mentioned back with my training when I first got involved with SLIT and at the exact same time we were directly studying oral dermatotherapy. Oh, I, actually one of my colleagues, was more focused on the oh I T and then I happened to be involved with the slit and so we were watching with oh I T that, on the one hand, works really good, really strong desensitization, but at the same time we saw a lot of the side effects that came with it the, you know, the allergic reactions, some of the taste aversion, some of these co factors that you mentioned about exercise. And so, seeing that with our slit, we started very conservatively as well. So we had a long buildup period, six, seven months, coming in every two weeks, similar to oh I T.

Edwin Kim, MD: 13:06

But the nice thing with our studies is, over that first cohort that we studied for five years, we looked at the safety data and, my goodness, it was great. We weren't having a lot of side effects, we weren't having anaphylaxis, we were having a decent amount of this mouth itch that is very common with SLIT, and when we checked out the timing of this, what we realized was, if it's going to happen, it happens really short in time, like within a few minutes maybe last 10, 15 minutes and then it's done. But we weren't seeing people one hour out, two hours out, three hours out, having any such a side effects, and so we were able to shrink down the observation time all the way down the 30 minutes and feel very confident with that, and then, as we continued to look at it, we just did any pre observation time?

Alice Hoyt, MD: 13:47

Was there any time they needed to be not doing activities prior to their death?

Edwin Kim, MD: 13:50

So that's the other aspect as well. So we were paying attention to this because we had seen it with oh I T, but for this thinking that the dose was so small that this first study we actually looked at only two milligrams compared to oh I T, where they're using anywhere from 300 to 4000. So we were paying attention but we didn't directly say avoid this or avoid that. It was more sort of the idea of well, with oh I T, we've seen this. So if you notice anything, let us smell. And we did not. Now, again, it's not a perfect way to study this, but we didn't see those same problems.

Edwin Kim, MD: 14:20

But, again when we went back and looked at how often are people having anaphylaxis wheezing, you know more serious side effects and we just didn't see it. And so the protocol that we use for this study that you're talking about, what we incorporated there, we're going to be a lot of home up dosing because we just hadn't seen the problems with it. So what this current protocol looks like, which we hope.

Alice Hoyt, MD: 14:41

We hope it's a pretty. Yeah, we hope this is a friendly yeah right.

Edwin Kim, MD: 14:45

Our hope is that this will be sort of a good sort of in the middle type of thing. So the first dose, of course, would be in the clinic, just to absolutely make sure that we're all on the same page, show them how to show the patients, the families, how to do the medicine. And then the idea would be to take the bottle home, which is a bottle filled with the, the slick liquid, and a pumper, and then they're given specific instructions on how many pumps to do, and each time should be one today, and so the idea would be that they go home, do the single pump once, once a day for a week, and then they're given instructions to double it up to two and a week later, to four and then to eight, and then they come back into the clinic one month later and then we give them the next strength of bottle and then they follow that same pattern. So at home they do the increases once a week and then come back in a month later, and so there's four direct in clinic monthly visits. So rather than the 10, 11, 12 that you might see with an OIT protocol. And then they're a month apart as opposed to every two weeks.

Edwin Kim, MD: 15:43

It's still visits to the clinic, which could be difficult for folks. But it's what we are learning is that it's it's fairly flexible and so a little bit longer and a dose is never going to hurt anyone. And so we're hoping that this can sort of be that happy medium between, like not being so burdensome of too many visits to the office, but enough that they have a lot of face time with us, because I do think that it's so important that we have that opportunity to talk through sort of what are the risks, how would you treat a reaction? You know, is this a cure, is this not a cure? You know some of these things just to make sure that the families feel confident in kind of what they're doing and what the benefits are and aren't, because we don't want folks going out there thinking that this is going to be a cure all either. And so I do think that those touch points really help a lot.

Alice Hoyt, MD: 16:31

A million percent, I think.

Alice Hoyt, MD: 16:33

The more that we as allergists can directly engage with our patients and answer their questions hence this podcast the better, so that they don't have to go on to social media to try to find those answers.

Alice Hoyt, MD: 16:47

And when you're going through something like subliminal immunotherapy or oral immunotherapy or even sometimes a series of ingestion challenges, you are getting that face time with your doctor. That isn't necessarily what the visit is directly about, but is so important. It's just such important critical time, I find, to help not just grow a family's depth of knowledge regarding their child's allergic disorder but also ease that anxiety that absolutely comes along with kiddos who have food allergies. So I, just as my patients know, I love to sit and talk with them and make sure that they know that they can come to me with questions. They can still look, of course, online, but please by all means ask me your questions, and so that's just. That's so great and I love that you recognize that, that it is good time for you guys to connect. But then you're also recognizing the burden that OIT can be on families and coming in for the multiple appointments and missing work and missing school, into all of the things. So that's amazing. That's amazing.

Edwin Kim, MD: 18:03

If it's okay, can I add one more piece in here? You can add whatever you want, your guess. The thing I do want to add in here too is and I think this is being recognized a lot more now is that food allergy patients and families they're not a one size fits all, so every family out there has it, affects them in different ways, unique ways, and again, I think that's where those touch points really matter. The families can really have the opportunity to tell you hey, you know, little Joey just wants to go to a birthday party. That's what's important to them, and then you can speak to them of, okay, this is how that slit treatment will sort of enable that. Or, you know, this is what's happening at their daycare, and so we just want some reassurance.

Edwin Kim, MD: 18:41

And so I also think that that's a great opportunity to talk specifically about that patient's experience. And then again making sure that the expectations sort of line up and maybe that someone comes in and says, oh, I just want to eat a peanut butter sandwich, and then you know, then we got to back up and say I'm not sure there's a small subset of kids that might get there but most won't. But just level setting and but then personalizing it, I think really being able to sort of speak to like for your situation and what you're looking for. This is what we can expect and again, it's hard to get that through. You know a bunch of informational pieces of paper. I think you really got to have those conversations to get there.

Alice Hoyt, MD: 19:17

A million percent. The goals, setting the goals. What is your goal? Is your goal to be bite-proof?

Edwin Kim, MD: 19:22

That's right.

Alice Hoyt, MD: 19:23

You didn't get accidentally ate a little bit that he wouldn't have a severe reaction? Or is your goal to free eat and then really having honest discussion and revisiting that throughout the course of therapy, because we might have a little kiddo that we think is going to get to the free eating, that is having trouble along the way, and then we might have some older kiddos that surprise us.

Edwin Kim, MD: 19:45

That's right.

Alice Hoyt, MD: 19:46

And so it's so important to be able to have those shared decision-making discussions and really be engaged with our families, and I mean, I think that goes across healthcare.

Alice Hoyt, MD: 19:57

Yes, for sure, we all need doctors to engage with us and let us know what the best potential treatment plan is for us or for our child, you know, and discuss the options and I mean based on the studies that are coming out about subliminal immunotherapy. It's certainly an option, and what fascinates me is the age group here, and so we talked about desensitization, remission, we talked about subliminal immunotherapy. One question, though, about that described to me the process of the method is the kiddo holds it under the tongue for two minutes, right, but, and then doesn't eat for a few minutes after that. But a one-year-old holding something under tongue for two minutes. So talk to talk me through that. I asked you, bert, about this a few months ago at our Louisiana allergy conference. He had a great response about it, so, but I know our listeners would love to, because I know they're thinking wait, they're one-year-old.

Alice Hoyt, MD: 21:06

That's right, they hold it something. How are you getting them to listen and do what you say for two minutes?

Edwin Kim, MD: 21:13

Yeah, we just hold their tongue up for them. Now, I'm joking, of course not. So I mean we do have within our studies. We have very, very, very experienced nurse coordinators who walk parents through some tips and tricks, trying to get the kids to sort of sing and things like that that will try to help this.

Edwin Kim, MD: 21:29

But the reality is, I think, what everyone out there recognizes, that for kids that young it's quite difficult and most are probably not holding it for the whole two minutes, if not even for several seconds, and so this is an aspect that we are trying to understand more is how long is the right amount of time?

Edwin Kim, MD: 21:46

So two minutes actually was an arbitrary sort of amount that we had seen from other types of sublingual treatments, so we had started with that. But in this particular case, we know that the kids probably struggle to keep it that long, but the benefits are actually the strongest that we've seen with sublingual. So it suggests that you probably don't need to be that long. Again, what is the sort of magic amount of time is something we definitely want to learn for the next step to be able to give sort of the best advice for families doing this. I will also mention that this is also a place where there is an opening for new types of sublingual treatment, and so there's been some folks and we're one of them that have looked into like, oh, could we do this as a dissolving film, like like they had those breath strips that would?

Alice Hoyt, MD: 22:31

melt on your tongue.

Edwin Kim, MD: 22:32

Could we do that? Or there's a company that's in looking into a dissolving tablet Could you do? Probably a choking hazard, but could you do a las-ins or, you know, are there other ways that we can sort of do it? That might better ensure that it's actually held under the tongue as long as it is. But again, coming back to the question, in this case we did everything we could to train the patients, the families, how to do it. I think they tried, everyone tried their best and then, amazingly, the results turned out really, really, really good. And so we do still have more to understand about exactly what the right exposure is, but not a reason for us to necessarily not pursue this in the short term, though, based on the results and I do want to talk a little bit about the study group not the most diverse group, but unfortunately not unfortunately what we see in research at this time.

Alice Hoyt, MD: 23:25

But talk a little bit about the study group.

Edwin Kim, MD: 23:28

Yeah. So what we wanted to do, again, the major focus was really on age. So we wanted to go younger, just because from some of the other research we had seen, in particular, there was a study that we had started at Duke and finished at the University of North Carolina called the Devil Study. That looked at these young 9 to 36-month-olds and, sure enough, found the strong, really really strong, desensitization with oral, and so we wanted to see is that the same concept for the one to four-year-olds? Because we anticipated that it would be a lot safer and so that was probably the most important thing.

Edwin Kim, MD: 24:01

But still, clinical trials are really difficult.

Edwin Kim, MD: 24:03

There's still lots of visits to the office, blood draws and this and that, and so, as much as we wanted to expand out and try to have all comers come in, usually it's folks that have the time, and so it's going to be families, where someone is either home or just it has really flexible work that can bring their child in, and so it ends up not being a very diverse, diverse group at all.

Edwin Kim, MD: 24:27

So in our case it's heavy, heavy white population and probably more sort of upper middle class, and we know from other data that that's not necessarily who has food allergy. Food allergy is more distributed and, if anything, sort of non-whites maybe more prone, and so definitely a big hole in our research that we're trying to in the design of future studies as well as sort of in the clinic. We're trying to understand this as well and just make sure, before we broadly advise this to everybody, that you know different groups do respond the same, because we don't want to. That would be one of the worst things we could do is we just sort of generalize this out to everybody and realize that's not the case.

Alice Hoyt, MD: 25:06

Absolutely, absolutely. Thanks for talking us through that. Yeah, and talking about sort of this particular young age group and the effectiveness of this, figure four specifically be the month 36 desensitization, oral food challenge. The intention to treat group 75% of kids one to two who started when they were one to two had a negative oral food challenge at that time or past the per protocol 100%. So talk us through what intent to treat versus per protocol means and then 100%.

Edwin Kim, MD: 25:52

That's right, yeah, so in our clinical research, I think one of the factors that we're always dealing with is going to be patients who are not able to finish, who drop out of the study for one reason or another, and what is sort of the right way to count them if they've, again not done everything? And that's where this concept of intent to treat comes in, and typically what we would say the safest, most conservative whatever you want to say way to approach this is going to be to think that anyone who couldn't finish it would have failed, would have not sort of achieved what you're looking for. So that's what that intent to treat population means. So that includes all 25 kids that were on treatment, all 25 that are on placebo, and of the ones who dropped out, we counted them as actually failing the food challenge. Now, the reality is, could they have passed? Maybe, maybe not. Again, we don't know that, but just so that we don't overcall the data, we consider them on the negative side of failing, and so that's how we get that. Now for protocol.

Alice Hoyt, MD: 26:46

That's a good approach to science.

Edwin Kim, MD: 26:48

Right, that's right yeah.

Alice Hoyt, MD: 26:50

We don't want to overcall the data.

Edwin Kim, MD: 26:50

That's exactly right. And then for protocol, what that would be is anyone who actually was able to start to finish, to be able to do everything that we had said, which again could represent sort of how well or not the treatment works. And so it's sort of showing two sides of the spectrum On the one hand, probably overly conservative and undercalling and on the other hand, probably overcalling. But it's important for people that are seeing the data to understand. It's probably something in the middle is probably what we're looking at.

Alice Hoyt, MD: 27:18

Which is tremendous so little drops of peanut, tiny, tiny amounts, most of which was done at home, has permitted these very young children, who are not of the age, to say excuse me, I am not a large-time person who cannot protect themselves, who cannot say, oh, this is making my mouth feel funny. Very well, right. So, like a very vulnerable population, is my point of kiddos with peanut allergy, 100% of them who were per protocol, 75% intent to treat. I mean, this is amazing Now that again for our listeners, that means that when they went through the study and they got to the point of the study of being on the slip for 36 months, they did a full whopping dose ingestion challenge. They didn't react.

Alice Hoyt, MD: 28:13

And so in real practice, some people will do that next step that you guys did, dr Kim, the let's look for remission. So let's stop treatment, have them very much avoid for one, one, three months, six months, whatever. But a lot of people in practice would say, okay, we don't want to figure out if you're in remission, because our goal is to either get you bite-proof or to free eat. And so what do we need to do now to continue this? Because, as of right now, you're definitely bite-proof, right, and that gives families just so much relief. I mean I love seeing our families come through our practice and just the look on their faces when they're seeing their kiddos like a whopping spoon of peanut butter, when such a small amount sent them to the ER last year, I mean this is pretty amazing.

Edwin Kim, MD: 29:11

Obviously I'm biased, but I'm very, very excited by this as well, and I think just a couple points that you mentioned. One of them is the age factor. So in particular that one to two year old group, we had a good number of those kids and they seem to do really well and this really lines up with recent data that's come out of. Well, first of all, that impact paper for oral immunotherapy I mentioned also suggests that younger, even within the one to four, the younger was better. But there's also recent data that's coming out of the LEAP study so that the whole that study that looked at giving peanut early to prevent peanut allergy, and even in that study they looked at four to 11 month old. But they're easily seeing the four to five month olds did better than the five to six and six to seven and so on, and so there definitely seems to be something with your immune system that is just. It's just more willing to be treated and more able to change if you can get in there early, and so it's great to see that our data supports that in our group.

Edwin Kim, MD: 30:06

I do want to add one more piece, though, because I want to be so excited with the numbers, as you said the hundred percent and all, but clearly it's a small study. So in our case it was painful because we did all. All those patients came to us in Southwestern, so it was a lot for us. But 50 kids is 50 kids and so if we had a thousand or 10,000 kids, would we have those same numbers Again? Probably not, but it's going to be good. I mean, the numbers wouldn't be way off from this, and so we do think that this has the potential to help a lot of kids that are out there.

Alice Hoyt, MD: 30:35

The other important point was that none of the kids in the placebo group outgrew their peanut allergy.

Edwin Kim, MD: 30:43

That's right.

Alice Hoyt, MD: 30:44

Which is also not necessarily consistent with what we see Now. I mean we're not seeing 50% of kids. I'm not seeing 50% of kids. The studies are not seeing 50% of kids outgrew their peanut allergy. But you know, we hedge it 20 to 30%, and that's an important discussion. When we're saying you know, do we want to embark on oral immunotherapy right now or something, or immunotherapy, or is there a potential of them outgrowing it, do you want to comment? That's really interesting, yeah, yeah. So I mean.

Edwin Kim, MD: 31:11

It's really allergic to kids. Yeah, really allergic to kids. But here's a moment that I do just want to call out the families that participated. I mean, my gosh, the sacrifices that these families give for, not only for their own kids but for all families out there where it's root allergy can't be. I mean it's just, it's so important because, I mean, these are they.

Edwin Kim, MD: 31:33

There are families that spent three years on a placebo for to help us to try to understand this of does this work or not. And the reason we needed that long placebo is what you mentioned we needed to make sure is there really is this treatment or the kids naturally outgrowing it? And so in this study we clearly saw no one outgrew it during the same time period. So we can pretty confidently say that the majority of what we saw was from the treatment. Now, for those same families, again, we can't there's no way ethically we can leave them out in the cold, and so we had a separate protocol afterwards to be able to give them the treatment that they, you know, had willingly sacrificed.

Edwin Kim, MD: 32:07

But it's just so important that none of this happens without the families. And you know, again, some naysayers may say, well, they're just trying to get early access. I mean no, no, these families of course they like that, but these families are absolutely dedicated to the field and making sure that you know whatever sacrifice they put in is going to help not only their kid but all these other families out there. So I mean again, can't say thank you enough to them.

Alice Hoyt, MD: 32:31

The allergy families are amazing.

Edwin Kim, MD: 32:33

They are.

Alice Hoyt, MD: 32:33

What are some ways that they can get involved in research?

Edwin Kim, MD: 32:37

Yeah, I mean I think there's. One of them is to participate, of course. Another is to spread the word. So another could just be that they've heard us in studies, participated in some studies and be able to share sort of their experiences. Another is to support studies. So again, we're always looking for groups like fair or the NIH and stuff to support studies.

Edwin Kim, MD: 32:56

But you know, again, if there may be opportunities to sort of give as well, to help with that. But I think, in all those different ways, but if anything, the way that most families can help is just to continue to bring this positive attention to food allergy. You know, make sure that the awareness is there that food allergy is real. There's lots and lots and lots of families and unfortunately the number keeps going up, but families that have this and we really need something that will help our kids just go back to normal. I mean, I think because in every other way they're normal, but the, the everyday sort of burden that comes with this, the anxiety, the changes, you know the effects on quality life, they're real and so I think that's probably the number one way that they can help.

Alice Hoyt, MD: 33:42

Love it, I love it. Thanks so much for joining us. What, what sort of last words would you have for the food allergy mom, dad, who's? Who's hearing this? Maybe they have a little kiddo, or maybe they have a teenager. What would some of your encouragement to our food allergy families listening?

Edwin Kim, MD: 33:57

Yeah, so you mentioned earlier that. I mean not that we ever want anyone to have a food allergy, but now is a really good time because there's so much hope. We have oral immunotherapy available in many clinics. Our data suggests that lingual could be an option as well. There's studies on this patch medicine, the epigutaneous and biological medicine, and so there are options available now. There are options coming in the near future and then there are options coming further out than that, and so I think, just you know again, there's plenty of hope out there at this point for the families. What I would say is you know, take your time and understand sort of what those options are, and understand that if the right option may be there now but it may not be, because food allergy is individual to each family, and so just to hear those out and you know, maybe that next one coming down the road is the right one for you all as well, and so you know again, just, we're in a good place now and there's plenty of hope coming.

Alice Hoyt, MD: 34:55

I love it. Dr Kim, thank you so much for joining us.

Edwin Kim, MD: 34:58

Thank you very much for the invitation. This is great.

Alice Hoyt, MD: 35:02

Okay, that's where I will cut it. If I stop the recording now, it's going to hang up on us.

Edwin Kim, MD: 35:07

No problem.

Alice Hoyt, MD: 35:09

Was that okay?

Edwin Kim, MD: 35:09

I hope oh my gosh, that was awesome, oh yeah good, I can never tell, because I just I mean I love this stuff right, so I can go forever.

Alice Hoyt, MD: 35:19

I understand. I do too. Hints the podcast.

Edwin Kim, MD: 35:24

That's right.

Alice Hoyt, MD: 35:26

No, this is so awesome.

Edwin Kim, MD: 35:29

I love it.

Alice Hoyt, MD: 35:31

I mean, I just love that there's more. You know, there's more than avoidance or OIT, and this is something that can definitely be done in many families, and I'm just so. I'm so grateful to groups like yours that do this research. So anytime you want to come back on and talk about anything, you are more than welcome to come onto this platform. We would love to have you, sure.

Edwin Kim, MD: 36:04

I mean, I think the big one that you've probably already heard of is going to be Zolaire. So Zolaire is actively being studied now. I think there's lots of hope that in the next one or two years it could be added to the label. I mean, they have to be able to decide that. Is that going to be for everyone? No, but I think it's going to be an important one, and so that could be a good time for if you may have someone else you want to talk to, but if not, I would love to talk about that.

Alice Hoyt, MD: 36:27

I heard it was coming like next quarter.

Edwin Kim, MD: 36:29

I mean I think the company would hope, but it seems very likely and very likely soon. And so I mean one other concept. I mean the two concepts that I've been saying a lot in talks and in clinic. Number one is going to be going back to your point of it's so different now. So, as opposed to always the OK, I'm sorry you're allergic, go ahead. Good luck with avoiding. Now it's proactive. It's about well, here are these treatments OID, there's a couple that are coming, and then there are more coming and just really more proactively thinking about what can we do about it. I mean, yeah, it's humongous, I think, just thinking in that way, sort of turning our minds more towards that, and so it's just been a lot more fun, and then I mean living with it in our house as well. It's the same. It's just sort of the defensive approach is just not very satisfactory. So I mean we want to do something about it as doctors and as parents.

Alice Hoyt, MD: 37:27

Yeah, and one of the things that I'm starting to grapple with is which treatment is best for which patient. So I do oral immunotherapy and I started doing slit. I was kind of like pushed into doing slit when one of my patients he's six years old he has a sesame IgE of greater than 100. And he reacted to the smallest dose of the OID.

Edwin Kim, MD: 37:56

Oh no, the oral. Yeah, that's right.

Alice Hoyt, MD: 37:57

Yeah, and though now mom is saying it may have been a confounder of sesame mislabeling, whole sesame label thing changed and he may have eaten a bar, but like no no, based on some other stuff. Anyway, it was too close to call. We were well too close to his reaction threshold for me to proceed on OID, when OID should be very boring for families.

Edwin Kim, MD: 38:19

Right.

Alice Hoyt, MD: 38:21

It's really, if we're doing it right, it should be. We should say well below that reaction threshold. So that's how I was kind of pushed into doing slit with this kiddo because he had accidental ingestion and he had severe reactions.

Alice Hoyt, MD: 38:34

And so now I am doing slit, but constantly looking for ways to make the treatments whatever the treatments are, to make them as safe as possible, of course, as potent as possible or effective, as powerful as possible, but then also as reasonable as possible. And for all of my patients that are peanut allergic, who are between 4 to 17, I offer them palporezia 0-1-1. They all want the peanut butter protocol, which is what I've been doing for years and it's lovely, and I also kind of think the peanut butter protocol we do is very helpful because it does stick in the mouth and I wonder how much of that is using that sort of background to the immune system to grow tolerance. But really trying to find. Ok, now, as more data like this comes, which kiddos am I going to say? You know what? Why don't we try slit with you?

Edwin Kim, MD: 39:31

Yeah, yeah. I mean I think just the fact that we have options is awesome. It's so awesome to even have this conversation. And then I think ages and stages. So I think there'll be treatments that might be right at a certain age, that might not be right at another, Sequential treatments, I mean all this kind of stuff. If we can just get them out there in our hands, then I think we can do lots of fun.

Edwin Kim, MD: 39:53

But as I realized, I'm getting texted because I was supposed to be on another call. I'm so sorry, oh my gosh, so I'm going to hop on.

Alice Hoyt, MD: 39:59

I'm so sorry, oh, no, no, no.

Edwin Kim, MD: 40:00

It's because you know me. I just I love talking about it.

Alice Hoyt, MD: 40:03

For your time. You're awesome. I hope you have a wonderful and blessed Thanksgiving and I will be inviting you back soon.

Edwin Kim, MD: 40:12

Love it. I'm going to say yes. I'll already tell you that.

Alice Hoyt, MD: 40:15

Thank you. Take care, see you, bye.