December 21, 2023 • 35 mins
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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
- SLIT is safe for children.
- SLIT is effective in children.
References
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Alice Hoyt, MD (00:10):
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 thefood allergist who is really,
really pioneering slit.
When I talk about slitsublingual immunotherapy,
(00:31):
evidence-based approach you allknow you're coming to this
podcast, so this show.
You're looking forfamily-focused, evidence-based
information and that is whatwe're providing here today.
Dr Kim, thank you so much forcoming on to the show.
Edwin Kim, MD (00:45):
Yeah, happy to be here.
Alice Hoyt, MD (00:48):
Awesome.
The first question I reallywant to ask, and what our
listeners are probably wondering, is really how did you find
yourself researching foodallergy?
Tell us about your journey.
Edwin Kim, MD (00:59):
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 seasonalallergies, food allergy, eczema
, asthma.
We had a lot of that floatingbetween my parents, my brother,
myself, and I think thatprobably planted the seeds that
I didn't realize Fast forwardall the way into college and
(01:19):
then I was starting to head downthe med school route and
immunology in particular reallystood out to me, the idea that
your immune system is perfectlytuned to be able to fight off
any possible infection thatcould be out there, and so that
was fascinating to me.
But then as I started to learnabout allergy and autoimmune
disease and starting to realize,wait, the immune system is not
(01:41):
perfect and there are ways thatit can overreact in the case of
allergy or even attack itself,and autoimmunity really stood
out.
So I got into our field, reallyinitially focused more on the
actual basic science immunologyside, but then, just by pure
chance, I happened to do arotation at Duke University
Medical Center, where Dr WesleyBirx was the allergy program
(02:04):
director as well as the chief ofallergy and one of the pioneers
of the food allergy researchthat we've been doing, and so I
was fortunate enough to workwith him for a month, hear him
talk and to just understand sortof the scope of the food
allergy problem and again, thisidea of how the immune system,
which is supposed to be soperfect, is not so perfect when
(02:26):
it comes to food allergy reallyreally wrong, true to me.
And so I ended up staying onand training under him, getting
exposure to these differenttreatments oral immunotherapy
and then the sublingual, andthen fast forward to this is
where I am, that's amazing andfor our moms and dads listening
and grandparents who arelistening to the podcast.
Alice Hoyt, MD (02:48):
I know that whenever you're looking for good
articles, good journal articles, you're sometimes you're
wondering well, how do I knowit's a good article.
If the name Wes Birx is anarticle, it's a good article.
Edwin Kim, MD (03:00):
Here's your Libystein.
That's exactly right.
Alice Hoyt, MD (03:03):
So, dr Kim, awesome that you've been able to
train under him and work withhim and collaborate with him,
and also, I mean just that wholearea is just so filled with
amazing food allergy focuseddocs.
So that's, that's awesome.
And I'm not surprised that suchcool research is coming out of
(03:24):
of y'all's labs and has been fordecades at this point.
But what I, what I really wantto talk about today is your
amazing paper desensitizationand remission after peanut
sublingual immunotherapy in oneto four year old peanut allergic
children.
(03:45):
A randomized placebo controlledtrial.
So that's a mouthful, but everysingle word in there is so
critical.
So let's and you have some realrock stars on this paper too
Drew Bird, karin Keat, wes BirxI mean it's a real deal y'all so
(04:07):
.
So let's talk through justbreaking down the title, because
also the term remission hasstarted really floating around
on the interwebs and the titleis desensitization and remission
after peanut slit.
So let's first talk about that.
(04:28):
How did you guys definedesensitization and how did you
define remission?
Edwin Kim, MD (04:34):
Yeah.
So that's probably the mostimportant question here and I
think as a field we've beentrying to figure, figure this
out.
What are the proper definitionsfor these?
And I think where our field hasreally come back to now, with
the word desensitization atleast, is the idea that while
you're actively being treatedand that could be whether it's
going to be oral, sublingual orother treatments that are out
(04:55):
there that we are able to makesomeone either non-reactive or
less reactive, so increase theamount of food that it takes to
actually have an outwardallergic reaction.
Now again, depending on sort ofwhat study you see that
threshold like, you'll seedifferences.
Some of them might just say themaximum that we gave during
that food challenge and nothinghappened.
(05:16):
Others will just say above acertain amount that we think
would be the likely exposure youwould have, you know, in
cross-contamination or somethingelse like that.
So I do think that it'simportant for us as allergists
and patients and families, allof us to be careful to
understand, when that word isbeing used, what they're
actually referring to.
For this particular study.
What we try to do is we, inassessing whether the actual
(05:39):
treatment was working, we gavekids up to 4,443 milligrams.
What in the world does thatmean?
We estimate that to be prettyclose to about a serving size of
peanuts for these kids, andit's equivalent of probably
about 15 peanuts, and so wewanted to make sure can the kids
eat that much peanut with nosort of symptoms at all?
Now, again, going back to thatpoint of like, how much does it
(06:02):
take to get sick?
What we have seen we don't havegreat data on this, but what
we've seen is most kids, ifthey're going to get sick from
eating a little bit of peanutcross-contamination, it takes
only about a third to one peanut.
It's about 100 to 300milligrams.
So in this case we push theenvelope.
We wanted to make sure you know, way over 4,000 plus milligrams
that nothing would happen atall, and so that's how we define
(06:24):
desensitization here.
Now the next part, though ispretty amazing yeah it's really
cool.
It's really cool just andespecially I mean I'm jumping
the gun here but the idea thatour treatment is only giving
four milligrams, a tiny littleamount of peanut every day, and
then we're getting a thousandtimes that in benefit, like over
4,000 milligrams, which is just.
It's kind of mind-boggling in agood way.
Alice Hoyt, MD (06:46):
Yeah, we'll talk about the protocol in a minute
because I know our listeners arewondering wait, how?
How do they go from?
Edwin Kim, MD (06:52):
4,000, and then 100, and then 4,000, like what.
Yep, and then jumping to thatremission, and so this is
another problem we've had in ourfield of.
Of course, the goal we'relooking for is we want to cure
the kids.
We want the kids to be able toeat whatever they want whenever
they want.
We're trying to get there.
We're not there yet,unfortunately, we're probably
(07:13):
not close, but in the process ofgetting there.
One of the things that I thinkwe're all thinking about is how
do we even know, like we, whenwe think about what we're eating
on an everyday basis, we don'tsay, oh, I haven't had a trip
today, like it's been a coupleof weeks.
I need to go eat it, like whenyou're not allergic, you just
eat it whenever you want to andwhatever you want to do.
But in a research study youkind of can't do it that way,
(07:34):
and so we've been trying tofigure out in a research study,
how can we fairly confidentlysay, okay, you're not reactive
and that's okay.
And so the earliest kind ofways we tried to do this was we
would treat someone, show thatthey were not reactive,
desensitized, and then take thetreatment away for a couple of
weeks, maybe up to a month, andthen come back and try that
(07:54):
again, and if you were again,we're not reactive.
That looked pretty good, butthen you could easily say well,
how do we know?
Like a month, in a day or twomonths, then suddenly you're
allergic again.
So then we started pushing itout a little further, and so so
we have found that a group ofkids, especially when they start
young, seem to be able to getto this point where there's some
(08:15):
lasting change in the immunesystem again we're nervous to
say permanent, but at least somelasting change that even a few
months later they're still notreactive.
And so the impact study whichwas published last year looked
at the oral immunotherapy, theOIT for peanut, and found that
it wasn't a large number, butabout a fifth of those patient
(08:37):
20% of them, even six monthsafter stopping the peanuts,
still stayed not reactive at all, and so, for lack of a better
term, we decided that that mightbe the best.
The best way to describe thatwould be remission, so that
disease is there, but it's sortof in hiding, it's not doing
anything, and could theyeventually have a relapse where
the symptoms come back?
(08:57):
Possibly we hope not, butpossibly.
And so that's kind of where theremission 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 decidedthree months seem like a really
long time, and so in our mindswe thought well, again, this
(09:21):
seems pretty good and it seemsto suggest that the immune
system has some lasting benefits.
So that's how we've used thatword here.
Alice Hoyt, MD (09:27):
Well, also because if you're listening,
you're probably thinking well,if it worked, why would you stop
it?
yes, that's right, that's rightif you get to where a kid who
has desensitized, why would youstop it?
And we stop it because, in theworld of oral immunotherapy,
participating in oralimmunotherapy is is a big
commitment, specifically of timeand having a kiddo avoid
(09:50):
strenuous activities during,during what's called their
safety window being an hourbefore, two hours, after their
dose, they really need to notparticipate in anything that's
going to raise their heart rate,raise their body temperature,
because those things can lowerthe threshold to have an
allergic reaction.
So undergoing oralimmunotherapy is is a big
commitment and so when you canget to a sense of normalcy and
(10:13):
start to step away of thatgazelle intensity essentially
for for dosing, and you do havea negative ingestion challenge
after being on oralimmunotherapy, it is really an
art at this time to figure outokay, how much do they need to
keep in the diet?
that's right do they still needa safety window?
(10:34):
Do they need to carry epi?
Usually we are on the side ofyes for that, at least for the
through, the time being.
And what's so amazing aboutSLIT, as we'll talk about, is
that that safety window is ismuch looser, and that is because
of the low side effect risk but, I'm getting ahead of myself.
(10:58):
I do want to talk about, I dowant to talk about the protocol
that you guys used.
And how did you?
Can you just sort of talk usthrough what it would look like
for a family to come in andparticipate?
Of course they were blinded,you guys were blinded, so you
didn't know if they were gettingthe actual peanuts slit or a
(11:22):
placebo slit.
But talk us through what thatlooked like.
How many up doses, really updosing at home, all of those
things.
Edwin Kim, MD (11:29):
Yeah.
So if it's okay, I'm going totake one like a few seconds just
to kind of tell, explain how wegot to where we got to.
And so I mentioned back with mytraining when I first got
involved with SLIT and at theexact same time we were directly
studying oral dermatotherapy.
Oh, I, actually one of mycolleagues, was more focused on
the oh I T and then I happenedto be involved with the slit and
(11:50):
so we were watching with oh I Tthat, on the one hand, works
really good, really strongdesensitization, but at the same
time we saw a lot of the sideeffects that came with it the,
you know, the allergic reactions, some of the taste aversion,
some of these co factors thatyou mentioned about exercise.
And so, seeing that with ourslit, we started very
conservatively as well.
(12:11):
So we had a long buildup period, six, seven months, coming in
every two weeks, similar to oh IT.
But the nice thing with ourstudies is, over that first
cohort that we studied for fiveyears, we looked at the safety
data and, my goodness, it wasgreat.
We weren't having a lot of sideeffects, we weren't having
anaphylaxis, we were having adecent amount of this mouth itch
that is very common with SLIT,and when we checked out the
(12:33):
timing of this, what we realizedwas, if it's going to happen,
it happens really short in time,like within a few minutes maybe
last 10, 15 minutes and thenit's done.
But we weren't seeing peopleone hour out, two hours out,
three hours out, having any sucha side effects, and so we were
able to shrink down theobservation time all the way
down the 30 minutes and feelvery confident with that, and
(12:54):
then, as we continued to look atit, we just did any pre
observation time?
Alice Hoyt, MD (12:58):
Was there any time they needed to be not doing
activities prior to their death?
Edwin Kim, MD (13:01):
So that's the other aspect as well.
So we were paying attention tothis because we had seen it with
oh I T, but for this thinkingthat the dose was so small that
this first study we actuallylooked at only two milligrams
compared to oh I T, wherethey're using anywhere from 300
to 4000.
So we were paying attention butwe didn't directly say avoid
this or avoid that.
It was more sort of the idea ofwell, with oh I T, we've seen
(13:23):
this.
So if you notice anything, letus smell.
And we did not.
Now, again, it's not a perfectway to study this, but we didn't
see those same problems.
But, again when we went back andlooked at how often are people
having anaphylaxis wheezing, youknow more serious side effects
and we just didn't see it.
And so the protocol that we usefor this study that you're
talking about, what weincorporated there, we're going
(13:44):
to be a lot of home up dosingbecause we just hadn't seen the
problems with it.
So what this current protocollooks like, which we hope.
Alice Hoyt, MD (13:52):
We hope it's a pretty.
Yeah, we hope this is afriendly yeah right.
Edwin Kim, MD (13:56):
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'reall on the same page, show them
how to show the patients, thefamilies, how to do the medicine
.
And then the idea would be totake the bottle home, which is a
bottle filled with the, theslick liquid, and a pumper, and
then they're given specificinstructions on how many pumps
(14:18):
to do, and each time should beone today, and so the idea would
be that they go home, do thesingle pump once, once a day for
a week, and then they're giveninstructions to double it up to
two and a week later, to fourand then to eight, and then they
come back into the clinic onemonth later and then we give
them the next strength of bottleand then they follow that same
pattern.
So at home they do theincreases once a week and then
(14:41):
come back in a month later, andso there's four direct in clinic
monthly visits.
So rather than the 10, 11, 12that you might see with an OIT
protocol.
And then they're a month apartas opposed to every two weeks.
It's still visits to the clinic,which could be difficult for
folks.
But it's what we are learningis that it's it's fairly
(15:01):
flexible and so a little bitlonger and a dose is never going
to hurt anyone.
And so we're hoping that thiscan sort of be that happy medium
between, like not being soburdensome of too many visits to
the office, but enough thatthey have a lot of face time
with us, because I do think thatit's so important that we have
that opportunity to talk throughsort of what are the risks, how
(15:22):
would you treat a reaction?
You know, is this a cure, isthis not a cure?
You know some of these thingsjust to make sure that the
families feel confident in kindof what they're doing and what
the benefits are and aren't,because we don't want folks
going out there thinking thatthis is going to be a cure all
either.
And so I do think that thosetouch points really help a lot.
Alice Hoyt, MD (15:42):
A million percent, I think.
The more that we as allergistscan directly engage with our
patients and answer theirquestions hence this podcast the
better, so that they don't haveto go on to social media to try
to find those answers.
And when you're going throughsomething like subliminal
immunotherapy or oralimmunotherapy or even sometimes
(16:04):
a series of ingestion challenges, you are getting that face time
with your doctor.
That isn't necessarily what thevisit is directly about, but is
so important.
It's just such importantcritical time, I find, to help
not just grow a family's depthof knowledge regarding their
child's allergic disorder butalso ease that anxiety that
(16:28):
absolutely comes along withkiddos who have food allergies.
So I, just as my patients know,I love to sit and talk with
them and make sure that theyknow 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 sothat's just.
(16:49):
That's so great and I love thatyou recognize that, that it is
good time for you guys toconnect.
But then you're alsorecognizing the burden that OIT
can be on families and coming infor the multiple appointments
and missing work and missingschool, into all of the things.
So that's amazing.
(17:11):
That's amazing.
Edwin Kim, MD (17:14):
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 inhere too is and I think this is
being recognized a lot more nowis that food allergy patients
and families they're not a onesize fits all, so every family
out there has it, affects themin different ways, unique ways,
and again, I think that's wherethose touch points really matter
(17:35):
.
The families can really havethe opportunity to tell you hey,
you know, little Joey justwants 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 slittreatment will sort of enable
that.
Or, you know, this is what'shappening at their daycare, and
so we just want some reassurance.
And so I also think that that'sa great opportunity to talk
specifically about thatpatient's experience.
(17:57):
And then again making sure thatthe expectations sort of line
up and maybe that someone comesin 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 surethere's a small subset of kids
that might get there but mostwon't.
But just level setting and butthen personalizing it, I think
really being able to sort ofspeak to like for your situation
(18:17):
and what you're looking for.
This is what we can expect andagain, it's hard to get that
through.
You know a bunch ofinformational pieces of paper.
I think you really got to havethose conversations to get there
.
Alice Hoyt, MD (18:28):
A million percent.
The goals, setting the goals.
What is your goal?
Is your goal to be bite-proof?
Edwin Kim, MD (18:33):
That's right.
Alice Hoyt, MD (18:34):
You didn't get accidentally ate a little bit
that he wouldn't have a severereaction?
Or is your goal to free eat andthen really having honest
discussion and revisiting thatthroughout the course of therapy
, because we might have a littlekiddo that we think is going to
get to the free eating, that ishaving trouble along the way,
(18:54):
and then we might have someolder kiddos that surprise us.
Edwin Kim, MD (18:56):
That's right.
Alice Hoyt, MD (18:57):
And so it's so important to be able to have
those shared decision-makingdiscussions and really be
engaged with our families, and Imean, I think that goes across
healthcare.
Yes, for sure, we all needdoctors to engage with us and
let us know what the bestpotential treatment plan is for
(19:19):
us or for our child, you know,and discuss the options and I
mean based on the studies thatare coming out about subliminal
immunotherapy.
It's certainly an option, andwhat fascinates me is the age
group here, and so we talkedabout desensitization, remission
(19:40):
, we talked about subliminalimmunotherapy.
One question, though, aboutthat described to me the process
of the method is the kiddoholds it under the tongue for
two minutes, right, but, andthen doesn't eat for a few
minutes after that.
But a one-year-old holdingsomething under tongue for two
(20:00):
minutes.
So talk to talk me through that.
I asked you, bert, about this afew months ago at our Louisiana
allergy conference.
He had a great response aboutit, so, but I know our listeners
would love to, because I knowthey're thinking wait, they're
one-year-old.
That's right, they hold itsomething.
How are you getting them tolisten and do what you say for
(20:23):
two minutes?
Edwin Kim, MD (20:24):
Yeah, we just hold their tongue up for them.
Now, I'm joking, of course not.
So I mean we do have within ourstudies.
We have very, very, veryexperienced nurse coordinators
who walk parents through sometips and tricks, trying to get
the kids to sort of sing andthings like that that will try
to help this.
But the reality is, I think,what everyone out there
recognizes, that for kids thatyoung it's quite difficult and
(20:45):
most are probably not holding itfor the whole two minutes, if
not even for several seconds,and so this is an aspect that we
are trying to understand moreis how long is the right amount
of time?
So two minutes actually was anarbitrary sort of amount that we
had seen from other types ofsublingual treatments, so we had
started with that.
But in this particular case, weknow that the kids probably
(21:08):
struggle to keep it that long,but the benefits are actually
the strongest that we've seenwith sublingual.
So it suggests that youprobably don't need to be that
long.
Again, what is the sort ofmagic amount of time is
something we definitely want tolearn for the next step to be
able to give sort of the bestadvice for families doing this.
I will also mention that thisis also a place where there is
(21:28):
an opening for new types ofsublingual treatment, and so
there's been some folks andwe're one of them that have
looked into like, oh, could wedo this as a dissolving film,
like like they had those breathstrips that would?
Alice Hoyt, MD (21:42):
melt on your tongue.
Edwin Kim, MD (21:43):
Could we do that?
Or there's a company that's inlooking into a dissolving tablet
Could you do?
Probably a choking hazard, butcould you do a las-ins or, you
know, are there other ways thatwe can sort of do it?
That might better ensure thatit's actually held under the
tongue as long as it is.
But again, coming back to thequestion, in this case we did
everything we could to train thepatients, the families, how to
(22:04):
do it.
I think they tried, everyonetried their best and then,
amazingly, the results turnedout really, really, really good.
And so we do still have more tounderstand about exactly what
the right exposure is, but not areason for us to necessarily
not pursue this in the shortterm, though, based on the
results and I do want to talk alittle bit about the study group
(22:29):
not the most diverse group, butunfortunately not unfortunately
what we see in research at thistime.
Alice Hoyt, MD (22:36):
But talk a little bit about the study group
.
Edwin Kim, MD (22:38):
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, inparticular, there was a study
that we had started at Duke andfinished at the University of
North Carolina called the DevilStudy.
That looked at these young 9 to36-month-olds and, sure enough,
(22:59):
found the strong, really reallystrong, desensitization with
oral, and so we wanted to see isthat the same concept for the
one to four-year-olds?
Because we anticipated that itwould be a lot safer and so that
was probably the most importantthing.
But still, clinical trials arereally difficult.
There's still lots of visits tothe office, blood draws and this
and that, and so, as much as wewanted to expand out and try to
(23:22):
have all comers come in,usually it's folks that have the
time, and so it's going to befamilies, where someone is
either home or just it hasreally flexible work that can
bring their child in, and so itends up not being a very diverse
, diverse group at all.
So in our case it's heavy, heavywhite population and probably
(23:43):
more sort of upper middle class,and we know from other data
that that's not necessarily whohas food allergy.
Food allergy is moredistributed and, if anything,
sort of non-whites maybe moreprone, and so definitely a big
hole in our research that we'retrying to in the design of
future studies as well as sortof in the clinic.
We're trying to understand thisas well and just make sure,
(24:05):
before we broadly advise this toeverybody, that you know
different groups do respond thesame, because we don't want to.
That would be one of the worstthings we could do is we just
sort of generalize this out toeverybody and realize that's not
the case.
Alice Hoyt, MD (24:17):
Absolutely, absolutely.
Thanks for talking us throughthat.
Yeah, and talking about sort ofthis particular young age group
and the effectiveness of this,figure four specifically be the
month 36 desensitization, oralfood challenge.
The intention to treat group75% of kids one to two who
(24:42):
started when they were one totwo had a negative oral food
challenge at that time or pastthe per protocol 100%.
So talk us through what intentto treat versus per protocol
means and then 100%.
Edwin Kim, MD (25:02):
That's right, yeah, so in our clinical
research, I think one of thefactors that we're always
dealing with is going to bepatients who are not able to
finish, who drop out of thestudy for one reason or another,
and what is sort of the rightway to count them if they've,
again not done everything?
And that's where this conceptof intent to treat comes in, and
typically what we would say thesafest, most conservative
(25:25):
whatever you want to say way toapproach this is going to be to
think that anyone who couldn'tfinish it would have failed,
would have not sort of achievedwhat you're looking for.
So that's what that intent totreat population means.
So that includes all 25 kidsthat were on treatment, all 25
that are on placebo, and of theones who dropped out, we counted
them as actually failing thefood challenge.
(25:46):
Now, the reality is, could theyhave passed?
Maybe, maybe not.
Again, we don't know that, butjust so that we don't overcall
the data, we consider them onthe negative side of failing,
and so that's how we get that.
Now for protocol.
Alice Hoyt, MD (25:57):
That's a good approach to science.
Edwin Kim, MD (25:58):
Right, that's right yeah.
Alice Hoyt, MD (26:00):
We don't want to overcall the data.
Edwin Kim, MD (26:01):
That's exactly right.
And then for protocol, whatthat would be is anyone who
actually was able to start tofinish, to be able to do
everything that we had said,which again could represent sort
of how well or not thetreatment works.
And so it's sort of showing twosides of the spectrum On the
one hand, probably overlyconservative and undercalling
and on the other hand, probablyovercalling.
But it's important for peoplethat are seeing the data to
(26:24):
understand.
It's probably something in themiddle is probably what we're
looking at.
Alice Hoyt, MD (26:29):
Which is tremendous so little drops of
peanut, tiny, tiny amounts, mostof which was done at home, has
permitted these very youngchildren, who are not of the age
, to say excuse me, I am not alarge-time person who cannot
protect themselves, who cannotsay, oh, this is making my mouth
(26:51):
feel funny.
Very well, right.
So, like a very vulnerablepopulation, is my point of
kiddos with peanut allergy, 100%of them who were per protocol,
75% intent to treat.
I mean, this is amazing Nowthat again for our listeners,
that means that when they wentthrough the study and they got
(27:13):
to the point of the study ofbeing on the slip for 36 months,
they did a full whopping doseingestion challenge.
They didn't react.
And so in real practice, somepeople will do that next step
that you guys did, dr Kim, thelet's look for remission.
So let's stop treatment, havethem very much avoid for one,
(27:35):
one, three months, six months,whatever.
But a lot of people in practicewould say, okay, we don't want
to figure out if you're inremission, because our goal is
to either get you bite-proof orto free eat.
And so what do we need to donow to continue this?
Because, as of right now,you're definitely bite-proof,
right, and that gives familiesjust so much relief.
(27:59):
I mean I love seeing ourfamilies come through our
practice and just the look ontheir faces when they're seeing
their kiddos like a whoppingspoon of peanut butter, when
such a small amount sent them tothe ER last year, I mean this
is pretty amazing.
Edwin Kim, MD (28:21):
Obviously I'm biased, but I'm very, very
excited by this as well, and Ithink just a couple points that
you mentioned.
One of them is the age factor.
So in particular that one totwo year old group, we had a
good number of those kids andthey seem to do really well and
this really lines up with recentdata that's come out of.
Well, first of all, that impactpaper for oral immunotherapy I
mentioned also suggests thatyounger, even within the one to
(28:44):
four, the younger was better.
But there's also recent datathat's coming out of the LEAP
study so that the whole thatstudy that looked at giving
peanut early to prevent peanutallergy, and even in that study
they looked at four to 11 monthold.
But they're easily seeing thefour to five month olds did
better than the five to six andsix to seven and so on, and so
(29:05):
there definitely seems to besomething with your immune
system that is just.
It's just more willing to betreated 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 ourgroup.
I do want to add one more piece,though, because I want to be so
excited with the numbers, asyou said the hundred percent and
all, but clearly it's a smallstudy.
So in our case it was painfulbecause we did all.
(29:27):
All those patients came to usin Southwestern, so it was a lot
for us.
But 50 kids is 50 kids and soif we had a thousand or 10,000
kids, would we have those samenumbers Again?
Probably not, but it's going tobe good.
I mean, the numbers wouldn't beway off from this, and so we do
think that this has thepotential to help a lot of kids
that are out there.
Alice Hoyt, MD (29:46):
The other important point was that none of
the kids in the placebo groupoutgrew their peanut allergy.
Edwin Kim, MD (29:54):
That's right.
Alice Hoyt, MD (29:54):
Which is also not necessarily consistent with
what we see Now.
I mean we're not seeing 50% ofkids.
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 to30%, and that's an important
discussion.
When we're saying you know, dowe want to embark on oral
immunotherapy right now orsomething, or immunotherapy, or
(30:15):
is there a potential of themoutgrowing it, do you want to
comment?
That's really interesting, yeah, yeah.
So I mean.
Edwin Kim, MD (30:22):
It's really allergic to kids.
Yeah, really allergic to kids.
But here's a moment that I dojust want to call out the
families that participated.
I mean, my gosh, the sacrificesthat these families give for,
not only for their own kids butfor all families out there where
it's root allergy can't be.
I mean it's just, it's soimportant because, I mean, these
(30:43):
are they.
There are families that spentthree years on a placebo for to
help us to try to understandthis of does this work or not.
And the reason we needed thatlong placebo is what you
mentioned we needed to make sureis there really is this
treatment or the kids naturallyoutgrowing it?
And so in this study we clearlysaw no one outgrew it during
the same time period.
So we can pretty confidentlysay that the majority of what we
(31:05):
saw was from the treatment.
Now, for those same families,again, we can't there's no way
ethically we can leave them outin the cold, and so we had a
separate protocol afterwards tobe able to give them the
treatment that they, you know,had willingly sacrificed.
But it's just so important thatnone of this happens without the
families.
And you know, again, somenaysayers may say, well, they're
(31:26):
just trying to get early access.
I mean no, no, these familiesof course they like that, but
these families are absolutelydedicated to the field and
making sure that you knowwhatever sacrifice they put in
is going to help not only theirkid but all these other families
out there.
So I mean again, can't saythank you enough to them.
Alice Hoyt, MD (31:42):
The allergy families are amazing.
Edwin Kim, MD (31:44):
They are.
Alice Hoyt, MD (31:44):
What are some ways that they can get involved
in research?
Edwin Kim, MD (31:48):
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 thatthey've heard us in studies,
participated in some studies andbe able to share sort of their
experiences.
Another is to support studies.
So again, we're always lookingfor groups like fair or the NIH
and stuff to support studies.
But you know, again, if theremay be opportunities to sort of
(32:10):
give as well, to help with that.
But I think, in all thosedifferent ways, but if anything,
the way that most families canhelp is just to continue to
bring this positive attention tofood allergy.
You know, make sure that theawareness is there that food
allergy is real.
There's lots and lots and lotsof families and unfortunately
(32:31):
the number keeps going up, butfamilies that have this and we
really need something that willhelp our kids just go back to
normal.
I mean, I think because inevery other way they're normal,
but the, the everyday sort ofburden that comes with this, the
anxiety, the changes, you knowthe effects on quality life,
they're real and so I thinkthat's probably the number one
way that they can help.
Alice Hoyt, MD (32:53):
Love it, I love it.
Thanks so much for joining us.
What, what sort of last wordswould 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 yourencouragement to our food
allergy families listening?
Edwin Kim, MD (33:08):
Yeah, so you mentioned earlier that.
I mean not that we ever wantanyone to have a food allergy,
but now is a really good timebecause there's so much hope.
We have oral immunotherapyavailable in many clinics.
Our data suggests that lingualcould be an option as well.
There's studies on this patchmedicine, the epigutaneous and
biological medicine, and sothere are options available now.
(33:30):
There are options coming in thenear future and then there are
options coming further out thanthat, and so I think, just you
know again, there's plenty ofhope 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 itmay not be, because food allergy
(33:51):
is individual to each family,and so just to hear those out
and you know, maybe that nextone 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 andthere's plenty of hope coming.
Alice Hoyt, MD (34:06):
I love it.
Dr Kim, thank you so much forjoining us.
Edwin Kim, MD (34:08):
Thank you very much for the invitation.
This is great.
Alice Hoyt, MD (34:13):
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 (34:18):
No problem.
Alice Hoyt, MD (34:20):
Was that okay?
Edwin Kim, MD (34:20):
I hope oh my gosh , that was awesome, oh yeah good
, I can never tell, because Ijust I mean I love this stuff
right, so I can go forever.
Alice Hoyt, MD (34:30):
I understand.
I do too.
Hints the podcast.
Edwin Kim, MD (34:35):
That's right.
Alice Hoyt, MD (34:37):
No, this is so awesome.
Edwin Kim, MD (34:40):
I love it.
Alice Hoyt, MD (34:41):
I mean, I just love that there's more.
You know, there's more thanavoidance or OIT, and this is
something that can definitely bedone in many families, and I'm
just so.
I'm so grateful to groups likeyours that do this research.
(35:02):
So anytime you want to comeback on and talk about anything,
you are more than welcome tocome onto this platform.
We would love to have you, sure.
Edwin Kim, MD (35:15):
I mean, I think the big one that you've probably
already heard of is going to beZolaire.
So Zolaire is actively beingstudied now.
I think there's lots of hopethat in the next one or two
years it could be added to thelabel.
I mean, they have to be able todecide that.
Is that going to be foreveryone?
No, but I think it's going tobe an important one, and so that
could be a good time for if youmay have someone else you want
(35:35):
to talk to, but if not, I wouldlove to talk about that.
Alice Hoyt, MD (35:38):
I heard it was coming like next quarter.
Edwin Kim, MD (35:40):
I mean I think the company would hope, but it
seems very likely and verylikely soon.
And so I mean one other concept.
I mean the two concepts thatI've been saying a lot in talks
and in clinic.
Number one is going to be goingback to your point of it's so
different now.
So, as opposed to always the OK, I'm sorry you're allergic, go
(36:02):
ahead.
Good luck with avoiding.
Now it's proactive.
It's about well, here are thesetreatments OID, there's a
couple that are coming, and thenthere are more coming and just
really more proactively thinkingabout what can we do about it.
I mean, yeah, it's humongous, Ithink, just thinking in that
way, sort of turning our mindsmore towards that, and so it's
(36:23):
just been a lot more fun, andthen I mean living with it in
our house as well.
It's the same.
It's just sort of the defensiveapproach is just not very
satisfactory.
So I mean we want to dosomething about it as doctors
and as parents.
Alice Hoyt, MD (36:38):
Yeah, and one of the things that I'm starting to
grapple with is which treatmentis best for which patient.
So I do oral immunotherapy andI started doing slit.
I was kind of like pushed intodoing slit when one of my
patients he's six years old hehas a sesame IgE of greater than
(37:01):
100.
And he reacted to the smallestdose of the OID.
Edwin Kim, MD (37:07):
Oh no, the oral.
Yeah, that's right.
Alice Hoyt, MD (37:08):
Yeah, and though now mom is saying it may have
been a confounder of sesamemislabeling, whole sesame label
thing changed and he may haveeaten a bar, but like no no,
based on some other stuff.
Anyway, it was too close tocall.
We were well too close to hisreaction threshold for me to
proceed on OID, when OID shouldbe very boring for families.
Edwin Kim, MD (37:30):
Right.
Alice Hoyt, MD (37:31):
It's really, if we're doing it right, it should
be.
We should say well below thatreaction threshold.
So that's how I was kind ofpushed into doing slit with this
kiddo because he had accidentalingestion and he had severe
reactions.
And so now I am doing slit, butconstantly looking for ways to
(37:52):
make the treatments whatever thetreatments are, to make them as
safe as possible, of course, aspotent as possible or effective
, as powerful as possible, butthen also as reasonable as
possible.
And for all of my patients thatare peanut allergic, who are
between 4 to 17, I offer thempalporezia 0-1-1.
(38:14):
They all want the peanut butterprotocol, which is what I've
been doing for years and it'slovely, and I also kind of think
the peanut butter protocol wedo is very helpful because it
does stick in the mouth and Iwonder how much of that is using
that sort of background to theimmune system to grow tolerance.
But really trying to find.
(38:34):
Ok, now, as more data like thiscomes, which kiddos am I going
to say?
You know what?
Why don't we try slit with you?
Edwin Kim, MD (38:42):
Yeah, yeah.
I mean I think just the factthat we have options is awesome.
It's so awesome to even havethis conversation.
And then I think ages andstages.
So I think there'll betreatments that might be right
at a certain age, that might notbe right at another, Sequential
treatments, I mean all thiskind of stuff.
If we can just get them outthere in our hands, then I think
(39:02):
we can do lots of fun.
But as I realized, I'm gettingtexted because I was supposed to
be on another call.
I'm so sorry, oh my gosh, soI'm going to hop on.
Alice Hoyt, MD (39:09):
I'm so sorry, oh , no, no, no.
Edwin Kim, MD (39:11):
It's because you know me.
I just I love talking about it.
Alice Hoyt, MD (39:14):
For your time.
You're awesome.
I hope you have a wonderful andblessed Thanksgiving and I will
be inviting you back soon.
Edwin Kim, MD (39:23):
Love it.
I'm going to say yes.
I'll already tell you that.
Alice Hoyt, MD (39:26):
Thank you.
Take care, see you, bye.
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 thefood allergist who is really,
really pioneering slit.
When I talk about slitsublingual immunotherapy,
(00:31):
evidence-based approach you allknow you're coming to this
podcast, so this show.
You're looking forfamily-focused, evidence-based
information and that is whatwe're providing here today.
Dr Kim, thank you so much forcoming on to the show.
Edwin Kim, MD (00:45):
Yeah, happy to be here.
Alice Hoyt, MD (00:48):
Awesome.
The first question I reallywant to ask, and what our
listeners are probably wondering, is really how did you find
yourself researching foodallergy?
Tell us about your journey.
Edwin Kim, MD (00:59):
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 seasonalallergies, food allergy, eczema
, asthma.
We had a lot of that floatingbetween my parents, my brother,
myself, and I think thatprobably planted the seeds that
I didn't realize Fast forwardall the way into college and
(01:19):
then I was starting to head downthe med school route and
immunology in particular reallystood out to me, the idea that
your immune system is perfectlytuned to be able to fight off
any possible infection thatcould be out there, and so that
was fascinating to me.
But then as I started to learnabout allergy and autoimmune
disease and starting to realize,wait, the immune system is not
(01:41):
perfect and there are ways thatit can overreact in the case of
allergy or even attack itself,and autoimmunity really stood
out.
So I got into our field, reallyinitially focused more on the
actual basic science immunologyside, but then, just by pure
chance, I happened to do arotation at Duke University
Medical Center, where Dr WesleyBirx was the allergy program
(02:04):
director as well as the chief ofallergy and one of the pioneers
of the food allergy researchthat we've been doing, and so I
was fortunate enough to workwith him for a month, hear him
talk and to just understand sortof the scope of the food
allergy problem and again, thisidea of how the immune system,
which is supposed to be soperfect, is not so perfect when
(02:26):
it comes to food allergy reallyreally wrong, true to me.
And so I ended up staying onand training under him, getting
exposure to these differenttreatments oral immunotherapy
and then the sublingual, andthen fast forward to this is
where I am, that's amazing andfor our moms and dads listening
and grandparents who arelistening to the podcast.
Alice Hoyt, MD (02:48):
I know that whenever you're looking for good
articles, good journal articles, you're sometimes you're
wondering well, how do I knowit's a good article.
If the name Wes Birx is anarticle, it's a good article.
Edwin Kim, MD (03:00):
Here's your Libystein.
That's exactly right.
Alice Hoyt, MD (03:03):
So, dr Kim, awesome that you've been able to
train under him and work withhim and collaborate with him,
and also, I mean just that wholearea is just so filled with
amazing food allergy focuseddocs.
So that's, that's awesome.
And I'm not surprised that suchcool research is coming out of
(03:24):
of y'all's labs and has been fordecades at this point.
But what I, what I really wantto talk about today is your
amazing paper desensitizationand remission after peanut
sublingual immunotherapy in oneto four year old peanut allergic
children.
(03:45):
A randomized placebo controlledtrial.
So that's a mouthful, but everysingle word in there is so
critical.
So let's and you have some realrock stars on this paper too
Drew Bird, karin Keat, wes BirxI mean it's a real deal y'all so
(04:07):
.
So let's talk through justbreaking down the title, because
also the term remission hasstarted really floating around
on the interwebs and the titleis desensitization and remission
after peanut slit.
So let's first talk about that.
(04:28):
How did you guys definedesensitization and how did you
define remission?
Edwin Kim, MD (04:34):
Yeah.
So that's probably the mostimportant question here and I
think as a field we've beentrying to figure, figure this
out.
What are the proper definitionsfor these?
And I think where our field hasreally come back to now, with
the word desensitization atleast, is the idea that while
you're actively being treatedand that could be whether it's
going to be oral, sublingual orother treatments that are out
(04:55):
there that we are able to makesomeone either non-reactive or
less reactive, so increase theamount of food that it takes to
actually have an outwardallergic reaction.
Now again, depending on sort ofwhat study you see that
threshold like, you'll seedifferences.
Some of them might just say themaximum that we gave during
that food challenge and nothinghappened.
(05:16):
Others will just say above acertain amount that we think
would be the likely exposure youwould have, you know, in
cross-contamination or somethingelse like that.
So I do think that it'simportant for us as allergists
and patients and families, allof us to be careful to
understand, when that word isbeing used, what they're
actually referring to.
For this particular study.
What we try to do is we, inassessing whether the actual
(05:39):
treatment was working, we gavekids up to 4,443 milligrams.
What in the world does thatmean?
We estimate that to be prettyclose to about a serving size of
peanuts for these kids, andit's equivalent of probably
about 15 peanuts, and so wewanted to make sure can the kids
eat that much peanut with nosort of symptoms at all?
Now, again, going back to thatpoint of like, how much does it
(06:02):
take to get sick?
What we have seen we don't havegreat data on this, but what
we've seen is most kids, ifthey're going to get sick from
eating a little bit of peanutcross-contamination, it takes
only about a third to one peanut.
It's about 100 to 300milligrams.
So in this case we push theenvelope.
We wanted to make sure you know, way over 4,000 plus milligrams
that nothing would happen atall, and so that's how we define
(06:24):
desensitization here.
Now the next part, though ispretty amazing yeah it's really
cool.
It's really cool just andespecially I mean I'm jumping
the gun here but the idea thatour treatment is only giving
four milligrams, a tiny littleamount of peanut every day, and
then we're getting a thousandtimes that in benefit, like over
4,000 milligrams, which is just.
It's kind of mind-boggling in agood way.
Alice Hoyt, MD (06:46):
Yeah, we'll talk about the protocol in a minute
because I know our listeners arewondering wait, how?
How do they go from?
Edwin Kim, MD (06:52):
4,000, and then 100, and then 4,000, like what.
Yep, and then jumping to thatremission, and so this is
another problem we've had in ourfield of.
Of course, the goal we'relooking for is we want to cure
the kids.
We want the kids to be able toeat whatever they want whenever
they want.
We're trying to get there.
We're not there yet,unfortunately, we're probably
(07:13):
not close, but in the process ofgetting there.
One of the things that I thinkwe're all thinking about is how
do we even know, like we, whenwe think about what we're eating
on an everyday basis, we don'tsay, oh, I haven't had a trip
today, like it's been a coupleof weeks.
I need to go eat it, like whenyou're not allergic, you just
eat it whenever you want to andwhatever you want to do.
But in a research study youkind of can't do it that way,
(07:34):
and so we've been trying tofigure out in a research study,
how can we fairly confidentlysay, okay, you're not reactive
and that's okay.
And so the earliest kind ofways we tried to do this was we
would treat someone, show thatthey were not reactive,
desensitized, and then take thetreatment away for a couple of
weeks, maybe up to a month, andthen come back and try that
(07:54):
again, and if you were again,we're not reactive.
That looked pretty good, butthen you could easily say well,
how do we know?
Like a month, in a day or twomonths, then suddenly you're
allergic again.
So then we started pushing itout a little further, and so so
we have found that a group ofkids, especially when they start
young, seem to be able to getto this point where there's some
(08:15):
lasting change in the immunesystem again we're nervous to
say permanent, but at least somelasting change that even a few
months later they're still notreactive.
And so the impact study whichwas published last year looked
at the oral immunotherapy, theOIT for peanut, and found that
it wasn't a large number, butabout a fifth of those patient
(08:37):
20% of them, even six monthsafter stopping the peanuts,
still stayed not reactive at all, and so, for lack of a better
term, we decided that that mightbe the best.
The best way to describe thatwould be remission, so that
disease is there, but it's sortof in hiding, it's not doing
anything, and could theyeventually have a relapse where
the symptoms come back?
(08:57):
Possibly we hope not, butpossibly.
And so that's kind of where theremission 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 decidedthree months seem like a really
long time, and so in our mindswe thought well, again, this
(09:21):
seems pretty good and it seemsto suggest that the immune
system has some lasting benefits.
So that's how we've used thatword here.
Alice Hoyt, MD (09:27):
Well, also because if you're listening,
you're probably thinking well,if it worked, why would you stop
it?
yes, that's right, that's rightif you get to where a kid who
has desensitized, why would youstop it?
And we stop it because, in theworld of oral immunotherapy,
participating in oralimmunotherapy is is a big
commitment, specifically of timeand having a kiddo avoid
(09:50):
strenuous activities during,during what's called their
safety window being an hourbefore, two hours, after their
dose, they really need to notparticipate in anything that's
going to raise their heart rate,raise their body temperature,
because those things can lowerthe threshold to have an
allergic reaction.
So undergoing oralimmunotherapy is is a big
commitment and so when you canget to a sense of normalcy and
(10:13):
start to step away of thatgazelle intensity essentially
for for dosing, and you do havea negative ingestion challenge
after being on oralimmunotherapy, it is really an
art at this time to figure outokay, how much do they need to
keep in the diet?
that's right do they still needa safety window?
(10:34):
Do they need to carry epi?
Usually we are on the side ofyes for that, at least for the
through, the time being.
And what's so amazing aboutSLIT, as we'll talk about, is
that that safety window is ismuch looser, and that is because
of the low side effect risk but, I'm getting ahead of myself.
(10:58):
I do want to talk about, I dowant to talk about the protocol
that you guys used.
And how did you?
Can you just sort of talk usthrough what it would look like
for a family to come in andparticipate?
Of course they were blinded,you guys were blinded, so you
didn't know if they were gettingthe actual peanuts slit or a
(11:22):
placebo slit.
But talk us through what thatlooked like.
How many up doses, really updosing at home, all of those
things.
Edwin Kim, MD (11:29):
Yeah.
So if it's okay, I'm going totake one like a few seconds just
to kind of tell, explain how wegot to where we got to.
And so I mentioned back with mytraining when I first got
involved with SLIT and at theexact same time we were directly
studying oral dermatotherapy.
Oh, I, actually one of mycolleagues, was more focused on
the oh I T and then I happenedto be involved with the slit and
(11:50):
so we were watching with oh I Tthat, on the one hand, works
really good, really strongdesensitization, but at the same
time we saw a lot of the sideeffects that came with it the,
you know, the allergic reactions, some of the taste aversion,
some of these co factors thatyou mentioned about exercise.
And so, seeing that with ourslit, we started very
conservatively as well.
(12:11):
So we had a long buildup period, six, seven months, coming in
every two weeks, similar to oh IT.
But the nice thing with ourstudies is, over that first
cohort that we studied for fiveyears, we looked at the safety
data and, my goodness, it wasgreat.
We weren't having a lot of sideeffects, we weren't having
anaphylaxis, we were having adecent amount of this mouth itch
that is very common with SLIT,and when we checked out the
(12:33):
timing of this, what we realizedwas, if it's going to happen,
it happens really short in time,like within a few minutes maybe
last 10, 15 minutes and thenit's done.
But we weren't seeing peopleone hour out, two hours out,
three hours out, having any sucha side effects, and so we were
able to shrink down theobservation time all the way
down the 30 minutes and feelvery confident with that, and
(12:54):
then, as we continued to look atit, we just did any pre
observation time?
Alice Hoyt, MD (12:58):
Was there any time they needed to be not doing
activities prior to their death?
Edwin Kim, MD (13:01):
So that's the other aspect as well.
So we were paying attention tothis because we had seen it with
oh I T, but for this thinkingthat the dose was so small that
this first study we actuallylooked at only two milligrams
compared to oh I T, wherethey're using anywhere from 300
to 4000.
So we were paying attention butwe didn't directly say avoid
this or avoid that.
It was more sort of the idea ofwell, with oh I T, we've seen
(13:23):
this.
So if you notice anything, letus smell.
And we did not.
Now, again, it's not a perfectway to study this, but we didn't
see those same problems.
But, again when we went back andlooked at how often are people
having anaphylaxis wheezing, youknow more serious side effects
and we just didn't see it.
And so the protocol that we usefor this study that you're
talking about, what weincorporated there, we're going
(13:44):
to be a lot of home up dosingbecause we just hadn't seen the
problems with it.
So what this current protocollooks like, which we hope.
Alice Hoyt, MD (13:52):
We hope it's a pretty.
Yeah, we hope this is afriendly yeah right.
Edwin Kim, MD (13:56):
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'reall on the same page, show them
how to show the patients, thefamilies, how to do the medicine
.
And then the idea would be totake the bottle home, which is a
bottle filled with the, theslick liquid, and a pumper, and
then they're given specificinstructions on how many pumps
(14:18):
to do, and each time should beone today, and so the idea would
be that they go home, do thesingle pump once, once a day for
a week, and then they're giveninstructions to double it up to
two and a week later, to fourand then to eight, and then they
come back into the clinic onemonth later and then we give
them the next strength of bottleand then they follow that same
pattern.
So at home they do theincreases once a week and then
(14:41):
come back in a month later, andso there's four direct in clinic
monthly visits.
So rather than the 10, 11, 12that you might see with an OIT
protocol.
And then they're a month apartas opposed to every two weeks.
It's still visits to the clinic,which could be difficult for
folks.
But it's what we are learningis that it's it's fairly
(15:01):
flexible and so a little bitlonger and a dose is never going
to hurt anyone.
And so we're hoping that thiscan sort of be that happy medium
between, like not being soburdensome of too many visits to
the office, but enough thatthey have a lot of face time
with us, because I do think thatit's so important that we have
that opportunity to talk throughsort of what are the risks, how
(15:22):
would you treat a reaction?
You know, is this a cure, isthis not a cure?
You know some of these thingsjust to make sure that the
families feel confident in kindof what they're doing and what
the benefits are and aren't,because we don't want folks
going out there thinking thatthis is going to be a cure all
either.
And so I do think that thosetouch points really help a lot.
Alice Hoyt, MD (15:42):
A million percent, I think.
The more that we as allergistscan directly engage with our
patients and answer theirquestions hence this podcast the
better, so that they don't haveto go on to social media to try
to find those answers.
And when you're going throughsomething like subliminal
immunotherapy or oralimmunotherapy or even sometimes
(16:04):
a series of ingestion challenges, you are getting that face time
with your doctor.
That isn't necessarily what thevisit is directly about, but is
so important.
It's just such importantcritical time, I find, to help
not just grow a family's depthof knowledge regarding their
child's allergic disorder butalso ease that anxiety that
(16:28):
absolutely comes along withkiddos who have food allergies.
So I, just as my patients know,I love to sit and talk with
them and make sure that theyknow 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 sothat's just.
(16:49):
That's so great and I love thatyou recognize that, that it is
good time for you guys toconnect.
But then you're alsorecognizing the burden that OIT
can be on families and coming infor the multiple appointments
and missing work and missingschool, into all of the things.
So that's amazing.
(17:11):
That's amazing.
Edwin Kim, MD (17:14):
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 inhere too is and I think this is
being recognized a lot more nowis that food allergy patients
and families they're not a onesize fits all, so every family
out there has it, affects themin different ways, unique ways,
and again, I think that's wherethose touch points really matter
(17:35):
.
The families can really havethe opportunity to tell you hey,
you know, little Joey justwants 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 slittreatment will sort of enable
that.
Or, you know, this is what'shappening at their daycare, and
so we just want some reassurance.
And so I also think that that'sa great opportunity to talk
specifically about thatpatient's experience.
(17:57):
And then again making sure thatthe expectations sort of line
up and maybe that someone comesin 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 surethere's a small subset of kids
that might get there but mostwon't.
But just level setting and butthen personalizing it, I think
really being able to sort ofspeak to like for your situation
(18:17):
and what you're looking for.
This is what we can expect andagain, it's hard to get that
through.
You know a bunch ofinformational pieces of paper.
I think you really got to havethose conversations to get there
.
Alice Hoyt, MD (18:28):
A million percent.
The goals, setting the goals.
What is your goal?
Is your goal to be bite-proof?
Edwin Kim, MD (18:33):
That's right.
Alice Hoyt, MD (18:34):
You didn't get accidentally ate a little bit
that he wouldn't have a severereaction?
Or is your goal to free eat andthen really having honest
discussion and revisiting thatthroughout the course of therapy
, because we might have a littlekiddo that we think is going to
get to the free eating, that ishaving trouble along the way,
(18:54):
and then we might have someolder kiddos that surprise us.
Edwin Kim, MD (18:56):
That's right.
Alice Hoyt, MD (18:57):
And so it's so important to be able to have
those shared decision-makingdiscussions and really be
engaged with our families, and Imean, I think that goes across
healthcare.
Yes, for sure, we all needdoctors to engage with us and
let us know what the bestpotential treatment plan is for
(19:19):
us or for our child, you know,and discuss the options and I
mean based on the studies thatare coming out about subliminal
immunotherapy.
It's certainly an option, andwhat fascinates me is the age
group here, and so we talkedabout desensitization, remission
(19:40):
, we talked about subliminalimmunotherapy.
One question, though, aboutthat described to me the process
of the method is the kiddoholds it under the tongue for
two minutes, right, but, andthen doesn't eat for a few
minutes after that.
But a one-year-old holdingsomething under tongue for two
(20:00):
minutes.
So talk to talk me through that.
I asked you, bert, about this afew months ago at our Louisiana
allergy conference.
He had a great response aboutit, so, but I know our listeners
would love to, because I knowthey're thinking wait, they're
one-year-old.
That's right, they hold itsomething.
How are you getting them tolisten and do what you say for
(20:23):
two minutes?
Edwin Kim, MD (20:24):
Yeah, we just hold their tongue up for them.
Now, I'm joking, of course not.
So I mean we do have within ourstudies.
We have very, very, veryexperienced nurse coordinators
who walk parents through sometips and tricks, trying to get
the kids to sort of sing andthings like that that will try
to help this.
But the reality is, I think,what everyone out there
recognizes, that for kids thatyoung it's quite difficult and
(20:45):
most are probably not holding itfor the whole two minutes, if
not even for several seconds,and so this is an aspect that we
are trying to understand moreis how long is the right amount
of time?
So two minutes actually was anarbitrary sort of amount that we
had seen from other types ofsublingual treatments, so we had
started with that.
But in this particular case, weknow that the kids probably
(21:08):
struggle to keep it that long,but the benefits are actually
the strongest that we've seenwith sublingual.
So it suggests that youprobably don't need to be that
long.
Again, what is the sort ofmagic amount of time is
something we definitely want tolearn for the next step to be
able to give sort of the bestadvice for families doing this.
I will also mention that thisis also a place where there is
(21:28):
an opening for new types ofsublingual treatment, and so
there's been some folks andwe're one of them that have
looked into like, oh, could wedo this as a dissolving film,
like like they had those breathstrips that would?
Alice Hoyt, MD (21:42):
melt on your tongue.
Edwin Kim, MD (21:43):
Could we do that?
Or there's a company that's inlooking into a dissolving tablet
Could you do?
Probably a choking hazard, butcould you do a las-ins or, you
know, are there other ways thatwe can sort of do it?
That might better ensure thatit's actually held under the
tongue as long as it is.
But again, coming back to thequestion, in this case we did
everything we could to train thepatients, the families, how to
(22:04):
do it.
I think they tried, everyonetried their best and then,
amazingly, the results turnedout really, really, really good.
And so we do still have more tounderstand about exactly what
the right exposure is, but not areason for us to necessarily
not pursue this in the shortterm, though, based on the
results and I do want to talk alittle bit about the study group
(22:29):
not the most diverse group, butunfortunately not unfortunately
what we see in research at thistime.
Alice Hoyt, MD (22:36):
But talk a little bit about the study group
.
Edwin Kim, MD (22:38):
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, inparticular, there was a study
that we had started at Duke andfinished at the University of
North Carolina called the DevilStudy.
That looked at these young 9 to36-month-olds and, sure enough,
(22:59):
found the strong, really reallystrong, desensitization with
oral, and so we wanted to see isthat the same concept for the
one to four-year-olds?
Because we anticipated that itwould be a lot safer and so that
was probably the most importantthing.
But still, clinical trials arereally difficult.
There's still lots of visits tothe office, blood draws and this
and that, and so, as much as wewanted to expand out and try to
(23:22):
have all comers come in,usually it's folks that have the
time, and so it's going to befamilies, where someone is
either home or just it hasreally flexible work that can
bring their child in, and so itends up not being a very diverse
, diverse group at all.
So in our case it's heavy, heavywhite population and probably
(23:43):
more sort of upper middle class,and we know from other data
that that's not necessarily whohas food allergy.
Food allergy is moredistributed and, if anything,
sort of non-whites maybe moreprone, and so definitely a big
hole in our research that we'retrying to in the design of
future studies as well as sortof in the clinic.
We're trying to understand thisas well and just make sure,
(24:05):
before we broadly advise this toeverybody, that you know
different groups do respond thesame, because we don't want to.
That would be one of the worstthings we could do is we just
sort of generalize this out toeverybody and realize that's not
the case.
Alice Hoyt, MD (24:17):
Absolutely, absolutely.
Thanks for talking us throughthat.
Yeah, and talking about sort ofthis particular young age group
and the effectiveness of this,figure four specifically be the
month 36 desensitization, oralfood challenge.
The intention to treat group75% of kids one to two who
(24:42):
started when they were one totwo had a negative oral food
challenge at that time or pastthe per protocol 100%.
So talk us through what intentto treat versus per protocol
means and then 100%.
Edwin Kim, MD (25:02):
That's right, yeah, so in our clinical
research, I think one of thefactors that we're always
dealing with is going to bepatients who are not able to
finish, who drop out of thestudy for one reason or another,
and what is sort of the rightway to count them if they've,
again not done everything?
And that's where this conceptof intent to treat comes in, and
typically what we would say thesafest, most conservative
(25:25):
whatever you want to say way toapproach this is going to be to
think that anyone who couldn'tfinish it would have failed,
would have not sort of achievedwhat you're looking for.
So that's what that intent totreat population means.
So that includes all 25 kidsthat were on treatment, all 25
that are on placebo, and of theones who dropped out, we counted
them as actually failing thefood challenge.
(25:46):
Now, the reality is, could theyhave passed?
Maybe, maybe not.
Again, we don't know that, butjust so that we don't overcall
the data, we consider them onthe negative side of failing,
and so that's how we get that.
Now for protocol.
Alice Hoyt, MD (25:57):
That's a good approach to science.
Edwin Kim, MD (25:58):
Right, that's right yeah.
Alice Hoyt, MD (26:00):
We don't want to overcall the data.
Edwin Kim, MD (26:01):
That's exactly right.
And then for protocol, whatthat would be is anyone who
actually was able to start tofinish, to be able to do
everything that we had said,which again could represent sort
of how well or not thetreatment works.
And so it's sort of showing twosides of the spectrum On the
one hand, probably overlyconservative and undercalling
and on the other hand, probablyovercalling.
But it's important for peoplethat are seeing the data to
(26:24):
understand.
It's probably something in themiddle is probably what we're
looking at.
Alice Hoyt, MD (26:29):
Which is tremendous so little drops of
peanut, tiny, tiny amounts, mostof which was done at home, has
permitted these very youngchildren, who are not of the age
, to say excuse me, I am not alarge-time person who cannot
protect themselves, who cannotsay, oh, this is making my mouth
(26:51):
feel funny.
Very well, right.
So, like a very vulnerablepopulation, is my point of
kiddos with peanut allergy, 100%of them who were per protocol,
75% intent to treat.
I mean, this is amazing Nowthat again for our listeners,
that means that when they wentthrough the study and they got
(27:13):
to the point of the study ofbeing on the slip for 36 months,
they did a full whopping doseingestion challenge.
They didn't react.
And so in real practice, somepeople will do that next step
that you guys did, dr Kim, thelet's look for remission.
So let's stop treatment, havethem very much avoid for one,
(27:35):
one, three months, six months,whatever.
But a lot of people in practicewould say, okay, we don't want
to figure out if you're inremission, because our goal is
to either get you bite-proof orto free eat.
And so what do we need to donow to continue this?
Because, as of right now,you're definitely bite-proof,
right, and that gives familiesjust so much relief.
(27:59):
I mean I love seeing ourfamilies come through our
practice and just the look ontheir faces when they're seeing
their kiddos like a whoppingspoon of peanut butter, when
such a small amount sent them tothe ER last year, I mean this
is pretty amazing.
Edwin Kim, MD (28:21):
Obviously I'm biased, but I'm very, very
excited by this as well, and Ithink just a couple points that
you mentioned.
One of them is the age factor.
So in particular that one totwo year old group, we had a
good number of those kids andthey seem to do really well and
this really lines up with recentdata that's come out of.
Well, first of all, that impactpaper for oral immunotherapy I
mentioned also suggests thatyounger, even within the one to
(28:44):
four, the younger was better.
But there's also recent datathat's coming out of the LEAP
study so that the whole thatstudy that looked at giving
peanut early to prevent peanutallergy, and even in that study
they looked at four to 11 monthold.
But they're easily seeing thefour to five month olds did
better than the five to six andsix to seven and so on, and so
(29:05):
there definitely seems to besomething with your immune
system that is just.
It's just more willing to betreated 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 ourgroup.
I do want to add one more piece,though, because I want to be so
excited with the numbers, asyou said the hundred percent and
all, but clearly it's a smallstudy.
So in our case it was painfulbecause we did all.
(29:27):
All those patients came to usin Southwestern, so it was a lot
for us.
But 50 kids is 50 kids and soif we had a thousand or 10,000
kids, would we have those samenumbers Again?
Probably not, but it's going tobe good.
I mean, the numbers wouldn't beway off from this, and so we do
think that this has thepotential to help a lot of kids
that are out there.
Alice Hoyt, MD (29:46):
The other important point was that none of
the kids in the placebo groupoutgrew their peanut allergy.
Edwin Kim, MD (29:54):
That's right.
Alice Hoyt, MD (29:54):
Which is also not necessarily consistent with
what we see Now.
I mean we're not seeing 50% ofkids.
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 to30%, and that's an important
discussion.
When we're saying you know, dowe want to embark on oral
immunotherapy right now orsomething, or immunotherapy, or
(30:15):
is there a potential of themoutgrowing it, do you want to
comment?
That's really interesting, yeah, yeah.
So I mean.
Edwin Kim, MD (30:22):
It's really allergic to kids.
Yeah, really allergic to kids.
But here's a moment that I dojust want to call out the
families that participated.
I mean, my gosh, the sacrificesthat these families give for,
not only for their own kids butfor all families out there where
it's root allergy can't be.
I mean it's just, it's soimportant because, I mean, these
(30:43):
are they.
There are families that spentthree years on a placebo for to
help us to try to understandthis of does this work or not.
And the reason we needed thatlong placebo is what you
mentioned we needed to make sureis there really is this
treatment or the kids naturallyoutgrowing it?
And so in this study we clearlysaw no one outgrew it during
the same time period.
So we can pretty confidentlysay that the majority of what we
(31:05):
saw was from the treatment.
Now, for those same families,again, we can't there's no way
ethically we can leave them outin the cold, and so we had a
separate protocol afterwards tobe able to give them the
treatment that they, you know,had willingly sacrificed.
But it's just so important thatnone of this happens without the
families.
And you know, again, somenaysayers may say, well, they're
(31:26):
just trying to get early access.
I mean no, no, these familiesof course they like that, but
these families are absolutelydedicated to the field and
making sure that you knowwhatever sacrifice they put in
is going to help not only theirkid but all these other families
out there.
So I mean again, can't saythank you enough to them.
Alice Hoyt, MD (31:42):
The allergy families are amazing.
Edwin Kim, MD (31:44):
They are.
Alice Hoyt, MD (31:44):
What are some ways that they can get involved
in research?
Edwin Kim, MD (31:48):
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 thatthey've heard us in studies,
participated in some studies andbe able to share sort of their
experiences.
Another is to support studies.
So again, we're always lookingfor groups like fair or the NIH
and stuff to support studies.
But you know, again, if theremay be opportunities to sort of
(32:10):
give as well, to help with that.
But I think, in all thosedifferent ways, but if anything,
the way that most families canhelp is just to continue to
bring this positive attention tofood allergy.
You know, make sure that theawareness is there that food
allergy is real.
There's lots and lots and lotsof families and unfortunately
(32:31):
the number keeps going up, butfamilies that have this and we
really need something that willhelp our kids just go back to
normal.
I mean, I think because inevery other way they're normal,
but the, the everyday sort ofburden that comes with this, the
anxiety, the changes, you knowthe effects on quality life,
they're real and so I thinkthat's probably the number one
way that they can help.
Alice Hoyt, MD (32:53):
Love it, I love it.
Thanks so much for joining us.
What, what sort of last wordswould 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 yourencouragement to our food
allergy families listening?
Edwin Kim, MD (33:08):
Yeah, so you mentioned earlier that.
I mean not that we ever wantanyone to have a food allergy,
but now is a really good timebecause there's so much hope.
We have oral immunotherapyavailable in many clinics.
Our data suggests that lingualcould be an option as well.
There's studies on this patchmedicine, the epigutaneous and
biological medicine, and sothere are options available now.
(33:30):
There are options coming in thenear future and then there are
options coming further out thanthat, and so I think, just you
know again, there's plenty ofhope 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 itmay not be, because food allergy
(33:51):
is individual to each family,and so just to hear those out
and you know, maybe that nextone 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 andthere's plenty of hope coming.
Alice Hoyt, MD (34:06):
I love it.
Dr Kim, thank you so much forjoining us.
Edwin Kim, MD (34:08):
Thank you very much for the invitation.
This is great.
Alice Hoyt, MD (34:13):
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 (34:18):
No problem.
Alice Hoyt, MD (34:20):
Was that okay?
Edwin Kim, MD (34:20):
I hope oh my gosh , that was awesome, oh yeah good
, I can never tell, because Ijust I mean I love this stuff
right, so I can go forever.
Alice Hoyt, MD (34:30):
I understand.
I do too.
Hints the podcast.
Edwin Kim, MD (34:35):
That's right.
Alice Hoyt, MD (34:37):
No, this is so awesome.
Edwin Kim, MD (34:40):
I love it.
Alice Hoyt, MD (34:41):
I mean, I just love that there's more.
You know, there's more thanavoidance or OIT, and this is
something that can definitely bedone in many families, and I'm
just so.
I'm so grateful to groups likeyours that do this research.
(35:02):
So anytime you want to comeback on and talk about anything,
you are more than welcome tocome onto this platform.
We would love to have you, sure.
Edwin Kim, MD (35:15):
I mean, I think the big one that you've probably
already heard of is going to beZolaire.
So Zolaire is actively beingstudied now.
I think there's lots of hopethat in the next one or two
years it could be added to thelabel.
I mean, they have to be able todecide that.
Is that going to be foreveryone?
No, but I think it's going tobe an important one, and so that
could be a good time for if youmay have someone else you want
(35:35):
to talk to, but if not, I wouldlove to talk about that.
Alice Hoyt, MD (35:38):
I heard it was coming like next quarter.
Edwin Kim, MD (35:40):
I mean I think the company would hope, but it
seems very likely and verylikely soon.
And so I mean one other concept.
I mean the two concepts thatI've been saying a lot in talks
and in clinic.
Number one is going to be goingback to your point of it's so
different now.
So, as opposed to always the OK, I'm sorry you're allergic, go
(36:02):
ahead.
Good luck with avoiding.
Now it's proactive.
It's about well, here are thesetreatments OID, there's a
couple that are coming, and thenthere are more coming and just
really more proactively thinkingabout what can we do about it.
I mean, yeah, it's humongous, Ithink, just thinking in that
way, sort of turning our mindsmore towards that, and so it's
(36:23):
just been a lot more fun, andthen I mean living with it in
our house as well.
It's the same.
It's just sort of the defensiveapproach is just not very
satisfactory.
So I mean we want to dosomething about it as doctors
and as parents.
Alice Hoyt, MD (36:38):
Yeah, and one of the things that I'm starting to
grapple with is which treatmentis best for which patient.
So I do oral immunotherapy andI started doing slit.
I was kind of like pushed intodoing slit when one of my
patients he's six years old hehas a sesame IgE of greater than
(37:01):
100.
And he reacted to the smallestdose of the OID.
Edwin Kim, MD (37:07):
Oh no, the oral.
Yeah, that's right.
Alice Hoyt, MD (37:08):
Yeah, and though now mom is saying it may have
been a confounder of sesamemislabeling, whole sesame label
thing changed and he may haveeaten a bar, but like no no,
based on some other stuff.
Anyway, it was too close tocall.
We were well too close to hisreaction threshold for me to
proceed on OID, when OID shouldbe very boring for families.
Edwin Kim, MD (37:30):
Right.
Alice Hoyt, MD (37:31):
It's really, if we're doing it right, it should
be.
We should say well below thatreaction threshold.
So that's how I was kind ofpushed into doing slit with this
kiddo because he had accidentalingestion and he had severe
reactions.
And so now I am doing slit, butconstantly looking for ways to
(37:52):
make the treatments whatever thetreatments are, to make them as
safe as possible, of course, aspotent as possible or effective
, as powerful as possible, butthen also as reasonable as
possible.
And for all of my patients thatare peanut allergic, who are
between 4 to 17, I offer thempalporezia 0-1-1.
(38:14):
They all want the peanut butterprotocol, which is what I've
been doing for years and it'slovely, and I also kind of think
the peanut butter protocol wedo is very helpful because it
does stick in the mouth and Iwonder how much of that is using
that sort of background to theimmune system to grow tolerance.
But really trying to find.
(38:34):
Ok, now, as more data like thiscomes, which kiddos am I going
to say?
You know what?
Why don't we try slit with you?
Edwin Kim, MD (38:42):
Yeah, yeah.
I mean I think just the factthat we have options is awesome.
It's so awesome to even havethis conversation.
And then I think ages andstages.
So I think there'll betreatments that might be right
at a certain age, that might notbe right at another, Sequential
treatments, I mean all thiskind of stuff.
If we can just get them outthere in our hands, then I think
(39:02):
we can do lots of fun.
But as I realized, I'm gettingtexted because I was supposed to
be on another call.
I'm so sorry, oh my gosh, soI'm going to hop on.
Alice Hoyt, MD (39:09):
I'm so sorry, oh , no, no, no.
Edwin Kim, MD (39:11):
It's because you know me.
I just I love talking about it.
Alice Hoyt, MD (39:14):
For your time.
You're awesome.
I hope you have a wonderful andblessed Thanksgiving and I will
be inviting you back soon.
Edwin Kim, MD (39:23):
Love it.
I'm going to say yes.
I'll already tell you that.
Alice Hoyt, MD (39:26):
Thank you.
Take care, see you, bye.
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