It's a 16 to 20 week course of treatment and reduces risk of anaphylaxis for accidental exposure to food allergens. There is at least one other drug that is used to treat peanut allergies, but this treats multiple food allergies.
Given that anaphylaxis can be deadly and staff at food places can be sometimes less than reliable about food allergy concerns, I can see this being appealing to someone with severe food allergies who wants a more normal life.
It would be nice if we figured out what causes allergies and fixed it but, I mean, we may never fully solve that. For some people, "take injections for a few weeks and be able to go out with friends without stressing this will involve another life-threatening health event and trip to the ER" will be of adequate value to endure the course of treatment.
> staff at food places can be sometimes less than reliable about food allergy concerns
As someone with Celiac disease, who often eats at restaurants, this is a bit of an understatement. Even in restaurants where things are marked allergen free on the menu, it is often the case that staff will make mistakes. More often than not, staff aren't even informed about the basics of food, things like eggs and dairy being two separate foods, or that they can't just scrape some sauce off of a bun if they put it there by mistake, etc. If I had a life threatening allergy, I would never set foot in a restaurant. It's terrifying.
The study refers to checking patients after this many weeks, but my understanding is that you're supposed to keep taking it forever. From NPR:
> The medication is not intended for use during an allergic reaction. Instead, it is designed to be taken repeatedly every few weeks to help reduce the risk of reactions over time.
The study lasted 20 weeks, but I believe you have to continue the treatment indefinitely if you want the effects to continue. It's not a permanent fix, and a once or twice monthly injection for the rest of my life is not something I'd like to sign up for.
I’m in that camp. My kids and I don’t have issues, but my wife does. We’ve had to de-train in Germany once and go to a hospital due to a reaction while on vacation. Last week in NYC, we bought food and were ensured that it didn’t have nuts. But we forgot to ask about sesame seeds/oil. No hospital this time, but she was unwell (vomiting) for the rest of the trip.
We are pretty vigilant. If her anaphylactic reactions were more severe (I.e. airway constricting) we would be much more strict. But this approval seems perfect for us, since it won’t change our routines, but means we’re not punished for accidents.
There are countries with significantly less allergies amongst children. The difference is so stark as to be visible at the country border level. This is well studied. For political reasons, I'm gonna let you search what those countries are for yourself.
It would probably be a good idea to make it a recommendation to start giving allergy prone foods such as peanuts in small dosis to baby's so there is a higher chance for developing a tolerance.
I've been following this closely. I'm most interested in Xolair (and another one, Dupixent) as a way to make oral immunotherapy (OIT) safer and more effective. Xolair can reduce reactions for sure, but it can't get people to the point where they can actually eat normal serving sizes of their food allergens. Oral immunotherapy can do that. And Xolair is a twice monthly injection. Nobody wants to do that for the rest of their life, and if OIT is successful presumably you could stop Xolair after.
Unfortunately neither Xolair or Dupixent has looked super promising in early study results when combined with OIT. But Dupixent in particular is approved to treat one of the possible side effects of OIT, EoE (inflammation of the esophagus), so I'm still hopeful.
I’ve been on Dupixent and have a large number of allergies.
100% helped eczema. I used to have it to the point all my fingers were split in 5-8 places and I’d rate the pain scale at 8-9/10 (10 being arm cut off). I used to get blisters under the skin that’d combine and basically just peal off the skin - https://www.mayoclinic.org/diseases-conditions/dyshidrosis/s...
Anyway, Dupixent made it entirely go away. I also found my allergies did improve (suddenly wasn’t allergic to dogs). That said, it did have a side effect of severely drying out my eyes and I’ll get weird rashes on my face periodically and it requires injections 2x per month. That said, I can use my hands now, frankly I can think too. Pain is gone, and idc about the symptoms.
I've been taking Xolair for the last ~4 years for general allergies (with stellar results) and at least for my regimen, it's only once a month, not twice.
My partner was on Dupixent for a while to shrink some nasal polyps—that one is twice a month.
I'm not sure of the current progress, but I was at a conference a couple years ago, and the Dupixent folks were presenting. It was right after the approval for pediatric atopic derm, and they were hopeful that for people with severe allergies, they could essentially use dupixent to wipe out the immune sensitivity to allergens and then retrain. This is pretty extreme, so you'd only want to do it in patients with life-threatening allergies, but it was an interesting plan.
Somewhat related, I am allergic to an assortment of fruits and vegetables (celery, carrots, watermelon, cantaloupe, bananas, etc…). Most of my food allergies are related to Oral Allergy Syndrome. I’ve been taking Flonase now for more than a year for sinus congestion from allergies, and my food allergies have all but gone away. It has been great being able to enjoy these foods without my mouth, throat, and ears itching.
I've been taking fluticasone propionate (which Flonase is) as a nasal spray nightly, and it's completely stopped me snoring and cured sleep apnea that previously I needed a CPAP machine for. Great stuff.
From what I read of this, it's very expensive (thousands/mo), requires at least monthly injections at a facility, has a risk of anaphylaxis (so the injections can't be done at home), doesn't eliminate the risk of allergic reactions, and has no off-ramp (so you have to take it forever). Not exactly a silver bullet...
My first thought was that it could be good for kids, who are less good at checking for trace amounts of allergens, but then I saw that it requires injections, which kids aren't so great at.
Longtime Xolair patient here: as far as cost goes, there are copay programs that knock the price down to $5/mo, but the catch is that you have to be insured (via commercial health insurance, not Medicare/Medicaid) to qualify.
A lot of drug manufacturers offer these programs: the bargain is essentially that they'll cover the brunt of your copay cost so long as your insurance company is still paying for the rest of it. Better to collect a few grand from the insurance company and reimburse the patient for a few hundred than to miss out on the sale entirely.
Right. But the selling point isn’t “start packing pb&js for lunch”, but rather “go to a restaurant for the first time” or “worry less about your kid’s life being at risk from a classmate’s snack”.
Far from a silver bullet, but still exciting as the first medicine of its kind! Accidental exposure happens to pretty much everyone with food allergies, so reducing the risk of anaphylaxis by ~70% is huge and will save lives.
It’s annoying to read “so and so new drug costs too much.”
Creating new drugs is absurdly expensive. Most new drugs target small population groups, which is why treatments do not already exist - the low hanging fruit with large market potential gets targeted first.
Just be happy a flag is planted in the ground. New drugs will be created from this that are different enough to avoid the patent, and new research will enhance it and reduce the side effects. This is just the beginning.
Exciting to see FDA approval here. Hopefully next is FDA approval for programs like TIP (https://foodallergyinstitute.com/food-allergy-treatment/). I'm a TIP grad, its life changing to be cured versus still avoiding your allergens and only having reduced anaphylaxis risk.
If TIP does work as well as the Food Allergy Institute claims, it should be subjected to a double-blind randomized clinical trial that surfaces the risks and benefits, and then practiced across the US. I'd truly love to see that happen. Until then, I'm deeply skeptical, even with testimonials like yours.
I had an interesting conversation with a doctor recently. They suggested that people have overreacted to the risk of anaphylactic shock. We automatically treat it as a life ending event, but I guess even if you go into shock it's a pretty long tail event that causes permanent damage.
All this to say its hard to even get an EpiPen now. People using it unnecessarily during any panic attack and ending up in the ER is a bigger risk than the allergy itself.
It might be fair to say these treatments would be just as much as a psychological treatment - you have millions of people living in constant fear that this could help.
In my experience epipens and generics are easy to come by, and as a parent that has given epipens to a kid, passed out and deep in anaphylactic shock, and hearing ER nurses casually talk to each other about how many epipens they've given to kids that didn't make it, I think you might feel differently if you lived through that first-hand.
There's also oral immunotherapy, where you give children increasing amounts of peanut (or other food allergens) to desensitize their immune system. Initial studies showed it was effective in achieving desensitization in 71% of patients (vs. 2% of controls) and remission in 21% (vs. 2% of controls):
It's largely limited to young children (the immune system under age 5 is more resilient than it gets later), but for parents that are willing to front the fairly considerable expense and inconvenience up front, it does offer the prospect of actually outgrowing the peanut allergy and not suffering from it as an adult.
Very cool. I hope some day all autoimmune diseases are prevented and no lifelong treatment is necessary. A lot of exciting research around the hygiene hypothesis, even though the progress has been slow, it's going forward.
I'm a little rusty when it comes to statistical analysis, but is 168 total participants ranging from 1 to 56 years old really enough for any meaningful level of statistical significance?
Sure the efficacy rates seem really promising here, but that's an extremely small group and if there are any concerns over age-based factors the cohorts are even smaller.
Add the fact that this medication is meant for long term use and I really don't know how we can claim any level of certainty with regards to long term safety. The study only followed the 168 participants (including placebos) for 16-20 weeks.
Xolair (omalizumab) is already approved in my country, however, there is some risk of cancer developing ( _its use has been recently linked to potential increased cancer risk_ ), and having been informed about it, I decided that my allergy is not as bad, to try it out, at least at the moment
There’s something I don’t understand. I took allergy shots to treat my sinus allergies to grass pollen, pet dander, and rag weed. It’s not perfect but it built up my tolerance to these so that I can have cats and survive grass season. Why can’t a similar treatment work for food allergies.
Oral immunotherapy is currently the baseline treatment for things like peanut allergies, and it works, but it requires daily dosing. Also, for adults that start doing it, it often leads to feeling like you have perpetual digestive discomfort. Many people decide the discomfort isn’t worth it and stick with avoidance, especially for things like nut allergies where avoidance is quite doable in the US.
The good news is that if you diagnose food allergies early and start someone on oral immunotherapy when they’re extremely young (<2 years old), the early evidence is that you can build up significant tolerance with basically no side effects. That’s the boat my child is in - we started them on peanut OIT at just over 1 year old, and the worst symptoms were a skin breakout or two, and today they’d probably be able to eat a couple peanuts with no reaction.
The downside is they have to continue their daily dose forever. There are some interesting alternatives coming into the market though.
Edit: they will still need to always keep epipens nearby, but at least now there’s no fear of anaphylaxis when someone nearby on the plane eats a bag of peanuts.
I’ve been dealing with a seemingly impossible condition for the better part of a decade now seemingly related to allergies and aberrant immune function.
The problem is extremely consistent and simple to describe. Every food I eat for more than a few days trends toward causing an anaphylactic reaction. I’ve heard every response imaginable from doctors, especially all the unhelpful and harmful gas-lighting type responses. “You can’t be allergic to everything!” I’ve changed hospital centers multiple times until now I see basically some of the absolutely most credentialed providers in the world. Their best guess is a condition called MCAS. This is a poorly described syndrome basically summarized as aberrant allergic type responses without a known cause. It is a diagnosis of exclusion. What’s absolutely insane about it is that it is “not criteria for disability” according to United States current standards. It has got to be the most insane thing that someone with a rare, life-threatening condition is struggling to stay alive and at the same time struggling to survive financially.
My primary care provider didn’t believe me for over a year until I brought beans to his appointment, a food I definitely do not have IgE allergy to (but have been eating for a week prior to that appointment), ate one bite, then he just watched me turn pale, have my HR go from 75 to 125, and have immense discomfort that lasted for a few hours. My stomach also ballooned out like I was pregnant. Even after that, he is like “I think you have something like splenic sequestration.” Yeah, I've never had changes in hemoglobin levels on labs at the emergency room. It really is like dystopian. It took 6 years before providers checked things like tryptase and PGD2, known immune mediators, to notice they are variable and for some sometimes out of the normal range.
I guess I bring this up because I really am at a loss for how to deal with this condition. I take all of the standard MCAS medications, which seem to reduce the severity of my reactions, however they do not prevent me from having to constantly switch what I eat or drink. I constantly struggle with malnutrition and disordered eating because I cannot eat anything regularly and stably.
Many patients with MCAS take Xolair after they try other medications that do not work well enough to see if it will help. We really need more efforts to deal with these types of problems and more medication research. More biological research as well because clearly immune knowledge is severely lacking. Supposedly many patients that develop Long Covid also develop problems with their mast cells too, so problems like this have to be increasing in incidence. Asthma, an immune system problem that used to be rare, has an almost 10% incidence now in the United States.
So Xolair can cause anaphylaxis at any point in time, even if it didn't cause it initially.
Is accidental exposure to these food allergens so common, even after being careful, that those at risk are willing to take that risk and spend the cost?
Omalizumab is mostly used as a last resort. It requires long-term treatment, and the symptoms usually come back quickly after stopping the treatment. Most doctors will try antihistamines first, they are safe and cheap.
> Xolair is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.
Xolair works by targeting IgE antibodies, which are the part of your immune system that responds to allergens. The shot essentially neuters those antibodies to prevent them from reacting as often/severely, which dampens your body's allergic response across the board.
(Crucially, IgE antibodies are not the part of your immune system that responds to infectious disease, so anti-IgE meds won't make you immunocompromised in any significant way.)
Immune system needs to take in some dirty stuffs to adjust itself. The hygiene standards and ultra-processed foods in developed countries have made people's immune system highly sensitive by not giving them chance to be better adapted.
A) hygiene hypothesis, people ate way more dirt and straight up almost everyone had worms
B) the people with really bad food allergies like Coeliac just died young.
We have severe amnesia when it comes to just how rough the state of health was until basically the 50s (eradicating Polio is a big turning point). Fortunately, we can learn about history so we don't repeat it :massive eyeroll:
They feed us poison, so they can sell us the cure. I believe that food additives and artificial foods are one of the main culprits for the increase in food allergies. That doesn't mean that the food allergies aren't real, or that this drug doesn't really treat them. Just that there are some insidious forces at play here as well and that if we ate a better diet, free of poisons, we might not need quite as many of these extreme medical technologies to fix the problems the industrial way of life has created for us (while simultaneously solving many other problems).
Yup sounds like medicine in the 21st century. I think we're going to cull ourselves as a species because we're not at all aligned with doing things that actually make people healthier, unless that also happens to make good money.
DoreenMichele|2 years ago
Given that anaphylaxis can be deadly and staff at food places can be sometimes less than reliable about food allergy concerns, I can see this being appealing to someone with severe food allergies who wants a more normal life.
It would be nice if we figured out what causes allergies and fixed it but, I mean, we may never fully solve that. For some people, "take injections for a few weeks and be able to go out with friends without stressing this will involve another life-threatening health event and trip to the ER" will be of adequate value to endure the course of treatment.
yosito|2 years ago
As someone with Celiac disease, who often eats at restaurants, this is a bit of an understatement. Even in restaurants where things are marked allergen free on the menu, it is often the case that staff will make mistakes. More often than not, staff aren't even informed about the basics of food, things like eggs and dairy being two separate foods, or that they can't just scrape some sauce off of a bun if they put it there by mistake, etc. If I had a life threatening allergy, I would never set foot in a restaurant. It's terrifying.
gnicholas|2 years ago
The study refers to checking patients after this many weeks, but my understanding is that you're supposed to keep taking it forever. From NPR:
> The medication is not intended for use during an allergic reaction. Instead, it is designed to be taken repeatedly every few weeks to help reduce the risk of reactions over time.
1: https://www.npr.org/2024/02/18/1232304606/fda-approval-food-...
modeless|2 years ago
HorizonXP|2 years ago
We are pretty vigilant. If her anaphylactic reactions were more severe (I.e. airway constricting) we would be much more strict. But this approval seems perfect for us, since it won’t change our routines, but means we’re not punished for accidents.
ImHereToVote|2 years ago
wouldbecouldbe|2 years ago
modeless|2 years ago
Unfortunately neither Xolair or Dupixent has looked super promising in early study results when combined with OIT. But Dupixent in particular is approved to treat one of the possible side effects of OIT, EoE (inflammation of the esophagus), so I'm still hopeful.
lettergram|2 years ago
100% helped eczema. I used to have it to the point all my fingers were split in 5-8 places and I’d rate the pain scale at 8-9/10 (10 being arm cut off). I used to get blisters under the skin that’d combine and basically just peal off the skin - https://www.mayoclinic.org/diseases-conditions/dyshidrosis/s...
Anyway, Dupixent made it entirely go away. I also found my allergies did improve (suddenly wasn’t allergic to dogs). That said, it did have a side effect of severely drying out my eyes and I’ll get weird rashes on my face periodically and it requires injections 2x per month. That said, I can use my hands now, frankly I can think too. Pain is gone, and idc about the symptoms.
spondylosaurus|2 years ago
My partner was on Dupixent for a while to shrink some nasal polyps—that one is twice a month.
jonlucc|2 years ago
JTbane|2 years ago
heywire|2 years ago
petesergeant|2 years ago
gnicholas|2 years ago
My first thought was that it could be good for kids, who are less good at checking for trace amounts of allergens, but then I saw that it requires injections, which kids aren't so great at.
spondylosaurus|2 years ago
A lot of drug manufacturers offer these programs: the bargain is essentially that they'll cover the brunt of your copay cost so long as your insurance company is still paying for the rest of it. Better to collect a few grand from the insurance company and reimburse the patient for a few hundred than to miss out on the sale entirely.
el_benhameen|2 years ago
TheCoelacanth|2 years ago
twothamendment|2 years ago
In her case, this doesn't cure anything, but manages symptoms of MCAS. Not ideal, but way better than life without it.
nimbleplum40|2 years ago
monero-xmr|2 years ago
Creating new drugs is absurdly expensive. Most new drugs target small population groups, which is why treatments do not already exist - the low hanging fruit with large market potential gets targeted first.
Just be happy a flag is planted in the ground. New drugs will be created from this that are different enough to avoid the patent, and new research will enhance it and reduce the side effects. This is just the beginning.
unknown|2 years ago
[deleted]
jwstanly|2 years ago
andrewchilds|2 years ago
legitster|2 years ago
All this to say its hard to even get an EpiPen now. People using it unnecessarily during any panic attack and ending up in the ER is a bigger risk than the allergy itself.
It might be fair to say these treatments would be just as much as a psychological treatment - you have millions of people living in constant fear that this could help.
andrewchilds|2 years ago
LUmBULtERA|2 years ago
nostrademons|2 years ago
https://www.nih.gov/news-events/nih-research-matters/oral-im...
It's largely limited to young children (the immune system under age 5 is more resilient than it gets later), but for parents that are willing to front the fairly considerable expense and inconvenience up front, it does offer the prospect of actually outgrowing the peanut allergy and not suffering from it as an adult.
rzmmm|2 years ago
_heimdall|2 years ago
Sure the efficacy rates seem really promising here, but that's an extremely small group and if there are any concerns over age-based factors the cohorts are even smaller.
Add the fact that this medication is meant for long term use and I really don't know how we can claim any level of certainty with regards to long term safety. The study only followed the 168 participants (including placebos) for 16-20 weeks.
az226|2 years ago
p0w3n3d|2 years ago
joshmarinacci|2 years ago
munchbunny|2 years ago
The good news is that if you diagnose food allergies early and start someone on oral immunotherapy when they’re extremely young (<2 years old), the early evidence is that you can build up significant tolerance with basically no side effects. That’s the boat my child is in - we started them on peanut OIT at just over 1 year old, and the worst symptoms were a skin breakout or two, and today they’d probably be able to eat a couple peanuts with no reaction.
The downside is they have to continue their daily dose forever. There are some interesting alternatives coming into the market though.
Edit: they will still need to always keep epipens nearby, but at least now there’s no fear of anaphylaxis when someone nearby on the plane eats a bag of peanuts.
mbrubeck|2 years ago
Madmallard|2 years ago
The problem is extremely consistent and simple to describe. Every food I eat for more than a few days trends toward causing an anaphylactic reaction. I’ve heard every response imaginable from doctors, especially all the unhelpful and harmful gas-lighting type responses. “You can’t be allergic to everything!” I’ve changed hospital centers multiple times until now I see basically some of the absolutely most credentialed providers in the world. Their best guess is a condition called MCAS. This is a poorly described syndrome basically summarized as aberrant allergic type responses without a known cause. It is a diagnosis of exclusion. What’s absolutely insane about it is that it is “not criteria for disability” according to United States current standards. It has got to be the most insane thing that someone with a rare, life-threatening condition is struggling to stay alive and at the same time struggling to survive financially.
My primary care provider didn’t believe me for over a year until I brought beans to his appointment, a food I definitely do not have IgE allergy to (but have been eating for a week prior to that appointment), ate one bite, then he just watched me turn pale, have my HR go from 75 to 125, and have immense discomfort that lasted for a few hours. My stomach also ballooned out like I was pregnant. Even after that, he is like “I think you have something like splenic sequestration.” Yeah, I've never had changes in hemoglobin levels on labs at the emergency room. It really is like dystopian. It took 6 years before providers checked things like tryptase and PGD2, known immune mediators, to notice they are variable and for some sometimes out of the normal range.
I guess I bring this up because I really am at a loss for how to deal with this condition. I take all of the standard MCAS medications, which seem to reduce the severity of my reactions, however they do not prevent me from having to constantly switch what I eat or drink. I constantly struggle with malnutrition and disordered eating because I cannot eat anything regularly and stably.
Many patients with MCAS take Xolair after they try other medications that do not work well enough to see if it will help. We really need more efforts to deal with these types of problems and more medication research. More biological research as well because clearly immune knowledge is severely lacking. Supposedly many patients that develop Long Covid also develop problems with their mast cells too, so problems like this have to be increasing in incidence. Asthma, an immune system problem that used to be rare, has an almost 10% incidence now in the United States.
hereme888|2 years ago
Is accidental exposure to these food allergens so common, even after being careful, that those at risk are willing to take that risk and spend the cost?
feverzsj|2 years ago
mgh2|2 years ago
acquacow|2 years ago
zzz999|2 years ago
hanniabu|2 years ago
darknavi|2 years ago
> Xolair is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.
irjustin|2 years ago
spondylosaurus|2 years ago
(Crucially, IgE antibodies are not the part of your immune system that responds to infectious disease, so anti-IgE meds won't make you immunocompromised in any significant way.)
unknown|2 years ago
[deleted]
nimbleplum40|2 years ago
dukeofdoom|2 years ago
[deleted]
dboreham|2 years ago
feverzsj|2 years ago
kortex|2 years ago
B) the people with really bad food allergies like Coeliac just died young.
We have severe amnesia when it comes to just how rough the state of health was until basically the 50s (eradicating Polio is a big turning point). Fortunately, we can learn about history so we don't repeat it :massive eyeroll:
yosito|2 years ago
hmcq6|2 years ago
The medicine exists, now it is just a matter of willpower.
Edit: I would save up and pay $1000 but twice a month forever? womp womp
Madmallard|2 years ago
Not a great side effect profile
Not even very effective
Yup sounds like medicine in the 21st century. I think we're going to cull ourselves as a species because we're not at all aligned with doing things that actually make people healthier, unless that also happens to make good money.
umanwizard|2 years ago
spondylosaurus|2 years ago