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.
> staff at food places can be sometimes less than reliable about food allergy concerns
In 2000, I was working at an NYC restaurant (Josie's on Third) -- it was a new non-dairy health-focused organic-everything restaurant. The waitstaff was trained in all the ingredients and many of the sources and were highly conscious of needs of our customers. We were tested on it a staff meal.
One day, two friends sat to dine... we brought bread and our non-dairy spread. Customer asked "what is this?" I replied, "it is red-pepper tahini, an alternative to butter". I take their order, tend to other tables and arranging beverages, when I come back around 5 minutes later the table is empty. I ask my manager "what happened?"
The lady had a severe sesame allergy and was rushed to the hospital -- *she did not know that tahini was sesame paste and I did not tell her*. I have no idea what happened to her and I think about this several times per year.
For the last 15+ years, I have been a hands-on operator of complex computer systems operator. This experience has absolutely shaped how I communicate with teams, how I look at how failures may happen, how to expect the unexpected, etc.
I now have a son with peanut allergies. It also influences how we dine. It is not easy and I'm glad there's out-of-band solutions like these drug therapies. We are not there yet, but might consider it.
I don’t think you should feel too bad about this. Having a severe sesame allergy and not knowing what tahini is and also not asking about sesame in dishes is quite reckless IMO. They were bound to accidentally eat something with tahini in it eventually.
> The lady had a severe sesame allergy and was rushed to the hospital -- she did not know that tahini was sesame paste and I did not tell her.
I saw similar with corn, my cat was having a severe reaction to something and vet suggested getting food without corn in it, then gave me a list of like 20 different names for ingredients manufacturers use to hide corn.
(though with your's it's not we're trying to hide/obfuscate ingredients)
I am so sorry.
I was a server... 20 years ago holy crap...
I've been that server. They asked if something was safe for celiac. I had no idea, nobody else did either.
Today, my partner is a severe celiac. Any traces of gluten takes them out for at least 2 weeks.
Any hesitation from a restaurant from a restaurant and we are gone.
I think that person ended up ordering.
Of course literally nothing in that restaurant was safe for celiac if for nothing else than cross contamination.
Completely disagree.
For the restaurant in question it is a major national chain, so indeed it is harder for the server to have this knowledge on every dish, but at least a book of allergens... really the company should have this available in a friendly manner online.
But even then, the server should absolutely know (and therefore be trained on) major allergens in the kitchen because its not just the food, its how its prepared.
20 years ago I didn't know, I didn't know that I ought to know.
I didn't know that I could have caused that person significant harm.
I was a teenager.
But my managers absolutely should have known and not put me in that position where I didn't know something so fundamental to food service.
We were trained on other things.
The staff should be able to answer questions about what ingredients are used in the kitchen and in specific dishes. but they shouldn't be responsible for answering the question as you posed it : "is this safe for someone with celiac" ? Safety is up to you to decide, as only the customer knows how sensitive they are and what the reaction will be.
Celiac is a specific condition, not even an allergy.
If someone has celiac, they cannot have gluten without bad consequences.
Being able to serve someone with celiac means the kitchen has deliberately chosen to do so and have procedures in place for doing it.
Things like changing out gloves, cleaning surfaces or having dedicated space.
This also means knowing what cannot be made safe, which often is things like french fries because friers tend to be shared with gluten products.
Our daughter is allergic to a few things,nuts being one of them.
When we ask for food information at restaurants, often staff have no clue. We had cases where they couldn't confirm for sure even after checking with the kitchen( we walked away).
I'm sorry, but why would you expect someone to know all of the food ingredients on the menu - even if they work there - if they don't personally prepare all of the foods? Heck, in the US, most of the places aren't even paying their staff a decent wage.
Servers go by the menu as well. It isn't like there is a list most places.
If the owners cared about your allergies, they'd make sure their staff could find out easily. Blame the folks that own the place, not the servers.
I didn't read GP as blaming servers so much as demonstrating what is effectively systemic ignorance in the restaurant industry. The inability to 100% confirm ingredients is highlighted as not only being due to servers not knowing the exact contents of all meals (which is understandable), but also the fact that those who prepare and cook the meals as also being uncertain.
The problem is a large portion of the food in restaurants is not prepared in the restaurant. If you order a burger meal, yes the meat is cooked on the grill at the restaurant, but the buns, and any sauce were likely made somewhere else. They might purchase the meat pre-seasoned from the food distributor. And the french fries likely even have a seasoning pre-applied to them before they are delivered to the restaurant.
You have the ingredients on a package to check. The head chef can do it while constructing the recipe. And you can explicitly order gluten free substitutes that stay in the freezer until needed.
There are some places that are much better about this than others. I remember in Europe several of the restaurants had _books_ containing all the potential ingredients and cross-allergens for each dish. I distinctly remember Wagamama's in London pulling one out and double-checking it due to my spouse's eggplant allergy. Sadly it removed most of the menu that we were excited to eat, but it was damn impressive.
In many countries, the restaurants are expected to know allergens by law. Each food on the menu is supposed to have list of allergens available. Usually they are available right there in the menu, you do not even have to ask.
> Heck, in the US, most of the places aren't even paying their staff a decent wage.
Getting > 20% of the total revenue in a restaurant seems like a pretty good deal though. I doubt most servers would prefer getting the 2-3x Federal minimum wage and no tips.
And in some states like CA, WA, NYC it’s a (relatively) very well paid job.
I don't expect people to know every single item on the menu and all the ingredients they are made of. What I do expect is if a meal is made in a restaurant, the restaurant ( as a whole) to know whether it contains milk, soya,nuts, bananas, whatever. We have fairly strict regulations when it comes to this, but how they are actually applied is a completely different thing.
Celiac disease is life threatening like smoking is life threatening. Yes, it can kill you, if you regularly ignore the harm you are doing to your body and continue indulging. But someone with Celiac Disease isn't going to go into anaphylactic shock and die on the spot.
Don’t forget this awesome quote: “However, a recent paper (Samsel & Seneff, 2013), argued that glyphosate may be a key contributor to the obesity epidemic and the autism epidemic in the United States, as well as to several other diseases and conditions, such as Alzheimer's disease, Parkinson's disease, infertility, depression, and cancer.”
It’s causing all the bad things? That would be amazing if true, unfortunately it sounds unlikely (chiropractic comes to mind) and the rest of the science world doesn’t believe these authors.
“In 2011, she began publishing controversial papers in low-impact, open access journals on biology and medical topics; the articles have received "heated objections from experts in almost every field she's delved into,"”
Not even gluten, one of the peptides it is composed of. Prolamins like gliadin, horadin, etc. depending on the grain. This is why gluten denaturing proteases aren't sufficient to protect a celiac, and thus some technically GF foods aren't necessarily safe.
I have celiac disease. When I eat foods that contain gluten or a similar protein, avenin, it triggers an immune reaction which causes inflammation and damage in my intestines. It's not an allergy, it's not a wheat allergy, it's not a glyphosate allergy. You may keep your uninformed opinion.
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 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
Deep in the bowels of corporate HQ, at a board meeting:
"And the best part is, if people ever stop using it, their allergic reactions become more severe than before they started!"
I've been getting allergy immunotherapy for the past 3.5 years (not for food allergies, for stuff like cat, dog, grass, dust mites, etc.), and I have to go for the shots once a month. It's honestly not that big a deal. I only have another 1.5 years until my treatment is over, but if I had to do it for the rest of my life, it wouldn't be the worst thing, given the benefits.
This is of course assuming there aren't any bad reactions to this medicine... didn't read enough of the article or beyond to get that info.
Would you mind telling me what immunotherapy you get, specifically for cats? I'm currently on Grazax for grasses etc. I would love to be able to get a cat, but I am quite allergic and get flu-like symptoms after a while. (Also, my blood tests don't show that I'm allergic to cats, so that complicates things).
In the US, most clinics don’t make a point of showing the patient what the product is. They screen the patient (usually a skin test), prescribe either a single antigen formulation, a combination of antigens in different vials, or they mix up a custom vial for the patient, and they keep it in a fridge in the clinic. The antigens come from whatever provider the clinic buys them from.
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 do non-food allergy immunotherapy once a month, and have been doing it for the past 3.5 years. I really don't mind going in that often, and the benefits are well worth it to me. I only have to go another 1.5 years before it's common to see diminishing returns for continuing longer, but if I had to do it for the rest of my life, that'd probably be ok.
I am doing the same and if it was for the rest of my life I wouldn't have started. The burden is just too high to justify it for my level of allergies. I'm kind of regretting it even though it did cure my allergies, I kept getting injection site reactions and having to go through up dosing repeatedly. It's a sunk cost now though.
> a once or twice monthly injection for the rest of my life is not something I'd like to sign up for.
I take this exact drug for not-even-life-threatening allergies and the hassle is really not that bad. It's certainly less annoying than suffering through ragweed season every year :P
I have mild asthma, a host of other "mild" (aka. non-life threating) seasonal allergies and oral antihistamines are becoming less effective as I get older. I will be talking to my doctor about this medication.
I'm interested in your experience if you don't mind sharing more? Any improvements to contact allergies?
I'm not positive if I have any contact allergies, though I do have a lifelong tendency for eczema, which has improved a lot on Xolair.
For background: I actually went on Xolair to treat eczema, which is an off-label use, but my IgE antibodies were high enough thanks to 5000 environmental allergies (mold, pollen, dust, more dust...) that they got my insurance to approve it under standard criteria. I also have asthma, which is one of the things it's approved to treat, so that might be a good pathway to approval and a symptom you can reduce.
Prior to Xolair, my skin used to get so fucked-up and dry that my eyelids would crack and bleed and weep some kind of liquid. On more than one occasion I had strangers ask me if I had lupus because it looked like I had the characteristic butterfly rash. And I'd get miserable allergy symptoms whenever it was windy (which is often, since I live in a valley) or I was around environmental triggers (which is also often, since I'm allergic to pretty much everything that grows in this biome).
After being on Xolair, I have pretty much zero problems with eczema (although the TNF inhibitors I started taking for general autoimmune shit share some of the credit there) and my allergies are all but gone. It's wild. I actually forgot about how shitty I used to feel in windy weather until I looked outside, saw that it's windy today, and was like "Oh yeah, that used to mess me up...."
Dust doesn't fuck me up the way it used to; when I vacuum under the bed, I can feel something happening in my skin, like the sensation of breaking out in the mildest of sweats, but otherwise it doesn't bother me. My pollen tolerance is also significantly better—we actually started growing some pepper plants indoors, and it's the same thing where I can almost feel the pollen coming off them when I get really close, but I have to be within two feet to notice and it's not, like, unpleasant. More like a sixth sense.
My asthma might be a little better too, but it's hard to say. I've been able to exercise more easily than I ever could when I was a kid, although I was a pretty wimpy kid in the first place, lol.
So, long story short: I'd definitely recommend Xolair! Other than the requisite insurance hassle and having to spend a few hours every month getting my shots, zero complaints here. One of the best success stories I've heard is that my allergist had a patient who was a professional archeologist with terrible allergies, but after going on Xolair they were able to go on digs without issue.
Also, regarding oral antihistamines, have you tried any Rx drugs like hydroxyzine? My allergist put me on 35mg of that nightly and it knocks down anything the Xolair wasn't already doing. My partner also takes it and it's helped their significantly-less-severe allergies as well, plus zafirlukast for polyp-spurred inflammation.
Thanks so much, sounds like we have quite similar allergies and symptoms, I can really relate to having weepy messed up eyes and comments from strangers! Funnily enough, I think I should hopefully qualify for it with my Asthma + IgE levels, that it could help my eczema would be a big bonus.
I tried allergy immunotherapy (aka. "allergy shots") but it was very rough and it aggravated blood pressure issues and gave me joint pains, so I opted to discontinue after the second attempt.
On hydroxyzine, I've taken cetirizine (2nd gen, metabolite of hydroxyzine) in the past. 1st gen antihistamines usually knock me out. I'm now on Fexofenadine (Allegra, Telfast) which is mostly covered by my insurance and works pretty good still.
One crazy thing for eczema sufferers, if you get bad eczema on neck and arms during summer don't assume you have a heat rash, patch test your sun screen. I now use zinc based sun screen after a dermatologist patch test identified I was allergic too Oxybenzone's. Never has a clue and I live in a country with very high UV levels.
We can hope it's not for the rest of one's life but only until a better solution is found. For people with deadly allergies, a few years of injections might not be too big of a price, I think.
Yeah this is one of those perspective things. I’m on a once-a-month regimen of eyeball injections to stave off macular degeneration. I’d trade it in a heartbeat for allergy-reducing injection. But even my case feels “routine” now.
I am not optimistic. The pace of progress in the field is very slow. Barring an AGI-induced revolution in medicine (not out of the question) I think the chances of curing common allergies in my lifetime are not super high.
Why would any of the pharma companies out there want to invent a permanent cure, when there's far more money to be made with a cure that is not permanent? Makes no sense.
My wife has been on Xolair for about a year, monthly injections (more would be nice, but that is all we can get from insurance). In her case, MCAS (Mast cell activation disorder) her body reacts to everything as if it were a food allergy - even though she isn't allergic to these foods.
They don't know the root cause for MCAS, so they sure don't have a cure or barely a clue it seems.
She lives a very restricted lifestyle, can't go in public places were people have perfume/strong smelling products on, can eat about 25 different ingredients (including a few spices), so eating out is not an option. A ripe banana in the room is enough to set her off and the impact is usually 2-3 days.
Xolair had allowed her to feel like a normal(ish) person - as long as all of the restrictions are followed.
Yup, it sucks to have to inject her monthly to have something that resembles normal and is in no way a cure - but I'll take it. Treating symptoms is far better than treating nothing. But a cure? If shell out quite a bit for that!
Copy paste for those wondering what MCAS does to a person. "MCAS is a condition in which the patient experiences repeated episodes of the symptoms of anaphylaxis – allergic symptoms such as hives, swelling, low blood pressure, difficulty breathing and severe diarrhea."
>Why would any of the pharma companies out there want to invent a permanent cure, when there's far more money to be made with a cure that is not permanent? Makes no sense
Then why are there permanent cures credited to pharmaceutical companies such as
First things first, pharma companies are OK with cures. Cures bring money as well, and some cures bring them patient trust.
Pharma companies aren't the only factor here either. Insurance companies, patients, and governments are definitely invested in cures. Preventative measures are OK with these groups as well - vaccines are one of these. Not all research is by big pharma either.
You are assuming other things bring magic profit when they don't do that as efficiently as you think.
Curing one disease doesn't cure them all, and there would still be profit to be made off of your other sicknesses. Probably especially those tied to lifestyle.
You are also assuming that we know how to cure the diseases we have treatments for. This is the real reason we don't have more cures - we know a good deal about the body, but there is a good deal we simply don't know.
It isn't that I think these folks are innocent - I have anger towards those exploiting sick folks to make obscene profits and the industry is greedy - but I don't buy your argument at all. It doesn't allow for the nuance that actual life has and only works if you don't look below the surface.
The risk of dying from anaphylaxis is almost universally exaggerated. There is a lot of fearmongering about it, especially for parents.
The truth is, even for food allergic people, the risk of death is low compared to other causes. EpiPens are very effective. Also, anaphylaxis is a very temporary condition. If you do get anaphylaxis then after a very short recovery period there are zero long term effects to worry about.
It's questionable whether intensive and risky treatments are warranted in most cases (remember Xolair carries its own risk of anaphylaxis).
Yes but that's not the full story... .It's true that the odds of dying from anaphylaxis are low, IF treated in time.
The sad thing is that the vast majority of all deaths from allergic reactions are preventable.
Things like not acting immediately and injecting Epipen in the first few minutes, not following up with a 2nd shot if no improvement in 15min. Having expired pens. Kids grow, and need larger pens. Teacher panics and uses pen upside down. Kids try foods as a teen or when they leave home as they "used to be allergic"
As the parent of an Parent of anaphylactic 7 year old - the fear is real. Low odds, but catastrophic outcome.
We are lucky that my partner is a nurse and we are knowledgable and manage places we go, but daycare, schools, birthday situations etc are a worry
My friend's son went into anaphylaxis while out with his girlfriend, and even though she carried a spare pen, the needle bent when it hit a seam in his pants, rendering it unusable.
She called sobbing that she'd killed him, but someone had an expired pen, and he ended up okay after getting to the hospital. Still, you never know if it could be the one.
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.
This is now the recommendation. Companies even make allergen packets to add to your baby’s breast milk / formula / early foods for gradual and systemic exposure.
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'm on Dupixent indefinitely for eczema, which it cures 100%. As a side effect, it 100% cured my seasonal hay fever and reduced many of my food allergies to a level, where I can just eat the food and ignore the very slight allergic reaction that remains.
For me, the entire field of monoclonal antibody therapy is pure magic. Absolutely amazing how well it works, a true silver bullet (with home injections twice a month and eye drops for the dry eyes).
I get dyshidrotic eczema on my hands, have for decades, and had no idea dupixent could help that. It doesn’t cause me pain though; the blisters and peeling skin are certainly annoying, but the side effects sound like the same level of annoying.
UV light therapy may be an option for that. It's even possible to self-administer with a 365nm UV flashlight, which I have done successfully. I'll stop short of recommending anyone else actually do that themselves, but I will definitely do it again if my symptoms return.
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.
Interesting. I looked at a dosage chart and it seems like you do either once or twice a month based on your IgE level determined by a blood test. So it is twice a month for some people.
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.
Is that the stuff that you can have withdrawal from? I remember after using a nasal spray when sick, if I used it too much for a week, the next two weeks id get really clogged up.
What you're talking about is oxymetazoline and its analogs, like in Afrin nasal spray.
Oxymetazoline is super potent and works immediately on nasal passages, but it can be risky to stay on for more than a few days straight.
Steroids like fluticasone don't work immediately, and take a couple of days to kick in, but you can use them indefinitely. Also, in addition to opening nasal passages, they have general anti-allergic effects -- i.e. they can help with itchy, watery eyes and facial swelling.
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.
I'm surprised that the commercial insurance policies would tolerate this kind of copay kickback, since it arguably induces patients to be less discriminating based on their own financial skin in the game.
I’m on a similar expensive (per sticker price) medication. After insurance pays a few thousand, they leave me with a $6,000 bill. But I’m on the manufacturer’s discount plan so I actually only pay $5. However, my insurance still thinks I paid $6,000 out of pocket, which very quickly eats up my deductible for the year.
It feels wildly perverse. I’m incentivized to purchase this “expensive” medication once or twice and then the cost of all of my medical care the rest of the year is negligible.
Move to Australia? On a script, cost is AUD $31.60 per syringe, a rather stark saving from $410 . I wonder how that latter price compares to the price in the US, I couldn't quite get the prices I read without insurance to compute in my head.
> I wonder how that latter price compares to the price in the US
My guess is not favourably for the US. My wife was diagnosed with MS about a year before we moved to America and, since I knew we were moving and was thinking about insurance, I asked the pharmacist once what they billed the govt per dose (monthly). We paid $40 out of pocket and the govt paid $1300 AUD.
Our insurance in the US pays nearly $10k USD/m for the same drug.
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”.
We did achieve this with OIT for peanut allergy. Once we reached bite-safe levels, our lives literally changed for the better. We didn't have to worry about interrogating anyone serving us food (restaurants, friends, family), and we could go to some places that were just never an option before where cross contamination is likely or even expected, like ice-cream parlors. There's still a protocol we have to follow every day though, so an actual cure is still a dream for us.
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.
Page 17 shows that R&D costs for pharma is 10-20x larger than equity-based compensation. That's all stock-based compensation, for execs and regular people. Your claim is that it's the opposite.
He's probably referring to this article: https://news.ycombinator.com/item?id=39405547 that made the rounds a few weeks ago, and bungled the meaning ("executive compensation / stock" rather than "executives and stockholders than on R&D").
Correct. I see this from the perspective of the society overall. I do not care whether the money goes to the CEO, a mid-level executive, a sales rep or the stock divident/buyback etc. What matters is how much money from the dollar I spend on a drug goes to research and how much into cost of production. Every other cent is something which has to be under scrutiny like is any tax dollar. Healthcare is like water, food, and shelter an elementary human need. Excessive profiteering or waste on it is just wrong.
Don't be annoyed — my comment was not focused just on cost. The point is that it's very expensive and also not that good. I have food allergies in my family and have talked with other families that are ostensibly in the key demographic. We are not impressed. I wouldn't complain about a drug that was a silver bullet, but was quite expensive.
To be fair, Xolair isn't a new drug at all (it's been around for 20-ish years, I think?), this is just a new thing that it's approved for.
I'm not sure why a generic hasn't hit the market yet, though. Maybe there's not enough demand to make it lucrative enough, unlike the golden child adalimumab...
IIRC, MABs aren't really a thing, because unlike small molecules, part of the approval is for the whole biological pipeline to produce the antibodies, from cell line to chromatography to formulation. When a small molecule goes off patent, you just have to prove to the FDA you can make that molecule to sufficient purity.
That's not to say there are no generic MABs, it's that it is a far costlier process for the generic manufacturers to get up and running.
I have seen a lot of generics for TNF inhibitors MABs, but that might just be because there's soooo much demand for those drugs. (Humira was one of the most profitable drugs of all time, after all.) Right now I'm on an infliximab biosimilar!
I wasn’t aware of this, thanks for clarification. I will leave my comment as-is because it’s my take on the general “we need to ban price gouging on new drugs!” sentiment.
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.
The skepticism is understandable at least academically. From my understanding FAI isn't prioritizing clinical trials because 1) their individualized process with AI/ML work isn't aligned with classical physician/allergist work and 2) that same time could be spent to grow the program's operation and get more patients off the waitlist.
The individualized work is also why TIP doesn't scale-- even FAI itself hasn't opened offices outside of SoCal yet (east coast patients like myself have been begging internally for years for them to open locations nationwide).
Everyone would love to see FAI be more transparent, but just because they aren't doesn't mean the program doesn't work. Arguing "its not clinically proven, therefore it's not legitimate" feels pedantic when there's thousands of us in remission.
You could also say that OIT "works", just from reading a couple success stories online. But the whole story is complicated. I know a family that spent enormous amounts of time and money on OIT, and ended up stopping due to a random anaphylactic reaction to a maintenance dose a few years in. I think it's perfectly reasonable to want to know what percentage of people have had a negative/mixed experience with TIP. If it's as safe and effective as they claim it is, that's truly incredible - and I'm glad to hear it worked for you! But I need real clinical trial data before I sign my kid up for it.
That's very fair, I'd want to know percentages before signing up too. Personally my family learned "TIP is legit" through word of mouth as well as through FAI's public Facebook group (https://www.facebook.com/groups/885290875293805/) which is super helpful for getting the scoop from families-- good and bad.
The family that introduced us to TIP had struggled with OIT. Fwiw TIP claims 99% success rate versus OIT's ~80%, but I understand this is the very contention point being discussed here. FAI does report TIP statistics (https://public.domo.com/embed/pages/X6NX5). Anecdotally from my 6 years as an (adult) patient at FAI, the "99% success rate" seems entirely plausible to me; it is very rare to hear of complications -- for example almost nobody on the internet makes posts about negative TIP reactions because everyones experience is indeed overwhelmingly positive.
However, none of this dismisses it's a huge bummer FAI isn't getting TIP clinically proven right now -- it'd be a much easier sell to prospective families than needing them to chat with other parents on Facebook about how really legit it is.
Deciding to not trust TIP is also totally fair. Everyones journey with food allergies are different. Completing TIP also takes an extraordinary amount of personal sacrifice too (I for one took a gap year away from school to finish). But as another food-allergic who's scientifically minded and initially thought "where's the research to back this up" too before enlisting, I feel almost obligated to share my story.
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.
That's the thing, I grew up hearing stories all the time of people almost dying. It wasn't until my doctor turned us down for an Epipen after our kid went to the ER for croup that he actually explained how rare it was for allergies to kill someone.
Out of curiosity I looked at actual case rate numbers: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5589409/
Less than 200 a year and more than half from drug related allergies. That's getting into death from lightning strike numbers or deaths from chicken pox.
(Obviously, this doesn't factor in the specific risk to someone with a known allergy, or without access to Epipens/care. But still a pretty low risk compared to the attention it gets.)
I also found a statement put out just last year by the American College of Allergy, Asthma & Immunology:
> "Injectable intramuscular epinephrine is the first-line treatment for anaphylaxis. Epinephrine is touted as "life-saving," in particular because observational studies have identified lack of prompt epinephrine treatment as a critical risk factor associated with anaphylaxis fatality. Although association is not causal, few would argue that epinephrine is not the optimal treatment for anaphylaxis, and do we have sufficient proof to suggest that epinephrine is actually "life-saving"? Epinephrine indeed works swiftly to reverse such symptoms of an immediate allergic reaction. However, there are abundant observational data that many cases of anaphylaxis are inherently self-limited and may resolve within 1 to 2 hours in most cases with or without treatment. In this perspective, the intent is to address and reframe the reality of the evidence we do have for what epinephrine does and does not accomplish and provide a perspective regarding the common "dogma" regarding the drug. There is a danger in using terms such as "life-threatening" and "life-saving" for anaphylaxis and epinephrine treatment, especially under the caution of frequently cited rhetoric that subsequent reactions are likely to be progressively more severe or potentially fatal. Use of such descriptions risks negatively polarizing our patients and adversely affecting their quality of life, given these terms can potentiate unnecessary fear. Epinephrine is in fact a wonderful drug, but it is important to not lose sight of the evidence for what it actually does in anaphylaxis treatment and why it is important to use this drug in anaphylaxis, as opposed to an emphasis on what it does not do."
> The delayed use of epinephrine, identified as a significant feature in several reports of fatal food anaphylaxis, is perhaps the risk factor most amenable to modification. This has, in part, driven the widespread provision of epinephrine autoinjectors for the management of anaphylaxis, although controversy exists as to their use in less severe, nonanaphylactic allergic reactions.
Your logic seems to be "because anaphylactic deaths are low, epipens generally aren't useful". It may be true that they're used too often - knowing what to do in the moment when your kid is swelling up, having trouble breathing, throwing up, or passing out, especially if they're very young or not verbal, is a challenge and an experience I don't wish on anyone. But the way I interpret the data is that anaphylactic deaths are low precisely because epipens are so commonly used and there is so much awareness and training around when/how to use them.
That could very well be! There's not any research I can find that says "people with access to epipens die at X rate and people without die Y rate" so we have to take the manufacturer's claims at face value.
Regardless of how we are achieving it, it's just something where my perceived overall risk was much higher than the actual data justified.
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.)
Edit: >Several lines of evidence suggest that IgE is important in host defense against parasites (see Section 9-23). Many parasites invade their hosts by secreting proteolytic enzymes that break down connective tissue and allow the parasite access to host tissues, and it has been proposed that these enzymes are particularly active at promoting TH2 responses. This idea receives some support from the many examples of allergens that are enzymes.
The IgE-parasite connection is actually a bit part of the hygiene hypothesis, and I have personal experience with helminth therapy. It put a serious permanent dent in my animal and pollen allergies, long after the session (I forget how long they were active but I re-inocculated N. americanus twice and it was roughly a 2-3 year period).
Once you get over the squick factor and the really terrible itching at the site that lasts 12-24h, it's great.
They also didn't prevent the abundance of pesticides and herbicides which may cause immune responses to other things in food.
Then there's all the microplastic and teflon and whatever else seeps into the food supply from industrial equipment operation.
We've not only eliminated a lot of "dirt" but introduced a lot of things which can cause issues whether due to volatility or chemical stability causing inability of the body to clear it up.
But FDA did stamp the covid vaccine. The study that touted its effectiveness, was used to approve it, was obviously flawed. A billion dollar Fraud, and theft from tax payers that were mandated into taking it. FDA so far has faced no repercussions for it. In fact, for the longest time you would get censored for questioning its effectiveness, or even asking for some accountability.
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:
There's a lot of evidence indicating that the hygiene hypothesis is not accurate or at the very least not the whole story. The old friends hypothesis suggests that exposure to certain pathogens is just as important or more so. Also microbiomes may play a part in things as well. Everything is a bit up in the air, tbh.
Coeliac is just a word that means "relating to the abdomen", Coeliac Disease is a disease of the abdomen characterized by an immune response to gluten that causes the villi in the intestines to consume themselves, among other characteristic symptoms. Coeliac (or Celiac) Disease is not a food allergy.
Americans take more and more pills. Yet life expectancy is going down. So please prove these drugs are doing anything to improve the health of the American Population.
Reproductive rates are worse than ever.
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.
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.