Making Sense of the NY Times Article on the New Peanut Allergy Drug: What Does it Mean for Your Family?
One of last week’s most shared article online in the New York Times was “New Peanut Allergy Drug Shows ‘Lifesaving’ Potential”, and I’m not surprised it is so popular. It talks about a new study that came out about a drug that could prevent severe allergic reactions to peanuts. Today 1 in 13 children in the US have a food allergy. Awareness is growing, but more work is needed. I was horrified to read many of the comments, some people are so mean and misinformed. I felt the need to respond and clarify as many of our Foublie families are just starting their food allergy journey and this was not straightforward. Comments are at 254 and ticking upwards. Please don’t be mean if you comment!
Why is this drug, called AR101, needed?
All avoidance of the food you or your child is allergic to isn’t that easy and straightforward. If a packaged food was made in a facility that handles peanuts, it is most likely not safe for someone severely allergic to peanuts. This is called cross contact and it can be very serious. For some children, an anaphylactic reaction is possible with a whiff of peanut dust. A lot of this exposure is completely accidental. A drug like this can increase a person’s tolerance if these accidents happen. Think of it as a way to prevent a severe, life-threatening reaction.
DYK: Cross contact warnings on food labels are voluntary.
What is so exciting?
The peanut allergy treatment is not a cure. It could prevent an anaphylactic reaction, which is life threatening, due to unintentional exposure through cross contact. While it is exciting, it isn’t the golden ticket or silver bullet for an easier life. As one man in the comment section puts it, “the peace of mind that accidental exposure will not lead to catastrophic results is priceless”.
The result of this study is that ⅔ of the children that received the therapy could eat 2 whole peanuts without developing allergic symptoms. 2 peanuts. Remember these kids will likely never eat a peanut butter sandwich, but they should feel safe eating a candy bar made in a facility where Pay Day’s are made.
- Unfortunately, 20% of the children in the treatment group quit the study because of adverse side effects.
- And. 4.3% of the children receiving the treatment had severe side effects.
- And. 14% of children receiving treatment had to use epinephrine.
- So even though it worked well for a lot of kids, it didn’t work for all of them.
Is this really new?
Yes and no. What is new is the drug formula used is on track to be approved by the FDA. Oral immunotherapy (OIT) has been in medical practice since the early 1900s. Historians tell of early use by kings to build tolerance for arsenic.
What is OIT and is it right for my family?
OIT is is a method of food desensitization that involves reintroducing the immune system to the allergenic food in very very small, gradually increases amounts over time by eating it. The goal is not treatment, but tolerance. Talk to your allergist to learn more about it and if it is right for you. There are many considerations, but to start:
- Time: do you have the ability to go to the Allergist once every 2 weeks?
- Money: Check with your insurance- I’m finding mixed experiences on this one.
- Mental health: see below, but these studies are stressful.
- Your child cannot have eosinophilic esophagitis (EOE) and if they have asthma, it must be under control.
- You must take the protocol seriously. The food must be consumed daily which includes a 2 hour observation period.
- There isn’t a lot of published data. For example, this study we talk about here is larger than all the others combined.
For this particular study, the protocol was 6 months of treatment followed by six months of follow up maintenance therapy. Children had to rest for 2 hours after received their daily dose, but not fall asleep because they needed to be monitored for a reaction. After the 6 month treatment, children did a food challenge to see if the drug worked. Maintenance will most likely continue indefinitely, which seems to be a small amount of peanuts every day (one boy in the article eats peanut M&Ms).
What is a food challenge?
A food challenge is where a person allergic to a food eats that food in small quantities in a controlled medical environment. It takes hours. The process has the person eat a little bit every 15 minutes or so to see if there is a reaction.
Balancing mental health
I have tremendous respect for families that participated in this study. These kids are brave. Even the treatment had a chance of causing a life threatening reaction, every time they took the drug. While there is certainly uncertainty of accidental exposure through cross contact or just accidentally eating something that has peanuts in it, I’m not sure I could do it. This is the trade off these families made: do we risk a reaction now to gain protection from accidental exposure later? Almost every participant in this study had an adverse reaction during this year long trial, from both groups. To me this underscores just how vigilant these families must be about peanuts.
Industry, Ethics, Commercial Opportunity & What’s next?
Who funded the study? The drug developer called Aimmune Therapeutics designed and sponsored the study. This is pretty normal as far as drug development goes. All 13 authors receive compensation from the firm, either as an employee or as a scientific advisory board member. Aimmune is a public company, but the first trading day after the study was published the stock price closed Monday 11/19 down over 10%. The analysts predict a 1 billion dollar annual market. This article notes a hesitation by investors due to the side effects we mention previously and also a hesitation of packaging a natural element, peanut, and adding a big price tag.
Aimmune Therapeutics, the company that is producing this drug will submit an application to the FDA. Because it is determined to be a ‘breakthrough therapy’ it will get a priority review, and potentially accelerated approval. It could be on the market by the end of 2019.
We’ll keep this on our radar!
This drug was approved by the FDA in early 2020. To read more, go to Aimmune’s press release.
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