Can a biologic treat food allergies? Can they protect against an accidental reaction to a food allergen or reduce adverse reactions to oral immunotherapy? Join us as we explore the future of using biologics for food allergies.
- Dr. Lindsey Moore
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Andrea: Hello, everyone. Thanks for joining us. We are waiting for people to get ready to go. We are just waiting for a few more folks to join us. Thank you in advance for holding . We will start soon. Good afternoon and thank you for joining us for today’s program. A few housekeeping items before we start. I am the education specialist and a certified asthma educator. We will record today’s webinar and posted on our website. You can scroll down to the bottom of the page. This will be one hour including time for questions. We will take questions at the end of the webinar. You can put them in the Q&A TAB. Often times we will have people put the questions in chat and I will miss those. Please use the Q&A TAB. We have someone monitoring the chat if you need any help. We will get to as many questions as we can. This is part of our series advances in allergy and asthma. You also have a link to the certificate of attendance. This is a grassroots organization that was started over 35 years ago. By a mother who knew that other mothers like her needed resources and support. Our mission is to end the needless death and suffering due to as — asthma and allergies and other conditions. It is my pleasure to introduce our speaker. She has been in allergy practice in Virginia for the last six years. She became a fellow in 2021. She is also active in asthma education. Thank you for joining us today. Food allergies is always a hot topic with our listeners. We are glad you are here to help us learn more about who’d allergies.
Dr. Moore: Thank you so much for the introduction. I am very excited to be here and give this talk to you day. This is my disclosure side. We will be briefly talking about that today. I don’t think that will cause any conflict. This is what we are going to cover today. The current management approach for what we do today. That is the center of all allergic diseases. Not just food allergies. You will see why biologic medications should work for food allergy. I will end with some future perspectives. Let’s get started. Studies estimate food allergies very. But the consensus is it is rising. It depends on the geographic location. The highest rates of food allergy are in North America, Europe, and Australia. In North America it is up to 11%. In the U.S., we think are 2 million Americans are dealing with food allergies. About one in 10 adults suffer from food allergies. And one in 13 children. Chances are your child has a friend that has food allergies. Food allergy management, this slide goes over what we have been doing over the last few decades. Minus the current decade. It has been relatively stagnant for some time. A mostly reactive approach to dealing with the problem. Typically what we see as we have a patient come to us with a history of a reaction. Hopefully it is a clear cut reaction. From there we launch into our diagnostic testing. Skin prig testing. We can also do CRM — serum specific testing. But these have limitations. We know if you do not have the right history of a reaction, this testing can lead to a lot of false positives. Also what we end up needing to do is an oral food challenge. And we see what happens. This is the gold standard for diagnosing food allergy. But it is time and resource intensive. We are always looking for new ways to diagnose this disease. Once we make the diagnosis, we teach people how to avoid their allergy. How to read labels. As many of you know, label reading is not straight forward. These statements are not regulated by the FDA. It is hard to know what to make of them. Food manufacturers change their labels all the time. We saw this recently with sesame. It can be very confusing. We teach patients how to react when they are having a problem. The good news is epinephrine works great for allergic reactions. But you have to be willing to use it. We know there is hesitancy on the part of some patients. It will be interesting to see in the future if a nasal device will be released. That will hopefully prompt patients sees epinephrine earlier. This is where we have been for a long time and I’m hoping to talk about where we are going. I hope to convince you why we need other approaches. The prevalence is continuing to rise. Accidental exposures are common. 19% of food allergic children sought emergency room care for reactions within the last 12 months. 40% repeated a reaction. There can be multiple food allergies. In some cases we can see avoidance lead to nutritional deficiencies. Avoidance can be challenging. This can cause significant impairment and quality of life. This is a cartoon of a large survey conducted back in 2020. Having a food allergy impacts many different facets of their life. 90% of respondents said it limited them from going to social gatherings. Children can feel isolated. This next slide hopefully brings some hope. These are not going anywhere. But I would like to talk about two new categories. Over the last 10 years we have been talking a lot more about preventing this problem from even happening. A landmark trial taught us that this decreases the risk by 80%. Other studies have showed this rings true for other foods. Early introduction is not the entire picture. We know that based on what we saw happen in Australia. They got the word out to parents that all babies need to have highly allergenic foods introduced in their diet. They found that 80% of Australian parents reported they have introduced PNC into their infants diet. Unfortunately, there was not a significant change in the prevalence of peanut allergies. It is not just one thing. We know that protecting the skin barrier is very important. That is a major risk factor. Studies have shown that children with eczema have water loss. As early as one week of life. This study is looking at if we are aggressive at protection early on. Maybe this will help prevent food allergies. Finally Biologics as disease modifiers. This was described 20 years ago by observation. This is in a nonlinear fashion. These are whole categories of allergic diseases. We are seeing this being started in younger infants. As early as six month. Maybe this will impact whether that child goes on to develop not only who’d allergy but potentially asthma as well. Another important one is a infection. It can impair the way we deal with our responses. Perhaps we can prevent asthma down the road. There is going on. Hopefully some of these can help us down the road. The other category we will spend some time on is treatment strategies. We will be talking about oral immunotherapy. A lot to look forward to. This is a desensitization therapy. It triggers an allergic reaction. This shows the general procedure. This is followed by several weeks of up dosing. This is continued daily at home. They will often stop the daily dose. This is the range of doses that I have found. There is a lot of range. Desensitization is a temporary state of clinical non-reactivity. It is persistent allergen exposure. The ability to tolerate small trace amounts of the food without a significant reaction. In 2018 there was a modeling study done that suggested if you can increase the baseline threshold , this will reduce the risk of experiencing an allergic reaction getting someone to that point you could talk about being bite proof. They feel safer. We know that safety is a concern. Most of these are mild. But anaphylaxis can occur. We think this can be a side effect. We know long-term adherence is an issue. You have to do this daily. Of course I will be an issue. It is meant to desensitize, not to cure. We are looking to raise the threshold dose. The allergy is still there. A biologic is a medicine made from cells of a living organism. This is a very busy cartoon. Allergy is associated with the breakdown of tolerance. There is some type of injury or stress. This warrants the immune system that there is a problem. This can cause inflammation. This causes the cells to make that chemical. We will be talking about the ones that interfere. We will talk a little bit about this. I would like to highlight some advantages and disadvantages of Biologics. The previous slide show you what happens in allergic inflammation. This is not specific to food allergy. A biologic should be able to treat comorbid conditions. If you’re already for food allergy, this should help all of those different conditions. The safety of the products themselves. We have a lot of experience with Biologics. We know they are safe medicines. They can help make other treatments safer. I will show you some of the studies that show that. Maybe they will interrupt that. Definitely the cost will be an issue. These are pricey medicines. We don’t know how long we have to have somebody on this treatment. They really only work while you are doing them. It will be important to determine how long we have to have patience on these. I’m not sure this is a huge deal for adults. But for children or babies, giving them a shot every few weeks is not ideal. That is a disadvantage. Let’s get into some of the studies. This is by far the most well studied. The mechanism of action binds to the IGE receptors. This down regulates the receptor. I found it fascinating. This was done with patients with severe, persistent asthma. We usually stay away from that into challenges. These were all subjects with a history of more than two food reactions. The researchers did in open food challenge. That introduced some bias. There were 23 food challenges conducted. Even if they were not highly sensitive, we still saw a before and after. There was a large increase in threshold. This was antigen nonspecific. They all had at improvement. This was a full serving. Another small study all had double blinded controls. They did a second food challenge. And then they did another one. The group really split on how they responded. You have one group that responded dramatically. In one group that did not do as well. It is almost like they declared themselves. The medium threshold those was three milligrams. It increased at the second food challenge. I do want to make a point. These people didn’t get much better. These patients were getting around a thousand milligrams. That is like three peanuts. That might be meaningful for some patients. There were a few other small studies. Not all studies were significant. But they all showed a treatment effect. The studies were heterogeneous. There were different quality-of-life measurements. This was a study. This was a study done at Stanford. Another small study. They only gave them one injection. This was a very short study. You can see only after two weeks 73% of patients or able to tolerate the dose. At day 45, that wore off a bit. This group experienced fewer moderate adverse events during the food challenge. This was a short follow-up time. A small sample size. But evidence that biologic agents can work quickly and effectively. I do not have any data to present. But there is a study with results pending. This is currently approved for several allergic conditions. This binds to the receptor. This prevents those cells from differentiating. This was a letter in the allergy Journal in 2022. There was a pretty substantial drop. There were no challenges associated with this. That doesn’t mean you can tolerate a food. Hopefully in the future it will play a role in food allergies. Biologics plus oral immunotherapies. I will go through this fairly quickly. We have cells that can grow up to do anything they want r. Those cells are more active in autoimmune diseases. They help keep the peace, keep the balance. They are induced to help suppress allergic response. They make a different antibody. It is more tolerating. They can make an antibody complex. That down regulates the receptors. We think effective. All patients underwent the trial. You will see them in these studies. They started the oral immunotherapy. They sell whether a patient could tolerate four grams of peanut protein. These are the results. It allowed 23 out of 29 subjects to tolerate peanut protein. That was day one. That is pretty remarkable. They were able to get to a cumulative dose of 490 on day one. It enabled them to do a very rapid desensitization. This was six weeks after stopping. As long as he maintains the oral immunotherapy, most patients were able to tolerate that dose. I want to bring up a potential concern. Six of the 20 subjects who passed the challenge had to reduce their dose at some point. At that point it had really worn out of their system. They were still able to tolerate at least two grams. They still were protected to a large amount of peanut protein. This trial had a similar design that was much longer. They did this for a very long time. 64 weeks on the drug. And then an extra year. They continued on eight weeks of oral immunotherapy. Then they stopped. The hope was that maybe in doing this for a long time, they could stop all of this and move on. Here are the outcomes. Most of them still got to maintenance. Your escalation phase was about a month shorter. 88% past. When we stopped for two months, both groups dropped in their ability to tolerate. There were less adverse reactions during the escalation phase. The take away point is that it showed significant improvement. But not in outcomes of efficacy. Many kids have multiple food allergies. Can this work with multiple food allergies? This was a study done at Stanford. They did up to five foods. Then they stopped after six weeks. Then they did a food challenge. You can see on the right these were all the foods included. They also looked at safety. Side effects were not invented. That occurred especially in the investigation phase. This is my last study that I will show you. This was interesting. This really tested sustained responsiveness. Everybody was put on this for multiple foods. They assessed whether they were still able to pass a food challenge. It was interesting that if you got a thousand milligrams, it’d normally matter. It would be nice to think you could do that. But it seems like we lose protection over time if we do not continue. This is a large trial. We have about 15 more minutes. This is an ongoing trial. I think when it is concluded it will set the stage. This is a prospective study. There are three stages to this study. The really interesting stage is stage three. Assessing the ability to switch to real-life life foods and how that works. I am really excited to see the results of this study. This is not the only drug still being studied. This is in a phase three trial. This is for patients with peanut allergy. This is looking at sequential use. The sky is the limit for these studies. There will be a lot more coming out. Some considerations moving forward. I like to ask myself, what are the outcomes we can measure? Even anaphylaxis can be defined differently and inference studies. We want to be thinking about what patients care about. What are those intangibles that matter to them? How would it affect them eating peanuts in the real world. What does that look like for patients? It seems like they are incorporating these real foods into the trial. To help better advise patients to what this means to them. We also have to ask ourselves, what are the goals and motivations of pursuing these treatments? This was a survey done by social media. Probably not representative of all patients with food allergies. But these were all parents who had pursued this for their children. The survey asked them, what was their primary goal. 62% said reduce the risk of a fatal food reaction. They were asked to quantify what they thought the risk of death from a food reaction was. 45% felt the risk was about one and 1000 that there child could die from a food allergy. We know those are far inflated numbers. There is an incidence of about 1.8 per million for seniors. We are doing these studies but we need to be talking more to our patients and reassuring them that doing this is not going to change the risk of fatality. It is already so low. What are your motivations for doing this? Most families would not consider this a success if the food could be included in the diet but they had more reactions. You are going to have reactions. Conversations with the families are so important. There are still unanswered questions. We don’t know when to stop Biologics. We don’t know the optimal dose. Studies are ongoing. Hopefully we will have some more information on that. We don’t know the optimal dosing. Will too high of a dose create side effects? Where is the sweet spot for maintenance? How can we make these medications affordable? Are there more we are not considering? Many of the treatments available in the near future will be costly and require long-term commitment. It is of the utmost importance to be transparent about the risks and benefits. Acknowledge the gaps in our knowledge. I thank you for your time. I hope you enjoyed and learned something.
Andrea: That was a lot of good information. I like the comments he made at the very end here. There is that fear of food allergies. I am including myself in that. 1.8 per million will have food allergies. Is that correct?
Dr. Moore: Yes.
Andrea: You are bringing a lot of hope. That is what I’m getting out of this. Let’s go through a few of these questions. Pediatricians are encouraging early introduction. That study was based on children receiving two milligrams. There are some things in the chat here. This series is with the American College of you knowledge he. This will be on a website. You will get an email from Zuma. There will be a link to the website for the college. That will be available for you. Do you want to repeat that question?
Dr. Moore: Pediatricians are encouraging early introduction. That study was based on children receiving two milligrams three times a week until they were five weeks old. — five years old. If the child is given less, is it still helpful? What if the family as a child with a peanut allergy. We know a lot of parents are nervous about that. Does any amount of that help. Or kin in frequent exposure cause allergy. A lot of different points to that question.
Andrea: I do not know the sweet spot. We think a couple of teaspoons three times a week is definitely and the to prevent the problem. If you are giving a little bit less of that, you can still prevent the problem. But if you are getting it in frequently in smaller amounts, that might not be enough to preventive. If you are predisposed anyways to that. We have had patients where we feed them and they passed the food challenge and they do not continue it later. Where that sweet spot is I do not know. There is such a thing as too little and not often enough. If you have one child that has a food allergy and you are trying to introduce it to the other, I still think you can do that. You just need to know when you do it when the other one is napping. Make sure you are washing hands this open water to get food all hands. It is too important to introduce it then to just avoid it. If your Other child has the allergy. A lot to unpack with that question. There is another question here. There is someone in California uses a gradual intervention. A specific dose of amounts. Instead of a set those. Why is this type of therapy not being furthered?
Dr. Moore: I am not sure about that company in California. I don’t know that the FDA needs to do that. The point we need to get across is that foods that are common allergens need to be introduced earlier. You don’t want to medicalize feeding food. You wanted this amount on a Monday and this amount on a Tuesday. It still needs to be fun. It needs to be early enough while the immune system is still developing. I don’t know why the FDA is saying that. I am hopeful it will still keep eating fun and not too regimented.
Andrea: A lot of us have a little bit of fear but we need to be able to enjoy our meals. I’m glad you mentioned that. Would it be possible if any of those Biologics are successful to introduce allergens into the diet.
Dr. Moore: Yes, definitely. They are not specific to peanut. A lot of the studies focus on peanut because it is common. It should work for any food allergy.
Andrea: Great. That is one thing I noticed that we talked about. I can use that. What symptoms does the patient experience when on biologic treatment?
Dr. Moore: The side effect profiles are really good. We use to be worried about anaphylaxis. But there is a very low rate of that. Almost all Biologics now can be given at home which speaks to their safety. We always monitor that for conjunctivitis. And then of course you can get injection site reactions. That is the most common side effect.
Andrea: Thank you. I had a son who was on a biologic for several years. No side effects. It kept him out of the hospital. I work with parents of children that have severe food allergies. During my pregnancy I was encouraged to eat in butter. I would like to know the best way to encourage parents with severe food allergies. How best to protect them from reactions?
Dr. Moore: Have a parent’s best protect their children from the reactions? We are left with what we have. It is at the next level with food allergies.
Dr. Moore: A lot of adults still have food allergies. I make sure that I follow my food all the way through the cook line. And then back to my table. So there’s note cross contact. Another tip that can help. When will more of the study results be available?
Dr. Moore: I am not sure. And in the results are pending. Hopefully in the next six to 12 months.
Andrea: Thank you. Another thing I wanted to mention , please talk to your doctor about it. Make sure you get the information you need about co-pay assistance. They could be a little bit hefty sometimes. We have someone who is asking for a link. The email is right there above. I will make sure you get that. There are a lot of different ones out on the market. They can usually be personalized to whatever your food allergen is. That would be a great option. Is there anything else we did not cover that you can think of that we needed to mention?
Dr. Moore: I don’t think so.
Andrea: I think all the data you shared with us today was absolutely effective. This is working. It may take a little bit of a mindset. Sometimes that can be a little bit interesting. I think this gives people hope for the future. I hope your child is better.
Dr. Moore: I’m going to go check it out as soon as I sign off.
Andrea: Thank you everyone for joining us. There is a survey. Please ill this out. We look at every single comment that comes in lists. I look at all of this. Feel free to register for our next webinar. All of ours are free. Thank you again.
Dr. Moore: You are welcome. Thank you for having me.
Andrea: Have a good day, everyone.