This webinar was recorded on May 2, 2024

Approximately 20 million Americans have food allergies according to 2021 data from the CDC. Individualized management of food allergies is important because symptoms of food allergies can vary from person to person and reaction to reaction. In this webinar, learn about the current approaches of food allergy management.

Speaker:

  • Aikaterini Anagnostou, MD (Hons) MSc PhD

Dr Anagnostou is Professor of Pediatrics at Texas Children’s Hospital and Baylor College of Medicine in Houston, Texas. She currently serves as Director of the Food Immunotherapy Program and Co-Director of the Food Allergy Program. She is also Lead for the Adolescent Transition Program for Allergy. Dr Anagnostou is passionate about investigating new and innovative therapies for food allergy. She is the PI for phase 3 trials of food allergy therapy and is also leading research projects on food allergy prevention, anaphylaxis, the microbiome and shared decision-making. She currently serves as the Chair of the Adverse Reactions to Foods Committee at the AAAAI and as the Vice Chair of the Food Allergy Committee at the ACAAI. She is also a member of the Practice, Diagnostics and Therapeutics Committee and the Anaphylaxis Committee at the AAAAI. Dr Anagnostou obtained her PhD from Cambridge University in the United Kingdom and her dissertation focused on two research trials of Peanut Oral Immunotherapy in children. Her research work was published in The Lancet and received international recognition.

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Transcript: While this transcript is believed to be accurate, errors sometimes occur. It remains your responsibility to evaluate the accuracy and completeness of the information in this transcript. This transcript is not intended to substitute for professional medical advice.

Catherine: We are still waiting for some people to join so we will be starting in a moment or so. Thank you for your patience. OK. Hello everyone. My name is Catherine Blackwell. Thank you for joining us today. I am the chief health equity officer for Allergy & Asthma Network. Welcome to this webinar this afternoon. We are in for a real treat today with Dr. Allergy & Asthma asked –Aikaterini Anagnostou today’s present or. We have a a few housekeeping items. All participants will be on mute for the webinar. We will record the webinar and posted on our website within a few days. You will be able to find all of the recorded webinars on her website at allergyasthmanetwork.org. Scroll to the bottom to find any webinars that may interest you. This will be for an hour and that includes time for questions. We will take the questions at the end of the webinar. You can put your questions and the Q&A at any time. That is located at the bottom of your screen. We will have somebody monitoring the chat if you have questions or need help. We will get to as many questions as we can before we conclude today’s webinar. This advanced webinar is a partnership with the American College of allergy asthma and immunology. ACAAI for short. They offer physicians and attendance credits. You can create a free ACAAI account and get attendance credits to the portal. All attendees will be offering a certificate of attendance and no continuing education credit is provided. A few days after the webinar to can receive an email with additional information and a link to download the certificate of attendance. We will also try to add the link o the certificate in the chat. Let’s get started. Today’s topic is food allergies, current approaches towards end of the largest — individualized management. 20 million Americans have food allergies. Individualized management is really important because, as you know, symptoms of food allergies can vary from person to person and reaction to reaction. In this webinar you will learn about the current approaches of food allergy management and the importance of shared decision-making with food allergy patients and their families. With all that said it is my great pleasure to introduce our speaker, Dr. Aikaterini Anagnostou. Dr. Anagnostou is professor of pediatrics at Texas Children’s Hospital at Baylor College of medicine in Houston, Texas. She currently serves as director of the food immunotherapy program and codirector of the food allergy program. She’s also lead for the adolescent transition program for allergy. Dr. Anagnostou is passionate about investigating new and end of eight of therapies for food allergy. She is the principal investigator. Her Phase 3 trials of therapy and is also a leading — is leading projects on prevention, anaphylaxis, the micro biome and shared decision-making. She currently serves as the chair of the adverse reactions to boost committee and as the vice chair of the food allergy committee at the ACAAI and a member of the practice, diagnostics and therapeutics committee and the anaphylaxis committee. She obtained her PhD from Cambridge University in the United Kingdom and her dissertation focused on two research trials in her research is published in the Lancet and received international recognition. Thank you for being here, Dr. Anagnostou. I will turn it over to you.

Dr. Anagnostou: Thank you very much. That is a kind introduction. It is my pleasure to be here and I would like to welcome everyone to this webinar. These are my active disclosures. The learning objectives for the day include a description of both traditional and novel approaches to managing food allergies. An excellent nation and discussion on food allergy treatment approaches using both immunotherapies and also Biologics. A discussion on the key components of shared decision-making and food allergy management. Very brief introduction because I’m sure this audience already knows a lot about food allergies. Based on prevalence studies we have, an estimated 8% of children and 10% of adults in the United States are reported to currently have at least one food allergy. We know that food pose a burden to both patients and their families, and that burden is multifaceted. They have to deal with a lot, both patients and their families. One of the most important parts of this burden I hear a lot in my clinic as well is fear and anxiety. Especially surrounding accidental exposures, potential for severe life-threatening reactions. This can significantly affect the quality of life. What has fascinated me is that although there are hundreds of food allergens, more than 90% of allergic reactions that patients encounter are caused by actually just those nine top food allergens. Which include milk, egg, soy, wheat, peanut, tree nuts, sesame, fish and shellfish. It’s important to point out these food allergies have a different natural progress in life. Milk, egg, soy and wheat are generally allergies to get outgrown. People go out of them — grow out of them. Peanut, tree nuts, sesame, fish and shellfish not as much. Today we are focusing on the management of food allergy. What do we mean by traditional approach? This refers to the approach that has been around for many decades which involves complete avoidance of the food that is the trigger of the food allergy. It is very much an acceptable approach that is still valid today and forms one of many choices that food allergic individuals have nowadays for the management of food allergy. Together with the traditional approach we educate patients on how to prevent future exposures to their allergenic trigger, how to recognize signs and symptoms of an allergic reaction, and how to treat those allergic reactions which include education on the use of epinephrine injectors. I cannot stress enough if you give — this is an important point. In addition to the traditional approach we know have novel management approaches that have come about in the last five to 10 years. These include various forms of food immunotherapy, including oral immunotherapy and sublingual and biologics. I believe most people attending this webinar have probably already heard about the recent FDA approval for the use of O malizumab There are other therapeutic approaches in the pipeline that are in phase one trial so we will not be discussing those today. Let’s start with food, and therapy. — immunotherapy.

I would like to point out that food immunotherapy has actually made it as part of various guidelines all around the world that refer to management of food allergens. This is the EAACI guideline. They brought information and guidance on food immunotherapy in 2018. According to the EAACI guideline, it should be considered from the age of 45 years with symptoms of persistent IgE mediated food allergy to cows milk, egg, and peanut with sensitization to the triggering allergen. The guideline recognizes the majority of children that are allergic to milk and egg are likely to develop tolerance spontaneously to both of these food allergens. For these patients they recognize it is acceptable to wait and see whether there allergy outgrows before initiating food immunotherapy. I will discuss the point of little later. I will be focusing on this presentation for early immunotherapy. These are more recent guidelines coming from the global allergy and asthma excellence network. They focus on food allergy management and they recommend offering peanut oral immunotherapy and especially supervision to selected children aged 4 and up with clinically diagnosed severe IgE mediated peanut allergy. They offer the same for children again age four and above for severe persistent mediated hands echo cow milk allergies. What is meant is for severe — a history of severe reactions but also this refers to the burden of food allergy. It recognizes that certain children and certain families may have a more severe burden compared to others. Let’s look a little bit about what data are out there to support our use of oral immunotherapy for food allergic patients. Most people are familiar by the study on the left. This is the Palisades study published in 2018. It is the largest unit oral immunotherapy study that has been published to date. It is a multicenter study that enrolled children between the ages of 4 to 17 years of age who were randomized to receive either oral immunotherapy to peanut or placebo. The primary outcome of the study was the percentage of participants able to tolerate 600 Villa grants of peanut protein — milligrams subpoena protein, equivalent to two to three peanuts. After a year of therapy. The children would initially go into a rush phase where they would get the dose increased pretty rapidly within a day. Then they would enter a slower up dosing phase, the buildup phase, with the aim to reach a top dose of 300 milligrams. Once that dose was reached the buildup period what and in the minutes period — maintenance period would start with they would take 300 milligrams for six months to complete a whole year of therapy. At the end of the trial it was noted that 67% of children were able to tolerate a 600 milligrams dose without any dose limiting symptoms compared to 4% and Nicholas Evo a –a placebo arm that did not receive immunotherapy. It’s important to remember their 600 milligrams doses double with the kids was taking for maintenance, the 300 milligrams dose. When you look at the far left, the 300 Miller Graham dose it is clear the percentage is much higher. When you look to the right for the 1000 milligrams dose, also reported after your therapy, the percentage is just over 50%. Just over half were also able to tolerate much higher doses, more than triple their maintenance at the end of a year of therapy. I mentioned the study was focused on children. There were also adults in the study.

The results were not statistically significant at the end. This is most likely because of the number of adults was quite small. We were not able to detect such a signal. Although adults generally and practice do not seek therapies as much as children, I didn’t see any reason why oral immunotherapy would not be appropriate for an adult as well or in any way less effective. The study on the right is the stop II trial. 100 peanut allergic children who after six months of oral immunotherapy were able to tolerate five peanuts. 82% reached that dose. When they were challenged to a much higher dose of their maintenance, 1400 milligrams of peanut protein, 62% were able to tolerate that higher dose as well. Two different studies. One multicenter and one single center. Different parts of the world. As you can see, the results in terms of efficacy are similar. The rate of treatment related anaphylaxis reported for the Palisades study was 14%. For the stop II trial, 1%. Moving on to real world studies, this was a study that recruited 145 peanut allergic individuals within the ages of 4 to 18 years old. 77.9% were successfully desensitized to a total of three grams of peanut protein. Then they investigators wanted to look at long-term maintenance. They split the patients into two groups. One was the high mains group. They received three grams. The other was the low dose manus group that received less than half of the initial maintenance dose. 1200 milligrams. Both groups were followed up for six months. It was found that when they were re-challenged to the initial dose of 3000 milligrams, 100% on the high-dose armor successful, which we expect because they took that same dose during maintenance. Versus 95.5% in the low dose maintenance arm. Adherence to treatment was quite different. It was found to be significantly higher in those patients that belonged to the low maintenance group. This is important because unit oral immunotherapy and oral immunotherapy in general is a long-term therapy. Adherence to treatment is very important. If patients discontinue for a long periods of time they can lose part or even all their tolerance. A lot of times adherence to high doses can be difficult. This was the reason the study was performed. The investigators wanted to see if patients could get away with lower dose maintenance doses. The study was encouraging because it showed similar efficacy for high and low maintenance dose with better adherence on the low maintenance dose arm. We talk a lot about peanuts. There are hundreds of studies now looking into peanut oral immunotherapy. What is happening with the rest of the food allergens? Happily, nowadays we have studies that have focused on different food allergens such as tree nuts. This was a nonrandomized study that looked into desensitizing patient. There were 50 patients between the ages of 4 to 25 years. 15 controls in the study that received no therapy. The target dose was 4000 milligrams, which is approximately equivalent to 16 cashews. The investigators reported that 88% of the participants who received oral immunotherapy versus zero in the control arm were able to tolerate the dose of 4000 milligrams of cashew protein at the end of the study. Those patients that were fully desensitized were split into a high and low maintenance dose group just as in the previous study with the peanut. They were challenged to a full cashew dose. It was found that all patients who had consumed a low cashew dose were able to pass a full dose cashew challenge after at least six months of maintenance. The results were pretty good for cashew as well. A reported 18% of patients received epinephrine associated with treatment related allergic reactions. What about those food allergen — allergies that don’t stay with most people but resolve over time and have a natural history that is favorable? One of those is hands egg — hen’s egg. This was published in 2012. A randomized controlled trial that included 40 active and 15 placebo individuals, all children in the age was — median age was 7 years. A rush phase, a buildup phase, and a maintenance phase of two grams of egg powder, equivalent to a third of a whole egg. After 10 months of therapy, there was a challenge to five grams of egg powder.

A much higher dose and maintenance, more than double. It was noted that 55% of the children were able to pass the challenge. They were able to tolerate approximately the equivalent of one whole egg. About a year later, they were re-challenged. This time to 10 grams of egg powder, double the dose of the previous challenge. Five times the dose of their regular maintenance. At that point in time 75% of the group that was challenged were able to tolerate that dose, which is approximately equivalent to two whole eggs. More individuals were able to tolerate the food challenge. They were able to tolerate higher doses as well. The study assessed sustained responsiveness or omission, which is based a check to see if patients can tolerate the same dose if the therapies stopped for a certain amount of time. The patients for this particular study were instructed to avoid all egg for four to six weeks and the food challenge was repeated. You can see that by stopping therapy for this amount of time at 24 months when the challenge was repeated a much lower percentage are able to tolerate the 10 gram dose . There were no severe reactions during the study. There is a lot of conversation that has been going on for a while, especially with regards to sesame and sesame allergic individuals. We are seeing more studies focusing on immunotherapy coming through. In included 60 patients that were receiving — receiving no therapy for the sesame allergy. The patients were four years and up. 88.4 percent were successfully desensitized to 4000 milligrams of protein versus zero in the control arm. Again, the patient’s that were desensitized were instructed to try either the high-dose or low-dose maintenance. Again, low-dose maintenance was found to be successful at equally effective or close to equally effective as high-dose maintenance dose. Epinephrine treated allergic reactions occurred in this cohort and about 16% of patients . 8.3% of patients were home doses. Like I mentioned before, I think it’s a good time to focus a little bit more on early life immunotherapy. By early life we are referring to preschoolers. Those children that are below the age of 4. Below school age. The reason we are focusing on this population is one, our guidelines have changed. We introduce allergenic foods a lot earlier than we used two in the past. I remember many years ago when I was training we advised individuals to not introduce allergenic foods if they were high-risk until at least the age of three years.

This was advice given to families and caregivers. We realized now that was the wrong advice. The earlier you introduce the foods the better your outcomes are going to be in terms of not developing a food allergy. This is one important point. We will see more reactions likely in the early age because children are introduced foods early. We did not diagnose peanut allergy until the age of three because that is when children were exposed to it but this has changed. Since I mentioned early allergenic food introduction I want to reassure everyone that based on current guidelines no screening is needed for infants before introducing all allergenic foods and early introduction is safe. Studies that have looked around the world in the early introduction have shown very safe outcomes. Very few infants will have significant allergic reactions. Going back to early life immunotherapy, this has come up from the Canadian Society of allergy and clinical immunology. It is one of very few guidelines and guidance documents that discuss early food OIT. Based on the Canadian guideline, OIT is indicated for toddlers and preschoolers. While they recognize there is a likelihood of August he spontaneously growing milk and egg allergy like was mentioned before, these allergies, when they persist and they don’t actually go away can cause a huge burden on patients and families. So the decision on whether to undertake early food, no therapy should involved –early food immunotherapy should involve decision-making rather than the physician making a decision on whether these kids should receive OIT or not. What they are basically saying is that early OIT is well-tolerated, has high efficacy for the young age group. Waiting for the food allergies to go away is absolutely an option if that is the choice of the parents. Also initiating therapy should be considered as an alternative option. Sometimes we cannot really tell if they are going to outgrow their food allergy are not. Sometimes we can. There are certain high-risk phenotypes but not always. When it does not go away it can cause problems. What are the data to support early oral immunotherapy? Early life oral immunotherapy? This was one of the first studies published on early OIT. It included 40 children between the ages of nine to 36 months with peanut allergy. They were randomized one to one to receive early oral immunotherapy at either of 300 milligrams or 3000 milligram agents dose for 2 — three years. This is an open label study, no control group. The preschoolers were recruited based on a history of a recent peanut reaction and also positive testing including specific IgE and food challenge. Responsiveness at four weeks after stopping early immunotherapy. This was assessed by a double-blind placebo food challenge up to five grams of peanut protein. Desensitize Asian rates were very high in this — desensitization rates were very high in this group. The rates of sustained unresponsiveness were also pretty high. As you can see there is not very much difference in the rates of sustained responsiveness between the low-dose and the high-dose maintenance arm. The investigators noted successful oral immunotherapy was associated with lower baseline specific IgE. That’s important since we are looking for biomarkers that were — will predict patient response. On the right you can see the number of adverse reactions and the type of reactions that occur during the study. The light gray color represents reactions that occur during buildup. The black color represents reactions that occur during maintenance. As in most oral immunotherapy studies, abdominal pain is top of the list. We often CGI symptoms that are related to therapy and adverse events. The other important observation I always take out of this graph is that most of the symptoms and reactions actually occur during the buildup phase and very few appear during maintenance, which is what we see during oral immunotherapy studies. Adverse events tend to go away over time. This is another trial investigating early peanut immunotherapy. It is the impact trial. In included 146 children that were randomly assigned two to one to either receive peanut oral immunotherapy for placebo. — or placebo.

These children were challenged 500 milligrams of peanut protein. In order to qualify for the study they needed to react before the dose provided they had a positive challenge. They were then started on an initial dose escalation day. That took them from just .1 milligrams of peanut protein all the way to six milligrams of peanut protein. After the initial dose escalation day was completed, they entered the slow buildup phase. Every couple of weeks they would be updosed from six milligrams all the way up to 2000 milligrams, which was the target maintenance dose. Once they reached the 2000 milligrams they entered the maintenance phase. This whole process of dose escalation and maintenance took 134 weeks. At the end of that time they were challenged again. This time to 5000 milligrams of peanut protein. More than double their maintenance dose. This challenge aimed to assess desensitization and was the primary outcome for the study. For those who were successful in tolerating the 5000 milligrams challenge, they were then instructed to stop therapy completely and stop eating any kind of peanut for 26 weeks. At the end they were rechallenged to 5000 milligrams to assess for emission. These are the results. On the top you can see intention to treat analysis for both groups. On the bottom is a protocol analysis. In terms of achieving desensitization, 71% in the active OIT are more successful in the primary outcome of the study versus only 2% in the placebo arm. In terms of remission, 21% were successful versus 2% in the placebo arm. Approximately one in five that received early OIT achieved remission. Percentages for the protocol analysis or higher. What was really interesting was, when the investigators looked at what could increase the probability of remission for participants in the study, they found younger aged and lower specific allergy to peanut worse associated with an increased probability of remission. When they looked at the analysis and this time broken down into different ages, young children that had the highest rate of remission were between one to two years. 71%. This dropped to 35% for those who were between two to three years and dropped to 19% for those between the ages of three to almost four. Now one thing I will say about this is the numbers were unfortunately quite small. This is providing some really interesting insight on starting therapy early but it would be very nice to have some further studies investigating early immunotherapy, not just for peanut but other food allergens as well and a young age group. Ideally below the age of two. Adverse event are really important in any therapeutic trial. In oral immunotherapy studies we tend to see a lot of them, although happily most are mild or moderate. This particular study 98% of participants in the peanut OIT active arm had at least one dosing reaction. The participants that received epinephrine for at least one dosing reactions were 22%. What about real-world studies in this very young group of kids? Looking at real-world studies in preschoolers there are quite a few. Most come out of Canada. The one I have chosen to present you today. This was a Canadian study looking at preschoolers between the ages of nine to 17 months who received an oral food challenge to 4000 milligrams of peanut protein after receiving therapy for one year, after being on maintenance for a year of 300 milligrams they were challenged. Out of the 170 patients, 92, 78.6% had a negative challenge. Interestingly, 115, 98.3%, were actually able to tolerate accumulated dose that was greater or equal to 1000 milligrams. There were some adverse reactions noted in this real-world study. There were 21.4%, 25 children reacted. In these children the threshold of reaction had significantly increased compared to baseline. There were two patients that received epinephrine associated with therapy. This represents a 1.7% of epinephrine administration in the study. For those of you who are more visual, this is the results in the form of graphs. You can see on the left-hand side the effectiveness noted for 1000 4000 — 1000 and 4000 grams in the change in the acumen lidded threshold of peanut that was tolerated at baseline and the follow-up oral food challenge .

Potential benefits in starting treatment early include the development of a higher threshold for patients. This reduces the risk of accidental exposures and increases probability for desensitization and sustained responsiveness before starting school. Is associated with a psychological benefit. Having a more controlled approach to including allergenic food and having a shift in avoidance requirements and reduced social vulnerability related to food allergy. That include bullying, which as we know it now — no network — know now occurs more with food allergies and thought. This can take a long time. It can be costly. It requires a lot of staff, effort and time. There are differences in insurance coverage plans and physician reimbursement across the country. There are areas that have limited access to allergy specialists. We are talking to parents here. There are a lot of parental hesitancy and anxiety, especially when dealing with malady events. I will move to a different form. This is epic you to any of — ep icutaneous. The Pats contains the dried allergen in the chamber and stays there for 24 hours before it is changed. It targets dendritic skin cells and its been locked into a single daily dose of 250 micrograms of peanut protein. A much lower dose compared to that with oral immunotherapy. This was the first epicutaneous immunotherapy trial published. Children received the patch for 12 months. You can see the intention to treat analysis, the success rate of 35% and those who had the patch versus 13% and those on the placebo. Looking at side effects, the most common involved the skin, which is expected in the way that the allergen is placed on the skin. The anaphylaxis rate was 3.4%. This was followed by the people trial and three year term analysis of 141 subjects that received epicutaneous immunotherapy. At month 36, 75.9% had demonstrated increased listing dose. If an individual had another listing dose of less than 10 milligrams at baseline, the primary outcome would involve the dose going to at least 300 milligrams or over. For those who had a dose of more than 10 milligrams at baseline, the aim was to bring the eliciting dose after the therapy to more than 1000. You can see on the graph on the right that the cumulative reactive dose increases significantly with multiple years of therapy, starting at 144 and going to 444 milligrams at month 12, and 934 at month 36. More than enough to protect them accidental exposures. Sustained nonresponsiveness was also looked at. Importantly, there were no treatment related epinephrine events in the years two and three. The study showed good compliance. The study was done as well for young infants. This is the Epitope study. The primary outcome showed 67% of infants and taught others been successful — toddlers being successful versus 33.5% in the placebo. Treatment related anaphylaxis occurred in only 1.6% in the intervention group. Creative treatment related anaphylaxis for food, therapy –immunotherapy tends to be lower in the early age group. Moving on to sublingual immunotherapy. This works a little differently. The doses are much smaller compared with oral immunotherapy . They were either swallowed or kept in the mouth for a few minutes and then spat out. This targets the cells. This was the first sublingual immunotherapy study including 40 subjects receiving either slipped or placebo. After 44 weeks of therapy it was found that 70% were successful in significantly raising their tolerated threshold versus 15% of the placebo subjects.

You can see the median tolerated dose is significantly increased from just 3.5 milligrams at baseline to 496 milligrams. This was the median tolerated dose. After further weeks of therapy looking at now 68 weeks of total treatment, the dose increased to 996 milligrams. More importantly, there were no noted severe reactions during this study. This is a difference with severe reactions. They are exceedingly uncommon. You can associate that with the way the treatment is administered. Epinephrine treated reactions are few and far between. In most studies they were actually none. This is the study looking at sublingual immunotherapy. Again, some results. Children between the ages of 1 ti 1 — to 11. 70% could target — side effects are similar to previous studies with symptoms being the most common. Let’s move onto biologics. I’m sure everyone by now has seen the results of the trial that looked at efficacy of Omalizumab. The primary endpoint for the study was ingestion of peanut protein in a single dose of 600 milligrams or more without having any dose limiting symptoms. The investigators looked at various secondary endpoints. There were children and adult included in the study. They all needed to be peanut allergic and also have at least two other food allergies, including potential for cashew, milk, egg, wheat and hazelnut. 300 milligrams or less for two other fruit. They were randomly assigned to either receive Omalizumab or placebo at the two to one ratio. The first 62 participants were enrolled in a 24 week open label extension. A total of 462 were screened. 180 randomized. 177 were children and adolescents. There were three adults in the study. I think we were all interested to see the efficacy results when you look at the primary endpoint that refers to tolerance of peanuts without any dose limiting systems — symptoms. Those receiving Omalizumab achieved 600 milligrams of peanut protein versus 7% in the placebo arm. When looking at other foods, cashew percentages, 41% versus 3%. Eggs, 67% versus 0%. It is difficult to cover the study in a presentation like this. I encourage everybody to look at it in more attention. We could literally dedicate a whole presentation to each one of the studies are presented today. These are more detailed results looking at the different foods and different doses tolerated. The investigators have also looked at tolerance of one food at a certain amount versus two foods versus three foods. The percentages start off pretty high, especially for doses over one gram. Then they dropped down to lower after you move on from the one gram to two, Four to six grams. I will spend my last few minutes talking a little bit about decision-making in food allergy management. Remember the title of this webinar was individualized management. We know now what works for one family and one individual may not work for others. Shared decision-making has come into our practice and is part of our standard consultation for many years now. Both clinicians and patients have an equal roll to a play in the optimal goal which is informed decision-making based on the patient once. — wants. The clinician has responsibility of making a correct diagnosis of food allergy, discussing options that are available with their patients. Looking for any conflict and also referring. Needed. — referring for support if needed. The patient has to identify and communicate their own informed values and priorities. These are often shaped by social circumstances. These are practical steps I use in my clinic when it perform those shared decision-making conversations. I start by saying to my patients let’s discuss this together because it’s a two-way communication between patients and physicians. It’s important to listen actively to what the patient’s have to say. As a second step we examine options together. I usually say let’s examine your options and what is available now, what choices you have. We go through benefits and risks for different options. We talk about available choices and alternatives. Step three can occur on the same visit or a future visit.

Sometimes quite a few times decision-making does not take place in one single consultation. When the patient is ready to make a decision then they will communicate that to me, to the physician, and after following all the steps together we feel like the decision is the most appropriate based on the goals, preferences and values. There were a lot of different decisions that can fall into this. Shared decision-making process. An example of one would be choosing versus therapeutic options and management options for food allergens. Avoidance, oral immunotherapy, Omalizumab. The future will bring even more of these into play. I have listed some of the considerations and discussion points we can bring together with patients. Another example would be discussing a high versus low dose OIT and I presented a lot of the data available discussing this. It’s important to remember that your goal, the patient’s goal is the one that is going to determine which option you choose. For those who are only interested for protection from accidental exposure, it reduces the chance of accidental exposures. For those aiming for free diet, we’re looking more for sustained unresponsiveness and remission. This is a different conversation and the steps that need to be taken in the clinic are quite different. I have included this reference. The study that gave us some information about a reduction of risk to accidental exposures in terms of high-yield threshold changes after therapy. To round this up I need to remind everyone that when we are making decisions about food allergen management it is not all targeting therapy. Of course therapies are a big part but there are other decisions that involve management that are associated with food allergies. For example, what to do if you have an Apple elected reaction — an anaphylactic reaction. This comes out of the update of the anaphylaxis parameter, then excellent document I encourage everyone to read. It actually comments on the need for activating emergency services in an episode of enough Alexis — anaphylaxis. Looking at episode related factors, is there a prompt response to a single dose of epinephrine? Is there complete resolution of symptoms following the single dose of epinephrine? What about other factors like does the patient have immediate access to more than one dose of F and Efrin? — epinephrine? Do they have a good understanding of when epinephrine should be used and what the benefits are when using it early? Is there immediate access to other people who may provide help? These are very important factors to consider when discussing activation of the emergency services for anaphylaxis. We have learned a lot and during the COVID-19 pandemic we were member how the patient did not want to activate emergency services, did not want to go to the emergency room. A lot of that experience has informed our most recent conversations and also the updates in the anaphylaxis parameter. In conclusion, the landscape of food allergy management has changed significantly over the past three years. There are different options now available. Those options can often be confusing for patients. I haven’t asked recently if, for example, the new biologic can be taken orally. It is not necessarily intuitive and don’t always be certain people are receiving the correct information.

There is a lot of misinformation out there that we need to tackle successfully. We are the ones as allergists that have the evidence that can actually cancel outpatient — out patients based on it. I cannot really stress this enough. We don’t give the same judgments to all of our patients. We give them the same options available but what they decide to do a be very different. The other ones that are going to guide us towards a final decision that reflects their values and priorities. In terms of unmet needs and future research, I am sure we can find a lot more than what I have put here. I just wanted some examples. I think we would all benefit from head-to-head studies that will examine efficacy and safety of different therapies. I would love to see some of those. I would like to see some larger studies which include diverse food allergy populations so that we can have much better insight into individual management. We can’t really make assumptions about a lot of these things. We may think patients require option A, but then we find out that actually that was not true . I think a lot more research is required in this space and will definitely be welcome. I would love to see studies that are focused on patient reported outcomes. Again, most studies are looking at efficacy and safety. Those two are stream the important. We still need to look at them. Patient reported outcomes are also key. This is something that only they can report to us. They only come from them. We cannot guess, cannot assume. Thank you very much for listening to me. Thank you for your attention. I am not very happy to answer any questions and the remaining time. Thank you.

Catherine: Dr. Anagnostou, we have a lot of questions that I’m not sure we will be able to get to them all by 1:00 but we will do our best. The first question was asked. Excuse me. What is the feasibility of doing PNET OIT — peanut OIT when the child vomits peanut butter?

Dr. Anagnostou: None. I can answer that in one word. This is a case where you’re looking it individualized management. If the patient has a taste aversion to the food, they will not eat it. You are not going to force-feed them even if the parents may offer. I have had that offer in my clinic as well. I immediately said no. You have to look at the patient factors. That was part of the decision-making. If you have a picky eater, if you have a child with severe taste aversion or any kind of limitation to digesting food than pursuing oral immunotherapy would not be the right choice at that point in time to put it mildly.

Catherine: OK. If a person is desensitized to one allergen does that bode well for successful OIT for other foods to which a child is allergic?

Dr. Anagnostou: Excellent question. We have looked into what we call cross decentralization. There are certain foods that share common proteins and common allergens. For example, tree nuts. There are common proteins shared among different tree nuts. We all know that patients who are allergic to cashew, a lot of times, although not always or also allergic to pistachio. Same for walnut. We call that cross-reactivity. For therapies we are reversing that term to cross desensitization. There have been oral immunotherapy studies have looked into desensitizing people to cashew. They find the majority are also desensitized to pistachio. There is this part of the question where foods that are closely related botanically can be cross desensitized. In terms of desensitization to irrelevant foods, when you do oral immunotherapy to peanut you are not going to cross desensitized anybody to milk. The foods are not related botanically. It is unlikely you will see that effect. They will also be no indication as to how successful the OIT is going to be in those very different foods. What I have to say however is that the efficacy of oral immunotherapy is pretty high. Looking at research studies, the percentages are almost always above 60% to 70% to any kind of food. When looking at multi-food studies with multiple foods given concurrently, the rates are equally high. Generally, it works and it works from a variety of different foods. I hope that answers the question in a different way.

Catherine: OK. How should eggs be introduced to infants? If a sibling is alerting to peanut or egg, are there guidelines to counsel the family?

Dr. Anagnostou: There is a lot of information nowadays from both the AI and college. There are leaflets you can print out to handier patients. I’m assuming the question refers to potential cross contact or cross-contamination of surfaces when there is already a child in the house that is allergic to one of those food allergens. I know there are a lot of fears surrounding this but I always tell me families that they can wipe down surfaces quite successfully just using water and soap, therefore avoiding this type of cross contact or cross-contamination. Other safe approaches like there is a five-year-old allergic tag. Now the family has a new infant they want to introduce egg. They can probably do that and introduce boiled egg to to the infant. They could choose a time with the other child is out of the house of they are so incredibly worried, although I don’t think that would be necessary. It is of incredible importance to do early allergen include introduction. I encourage all families to do it. There are multiple practical ways to overcome these barriers.

Catherine: We are just at the top of the hour. We don’t have time for any more questions. Thank you Dr. Anagnostou. This has been so informative. Just a close, join us next month on June 12 at 4:00 p.m. Eastern standard Time. We will welcome a doctor to discuss the relationship between atopic dermatitis and allergies. You will receive an evil from Zoom — and email from Zoom with a recording and valuation and supplement resources. Thank you again for joining us. From all of us at Allergy & Asthma Network, join us as we work everyday to breathe better together. Thank you. Have a good one.