Blog

Peanut oral immunotherapy (OIT)- one step closer to FDA approval

Many people or families affected by peanut allergy are likely aware that on Friday, September 13, 2019, an FDA advisory panel voted 7 to 2 to recommend Aimmune’s peanut oral immunotherapy (OIT) product originally identified as AR101 (now with the brand name Palforzia). Here is a link to a New York Times article regarding this. While the vote is non-binding, the FDA usually follows their advisory panel’s recommendation. If approved, Palforzia will be indicated as a treatment to reduce the incidence and severity of allergic reactions after accidental exposure to peanut in those aged 4 to 17 years of age with a confirmed diagnosis of peanut allergy. 

The data reviewed by the panel showed a 9.1% risk of anaphylaxis with Palforzia compared to 3.5% risk for placebo with dose escalations (updosing). There was an 8.7% risk of anaphylaxis with Palforzia compared to 1.7% risk for placebo while on maintenance dosing. Epinephrine use during dose escalations was 10.4% for Palforzia compared to 4.8% for placebo, and 7.7% for Palforzia compared to 3.4% for placebo while in the maintenance phase. 

Now let’s review the projected cost for the FDA approved product. Analysts have estimated the cost for Palforzia to be $4,200 a year for an individual patient. This is the cost of the standardized peanut flour alone and does not take into account the cost for office visits. Currently, the cost for peanut allergic patients going through our customized OIT program at Allergy, Asthma & Food Allergy Centers (AAFAC) is approximately $2/capsule, which would total $730/year IF TAKING IT DAILY FOR THE ENTIRE YEAR. As our peanut OIT patients know, if things are going smoothly, after approximately 16 weeks (112 day), our patients have transitioned to actual peanuts (sometimes this transition occurs sooner) for a cost of ~$224, which is obviously much, much lower than the cost of the “drug” Palforzia. Additionally, there is no recurring annual cost since patients are consuming regular store bought peanut products for their maintenance doses.  Some other practices just starting OIT this summer (2019) in the greater St. Louis area are taking another approach. Instead of billing insurance, they offer peanut OIT on a cash basis. At Allergy, Asthma & Food Allergy Centers, the typical expense to reach a maintenance dose is less than $2500, though this depends on an individual’s insurance plan (insurance companies set the amount for office visit copays and deductibles), so the out of pocket expenses could be significantly lower. Our practice goal is to ensure as much access to OIT as we can by making it as affordable as reasonably possible for our community. We know what it is like to have food allergies in our own families- the fear, the insecurity, the near constant worry when our kids with food allergies are in an environment we cannot control- which is the main reason we pioneered OIT in the St. Louis area. We have now expanded to Illinois to give even more patients and families suffering with food allergies additional options for treatment. Our office there is located at 510 Fullerton Road, Swansea, IL 62226.

So what exactly is the “drug” Palforzia (AR101)? While the FDA classifies it as a drug, it is basically standardized peanut flour in a capsule. The standardization is necessary for clinical trials and FDA approval, but there is no evidence that using Palforzia is superior to using regular peanut flour that is commercially available for OIT (as practices across the country have been doing for more than a decade). Nevertheless, we at Allergy, Asthma & Food Allergy Centers are very excited that at least some form of OIT will soon achieve FDA approval. This is a big step in giving more people a choice when it comes to managing peanut allergy, though as mentioned above, people in the greater St. Louis region have had the option of OIT through our practice since 2016, and we currently have patients going through OIT not only for peanut but also for cow’s milk/dairy, egg, wheat, soy, sesame, and tree nuts.

Oral immunotherapy is not for the faint of heart. It takes a lot of dedication and courage from patients and their families. While there are real risks, including both anaphylaxis, eosinophilic esophagitis, and lack of tolerability due to gastrointestinal issues for some patients, some of the concerns regarding anaphylaxis with OIT have been a bit sensationalized. The risk of having a serious reaction when purposely exposed to an allergen is of course higher than when trying to just avoid the allergen, JUST AS IT IS WITH ALLERGY SHOTS for seasonal/environmental allergens. However, both with allergy shots and with OIT, treatment is administered in a controlled fashion, so individuals know exactly what triggered the reaction and how much they consumed compared to accidental exposures to a food allergy. Many people have died from accidental exposures, but there are no known deaths in the U.S. associated with OIT. In fact, when a life threatening reaction occurs with OIT, there is usually an associated underlying circumstance (illness, exercise, hot showers, etc) that led to the reaction.

Going back to the example of allergy shots, you do not hear investigators, the press, or other individuals saying that allergy shots should not be administered due to the increased risk of anaphylaxis. There are generally risks with any form of medical treatment, but the potential improvement in the quality of life for an individual and family after either allergy shots (also done at AAFAC) or OIT can be HUGE, even LIFE CHANGING, as people who have been through these treatments in our office (and other places) can readily attest. While some investigators suggest that there is no evidence of an improved quality of life with OIT, we strongly disagree and address it in a previous post https://aafacenters.com/food-oit-and-quality-of-life/

Food allergy and OIT have become somewhat of a sub-specialty for allergists, and not all allergy offices will be equipped or even have an interest in offering this treatment. There are reasons for this, and this blog post from OIT 101 addresses this issue.

We at Allergy, Asthma & Food Allergy Centers look forward to continuing to partner with our patients and their families to improve health outcomes for environmental allergies, asthma, and food allergies! Thank-you for your trust and dedication!

 


Food OIT and Quality of Life

Recently, Chu et al published their analysis of randomized controlled trials of oral immunotherapy (OIT) for peanut in The Lancet. Their conclusions are worth reviewing, but it should also be made clear that at least one of the authors has long been opposed to OIT being available to the broader public outside of academic studies. You can read some of our thoughts on OIT and why academics do not approve of this treatment in of our older posts here- https://aafacenters.com/treatment-for-food-allergies-what-is-oral-immunotherapy-or-oit/

The recent analysis looked at 12 trials of 1024 patients who have gone through rigid controlled protocols for OIT and does not take into account the much, much larger number of patients who have successfully completed OIT through private practice groups such as The Food Allergy Center of St. Louis (division of Allergy, Asthma & Food Allergy Centers of St. Louis). To put this in perspective, our practice alone has over 90 patients on a maintenance dose of peanut OIT with over 80 active patients in the process of going through our customized peanut OIT program (more than 100 active patients if looking at all OIT foods), and THOUSANDS of individuals throughout the country have successfully completed OIT through private practice allergists. You can see the published data from the experience of private practice OIT allergists here- Private Practice OIT Experience.

The recent analysis determined that individuals treated with OIT have a higher risk of having food allergic reactions while actively going through OIT compared to those who just continue to strictly avoid the food allergen. This is not surprising, of course, since when someone goes through OIT, they are ingesting the food allergen and the main risk of OIT is having a reaction to that food.

The most interesting finding in the Lancet article is that the parents’ or individuals’ quality of life was not improved with OIT. While that may have been true for the people in those studies (possible reasons for this discussed below), at the Food Allergy Center of St. Louis, we know that OIT has had an incredible positive impact for patients and families with food allergies as well as ourselves. So how could the academic researchers find that OIT did not have an impact on people’s quality of life?

Here are some possible explanations.

  • Patient selection- The limited number of patients selected to go through OIT in academic studies may be different than people going through OIT in private practice. People may have different reasons to participate in a study versus going through active OIT treatment for themselves or their children. The OIT families in our practice are incredibly motivated to do what is best for their child and/or themselves. They are dedicated, cautious, and often very knowledgeable about OIT before they even come to see us.

 

  • People treated through academic OIT studies have to follow RIGID protocols that ARE NOT CUSTOMIZED to each individual. If someone going through an academic study protocol is having an adverse event (vomiting, abdominal pain, allergic reactions, etc), there are strict limitations on altering the study protocol. This is VERY different from our ability to tailor an OIT program for individuals with food allergies, especially when there are problems. This is also likely why the success rate of OIT from academic studies and from companies that are attempting to produce FDA approved OIT products are much lower  (<70% success) compared to our success rate (>85%). Our priorities are SAFETY and SUCCESS!

 

  • Approaches to OIT have changed since the initial OIT studies were done. So of course, if you include studies from over a decade ago, patients’ experiences from that time are likely very different than those going through OIT now, especially those going through OIT in private practice groups. We understand how to adapt and adjust therapy when there are any issues. We are also continually evaluating and re-evaluating our protocols to both standardize them while maintaining flexibility to customize them for each individual person in our OIT program.

 

We certainly appreciate the incredible pioneering work and time that academic researchers have invested into studying OIT. Their studies clearly show that OIT is very successful, which is why we and many of our colleagues throughout the world have dedicated themselves to bringing this life altering treatment option to those with food allergies.


Food Intolerances

There has been increasing concern regarding food intolerances over the past several years, and people are often confused regarding the difference between a food intolerance and a food allergy. Food allergies (especially the immediate type of food allergies of which most people are aware) can cause life-threatening reactions (anaphylaxis) while food intolerances are not life threatening. There are no standardized tests for food intolerances, and while companies may offer testing for food intolerances, no one actually knows what the testing means. These tests measure “IgG” antibody to foods and do not provide information about food allergies. Testing for “IgE” antibody to foods does provide information regarding food allergies.  With food allergy tests (as with most tests) there can be false positives, so these tests should never be done indiscriminately and should only be done under the care of an allergy specialist. In fact, avoiding a food that someone tolerates without any symptoms based on a positive “IgE” test alone can actually lead to the development of life-threatening food allergies, so allergists strongly advise against random food allergy testing. Since there are no standardized tests for food intolerances, and since most tests for food intolerances show many positive results that do not correlate with a person’s symptoms, the best approach for most individuals is to keep a food and symptom diary to help them determine if a food intolerance (again, not a food allergy) is triggering their symptoms.  Most patients who are healthy and have no symptoms will have IgG antibodies to one or more foods.  Our practice, Allergy, Asthma & Food Allergy Centers of St. Louis, has a very, very strong focus on FOOD ALLERGY but not food intolerances. When patients come to see us about food intolerances, we generally advise against any form of allergy testing.

 

Please follow this link to watch Dr. Vitale on the news from 2/27/19 discussing food intolerance.


Do you Truly Have a Penicillin Allergy?

Penicillin allergy has recently been on the news- see video below. Penicillin antibiotics are safe and effective. These important medications are often not used due to people having a diagnosis of penicillin allergy. While about 10% of the US population (~32 million people) think they have penicillin allergy, more than 90% of those individuals can take penicillins safely. The over diagnosis or incorrect labeling of penicillin allergy leads to the use of more expensive, more more potent antibiotics that can lead to increased side effects for those treated as well as increased bacterial resistance making it harder to treat serious infections. Risk for penicillin allergy can be broken down as follows:

  1. Low risk- those whose reactions have been limited to nausea, vomiting, diarrhea, or itching without rash as well as those who may only have a family history but no personal history of penicillin allergy. In addition, individuals who have a very distant history (over 10 years ago) or have had unknown reactions are also at low risk.
  2. Moderate risk- those who have had hives or other itchy rashes or other features suggestive of an allergic reaction
  3. High risk- those who have had anaphylaxis (life threatening allergic reaction), recurrent reactions to penicillins, positive testing, or multiple allergies to drugs related to penicillins

Evaluation by one of our board certified allergists can help identify people who truly have penicillin allergy. Here at Allergy Asthma Food Allergy Centers of St. Louis, we can help determine whether or not you or a loved one are truly allergic to penicillin through penicillin testing and or office based challenges to penicillin antibiotics. Contact our office to schedule an appointment.

Today Show Penicillin Allergy Story


Early Introduction of Peanut

Allergists have suspected for years that early introduction of foods likely decreases the development of food allergies. The LEAP (Learning Early About Peanut Allergy) study published in the New England Journal of Medicine in February 2015, definitively showed that early introduction and regular consumption of peanut (approximately 2 teaspoons of peanut butter 3 days per week) dramatically decreases the risk of developing peanut allergy by about 80%. Since the study was published, new guidelines were also released with the following recommendations:

  1. Children at the highest risk of developing peanut allergythose with severe eczema (atopic dermatitis) and/or egg allergy should have some form of testing to evaluate for the possible presence of peanut allergy. If testing is negative, home introduction or a supervised feeding can be done, and if the child tolerates peanut, they should regularly consume approximately 2 teaspoons of peanut butter at least three days per week. This process should start ideally between 4-6 months of age. If testing is positive, depending on the testing results and the comfort of the specialist, and office based food challenge to peanut may be done to determine if the infant is allergic before introduction at home is considered.
  2. Children in the moderate risk groupthose with mild to moderate eczema and no egg allergy should start consuming peanut (about 2 teaspoons) three days per week starting around 6 months of age. These children do not necessarily need testing before peanut is introduced, which can be done at home.
  3. Children at low risk for peanut allergy- those without signs of eczema and without egg allergy can start consuming peanut when age appropriate and according to family and cultural preferences.

While formal recommendation #3 does not stress early introduction, it is important to note that there is no real downside to early introduction, and delaying introduction even in those without eczema or egg allergy could potentially lead to an increase in developing peanut allergy compared to those who introduce early.

A question parents often have is how peanut can be introduced at home. The video below features Dr. Ruchi Gupta, one of the leading experts in food allergy, discussing home introduction of peanut. We hope you find this helpful!

 

 

 

If your infant or toddler is found to be allergic to peanut, do not despair. There is good recent evidence that early oral immunotherapy (OIT)/desensitization to peanut has very good outcomes (over 90% success rate when done correctly and carefully) and is safe. If you would like more information on OIT, see our Food Allergy Center of St. Louis page.


Allergy Asthma Food Allergy Centers of St. Louis- Our New Name!

As many of you know, our practice has a very large focus and significant expertise in food allergy- not just oral immunotherapy (“OIT”)/desensitization treatment for foods but also comprehensive management of food allergies.  We maintain our expertise in managing other allergic and immunologic conditions such as seasonal allergies, asthma, eczema, chronic hives, contact dermatitis, recurrent infections, and immune deficiencies. However, since treatment of food allergies has become a bigger proportion of our practice, we have decided to rebrand our practice with a new name that more closely corresponds with our mission statement.

Our mission is to use our expertise in allergy and immunology to improve the quality of life of adults and children through the diagnosis and management of asthma, food allergies, and allergic conditions.

We are thrilled to share with you our new name (Allergy Asthma Food Allergy Centers of St. Louis) and logos!

We also have a food allergy specific logo, which you will now find on our Food Allergy Center page of our website (http://www.aascare.com/our-services/food-allergy-center/).

We thank you for your continued support, and we look forward to continuing to partner with you and your families in pursuing our mutual goal, which is “FREEDOM FROM YOUR ALLERGIES”.


Sincerely,


Michael R. Borts, M.D.
Josie Vitale, M.D.
Manoj R. Warrier, M.D.

EpiPen and Mylan Generic Epinephrine Autoinjector Expiration Dates Extended for Some Lots.

Extended Use Dates Provided by Pfizer

Extended use dates to assist with EpiPen intermittent supply interruptions

[August 21, 2018] Due to the intermittent supply interruptions of EpiPen, FDA is alerting health care professionals and patients of updated dates through which some EpiPens and the authorized generic version, manufactured by Meridian Medical Technologies, a Pfizer company, may be used beyond the manufacturer’s labeled expiration date. To help ensure patient safety, these products should have been — and should continue to be — stored as labeled.

Based on stability data provided by Pfizer and reviewed by FDA, the following extended use dates are supported for specific batches indicated in the tables below. Patients that have the batch numbers below will be able to use them through the corresponding new use dates to help with supply. As data become available, this list can continue to expand.

FDA is not requiring or recommending that the identified batches in the following tables be relabeled with their new use dates. However, if replacement product becomes available during the extension period, then the agency expects the lots in these tables will be replaced and properly disposed of as soon as possible.

Please see the recent FDA in Brief for more information, and contact CDER Drug Shortage Staff at drugshortages@fda.hhs.gov with questions regarding these tables.

Epinephrine Injection, USP 0.3 mg Auto-Injectors
NDC 49502-102-02 appears on the box
NDC 49502-102-01 appears on the individual device within the box

BatchManufacturer’s Original
Expiration Date
New Expiration Date
(beyond manufacturer’s
original expiry date)
6FM7224/20188/2018
6FM7394/20188/2018
6FM7714/20188/2018
6FM7724/20188/2018
6FM7734/20188/2018
6FM7155/20189/2018
6FM7165/20189/2018
6FM7565/20189/2018
6FM7575/20189/2018
6FM7685/20189/2018
6FM7805/20189/2018
6FM7815/20189/2018
6FM7825/20189/2018
6FM7835/20189/2018
6FM7856/201810/2018
6FM7876/201810/2018
7FM1158/201812/2018
7FM1178/201812/2018
7FM1208/201812/2018
7FM1348/201812/2018
7FM1749/20181/2019
7FM1759/20181/2019
7FM27410/20182/2019
7FM27510/20182/2019
7FM27610/20182/2019

EpiPen® (epinephrine injection, USP) 0.3 mg Auto-Injectors
NDC 49502-500-02 appears on the box
NDC 49502-500-01 appears on the individual device within the box

BatchManufacturer’s Original
Expiration Date
New Expiration Date
(beyond manufacturer’s
original expiry date)
6GM4804/20188/2018
6GM4814/20188/2018
6GM5034/20188/2018
6GM5044/20188/2018
6GM5064/20188/2018
6GM5074/20188/2018
6GM5124/20188/2018
6GM6694/20188/2018
6GM5995/20189/2018
6GM6856/201810/2018
6GM7666/201810/2018
6GM7676/201810/2018
7GM0268/201812/2018
7GM0458/201812/2018
7GM0489/20181/2019
7GM0549/20181/2019
7GM1649/20181/2019
7GM1729/20181/2019
7GM1739/20181/2019
7GM2729/20181/2019
7GM19110/20182/2019
7GM20011/20183/2019
7GM20111/20183/2019
7GM20312/20184/2019
7GM20412/20184/2019
7GM21212/20184/2019
7GM21312/20184/2019
7GM36012/20184/2019
7GM36112/20184/2019

Midwest Food Allergy Conference, June 9-10

View full pdf here.

Midwest FACES Conference
June 9-10 • Chicago, IL

Please mark your calendars for the first-ever Midwest Food Allergy Conference for Education and Science (Midwest FACES) on Saturday, June 9th and Sunday, June 10th, 2018. This conference is hosted by the Science and Outcomes of Allergy and Asthma Research Program (SOAAR) at Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern Medicine.

Conference Details

Midwest FACES will bring together food allergy families, clinicians and key thought leaders throughout the Midwest region for two action-packed days of science, education, and engagement. Families who attend this conference will hear the latest research and advancements by top clinicians and researchers in the Midwest, connect with other families and build their network of support.

Additionally, at Midwest FACES, children with food allergies can find a supportive environment to connect with one another, and learn the latest research and techniques to help manage daily life with food allergies. Providing children with an opportunity to ask questions and engage with each other, clinicians, and researchers will empower them to better understand and manage their food allergy and build their network of support.

The Midwest FACES conference presents the perfect platform for exchanging ideas and creating connections among all dedicated stakeholders, in addition to learning the latest and greatest in food allergy research. Exhibitor booths will also provide an interactive, engaging space to connect food-allergic families with the industry leaders, including allergen-safe food companies and advocacy organizations- just to name a few!

Topic List

Midwest FACES will bring together food allergy families, clinicians, researchers and key thought leaders for two action-packed days that will include separate tracks for parents and children (ages 9+). Hot topics include:

  • Public Health Impact of Food Allergies
  • Diagnosis & Testing: What You Need to Know
  • Safe Food Ideas & Labeling Laws
  • School Issues: Plans, Policies, Peers & Pizza Parties
  • Microbiome & New Research
  • Immunotherapies & Emerging Treatments (physician presentations and panel with participating parents)
  • Latest in Food Allergy Prevention
  • Daily Life Tips to Reduce Stress & Anxiety
  • College Ready 101
  • Special sessions for asthma, eczema, environmental allergies and EoE
  • Plus, expert Q&A’s, vendor expo & interactive activities (live cooking, yoga demos and more!)

Cost

The Midwest FACES conference is free of charge for families and travel grants are available, as our goal is to have attendance without any cost barriers.

Website Information

To register for the conference and access more information, including an up-to-date agenda, please visit our website at www.midwestfaces.com.

I sincerely appreciate your time and consideration, and look forward to seeing your “FACES” on June 9th and 10th!