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Allergy, Asthma & Food Allergy Centers COVID-19 Update 3/18/20

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Dear Allergy, Asthma & Food Allergy Centers Patients and Families,

Our professional societies released COVID-19 Pandemic Contingency Planning for Allergy and Immunology on Tuesday, March 17, 2020. We are implementing these guidelines in order to continue providing essential medical care for our patients while keeping our community safe. As the virus spreads through our community, social distancing remains one of the centerpieces of prevention. Therefore, we are looking to minimize the amount of time patients may have to spend outside the home and are instituting the following:

 

  1. All food challenges and oral immunotherapy (OIT) new starts currently scheduled through April 3, 2020, will be rescheduled. Our staff will be contacting families regarding this, so there is no need to call our office at this time.
  2. All OIT dose escalations (updosing) currently scheduled through April 3, 2020, will need to be rescheduled. Our staff will be contacting families regarding this, so there is no need to call our office at this time. However, if you need more capsules, please make sure to inform the staff member who calls.
  3. Patients currently on allergy shots may continue to receive their injections. However, if you have been building up once weekly, you may start coming every 2 weeks for your buildup phase. If you are currently on maintenance dosing receiving injections every 2 or every 3 weeks, you may increase your interval to every 4 weeks. In the spirit of social distancing, if you have flexibility, please try to avoid any peak times to minimize the number of people in the waiting room. We have decreased the seating capacity in the waiting room. However, if you are uncomfortable coming into the office, you may skip injections during this period of social distancing.
  4. If you are on biologic injections (ex. Xolair, Nucala, Fasensra), you should keep your appointment as long as you are not acutely ill with any type of infection.
  5. Anyone who is currently scheduled for a new patient office visit through April 3, 2020,  will have the option of converting the in person office visit to a telemedicine visit or rescheduling the in person visit to a later date. The cost for the telemedicine visit will be $200 for the new patient appointment. We will collect payment at the time of service. Please contact your insurance company to see about reimbursement for your out of pocket costs.
  6. Anyone who is currently scheduled for a follow up visit through April 3, 2020, will also have the option of converting the in person office visit to a telemedicine visit or rescheduling the in person visit to a later date. The cost will be $50-$100 out of pocket depending on the complexity and duration of the telemedicine visit. This amount may be less than an in person office visit copay for some patients depending on their insurance.
  7. If you are having acute environmental allergy or asthma symptoms, please contact the office to schedule an acute telemedicine visit with one of our providers.
  8. If you are ill with fever, cough, and shortness of breath, have any possible COVID-19 exposures, or have traveled (domestic or international) in the past 2 weeks,  please do not come to the office. If you suspect you need testing, please check with the following screening resources:
    1. MO hotline:  877.435.8411
    2. IL hotline:  800.889.3931
    3. Mercy screening:  314.251.0500
    4. SSM Virtual screening:  www.ssmhealth.com

 

For more information regarding COVID-19, please see the CDC website: http://bit.ly/CDC-COVID-19_info 

We as a practice will continue to follow the precautionary measures recommended by the CDC and our professional societies to keep our office as safe as possible for our patients, families, and staff. Please continue to monitor our Facebook page for updates. Thank you for your understanding and continuing to partner with us to improve health outcomes. Working together in our local community and as a nation, we will overcome this crisis. Stay safe and healthy.

Singulair (montelukast) Black Box Warning

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On March 4, 2020 the U.S. Food & Drug Administration (FDA) decided to add a “Boxed Warning” to the oral medication montelukast (brand name, Singulair) due to an elevated concern regarding the risk of neuropsychiatric events, including suicidal thoughts and actions. Because of this new warning, the FDA is now recommending that montelukast only be used to treat patients with allergic rhinitis and asthma that do not tolerate or do not respond to alternative medications.

Montelukast is a leukotriene receptor antagonist that has been used to treat patients with asthma, allergic rhinitis and other conditions such as chronic urticaria (hives) since the drug was approved in the U.S. in 1998. There were no major reported safety concerns with this drug until 2007, when the manufacturer of Singulair updated the prescribing information and patient information to include post-marketing adverse events such as behavior/mood changes (i.e. agitation, anxiety, depression) and suicidality (suicidal thinking and behavior). 

Data collected by the FDA between 1998 and 2019 through their Adverse Event Reporting System identified 82 cases of completed suicide in patients taking montelukast, with 19 cases in patients under age 18. Interestingly, further data from the FDA’s Sentinel System collected between 2010 and 2015 did not show an increased risk of neuropsychiatric events in approximately 450,000 asthmatics older than age 6 taking montelukast vs. inhaled corticosteroids. Other observational studies also did not find an increased risk of mental health side effects. That being said, the reports of suicide along with evidence that montelukast crosses the blood-brain barrier in animal models persuaded the FDA to strengthen their warning.

Our medical providers at Allergy, Asthma & Food Allergy Centers are dedicated to providing the best possible treatment options for our patients while also keeping their safety in mind. Although the overall prevalence of severe neuropsychiatric events including suicide appears to be extremely low given the number of patients in the U.S. taking montelukast, we understand that our patients and caregivers may be hesitant to start or continue taking this medication. If you are already taking this medication it is safe to stop immediately, if you are not comfortable continuing it. However, we strongly advise that you contact our office to schedule an appointment to discuss alternative treatment options. As with any medication, either prescription or over-the-counter, we are more than happy to discuss the risks and benefits with you. If you are not having any problems while on montelukast, it is likely safe to continue the medication.

Dr. Laura Esswein is joining our practice!

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A warm welcome by Dr. Vitale & the team at Allergy, Asthma & Food Allergy Centers:

Shortly after graduating from medical school and returning to St. Louis, a family friend recommended I connect with Dr. Laura Esswein. I was not particularly familiar with the field of Allergy/Immunology at the time. I called Dr. Esswein, having never met her. She generously allowed me to shadow her in her office. She took the time to teach me about the field. Invaluably, she also shared her experiences as a working mother and “woman in medicine.” Her example and mentoring stayed with me and were pivotal in my own decision to pursue Allergy/Immunology. It is a true honor to welcome Dr. Laura Esswein to our practice!

Dr. Esswein graduated from the University of Missouri School of Medicine. She completed her residency at St. Louis Children’s and her fellowship in Allergy/Immunology at Washington University Medical Center. She joins us after an illustrious 23 years with Mercy.

In addition to establishing herself as a leading Allergist/Immunologist in St. Louis, she and her husband have raised 6 children – two of which have followed their mother’s footsteps into medicine and one is in dental school.

She will be joining us this April. She will see patients in our Sunset Hills office and new West/Chesterfield office. We have a lot to look forward to!

FDA Approves Palforzia for Treatment of Peanut Allergy

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Our providers and staff at Allergy, Asthma & Food Allergy Centers are excited to learn of the FDA’s decision to approve Palforzia as the first “drug” for the treatment of peanut allergy, as this signifies greater acceptance of oral immunotherapy (OIT) as mainstream treatment for life-threatening food allergies.

Based on our 3+ years of direct experience treating peanut-allergic patients with OIT and the collective 10+ years of experience from other private practice OIT centers across the country, the safety and efficacy data of the Palforzia “drug” is comparable to our method of using readily available sources of peanut protein to perform oral desensitization. This is where the similarities end.

First, the highest treatment dose of Palforzia is 300 mg of peanut protein, about the equivalent of 1 whole peanut or 1/4 teaspoon of peanut butter. Thus, the primary goal of this drug is to raise the threshold of having an allergic reaction to an accidental ingestion of peanut protein (“bite-proof”), which in itself can be a remarkable achievement for peanut allergy sufferers. On the other hand, our protocol is designed to allow patients to reach a daily maintenance dose of 2000 mg (2 grams) of peanut protein, equal to 8 whole peanuts or 2 teaspoons of peanut butter. Furthermore, this maintenance dose actually allows them to safely ingest at least 6000 mg (6 grams) of peanut protein, equal to 24 whole peanuts or 2 tablespoons of peanut butter. This provides the majority of our patients the freedom to eat any amount of peanut protein they wish. That being said, each patient and family may have a different safety goal in mind, and our OIT protocol also provides the flexibility to achieve this goal.

Second, Palforzia is only approved for the treatment of peanut-allergic patients between the ages of 4 and 17 years. Our OIT program has no age limits. In fact, some of our most impressive outcomes have been seen in our infants with peanut allergy!

Additionally, there is no OIT “drug” close to FDA approval for the treatment of food allergies other than peanut. We currently have patients undergoing OIT for egg, milk, tree nuts, wheat, soy and sesame.

Finally, the company that makes Palforzia has set the annual price for their “drug” at $10,680 (or $890 per month) with no guarantee of health insurance coverage at this point. Our current OIT patients/families will spend on average less than $200 in total for peanut flour capsules supplied by a local compounding pharmacy. Beyond that, they are using store-bought roasted peanuts or peanut butter. Palforzia may simply not be a cost-effective option, especially for the level of protection it will provide for those with peanut allergy.

For those of you interested in learning more about all treatment options for peanut allergy, please call our office to schedule an appointment with one of our board-certified allergists. As always, Drs. Borts, Warrier and Vitale are accepting new patients in our main (Sunset Hills, MO) office. Furthermore, Dr. Palis primarily sees new patients in our Swansea, IL office, only 15 miles east of downtown St. Louis.

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

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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://aascare.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

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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://aascare.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

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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?

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Penicillin allergy has periodically been on the news- see video below. Penicillin Allergy Day is September 28, which is the day the Sir Sir Alexander Fleming discovered penicillin in 1928. Penicillin antibiotics are safe and effective. These important medications are often not used due to people having a diagnosis of penicillin allergy, and individuals with with penicillin allergy labels are at risk for suboptimal treatment with antibiotics, poorer clinical outcomes, drug-resistant infections, and adverse drug events. 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 incorrect labeling of penicillin allergy leads to the use of more expensive, more potent antibiotics. 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, 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

 

Updated 9/27/2021

Early Introduction of Peanut

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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 allergy– those 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 group– those 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!

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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://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.