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After treating nearly 700 food allergy OIT patients, a common theme during initial office visits surrounds not just safety but the “risk of reactions” during OIT. Many parents state their child has not had anaphylaxis for years. Others will say reactions occur regularly. Some parents say their children’s allergy testing done at an outside allergist’s office labels them as “high risk” for reactions. This leaves a lot of uncertainty in the discussion.

My discussion with patients and families focuses on the TPIRC model of OIT. The comprehensive nature of analysis not only involves elaborate allergy testing. It also involves a clear evaluation of all allergic systems of the body.   These systems involve the skin, the blood vessels, the lungs, the heart, the liver, and more. It is most important to evaluate all these systems due to the involvement of these systems during different types of allergic reactions. But while all systems are critical, the lungs are one of the most important.

As a board certified pulmonologist, my bias toward excellent lung function prior to starting OIT is based on evidence. A large Australian study published in 2014 brought to light the risk factors of reactions during allergic food exposure. The study, entitled: Safety and clinical predictors of reacting to extensively heated cow’s milk challenge in cow’s milk-allergic children., sought to define the clinical “risk factors” of children allergic to milk who were about to undergo a baked milk challenge. 71 children with confirmed milk protein allergy were set to undergo a baked milk food challenge. Keep in mind the baked milk challenge is not done all at once. It is done in a graded, staged fashion over hours of time with small incremental dose increases. Of the 71 children tested, most passed (51 total, 73%). Of the 27% who did not pass, 4 children actually needed an epinephrine injection to rescue them.

This Australian group studied these 27% who did not pass by comparing them to those who passed and discovered the top “risk factors” associated with having an allergic reaction during food dosing:

  • Any history of asthma, especially asthma requiring preventer therapy (inhaled steroids, singulair)
  • IgE-mediated clinical reactions to more than 3 food groups (separate groups ie nuts, milk, peanut)
  • A history of cow’s milk reactions consistent with severe anaphylaxis

What is the take away message?

If you are considering OIT and your child has the “risk factors” mentioned above, do everything possible to control the lungs before and during treatment. The TPIRC model not only deploys state of the art lung function testing including complete body plethysmography, forced oscillation testing, exhaled nitric oxide and lung clearance index testing. The TPIRC model of OIT ensures patients undergoing OIT are maintained at a normal to super normal level of lung function.

The questions brought forth by this study need to be studied clearly in OIT patients. TPIRC and its OIT model is actively studying these clinical questions and looks forward to publishing its data in 2016.

 

Inderpal Randhawa, MD

 

Reference:

Ann Allergy Asthma Immunol. 2014 Oct;113(4):425-9. doi: 10.1016/j.anai.2014.06.023. Epub 2014 Jul 22.

 
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The Patch vs. TPIRC OIT Model: The Difference is Clear

Patch vs TPIRC OIT (2)
Phase IIB VIPES (Viaskin Peanut’s Efficacy and Safety) trial was conducted in 221 peanut allergy patients (6-55 years with 113 children, 73 adolescents and 35 adults).  The goal of the trial was to see if after 12 months of a “patch” placed on the skin daily, the patient would be able to eat more than 1000 mg of peanut protein or 10 times their baseline dose which made them have anaphylaxis.  The patch started at 50 micrograms then increased to 100 micrograms and finally 250 micrograms.  50% of the patients utilizing the highest dose patch reached the “goal” compared to 25% in the placebo group.  6% of patients dropped out.  No major adverse events were reported.  No epinephrine was used during patch treatment.

To the credit of the company, the study was conducted safely.  However, taking a closer look at the numbers, the graph above shows out of 221 patients in treatment, only half actually reached any benefit.  Of the half who reached a benefit, only a total of 28 patients were able to actually tolerate over 1000 mg of peanut protein.  The Phase III study is planned.

The arguments for the patch:

  • It is on the skin and poses little risk
  • It can be used at a young age
  • It has some effect on the immune system’s “view” of peanut protein

The arguments against the patch:

  • One year of treatment is lengthy
  • Only half the patients receive any kind of “safety” benefit.
  • Even the half who receive the safety benefit, many of them cannot eat over 1000 mg of peanut protein (or 4-5 peanuts)
  • What happens when they stop using the patch? Will just eating a certain “amount” of  peanut continue to help with protection?
  • Is there any long term immune system benefit toward tolerance?

While it looks promising, the details provide the real specifics.  Oral immunotherapy (OIT) utilizes much higher doses of peanut protein.  In fact, unique from any other model of OIT, the TPIRC model is able to treat peanut allergy patients and eventually achieve a very high dose of protein (15,000 to 30,000 mg dose) by mouth safely.  Instead of receiving treatment for one year, patients here receive treatment over 6-12 weeks.  The TPIRC model of food allergy OIT allows the ultimate dose to be safely eaten intermittently typically once every week to monthly.  By achieving these doses, the immune system food allergy profile of each patient shows dramatic shifts toward long term desensitization, clear safety, and free eating of peanuts.

 

The medical information on this site is provided as an information resource only, and is not to be used or relied on for any diagnostic or treatment purposes. This information does not create any patient-physician relationship, and should not be used as a substitute for professional diagnosis and treatment. We expressly disclaim responsibility, and shall have no liability, for any damages, loss, injury, or liability whatsoever suffered as a result of your reliance on the information contained in this site.

 
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Exercise Induced Anaphylaxis:  What To Know?

by Dr. Inderpal Randhawa, M.D.

Screenshot_2015-10-02-13-19-01 (2)Anaphylaxis from all causes impacts over 3 million Americans annually.  The most common cause of anaphylaxis involves the most common food triggers- milk, egg, wheat, soy, tree nuts, peanut, fish and shellfish.  Other triggers include medications, contrast dye, non-steroid anti-inflammatory drugs (NSAIDs), and other causes.  A very rare but interesting form of anaphylaxis is termed exercise induced anaphylaxis.

Exercise induced anaphylaxis has been described for decades.  It involves a patient eating foods like wheat or celery and typically one hour after ingestion with moderate exercise resulting in anaphylaxis symptoms.  The symptoms can be as mild as fatigue, red skin, lightheadedness, and throat tightening.  Symptoms can progress to life threatening anaphylaxis.  The causal relationship of the reaction is unclear.  The reaction is likely related to histamine release from mast cells and basophils primed by the food allergen exposure.

When should a parent be concerned about exercise induced anaphylaxis?  If a child, especially a teenager, notices a reduction in exercise tolerance after a new food exposure, it is worth a discussion with your primary care doctor.  It may be appropriate to perform food allergy testing and an exercise cardiopulmonary challenge to make the diagnosis.

An important note for OIT patients:  the reason most clinicians recommend a rest period after food dosing is due to the risk of a similar reaction described above.

 

 

 

The medical information on this site is provided as an information resource only, and is not to be used or relied on for any diagnostic or treatment purposes. This information does not create any patient-physician relationship, and should not be used as a substitute for professional diagnosis and treatment. We expressly disclaim responsibility, and shall have no liability, for any damages, loss, injury, or liability whatsoever suffered as a result of your reliance on the information contained in this site.

 
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Running Track with Exercise Induced Anaphylaxis: One Doctor Turns a Passionate Goal into a Reality

by DeeDee Riley

Screenshot_2015-10-02-13-30-12 (2)Kayla was in first grade when she first started running track. She was seven and loved to run. Her little legs moved so fast, and she was in the youngest age group. Her cheeks would flush and become spotty after each time she ran. There were times she complained of stomach cramps. Anyone who runs knows that a great run usually consists of stomach cramps and vomiting when you are getting conditioned. I thought this was what was happening – her body was conditioning and she was having physical symptoms.

In between her first and second grade years, Kayla began having struggles with her medical issues. She put on weight from the medications and we had a few challenges. When it came time to run track, I assumed her nausea, flushed cheeks, and weakness were due to lack of conditioning. I thought she just needed to push through and eventually her body would follow suit.  I had no idea that these symptoms she was experiencing were life threatening and a warning sign that anaphylaxis was fast approaching.

During one of Kayla’s visits with Dr. Randhawa, her symptoms were brought up. I thought maybe he would be able to help us condition her in a way that was more comfortable, given all of her other medical conditions. What he said shocked me, “I think she may have exercise induced anaphylaxis, and we need to test her.”

I can remember thinking, “Anaphylaxis caused by exercise. How is that possible?”

Dr. Randhawa challenged her system with an exercise test. Only 2 minutes into the test, her heart rate raised and her blood pressure dropped and separated. The test was immediately stopped. What Dr. Randhawa had suspected was quickly demonstrated during the exercise test – Kayla has E.I.A. (Exercise Induced Anaphylaxis). She was told she could not run. Kayla was devastated.

Dr. Randhawa is unique in the manner with which he handles his patients. He recognized Kayla’s devastation and put a plan together to get her back on the track. We experimented with two different medications – midodrin and cortef. Kayla was also told she no longer could eat wheat or celery – as both of these foods enhance E.I.A.  With time, everything became balanced enough for her to begin running again.Screenshot_2015-10-02-13-04-12 (2)

Kayla wore a heart rate monitor while she ran, I had a blood pressure cuff with me at all times, and her EpiPens were always within a few feet of her. The coaches and parents on her school track team were incredible. It was this village of people who allowed her to run. They were taught about her symptoms and trained on what to do if they arose. Kayla was taught to constantly check her heart rate monitor and maintain a certain reading.

As her mom, it is terrifying placing my child in a situation where anaphylaxis can occur. Knowing that running stimulates an anaphylactic reaction, and I am allowing the situation is challenging. Dr. Randhawa provided numerous resources to help us learn and understand this condition. Yes, it is life-threatening.  However, when E.I.A. is treated correctly, monitored safely, and challenged in a controlled setting prior to team runs, it is a condition that can be managed. Though extremely rare in children, and lacking in protocol for them, Dr. Randhawa knew what to do and how to keep her running. Instead of crushing her spirit and keeping her off of the track, Dr. Randhawa found a way for Kayla to continue doing what she enjoyed.

Kayla is now twelve. What felt like a long journey, began six years ago, half of her lifetime. E.I.A is a scary, life-threatening diagnosis. However, with the right physician and plan in place, exercise does not have to be stopped, just modified with safety precautions. We are so thankful that Kayla can continue doing what she loves!

 

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Our OIT Superhero

by Pujal Patel

Aanya Photo 2Aanya was born with a milk allergy. Barely a day old in the NICU, a nurse fed her cow based formula and she started projectile vomiting.  She was JUST A NEWBORN! It took us a few days to figure out that the issue was milk, not overeating! We came home with a newborn and advice to breast feed only, no milk based formula.

At 9 months old, our pediatrician asked us to ‘try’ some yogurt.  One lick resulted in full body hives, severe GI upset and fussiness for days. After being referred to an allergist, she tested positive for milk and nut allergies (we were already avoiding nuts due to her older sister who had multiple nut anaphylaxis).  We were sent home with epi pens and advice to avoid her allergens (which were everywhere!!!).

Aanya was two years old when, at the touch of chickpea chutney, she went into anaphylaxis. She had major GI distress, hives all over her tiny body, facial swelling and was struggling to breathe. I will never forget her frantically clawing at her chest with her tiny little hands. An EpiPen saved her life!

That night I knew we couldn’t keep our kids alive just by avoiding their allergens; danger lurked around every corner no matter how hard we tried. That was the darkest night but fortunately a light came on in the form of Dr. Inderpal Randhawa. I was full of hope for the first time when I walked out of our consultation appointment. After running comprehensive tests, Dr. Randhawa put Aanya on SLIT (Sublingual Immunotherapy) which greatly helped as she also had a history of asthma attacks every 3-4 weeks. Her asthma usually ended up in nebulization, steroids and lots of urgent care and doctor visits.

We then embarked on our OIT journey with milk, followed by almonds, pine nuts, pistachio, cashew, macadamia, and pecans. We will soon be working on the remaining tree nuts, peanuts and chickpeas!!

We cannot thank Dr. Randhawa enough! We were barely surviving and now we have this new life, full of freedom, just like childhood should be!! He is our SUPERHERO!!!

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It’s National Peanut Day:  Time to Understand the Anatomy of Peanuts

Why is it important in general to understand the inner “workings” of various nuts?

All nuts are composed of many components or subparts.  The most common parts are fats, carbohydrates, vitamins, minerals, water and protein.  When it comes to peanut food allergy, the protein is the most important part.

Why is knowing the subparts very important in OIT?

It is very important to know the subparts of peanuts in OIT to better understand dosing.  When a patient is able to eat one peanut, what does that really mean?  It means how much actual “food allergy molecule protein” is that child now eating.  This is particularly important when understanding the concept of safety.

For example, if a patient can tolerate 8 peanuts daily after being treated with OIT, can the patient safely eat more than 8 peanuts at any time?  The answer lies in that patient’s immune system response to OIT.  If the patient has demonstrated improved clinical markers of sensitization and clinical evidence of tolerating high doses of peanut, the question of safety is answered more scientifically.

What are the different types of peanuts?

Peanut Comparison

There are several types of “typical” peanuts in the United States.  Please keep in mind species of peanuts in China, India and Africa have different protein structures and weights than US based peanut products.  The most common US peanut is the runner peanut.  It is available at any grocery store.  Since each type has different weights, it is important to discuss the properties of these peanuts with your allergist when deciding how much of which peanut to consume during maintenance.

How much protein is in one peanut?

On average, 10 grams of peanuts are used to pass a food challenge in any standard allergy practice office.  This is deemed a “pass” for non-allergic patients.  10 grams of runner peanuts equals 18-20 peanuts daily.  However, this is the total weight of the peanuts.  How much actual protein is in the 18-20 peanuts?  It depends on whether the peanuts are heavily roasted or not roasted at all.  If it is unroasted, the protein count ranges from 5-6 grams.  If it is heavily roasted, it can range from 4-6 grams.

Of greater interest is what amount of protein actually contains the high anaphylaxis risk epitope sequences of Ara h1, Ara h2 and Ara h3.  Early experiments to purify this protein resulted in some approximations of the dosing.  However, an exact amount of how much of these epitopes is unclear.  The likely percentage ranges from 5-15% of the total protein is comprised of the high risk sequences.

Why do the number of maintenance peanuts matter?

Based on the last question’s response, everyone’s immune system responds to peanut protein differently.  Some may respond very quickly to OIT and their maintenance dose can be 20 grams every month in order to successfully maintain a “sensitized” immune system.  However, others may need to eat 10 grams every day to maintain the same sensitization.

Again, the anatomy of the peanut is important.  It contains complex subparts of which the protein is most important.  Specific epitopes of the protein are of even greater importance for food allergy dosing and safety.  One goal of research at The Translational Pulmonary & Immunology Research Center (TPIRC) is to better study and define the anatomy of peanut protein responsiveness in order to fine tune each patient’s maintenance dose to ensure maximal safety and simultaneously ensure maximal long term benefit.

Inderpal Randhawa, MD

Chief Medical Officer, TPIRC

 

References:

U.S. Department of Agriculture, Agricultural Research Service. 2013. USDA National Nutrient Database for Standard Reference, Release 25.

10.4049/​jimmunol.169.2.882.  The Journal of Immunology July 15, 2002.  vol. 169  no. 2  882-887

 

The medical information on this site is provided as an information resource only, and is not to be used or relied on for any diagnostic or treatment purposes. This information does not create any patient-physician relationship, and should not be used as a substitute for professional diagnosis and treatment.

We expressly disclaim responsibility, and shall have no liability, for any damages, loss, injury, or liability whatsoever suffered as a result of your reliance on the information contained in this site.

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JUST DON’T EAT IT!

by Leah Roffman

We have all seen the stereotypical portrayal of the allergy and asthma nerd. While I am proud to call myself a nerd, I take issue with the often weak, unpopular and uncoordinated caricature of the allergic and asthmatic child. I have carried the diagnosis of Food Allergies, severe Asthma, and Inflammatory Disorders my entire life. Contrary to the usual portrayal, I believe that the trials and tribulations of navigating a poisonous world has made me stronger.

Many of the less empathetic (let’s call these people “insensitives”) insist that severe food allergies are the same as the Pollen sniffles they get every spring. Much of the world remains misinformed about the dangers of anaphylactic allergies. As a result of this ignorance, insensitive people refuse to limit their consumption of airborne allergens in public places. Consequently, while advocacy and food allergy awareness remain near and dear to my heart, I realize that it is equally important to move swiftly toward the eradication or at least suppression of life threatening allergies.

Many people in my life would actually advise me …so if you’re allergic to it, just don’t eat it and you should be fine – those people completely ignoring the literature proving that many food allergies are airborne.  Once the allergens reached my body, whether through my mouth, my skin, or my nose, they caused a cascade of systemic reactions. The inflammation caused by my intense reaction to these microscopic molecules of destruction caused my body to be rapidly overwhelmed by itching, swelling, sneezing, coughing and worse.

After many emergency room visits, steroids, prolonged school absences and accompanying social consequences, my medication list kept growing.  One night, in middle school, I went to see the Harry Potter Midnight Premiere with a friend at which time something in the theater caused a severe allergic reaction.  The emergency room took a CT scan of my lungs which showed some nodular changes.  At that time my family decided that I could never recover in Michigan with the allergens and severe weather changes.  We picked up and moved to California in time for my first year of high school.

Unfortunately, things got so bad with my asthma that my immune system was beat. I was hospitalized with H1N1 my first week of high school. I was on IV Steroids and oxygen for a week and continued steroids for the better part of my first semester of school.  The steroid weight gain caused problems with my confidence as I had been a physically fit dancer up to that point.

I was allergic to Eggs, Nuts (peanuts and tree nuts and every cousin of legumes such as beans) and Fish (finned fish and shellfish). I was airborne. I couldn’t be within 10 feet of Nuts or Fish or I was at risk of anaphylaxis. The enemy was literally everywhere.  

By way of example:

– I went to Epcot with my family one year when they had Walnut trees on the grounds.  I broke out into hives 5 minutes inside the park.

– When I went to the movies we used to bring a towel for me to sit on so my skin never touched the seat.

– I’ve never been to a baseball game.

– I sat at a special table at lunch accompanied by a recess monitor to make sure I was safe-every single day of elementary school.  

– I was not allowed to play outside at recess during most of the winter due to my asthma.

– My first boyfriend had to give me a rundown of every food and beverage he consumed for the day if he intended to kiss me.

– I could only go to a few restaurants after the menu was checked out and with the clear understanding that they would cook in areas that were not cross contaminated.

– I could not get my hair washed or styled in a salon since we didn’t know if there were nut oils in the products. (Or manicures)

– My teachers had to physically carry a hip pack with EpiPen, liquid Benadryl, and inhaler– from room to room since I couldn’t have it too far away.

– My parents donated massive quantities of wipes to the school so that after lunch all hands could be wiped under supervision.

– My only camp experience was at an air conditioned dance camp. They went out of their way to keep allergens away from the camp. Nevertheless, my parents brought every single piece of food that I ate for the week

– I never got to ride the bus to field trips with the rest of the children. It was too much risk that someone would have an allergen aboard and there was no adult available to medicate me.

– My favorite game in high school was “Never Have I Ever” because of all the things I couldn’t eat or do.

Eventually, my body got so hyper-allergic to everything that I actually developed an allergy to cockroaches, which are often found in public high schools in California. I would develop a sandpaper rash as soon as I entered my high school campus.  I started an online program for my last two years of high school because I couldn’t stay in a public school with cockroaches and peanut dust.

The treatment was often isolating. I had recurrent pancreatitis from so much steroid use.  I was in such a dark place at that time. My illnesses were a source of stress at school, in dance class, and in my social life. I was depressed, I felt alone.

When I was 16, I was seeing a neurologist for severe migraines. A mother of another patient referred my mother to a specialist by the name of  Dr. Randhawa. We didn’t know it then, but that little business card was the start of the rest of my life.

When my parents took me to Dr. Randhawa, I was angry, depressed, and very skeptical. Every so called “specialist” I’d seen in California had failed me.  I was hostile and not very nice to him the first visit.

In spite of my negativity, the doc immediately started trying out different treatments and ordering tests. As we started to focus my issues, the doc started me on a new drug that he thought would help with the pain and help me get back out into the world.  I started sublingual immunotherapy (SLIT) for the environmental allergens.  As I started to improve, we realized my asthma was still causing more problems.  Dr. Randhawa suggested an injected drug that would help the allergic asthma…adding that it might also be helpful in reducing many of my allergies. I thought he was crazy.  Nevertheless, I agreed to the injections and improved dramatically.  With that success, Dr. Randhawa started to educate my family on the options of Oral Immunotherapy.  

Initially I refused, explaining that he previously described my food allergies as “off the charts” and “some of the highest test results he had seen”, and now he wanted to start feeding me the things I was allergic to? I wasn’t going to let that happen, and neither was my mom. He patiently explained in more detail his procedure (for more information on OIT treatment click here). We decided to try it.  I am so happy about that decision.

Fast forward 4 years:

– I’m a Sophomore in college (I got a 4.0 last semester).   

– I’m on the speech and debate team.   

– I feel free to go where I need to and do what I need to without the constant fear of death by lunch.

– I’m eating as many eggs daily as I please, a peanut butter and jelly sandwich every night, and every type of nut out there is A-OK.

– I can go to restaurants and Disneyland and Comic Con all by myself without worrying that something terrible will happen.

My world has completely changed from the young, fear-filled, little girl I was my entire life. I’m not ruled by my illness. The world is out there and I am ready to embrace it.

 

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