“Peanut allergy can have an adverse impact on quality of life for the child and family. Severe allergic reactions can occur with just a tiny ingestion of peanut allergen. A new NIH study provides encouraging news that children may be successfully treated with OIT for peanut allergy at a very young age.” – Lynda Mitchell, chief operating officer of the Asthma and Allergy Foundation of America

What health issue did the study examine?

We currently have no effective means to cure or treat food allergies. Families with food allergies must follow strict avoidance with constant observation and preparation for any accidental reaction.

Peanut allergy is a common food allergy among children and is usually life-long once acquired. Studies show that about 25% of children will outgrow their peanut allergy.

Peanut oral immunotherapy has garnered a lot of interest over the past several years. Oral immunotherapy (OIT) trials have showed some success in lessening the risk of a severe reaction, called anaphylaxis.

Most children have not been able to add their food allergen back into their diet without some restrictions.

A new study took a fresh approach to oral immunotherapy by studying this treatment in very young children for the first time.

What do we know about this issue so far?

Researchers around the world are trying different approaches to prevent food allergy or to cure it. Food oral immunotherapy (OIT) is one approach studied. OIT involves eating small, gradually increasing amounts of the food to which you are allergic each day, under very strict and careful supervision of a trained allergy specialist.

So far, OIT has shown modest success in selected people with peanut, egg or milk allergy. Data that OIT creates a permanent cure (called sustained unresponsiveness) remain limited. It remains unclear how OIT works or just how long the effects of OIT last.

What question did researchers try to answer?

The pivotal LEAP trial showed for the first time that early introduction of peanut to high-risk infants reduced the risk for development of peanut allergy. Researchers wonder if early use of oral immunotherapy could turn off peanut allergy after it has developed. Other questions are: How will young children, newly/recently diagnosed with peanut allergy, respond to OIT? Is OIT at this age safe, effective and feasible?

Whom did the study include?

For the first time, researchers recruited children less than 3 years of age to see if early use of oral immunotherapy could be more effective. They ranged in age from 9 – 36 months.

It is important to understand what children were included or excluded. This study did not enroll any children who had a life-threatening allergic reaction to peanut, wheat/oat allergy, severe eczema or severe asthma.

The study enrolled forty children. Three dropped out right away, leaving 37. An additional five withdrew during the study for a final total of 32 children.

All children had a food challenge at enrollment to prove they were allergic. That's important because testing alone sometimes will classify someone as being allergic, when in reality they are not. Having a positive food challenge makes sure that the child really does react to the food.

In this study, most children had eaten peanut previously and had a reaction, although no reactions were severe. A few children had peanut IgE levels indicating that they had allergy, although their parents denied that they had ever eaten peanuts.

The children in this study were almost all white. Most had other types of allergic conditions such as allergic rhinitis and mild to moderate eczema or asthma.

What methods did the researchers use?

All children first underwent an oral food challenge to see if they would react to peanut.
The researchers at the University of North Carolina at Chapel Hill then placed children into two groups:

• "High-dose" - meaning they ate a target daily dose of 3,000 milligrams of peanut protein.
• "Low-dose" - meaning they ate a target dose of 300 milligrams, mixed with 2700mg of filler.

Children received OIT for 29 months on average. Then they stopped the treatment for four weeks before adding peanuts back into their diet.

The children were compared with the medical records of children with peanut allergy from another site who did not get OIT. About 30% of those children were tolerating peanuts by the time they went to school. This shows that some children will develop tolerance naturally.

What did the researchers find?

At the end of the study, almost 80% of the study participants were able to eat 5 grams of peanut without developing an allergic reaction. There were no significant differences in the numbers of those children able to tolerate peanut between those who got the low-dose and high-dose peanut protein.

Side effects were noted in almost half of the children and mainly included stomach pain or other gastrointestinal symptoms like nausea or vomiting. Other side effects included skin or oral itching, nasal congestion, hives and rashes.

Five children from the high dose group did withdraw during the study. Side effects mostly occurred during the build up phase and most required no treatment, but when they were treated it was with minimal medicines, such as antihistamines.

One child developed a rather serious complication of eosinophilic esophagitis.

The rates of children developing side effects, and the recorded severity, were similar to past OIT studies.

Are there any limits to the study?

As with every study, there are always limits. For a parent trying to understand how this study may apply to their child, it is important to keep in mind that this is the first OIT study of its kind. It was conducted at one of the top research centers in the world for food allergy. These research centers tend to see more severe or atypical cases. These patients may differ to some extent than the “typical” patient with peanut allergy in the community. It is unclear if early OIT would work as well in those patients.

The study size was small – 40 children. Only 32 finished the study. This means nearly 25% did not.

With such small numbers, one has to be very careful since there is a very narrow margin to be able to see true differences between comparison groups. Things could change with additional enrollment.

Parents should know this was just a preliminary study, meant to see if OIT in this age was feasible and could result in some potential benefit. It was not intended to deliver a final answer.

Researchers will need to repeat the study in multiple locations with larger groups of children—something that is already being done, to further test this idea. The researchers also have to refine their entry criteria. Children who had never eaten peanut before, who had higher blood test levels, were allowed entry.

What does this study mean for me?

It appears that earlier use of peanut OIT in children with lower baseline IgE levels can successfully induce sustained unresponsiveness after 2 ½ years of treatment, and at low doses.
It remains unknown whether these children were truly “cured.” Researchers will continue to follow them over time. However, the majority were able to add peanut-containing foods into their diet.

Three final points:

#1 - We can continue to be excited for the future of food allergy treatment. Several research groups around the country are invested in developing treatments for food allergy. This study adds another piece to the puzzle of treating food allergy. With so many possibilities including OIT, sublingual immunotherapy, epicutaneous immunotherapy (through a skin patch), and nonspecific treatments, the work in this area is only continuing to grow. As we understand more about these treatments, the closer we can get to prevention and treatment.

#2 - This is only the first step. While this is an exciting study and the results show great promise for early-age OIT, it is important to understand that there are limitations. For the general population, OIT in young children should still be investigated thoroughly before it is ready for clinical practice. Now is NOT the time to call your allergist and ask for OIT. OIT is still not approved by the FDA.

#3 - More research needs to be done. The authors noted that their results need to be confirmed by additional studies, which are already underway. Continue to support funding for food allergy research and prevention strategies, public health efforts and school programs.

Mitchell Grayson, MD, is Director, Division of Allergy and Immunology and Professor of Pediatrics at Nationwide Children’s Hospital and The Ohio State University. He is a member of the Board of Directors of the Asthma and Allergy Foundation of America (AAFA) and Chair of its Medical Scientific Council (MSC).

Matthew Greenhawt, MD, MBA, MSc, is an Assistant Professor, Pediatrics-Allergy at the School of Medicine, University of Colorado and Section of Allergy, Department of Pediatrics, Children's Hospital Colorado. He is a member of the Food Allergy and Anaphylaxis Sub-Committee of AAFA's MSC.

Michael Land, MD, FAAAAI, works in the Allergy Department at Kaiser Permanente in San Diego, CA. He is also the Associate Training Program Director for the UCSD Allergy/Immunology fellowship program and Volunteer Clinical Assistant Professor with the UCSD Department of Pediatrics He is a member of the Food Allergy and Anaphylaxis Sub-Committee of AAFA's MSC.

David Stukus, MD, is an Assistant Professor of Pediatrics in the Section of Allergy/Immunology at Nationwide Children's Hospital, in Columbus Ohio. He also serves as Director of the Complex Asthma Clinic. He is Chair of the Food Allergy and Anaphylaxis Sub-Committee of AAFA's MSC and serves as Secretary on AAFA's Board of Directors.

Medical Review August 2016.

Reference:

Vickery, B.P., et al (2016).  "Early oral immunotherapy in peanut-allergic
preschool children is safe and highly effective." The Journal of Allergy and Clinical Immunology.