Peanut Oral Immunotherapy Safe for Preschoolers in Real-World

By Reuters Staff

April 30, 2019

NEW YORK (Reuters Health) - Oral immunotherapy for peanut allergy is safe in preschool-aged children when given as routine treatment in a hospital or clinic, a new study has found.

"Although there have been many clinical trials of peanut oral immunotherapy in older children, and one trial in preschoolers, there has been a lack of real-world data due to safety concerns of offering this treatment to preschoolers outside of a research setting," study leader Dr. Lianne Soller, from the University of British Columbia and BC Children's Hospital in Vancouver, Canada, said in a statement.

"But our findings confirm in a real-world setting that this treatment is not only safe but is well-tolerated in a large group of preschool-aged children," she added.

The study was published online April 16 in the Journal of Allergy and Clinical Immunology: In Practice.

Academic and community allergists from across Canada administered peanut OIT to 270 preschool-aged children 9 to 71 months with confirmed peanut allergy. Over 16 to 22 weeks, the children made biweekly office visits for up-dosing, and consumed the dose daily at home between visits.

Of the 270 children who started peanut OIT, 243 children (90%) successfully reached the target maintenance dose of 300 mg peanut protein over an average of 22 weeks, while 27 children (10%) dropped out. Reasons for dropping out included repeated allergic reactions, the child refusing to consume the daily dose, and parent's anxiety.

During the buildup phase, 67.8% of the preschoolers experienced at least one allergic reaction but most were mild (grade 1, 36.3%) or moderate (grade 2, 31.1%); 0.4% of children experienced a severe grade 4 reaction.

"Our data indicates that the risk of having reactions requiring epinephrine either in the clinic or at home is extremely low, with only 12 reactions requiring epinephrine out of more than 41,000 patient days on P-OIT," the researchers write in their article.

These findings, they say, build on a "seminal paper" published in 2017 ( that demonstrated the safety and effectiveness of peanut OIT in preschool-aged children with only mild to moderate reactions and one moderate reaction requiring epinephrine.

"The goal of our project was to confirm the safety of preschool peanut OIT in a much larger sample of patients in the real world," senior author Dr. Edmond Chan said in a statement.

"Many allergists do not believe OIT should be offered outside of research settings, and have not routinely offered it as a therapy for peanut allergy in their clinics due to safety concerns," added Dr. Chan, also at the University of British Columbia.

"We hope that our data demonstrates that the treatment is safe in preschoolers, and could be offered to families of preschool children with peanut allergy who ask for it. There appears to be a big difference in outcomes in preschoolers compared to older children," noted Dr. Chan.

In fact, a study in the Lancet this week in older children paints a different picture of the potential risk of peanut OIT, finding a marked increase in anaphylaxis and other allergic reactions with immunotherapy.

Dr. Derek Chu of McMaster University in Canada and colleagues did a systematic review of 12 studies with more than 1,000 children aged 5 to 12 years with peanut allergy. The trials compared oral immunotherapy against placebo, avoidance or other types of immunotherapy, and used different peanut products and doses.

The results, they say, provide "high-certainty evidence" that available peanut OIT regimens "considerably increase allergic and anaphylactic reactions over avoidance or placebo, despite effectively inducing desensitisation. Safer peanut allergy treatment approaches and rigorous randomised controlled trials that evaluate patient-important outcomes are needed."

In a Lancet Comment, Graham Roberts of the University of Southampton, UK, says: "Although oral immunotherapy undoubtedly reduces the likelihood of reacting to peanuts in a controlled clinic setting, its overall side-effect profile means that patients seem to have more allergic reactions while on therapy. Trading treatment-related side-effects at home for allergic reactions to accidental exposures out of the house (i.e., in social situations) might be beneficial for some patients."

"However, it is not clear which patients might benefit most and the relative balance of reactions in and out of patients' homes. It would also be useful to compare oral with epicutaneous immunotherapy. Although epicutaneous immunotherapy is less effective, it has a better safety profile than oral immunotherapy, which some patients might find more acceptable. Finally, we should not forget that we now know that the early introduction of peanut products into the infant diet can prevent most cases of peanut allergy. Moving forward we need to develop implementation strategies to reduce number of patients with peanut allergy," Roberts writes.


J Allergy Clin Immunol Pract 2019.

Lancet 2019.