Real-world data show oral immunotherapy for peanut allergy is safe, effective in infants
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In a real-world setting, peanut oral immunotherapy was safer in infants aged 12 months or younger than in children aged 1 to 5 years, according to recent data.
The peanut oral immunotherapy was “equally effective” among both cohorts, Lianne Soller, PhD, the research manager in the allergy clinic at British Columbia Children’s Hospital, and colleagues wrote.
Soller and colleagues previously reported that offering increasing amounts of peanut oral immunotherapy via one of three previously published Canadian protocols — Bamba peanut butter puffs (Osem Group), peanut flour or powdered peanut butter, or starting with peanut flour or powdered peanut butter and moving onto peanut puffs — over a 20-week period was safe and effective in 270 children aged 9 to 71 months, with 36.3% of patients experiencing mild allergic reactions and 4.1% requiring epinephrine.
In a second study previously conducted by Soller and colleagues, of 117 children with a peanut allergy (mean age, 26 months) who successfully completed 1 year of peanut oral immunotherapy and underwent a follow-up oral food challenge, 78.6% had negative challenge results and 98.3% tolerated a cumulative dose of 1,000 mg or higher.
“Our team started to notice that infants were doing extraordinarily well” in the first two studies, Soller told Healio.
Therefore, Soller and colleagues performed a subgroup analysis of infants from the first study, which they wrote “was the first to analyze real-world data on safety and effectiveness” of peanut oral immunotherapy in infants.”
The subgroup analysis included 62 infants aged younger than 12 months (mean age, 9.61 months). Their outcomes were compared with 341 noninfant preschoolers aged 1 to 5 years (mean age, 30.9 months). All the participants had an allergist-diagnosed peanut allergy and underwent updosing for peanut oral immunotherapy in a clinic every 2 weeks over eight to 11 office visits, with daily doses given at home until the patient reached a dose of 300 mg peanut protein. According to Soller, this is equivalent to about 1 to 1.5 peanut kernels.
The researchers wrote in The Journal of Allergy and Clinical Immunology: In Practice that the noninfant preschoolers who did not complete the buildup phase had significantly more severe reactions (14.2% vs. 0.9%) and epinephrine utilization (19% vs. 5.9%) compared with those who completed buildup. Conversely, none of the seven infants who dropped out of oral immunotherapy experienced severe reactions or needed epinephrine. Grade 2 or higher reactions during the baseline oral food challenge or buildup were significantly more common for the noninfant preschoolers who dropped out compared with infants who dropped out (90.5% vs. 57.1%).
In addition, of 42 infants who underwent a follow-up oral food challenge after a maintenance period lasting 1 year or longer, 81% tolerated 4,000 mg of peanut protein and 100% tolerated 1,000 mg. Researchers wrote those numbers were “comparable” to the 75.6% of noninfant preschoolers who tolerated 4,000 mg of peanut protein and 96.2% who tolerated 1,000 mg of peanut protein. The infants had no grade 2 or higher reactions during the follow-up oral food challenge. On the contrary, 7.7% of noninfant preschoolers had grade 2 or higher reactions (P = .03).
“There were 27 infants who did not receive a follow-up oral food challenge,” the researchers wrote. “Twenty of these infants remained on treatment but did not receive a follow-up oral food challenge and seven dropped out. Assuming that all 27 would have reacted, our intention-to-treat analysis would have resulted in 49.3% effectiveness.”
In addition, skin prick test and peanut-specific IgE measures dropped significantly from baseline to follow-up oral food challenges for noninfant preschoolers who had negative and positive oral food challenges. The infants only experienced significant decreases in their skin prick test measurements from baseline to follow-up oral food challenge.
The researchers wrote that limitations to the study included the small number of infants and an even smaller number of infants with peanut-specific IgE measurements, as well as the study being underpowered to recognize differences in safety outcomes such as severe reactions and epinephrine use.
“Our patients did not undergo baseline oral food challenges to confirm peanut allergy as is commonly done in prospective controlled oral immunotherapy studies,” they wrote. “This reflects the real-world nature of our retrospective analysis. We have attempted to mitigate this limitation through use of stricter inclusion criteria.”
In the interview, Soller said that due to the favorable safety profile, allergists and other physicians who are comfortable treating patients with food allergies should “start to think about offering peanut oral immunotherapy to infants.”
References:
Soller L, et al. J Allergy Clin Immunol Pract. 2021;doi:10.1016/j.jaip.2021.12.009
Soller L, et al. J Allergy Clin Immunol Pract. 2020;doi:10.1016/j.jaip.2020.10.045.
Soller L, et al. J Allergy Clin Immunol Pract. 2019;doi:10.1016/j.jaip.2019.04.010.
Perspective
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Robert A. Wood, MD, FAAAAI
The take-home message of this study by Soller and colleagues is that peanut oral immunotherapy appears safe and effective for infants and preschool-age children and that it may be as effective and even more safe for infants.
There are currently no National Institute of Allergy and Infectious Disease guidelines for the treatment of peanut allergy for infants who are already allergic, the clinical area covered by the study.
We recommend that physicians who have patients who are allergic to peanuts use peanut oral immunotherapy according to the guidelines established by the FDA for Palforzia (arachis hypogaea, Aimmune Therapeutics), the only FDA-approved oral immunotherapy for peanut allergy. At this time, arachis hypogaea is only approved for use in children aged 4 to 17 years. We hope to see approval of this product for lower ages in the future.
Professor of pediatrics, Johns Hopkins School of Medicine
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