New Data Strengthen Case for Oral Immunotherapy in Tots

Esther Landhuis

February 28, 2023

Considered fringe just a few years ago, oral immunotherapy (OIT) has entered mainstream conversation about treating food allergies — particularly in younger children.

The buzz surrounding OIT — which involves ingesting daily doses of the culprit food to raise the threshold that would trigger a reaction — grew with the approval by the US Food and Drug Administration of Palforzia, the peanut OIT pill, in January 2020. Yet many allergists remained wary about the treatment, a monthslong regimen that can itself trigger allergic reactions.

Now, accumulating research points to "a possible window of opportunity early in life, less than 3 years of age, for more successful disease remission," Justin Schwartz, MD, PhD, an allergist at Cincinnati Children's Hospital, told a crowd at the American Academy of Allergy, Asthma, & Immunology (AAAAI) 2023 Annual Meeting in San Antonio.

His presentation about OIT in toddlers kicked off a 3-hour clinical practice course, one of several dozen conference offerings highlighting this emerging approach.

Several AAAAI posters add to prior studies (eg, DEVIL and IMPACT) suggesting that OIT proceeds more smoothly and faster during a child's earliest years — a season fraught with accidental exposures and reactions.

One poster described a retrospective study of 73 children younger than 4 years who underwent OIT at the Cleveland Clinic Food Allergy Center. Sixty-four were treated for peanut allergies, and seven patients received OIT for multiple foods, including tree nuts, milk, wheat, and sesame.

Of the 80 total OIT courses, 76 (95%) reached maintenance — meaning the child tolerated a small amount (eg, 1–2 peanuts) without reacting — in a median of 104 days (~3.4 months).

That is "quite impressive," said allergist Hugh Windom, MD, whose clinic in Sarasota, Florida, has offered OIT since 2012.

Older children typically have 80% to 90% success and take longer (6–8 months) to reach maintenance because of busier schedules and reactions that slow them down, he said. In his clinic's larger retrospective analysis of preschool-aged OIT patients, presented at last year's AAAAI meeting, 89% of patients with peanut allergies and 72% of children with multiple food allergies achieved maintenance.

In the Cleveland Clinic study, children with favorable lab test results after receiving the maintenance dose for 6 months were offered an oral food challenge. Of 24 patients who completed the challenge, 75% "passed with a normal serving size of the treated food (eg, two tablespoons of peanut butter)," Sarah Johnson, MD, lead author and Cleveland Clinic allergy/immunology fellow, told Medscape Medical News.

Plus, OIT seemed safer for toddlers. Although 41% of the children had reactions during clinic updosing and 48% had reactions at home, only ~3% of toddler OIT courses required epinephrine. By comparison, ~11% of treatments required epinephrine in a large OIT study of older children.

When a child reacts, "you might keep them on the dose or go a little slower," said Johnson, who worked with allergist Jaclyn Bjelac, MD, on the study. These setbacks occurred less frequently in toddlers, allowing their OIT to "go a lot faster" than in older children. And so far, Johnson said, none of the toddlers have shown signs of eosinophilic esophagitis, a rare complication that can develop during OIT.

A smaller analysis of real-world outcomes in an academic clinical setting also found that OIT was well tolerated at very young ages. Since 2020, this ongoing study at UVA Children's Hospital in Charlottesville has enrolled 22 peanut-allergic children (aged 6 months to 3 years) for OIT. Three patients have dropped out, four are in the buildup phrase, and 15 have reached maintenance dosing. None have reported having to use epinephrine.

Three patients have completed 1 year of maintenance therapy, and another patient accidentally consumed ~3000 mg of peanut protein (equivalent to ~10 peanuts) after 5 months of maintenance. All four "now incorporate peanut into their diets ad lib," according to lead author and allergist Jonathan Hemler, MD, who directs the UVA pediatric food allergy program.

These findings are "really reassuring — because even if you may not offer OIT, you're still going to get questions about it," said Ama Alexis, MD, an allergist/immunologist in private practice in New York City and a clinical assistant professor at NYU Grossmann School of Medicine, commenting on the Cleveland Clinic study.

"It's great that we're hearing and seeing so much about OIT," she added. While training as an allergy/immunology fellow 15 years ago, many saw the treatment as dangerous — "an absolute no-no," she said.

The AAAAI still considers OIT "investigational," yet this year's annual meeting featured 22 posters — plus a course, workshop, seminar, and oral abstract session — on the approach.

The "thought process has shifted," Alexis said. "It's good to see all these numbers, these results. I think once you're comfortable, you should embrace new therapies."

Schwartz has consulted for Shire/Takeda and has received research funding from Knopp Biosciences. Alexis consults for AbbVie, serves on advisory boards for Jansen and Eli Lilli, and is a member of Pfizer's advisory board and speaker's bureau. Johnson, Windom, and Hemler report no relevant financial relationships.

American Academy of Allergy, Asthma, & Immunology (AAAAI) 2023 Annual Meeting: Course 1207, poster 112, and poster 80. Presented February 24, 2023.

Esther Landhuis is a freelance science & health journalist in the San Francisco Bay Area. She can be found on Twitter@elandhuis.

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