Children with severe cow’s milk allergy may be able to safely tolerate small amounts of baked milk after 12 months of oral immunotherapy, new research suggests.
The small, ongoing clinical trial has enabled some participants — all of whom reacted to less than a tablespoon of baked milk at baseline — to begin incorporating baked milk products into everyday diets and to eat in restaurants with less fear of allergic reactions, reported study author Jennifer Dantzer, MD, MHS, an assistant professor of pediatrics in the Division of Pediatric Allergy, Immunology and Rheumatology at Johns Hopkins School of Medicine in Baltimore.
Cow’s milk is the most common food allergy in young children, and “for many, it’s a constant stressor that’s always there,” Dantzer told Medscape Medical News. “For a lot of families, this impacts where they eat out, if they eat out, and sometimes where they vacation, or a lot of the social activities they do.
“This was a unique group of kids with a very severe milk phenotype who were reactive to teeny doses and may not have qualified or done well with other types of oral immunotherapy,” she added. “Using a modified allergen — baked milk — seems to work. But for now, we think this is something that still needs further research before it’s ready for a clinical setting.”
The study, for which 24-month unblinded results are being tallied, was recently published in The Journal of Allergy and Clinical Immunology.
About 2% to 3% of preschool-age children are affected by cow’s milk allergy. Children often outgrow it, but for about 20% of children, it persists into adolescence and adulthood. The only current management approaches are avoidance and emergency medications to treat reactions.
But for those with severe milk allergy who react to even trace amounts of milk in any form, the now-routine clinical practice of introducing baked milk isn’t an option, Dantzer said. The new trial stood out from prior research by using lower starting doses and a more gradual dose escalation of extensively heated milk to determine if oral immunotherapy could be safer but still effective.
Dantzer and her team randomly assigned 30 participants (aged 3 to 18 years) into two blinded groups. For 12 months, one group received baked milk oral immunotherapy (BMOIT), and the other a placebo consisting of tapioca flour. At baseline, for all participants, the milk skin prick test wheal diameter was ≥3 mm, and the cow’s milk immunoglobulin E (IgE) level was >5 kU/L. All the children experienced positive dose-limiting reactions to <1 tablespoon of baked milk protein but could tolerate at least 3 mg on initial dose escalation.
Measured doses of baked milk and placebo powders were supplied to participants for all doses consumed at home. Participants were given instructions on how to prepare it in cupcake or muffin batter. Over 12 months, doses were gradually increased to a maximum cumulative dose of 4044 mg baked milk protein, or approximately a half tablespoon.
Researchers collected blood samples for immune studies, and participants or their parents completed quality-of-life questionnaires that asked about food anxiety, social and dietary limitations, emotional impact, risk for accidental ingestion, and allergen avoidance.
Fourteen of 15 participants (93%) in the BMOIT group reached the goal-maintenance dose of 2000 mg of baked milk protein (about a quarter tablespoon). Of those who completed the 12-month challenge, 11 of 14 (79%) in the BMOIT group tolerated 4000 mg of baked milk protein, compared to none in the placebo group.
“We anticipated that by starting with really small amounts, we would be able to build up the amount of baked milk these kids could tolerate,” Dantzer said. “We were very pleased by how many could reach the maximal dose at the end of the first year. Once we get the results of the second year, that will provide a lot of additional detail about how this translates into unheated milk amounts they can tolerate and introduce into their diet at home.”
No significant changes were found in IgE levels over time in either study group. Most in the BMOIT group reported improvement in at least one quality-of-life domain, while more in the placebo group reported improvements in only the emotional impact domain.
Adverse events such as gastrointestinal side effects occurred in both groups of participants, but the vast majority of events were mild, Dantzer said. Fewer than 1% of dosing-related reactions were severe. Four participants required epinephrine.
“This highlights how this needs to be done by someone comfortable and trained, and not by a family at home on their own,” Dantzer said. “But potentially in the future, this concept of using a modified allergen could be applied to more kids with milk allergy.”
A Montreal-based pediatric allergy specialist who was not involved in the study said the results weren’t surprising. “We’ve known for a good while that the allergenic proteins found in certain foods, or caused by milk in this context, are influenced by the way in which food is processed,” said Christine McCusker, MD, an associate professor of pediatrics and director of the Division of Pediatric Allergy, Immunology, and Dermatology at Montreal Children’s Hospital at McGill University Health Center.
But “having this relatively definitive data that supports what you’re suggesting to patients is obviously the way to optimize your management,” McCusker told Medscape Medical News. “These types of studies are important steps, especially in this age of increased food allergies where many of these things can be dealt with in very young children before their immune systems are fixed.”
Dantzer and McCusker agreed that the small size of the study was a limitation, though “waiting for more participants means you don’t always get information out there in a timely manner,” McCusker said.
She said additional research should focus on preidentifying which children may be prone to severe, lasting food allergies. “If you have a milk allergy that will stay with you the rest of your life and we could maybe modify that outcome with early, targeted intervention, that would be the nirvana of the field,” McCusker said.
Dantzer said her research “showed us that oral immunotherapy is an option, but not a perfect option.
“We still need to keep working on other alternatives that can be even safer and potentially work better,” she added.
The study was supported by the Myra Reinhard Family Foundation. Dantzer and McCusker report no relevant financial relationships.
The Journal of Allergy and Clinical Immunology. Published online Octobet 27, 2021. Abstract
Maureen Salamon is a New Jersey-based freelance journalist with bylines in The New York Times, The Atlantic, CNN.com and other major outlets.
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