Oral immunotherapy with cooked milk is safe and effective
22 December 2021
2 minutes to read
According to a study published in The Journal of Allergy and Clinical Immunology.
âWe were prompted by our clinic patients and saw how much of an impact milk allergy has on their lives and the need for a treatment option,â study co-author Jennifer A. Dantzer, MD, MHS, said Healio, assistant professor of pediatrics in pediatric allergy, immunology and rheumatology at the Johns Hopkins School of Medicine.
Dantzer and colleagues began the study with 30 participants (male, 53%; median age at enrollment, 11 years; range, 3-18), of whom 19 (63%) had a history of milk reactions unheated and baked, eight (27%) with unheated milk only and three (10%) with cooked milk only.
All 30 participants completed the Initial Dose Escalation (IDE) and tolerated the minimum required dose of at least 3 mg of boiled milk protein or a placebo. Two participants, including one from the boiled milk oral immunotherapy (BMOIT) group and one from the placebo group, withdrew during accumulation.
Participants were given BMOIT or a placebo for 12 months, consisting of a daily dosage of baked milk or an OIT placebo at home. They returned to the clinic every 10 to 21 days for further dose increases to the target maintenance dose of 2000 mg, followed by visits every 2 months during maintenance.
At 12 months, participants took part in a double-blind, placebo-controlled eating challenge. While 11 of 15 (73%) BMOIT participants tolerated 4044 mg of baked milk protein, none of the placebo participants met this primary endpoint.
In addition, the BMOIT group had a significantly higher median maximum tolerated dose (4044 mg versus 144 mg; P = 0.001) and the median variation of the maximum tolerated dose from the start (3,900 mg versus 0 mg, P = 0.0001) than the placebo group.
Jennifer A. Dantzer
“After 1 year of treatment, people in the BMOIT group could ingest without symptoms significantly more baked milk, in cake form, than those who received placebo oral immunotherapy,” said Dantzer.
âWe were delighted to find that 11 of the 14 children in the baked milk group who completed the 12th Month Oral Food Challenge could tolerate the maximum amount of 4g of cooked milk (1/2 cup). The change in the amount of baked milk tolerated in BMOIT at month 12 from baseline was both clinically and statistically significant, âshe added.
Dose-related reactions were common, although over 95% in both groups were mild.
Additionally, the researchers found no significant changes in cow’s milk IgE or beta-lactoglobulin IgE from baseline for the BMOIT or placebo group.
The researchers further found a significant difference in the emotional impact on quality of life of food allergies reported by proxy, although with greater improvements with placebo than with BMOIT. The researchers speculated that this was because the BMOIT groups experienced more adverse events than the placebo group during treatment. Still, they added, most BMOIT group participants saw improvement in at least one area of ââquality of life testing.
The researchers then continued the study for another year.
âIn the second year of our trial, all participants received BMOIT, then at month 24 experienced more dietary challenges with baked milk then unheated milk,â Dantzer said. âWe then followed these children as they introduced milk into their diet at home. We expect these additional results to be released in spring 2022. â
However, Dantzler said larger studies are also needed.
“It would also be useful to have a study directly comparing oral immunotherapy with cooked and unheated milk,” she said.
For more information:
Jennifer Dantzer, MD, MHS, can be contacted at [email protected]