Baked milk oral immunotherapy proves safe, effective
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Most patients with severe cow’s milk allergy can be safely desensitized to substantial levels of baked milk through baked milk oral immunotherapy, according to a study published in The Journal of Allergy and Clinical Immunology.
“We were prompted by our clinic patients and seeing how much milk allergy impacts their lives and the need for a treatment option,” study co-author Jennifer A. Dantzer, MD, MHS, assistant professor of pediatrics in pediatric allergy, immunology and rheumatology at Johns Hopkins School of Medicine, told Healio.
Dantzer and colleagues began the study with 30 participants (male, 53%; median age at enrollment, 11 years; range, 3-18), 19 (63%) of whom had a history of reactions to unheated and baked milk, eight (27%) to unheated milk only and three (10%) to baked milk only.
All 30 of the participants completed the initial dose escalation (IDE) and tolerated the required minimal dose of at least 3 mg of baked milk protein or a placebo. Two participants, including one from the baked milk oral immunotherapy (BMOIT) group and one from the placebo group, withdrew during buildup.
Participants received BMOIT or a placebo for 12 months, consisting of daily baked milk or placebo OIT home dosing. They returned to the clinic every 10 to 21 days for further dose increases up to the target maintenance dose of 2,000 mg, followed by visits every 2 months during maintenance.
At 12 months, participants took part in a double-blind, placebo-controlled food challenge. Whereas 11 of the 15 (73%) BMOIT participants tolerated 4,044 mg of baked milk protein, none of the participants on the placebo reached that primary endpoint.
Also, the BMOIT group had a significantly higher median maximum tolerated dose (4,044 mg vs. 144 mg; P = .001) and median change in maximum tolerated dose from baseline (3,900 mg vs. 0 mg, P = .0001) than the placebo group.
“After 1 year of treatment, those in the BMOIT group could ingest without symptoms significantly more baked milk, in the form of cake, than those who had received placebo oral immunotherapy,” Dantzer said.
“We were pleased to see that 11 out of 14 of the children in the baked milk group who completed the month 12 oral food challenge could tolerate the maximum amount of 4 g of baked milk (1/2 cup). The change in the amount of baked milk tolerated in the BMOIT at month 12 compared with baseline was both clinically and statistically significant,” she added.
Dose-related reactions were common, although more than 95% in both groups were mild.
Additionally, the researchers found no significant change in cow’s milk IgE or beta lactoglobulin IgE from the baseline for the BMOIT or placebo group.
The researchers further found a significant difference in emotional impact on proxy-reported food allergy quality of life, although with greater improvements on placebo than on 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 of the participants in the BMOIT group saw improvement in at least one domain in the quality-of-life testing.
The researchers then continued the study for another year.
“During the second year of our trial, all participants received BMOIT and then, at month 24, underwent more food challenges to baked milk and then unheated milk,” Dantzer said. “We have then been following these children as they introduce milk into their diet at home. We expect these additional results to be published in spring 2022.”
However, Dantzler said that larger studies are needed as well.
“It would also be helpful to have a study directly comparing baked milk and unheated milk oral immunotherapy,” she said.
For more information:
Jennifer Dantzer, MD, MHS, can be reached at jwrubel@jhmi.edu.
Reference:
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These results are not surprising, and they are consistent with what we have seen at our food allergy treatment center, which has successfully treated more than 150 patients who have milk allergy with oral immunotherapy over the last 8 years.
If doctors are not aware that this treatment is available, then learning how to use it and safely and effectively implement it into their practice could really help patients. Peanut allergy tends to get a lot of media attention, but being able to get milk back into someone's diet is a substantial accomplishment.
Next, I think assessing the impact of milk OIT on gut inflammation and the microbiome in the long term would be important to research.
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This randomized controlled trial by Dantzer and colleagues is notable insofar as it applies a standardized OIT — an increasingly utilized method for systematically desensitizing food-allergic patients to their specific food allergen — to patients with allergy to baked cow’s milk.
This is noteworthy for a couple of major reasons. First, current FDA-approved food allergen immunotherapy is only available to treat peanut allergy. Second, cow’s milk allergy is one of the most common food allergies in the United States and is also a major food allergen globally, imposing substantial burden of disease on a large population of affected patients and their families.
Remarkably, unlike a previous study by Goldberg and colleagues published in 2015 in this same journal that found baked milk OIT to be unsuccessful in most patients and associated with a high rate of adverse events, the present study by Dantzer and colleagues had greater success with their baked milk OIT protocol, which incorporated a lower starting dose and more gradual dose-escalation.
In the present trial, which enrolled baked milk-allergic patients who were determined to have a relatively severe form of milk allergy that is believed unlikely to be naturally outgrown (because patients react to even very tiny doses of baked milk protein), 14 of 15 patients assigned to active OIT were able to tolerate a 2 g maintenance dose, and 11 of 14 were able to tolerate a 4 g dose. While it is unknown how much higher a dose those participants could tolerate after treatment due to the nature of the study design, being able to tolerate these doses is likely to provide considerable protection against accidental exposure to baked milk and could permit some limited deliberate consumption of baked milk-containing foods, such as a birthday cupcake or special holiday baked goods, depending on the recipe.
This is important because currently there are no FDA-approved therapies for patients with cow’s milk allergy, and current practice is to have patients practice strict allergen avoidance. It will be very interesting to see what the longer-term outcomes of these patients are, given that the authors plan to follow these participants and further characterize their ability to consume baked and unbaked milk products. That said, these are promising data, and they highlight the need for further study of this promising modality for treatment of severe cow’s milk allergy.
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