In eight of 13 evaluable children receiving the treatment for three months in a placebo-controlled pilot trial, the maximum amount of milk they were able to tolerate increased at least threefold, reported Christophe Dupont, M.D., Ph.D., of Hopital Saint Vincent de Paul in Paris.
None of the seven children in the placebo group showed that high an increase in tolerance, he said here at the American Academy of Allergy, Asthma, and Immunology meeting.
He said the improvements seen with the treatment were clinically significant.
"In some of [the children], you can normalize the diet," he said. One participant in the study was able to tolerate 670 mL (nearly 3 cups) after three months. But that was exceptional, as the median tolerance after three months was less than 6 mL.
- Explain to interested patients that milk allergy is among the most common childhood food allergies.
- Note that it seldom persists in adulthood, but is still potentially dangerous to children and creates significant lifestyle disruptions.
- Explain that the patch product in this study is investigational and not available outside a clinical trial setting.
- Note that this study was published as an abstract and presented orally at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
However, Dr. Dupont said, the improvements seen in most participants were enough to prevent them from reacting to foods with trace quantities of milk proteins.
The patch contained 1 mg of milk protein or placebo and was applied every other day to children in the study. Participants were from three months to 15 years of age and underwent oral milk challenges at baseline and after two and three months in the trial.
The mean maximum tolerated milk dose at baseline was 2.1 mL (SD 2.6) and 4.4 mL (SD 5.9) in the active-treatment and placebo groups, respectively.
After three months, the mean tolerated dose tended to increase to 21 mL (SD 24.3) in the active-treatment group compared with 5.4 (SD 5.9) in the placebo group (P=0.37).
But when the summary results were expressed as the median change from baseline, the improvements seen with the active patch were significantly greater than with placebo (5.6 mL versus 0.17 mL, P=0.02).
Skin prick testing also showed substantial reduction in wheal diameters in most of the treated children. Little change was seen in the placebo group.
About half of the children in both groups reported occasional dermatitis or itching at the patch site. Other adverse effects were less common and did not differ between groups.
Patch-based immunotherapy is an attractive approach to treating milk allergy because it is a proven technology, said Dr. Dupont, who is also co-founder of the company developing the product, DBV Technologies.
Subcutaneous immunotherapy is already available for milk allergy. "We thought we could get the same effect just by applying the patch on the skin," he said.
The main advantage is safety, he added. "If you see a reaction, you can remove the patch," he said, whereas subcutaneous injections can't be reversed.
A. Wesley Burks, M.D., a pediatric allergist at Duke University in Durham, N.C., who was not involved with the study, said the milk-allergy patch was a promising approach.
"It's an easy way to stimulate the immune system," he said, although more safety data are needed.
"Topically [delivered immunotherapy] can be quite sensitizing," Dr. Burks said, and dangerous reactions may not appear immediately.
Consequently, children treated with patches would need close monitoring, he said.
The manufacturer of the patch, DBV Technologies, is also developing a similar patch-based immunotherapy for dust mite allergies.
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