CHOP Assessing Milk EPIT for Eosinophilic Esophagitis
MAY 24, 2019
Jonathan M. Spergel, MD, PhD
The synthetic skin patch exposes the patient to the allergen—in this study’s case, milk—in micro-doses over time.
The double-blind study randomly assigned 20 children aged 4-17 years old with milk-induced EoE to either the Viaskin milk patch group (n= 15) or placebo group (n= 5). Both groups, upon receiving their skin patches, were assessed throughout a nine-month, no-milk diet period and a subsequent two-month exposure period.
Investigators examined patients for differences in sensitivity to the allergen, allowing those with significantly decreased sensitivity to enter an open-label phase. This final phase gradually integrated milk into patients’ diets for 11 months with continued use of EPIT therapy.
Unfortunately, the study results were reduced by what lead author Jonathan M. Spergel, MD, PhD, termed a “compliance issue.” Several of the patients involved in the study failed to follow their prescribed diet to the letter. Spergel told MD Magazine® an improved practice would have been to simplify the dietary restrictions.
In order to account for the current data, Spergel divided the participants into 2 groups: intent to treat and per-protocol. The former group includes participants who introduced dietary variables to the results, while the per-protocol group included those who fully committed to the intended diet for the most accurate research.
While the intent to treat population demonstrated minimal difference between those given the therapy verus placebo, the per-protocol population (n= 7; n= 2, respectively) showed a dramatic difference. At the study’s conclusion, patients given the treatment had a lower mean 5 eosinophil per high-power field (EOS/HPF) count (25.57 ± 31.19) than patients given the placebo (95.00 ± 63.34) (P= .038).
Right now, the only available treatment for food allergies relies upon either avoidance of the allergen or treatment of inflammation post-exposure. Milk-related EoE is chronic, characterized by redness, swelling, and itching in the esophagus in response to milk. These symptoms are also frequently accompanied by nausea, vomiting, or a burning sensation in the throat, which can lead to scarring and narrowing of the esophagus if left untreated.
Typical of food allergies, EoE has limited treatment options. Patients can either follow a restrictive diet, often impacting comorbidities like asthma or atopic dermatitis—or they can treat symptoms with off-label topical steroids, risking growth retardation as a side effect. The study takes investigators 1 step closer to instead addressing the allergy directly for the first time.
Alongside milk, DBV Technologies has also experimented with peanut allergy EPIT. Viaskin Peanut was just submitted for a Biologics License Application (BLA) this year, after receiving Food and Drug Administration (FDA) Fast Track Designation in 2012 and Breakthrough Designation in 2015.
“They have plans to work on egg, so that’s the next one,” Spergel said. “If they’re successful with both the milk and the egg, that would account for 2 of the major allergens for EoE: milk, eggs, and wheat.”
If further EPIT research is promising, DBV Technologies won’t be alone in the marketplace. Aimmune Therapeutics took initiative in late December 2018 with a similar therapy, submitting a supplemental BLA for investigative biologic AR-101.
If it continues to work in an additional phase, Spergel said, it would be the first therapy to potentially revolutionize the lives of patients with EoE.
The study, “Efficacy of Epicutaneous Immunotherapy in Children with Milk-Induced Eosinophilic Esophagitis,” was published online in Clinical Gastroenterology and Hepatology.