乌鸦传媒

SAN ANTONIO -- Epicutaneous immunotherapy (EPIT) administered through an investigational skin patch over 12 months led to more responses -- with favorable safety -- compared with placebo in peanut-allergic toddlers with and without other food allergies or atopic dermatitis (AD), according to two subanalyses of the phase III EPITOPE trial.

Among children ages 1 to 3 years, the response rate was 64.1% with the 250-mg peanut patch versus 34.7% with placebo in those with other food allergies, and 72.7% versus 31.4%, respectively, in those with peanut allergies only (P<0.001 for both), reported researchers led by David Fleischer, MD, of Children's Hospital Colorado in Aurora, in a poster presentation at the American Academy of Allergy, Asthma & Immunology annual meeting.

In the other subanalysis presented in a separate poster, the response rate was 66.7% with EPIT compared with 32.2% with placebo among kids with AD (P<0.001), and 68.8% versus 40.9% in those without (P<0.029), reported researchers led by Amy Scurlock, MD, of Arkansas Children's Hospital in Little Rock.

Overall results from EPITOPE, reported last year, showed a response rate of 67% among toddlers treated with EPIT compared with 33.5% in those randomized to placebo over 12 months.

In both subanalyses, the findings among very young children were consistent with data from the phase III trial involving older children (4-11 years of age).

There is currently no FDA-approved EPIT for peanut allergy, and there is no guarantee that clinicians and parents of peanut-allergic children will embrace the patch if it is approved, said pediatric allergist Corinne Keet, MD, PhD, of the University of North Carolina at Chapel Hill, who was not involved with the study.

"I think the lesson we've learned from oral immunotherapy [OIT] is that there is not a lot of appetite for it," she told 乌鸦传媒. "OIT places a high burden on doctors and patients. It is expensive and there are side effects, and when I talk to parents about it, they aren't all that interested."

"It is possible that the patch will turn out to be a lower-burden alternative to OIT, but that remains to be seen," she added.

Serious treatment-emergent adverse events (TEAEs) occurred in one patient with isolated peanut allergy and no patients with other food allergies. TEAEs leading to permanent study discontinuation occurred in two and six patients, respectively.

Serious TEAEs related to EPIT did not occur in any patient with, and in one patient without, AD. TEAEs leading to permanent study discontinuation related to treatment occurred in six and two patients, respectively. Rates of local EPIT-induced TEAEs were similar between patients with and without AD (any TEAEs: 99.5% vs 100%; severe TEAEs: 23.2% vs 20%).

The randomized, double-blind EPITOPE study included 362 children with peanut allergies who were 1 to 3 years of age at study entry, including 242 with other non-peanut food allergies and 290 with AD.

Treatment response was defined as reaching an eliciting dose of ≥300 mg of peanut protein at the end of 1 year of treatment in children with a baseline tolerance of ≤10 mg at study entry. Among children who could tolerate ≥10 mg of peanut protein at baseline, treatment response was defined as reaching an eliciting dose of ≥1,000 mg of peanut protein at month 12 without a reaction.