Peanut allergic children with other food allergies, eczema See reactions with EPIT

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

In children 1 to 3 years of age, the response rate was 64.1% with the 250 mg peanut patch versus 34.7% with placebo in children with other food allergies, and 72.7% versus 31.4%, respectively, in children with peanut alone. allergies (P<0.001 for both), researchers led by David Fleischer, MD, of Children's Hospital Colorado in Aurora, reported in a poster presentation at the annual meeting of the American Academy of Allergy, Asthma & Immunology.In the other sub-analysis presented on a separate poster, the response rate was 66.7% with EPIT compared to 32.2% with placebo in children with AD (P<0.001), and 68.8% vs. 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 of EPITOPE, reported last year, showed a response rate of 67% in toddlers treated with EPIT compared to 33.5% in those randomized to placebo for 12 months.In both sub-analyses, findings in very young children were consistent with data from the Phase III PEPITES trial in older children (4-11 years).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 approved, said pediatric allergist Corinne Keet, MD, PhD, of the University of North Carolina in Chapel Hill, who was not involved in the investigation."I think the lesson we've learned from oral immunotherapy [OIT] is that there is not much appetite," she said MedPage today. “OIT puts a heavy burden on doctors and patients. It’s expensive and there are side effects, and when I talk to parents about it, they’re not that interested.”

“It’s possible that the patch will prove to be a less burdensome alternative to OIT, but that remains to be seen,” she added.

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

Severe TEAEs related to EPIT occurred in no patient with and one patient without AD. TEAEs leading to treatment-related permanent discontinuations occurred in six and two patients, respectively. The rates of local EPIT-induced TEAEs were similar between patients with and without AD (all TEAEs: 99.5% vs. 100%; severe TEAEs: 23.2% vs. 20%).

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

Treatment response was defined as achieving a provoking dose of ≥ 300 mg 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 were able to tolerate ≥10 mg peanut protein at baseline, response to treatment was defined as achieving an induced dose of ≥1,000 mg peanut protein at Month 12 with no response.