麻豆传媒

LOUISVILLE, Ky. -- Epicutaneous immunotherapy administered through a patch applied to the skin (VP250) led to better responses compared with placebo for peanut allergies in toddlers, the phase III randomized EPITOPE study showed.

At 12 months, 67% of children ages 1 to 3 years met responder criteria compared with 33.5% of those on placebo (P<0.001), reported Matthew Greenhawt, MD, of Children's Hospital Colorado in Aurora, during the American College of Allergy, Asthma & Immunology annual meeting.

Regardless of baseline eliciting dose (ED), a significantly larger proportion of participants in the treatment group achieved an ED of ≥1,000 mg (64.2% vs 29.6% of placebo patients; P<0.001) or a cumulative reactive dose of ≥3,444 mg at 12 months (37% vs 10%, respectively; P<0.001).

Furthermore, the distribution of maximum symptom severity was shifted toward less severe in the VP250 group, with 12.5% experiencing severe symptoms at 12 months versus 28.6% of placebo patients (P<0.001).

"This is the first study of peanut desensitization in children less than 4 years of age using a non-oral immunotherapy route," Greenhawt said in his presentation. "Results from this study suggest VP250 may be a potential treatment option for young children with peanut allergy."

"There is currently no approved treatment for peanut allergy in children younger than 4 years, demonstrating a strong unmet need for an available treatment," he added. "Studies have shown early oral introduction of peanuts in children could reduce the risk of developing peanut allergy, suggesting the immune system in infancy may be particularly responsive to immunomodulation."

VP250 showed statistically significant benefits no matter which prespecified sensitivity analyses were performed, with the percentage of toddlers achieving the primary endpoint ranging from 65% to 79%.

"These are actual peanut-allergic patients who got the patch applied, so even though these are clinical trial patients, there is no reason to think that it would not work outside of a trial," session moderator Brian Kelly, MD, of Midwest Allergy and Asthma Clinic in Omaha, Nebraska, told 麻豆传媒.

"Cutaneous therapy has a known lower side effect risk profile than oral and sublingual therapies, which makes this delivery system an exciting possibility to potentially allow patients to have another alternative to treatment," he noted.

In this international double-blind study, Greenhawt and team included 362 children ages 1 to 3 years with peanut allergies across 51 sites and randomized them 2:1 to VP250 or placebo patches daily for 1 year. The patches were affixed to participants' backs between the shoulder blades at the clinic for the first dose, and then at home thereafter.

Greenhawt noted that there was high compliance in both arms, with 97% of the doses applied.

Median participant age was about 2.5 years, and 68-71% were boys. In addition to documented peanut allergies, participants also had asthma (16-23%), eczema or atopic dermatitis (80-81%), allergic rhinitis (20%), or other food allergies (66-69%).

The primary efficacy endpoint was the percent difference in responders between patients in the VP250 and placebo groups who could tolerate ≥1,000 mg if baseline ED was >10 mg, or ≥300 mg if baseline ED was ≤10 mg.

The safety profile of VP250 was consistent with previous studies. Most treatment-related adverse events in both groups were mild to moderate skin reactions. Only 1.6% of patients taking the treatment experienced treatment-related anaphylaxis, and 2.9% discontinued treatment due to adverse events.

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