PURPOSE OF THE STUDY.
To evaluate the clinical, safety, and immunologic effects of epicutaneous immunotherapy (EPIT) for the treatment of peanut allergy.
The study included 74 patients ages 4–25 years with a peanut allergy, defined as physician-diagnosed or as the patient having a convincing clinical history of a peanut allergy, a positive result on a peanut skin prick test, or peanut-specific IgE and a positive entry oral food challenge (OFC) to 1044 mg of peanut protein or less. Children with a history of severe anaphylaxis were excluded.
Participants were randomly assigned to double-blind peanut EPIT using Viaskin Peanut 100 µg (VP100) or 250 µg (VP250) or a placebo patch. The patch was placed on the back or upper arm daily for increasing lengths of time, up to 24 hours per day. The primary outcome, or treatment success, was defined as passing a 5044-mg peanut protein OFC or demonstrating a 10-fold or greater increase in the consumed dose from baseline after 52 weeks of treatment. Secondary outcomes included adverse reactions, adherence, effects of age and dose on outcomes, and immunologic changes.
Twelve percent of the placebo group, 46% of the VP100 group, and 48% of the VP250 group met the primary endpoint, though none in the treatment group passed the 52-week OFC. The median change of successfully consumed peanut protein was 0 mg of protein in the placebo group, 43 mg in the VP100 group, and 130 mg in the VP250 group. Children 11 years or younger were more likely to achieve treatment success. Adverse reactions, most commonly mild patch-site reactions, were more common in the treatment groups (80% of both VP100 and VP250 doses vs 14% of placebo). No epinephrine was used for treatment of dose reactions. Peanut-specific IgG4 levels and IgG4/IgE ratios increased in both treatment groups when compared with the placebo group, though no change was seen for peanut-specific IgE levels or skin test size among groups.
Peanut EPIT resulted in a modest but significant increase in the successfully consumed dose of peanut protein after 1 year of treatment with both the VP100 and VP250 doses when compared with placebo. Younger participants achieved greater treatment success. Immune modulation consistent with other forms of food immunotherapy was noted. Local patch-site reactions were common, but there were no serious reactions. Adherence to therapy was high.
This is the first trial to comprehensively evaluate EPIT for the treatment of peanut allergy, introducing another prospective treatment option for food allergy. Though clinical and immunologic responses in this study were modest, the safety profile and adherence rate were favorable. Future studies will investigate whether the treatment benefit will become more robust with longer duration of treatment and continue to refine the target patient population who may benefit most from EPIT.
- Copyright © 2017 by the American Academy of Pediatrics