Published Online: October 26, 2016
In the study published in The Journal of Allergy and Clinical Immunology (JACI) by Jones and colleagues, from the NIAID-sponsored Consortium of Food Allergy Research (CoFAR), researchers evaluated the clinical and safety outcomes of peanut epicutaneous immunotherapy (EPIT) used to treat children with peanut allergy.
During the study, 74 peanut-allergic children and young adults (ages 4-25 years) were randomized and received EPIT using active Viaskin® Peanut (provided by DBV Technologies, Montrouge, France) at doses of 100 mcg (VP100; 24 participants) or 250 mcg (VP250; 25 participants) or placebo treatment (25 participants) for 52 weeks of blinded therapy. Participants were evaluated by oral food challenge at study entry and after 52 weeks of EPIT treatment to establish the amount of peanut that could be successfully consumed without symptoms at each stage of the study. Treatment success was defined as either passing a 5044 mg peanut protein oral food challenge or achieving a >10-fold increase in the successfully consumed dose of peanut protein from the oral food challenge at the time of study entry to week 52. Safety assessments and immune system responses were evaluated at scheduled visits for all participants.
The primary endpoint was met. Of the 74 participants treated, those treated with Viaskin® Peanut experienced a modest, but significant, treatment benefit and treatment was safe and well-tolerated after 52 weeks of therapy. Treatment success was noted in 12% of placebo-treated participants compared to 46% of VP100 and 48% of VP250 treated participants (P=0.005 and P=.003, respectively compared with placebo). Treatment success was higher among younger children, ages 4-11 years, compared to those >11 years of age. Placebo-treated participants had no change in the amount of peanut that could be safely consumed during oral food challenge, while those treated with VP100 could consume a median dose of 43 mg more peanut protein (~1/7th peanut) and those treated with VP250 could consume a median dose of 130 mg (~1/2 peanut) more peanut protein. Adherence to EPIT dosing was >97% of expected doses for all participants, and <10% of participants withdrew from the study (1 due to adverse patch reactions). Dosing with Peanut EPIT was found to be safe and well tolerated by all; 79.8% on Peanut EPIT doses demonstrated reactions that were predominantly mild at the patch site and 14.4% of placebo doses had any reaction. Significant immunologic changes (increases in peanut IgG4 and IgG4/IgE ratio) were observed in participants treated with Peanut EPIT.
The authors conclude that treatment with Peanut EPIT administration is innovative and promising because it is safe, well-tolerated and associated with a modest treatment response after one year of therapy. Additional time on treatment will allow investigators to determine if the excellent adherence and safety profile and early immunologic changes translate to additional long-term clinical benefit.
The Journal of Allergy and Clinical Immunology (JACI) is an official scientific journal of the AAAAI, and is the most-cited journal in the field of allergy and clinical immunology.