DBV Technologies: VITESSE study shows less severe allergic reactions with Viaskin Peanut
Three additional analyses of the phase 3 VITESSE study were presented at the 2026 annual meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Phoenix. They cover the severity of allergic reactions, immunological biomarkers and the conditions of daily use of the Viaskin Peanut patch in children aged 4 to 7 with peanut allergy.
The trial, which randomized 654 children over 12 months, had met its primary endpoint: 46.6% responders in the treated group, versus 14.8% under placebo (p < 0.001). Fewer than half of the treated children therefore met the criteria for treatment response.
Less severe reactions and modified immunological markers with the patch
During the double-blind oral food challenge performed at month 12, the maximum severity of symptoms was lower with the patch than with placebo (p = 0.004). Severe reactions occurred in 8.4% of treated children, versus 12.5% under placebo.
During the same test, 12.5% of treated participants had no symptoms or mild symptoms, versus 1.5% in the placebo group. Assessed at a dose equal to or lower than each child's initial reactogenic dose, reactions were absent in 52.7% of treated children, versus 19.2% under placebo.
At this dose threshold, moderate or severe reactions concerned 14.0% of the treated group, versus 50.0% of the placebo group. From a biological standpoint, peanut-specific IgG4 increased from month 3 and remained elevated until month 12.
At month 12, median values of peanut-specific IgE and Ara h 2-specific IgE were lower with the patch than with placebo (p = 0.001). The mean diameter of skin test wheals also decreased (mean ratio of 0.74; p < 0.0001), changes that the company considers consistent with allergen immunotherapy.
Adherence of 96.1%, at the same level as in the placebo group
Mean adherence reached 96.1% with the Viaskin Peanut patch and 96.5% with placebo. The patches were rated “very easy” or “easy” to remove by 83.4% of treated participants and 84.8% of participants on placebo, and “painless” by 71.9% and 70.2% respectively.
These usage data thus concern the patch format itself, with similar results in both arms. The protocol imposed no restrictions on daily activities (bathing, sports, swimming) or on concomitant medication, in children frequently presenting with atopic dermatitis, asthma or other food allergies.
Medical director Pharis Mohideen considered that these data “provide important insight into the overall positive results of this study”. Dr. Edwin H. Kim, of the University of North Carolina, sees in them the potential for the patch to fit into children's daily lives “if it were to be approved”.
In its forward-looking statements, the company recalls that to date, its product candidates are not authorized for marketing in any country.
