D2.159 - Real-World Protective Effects of Epicutaneous Immunotherapy in Peanut-allergic Toddlers

Allergic reactions due to accidental peanut consumption (APC) are common among peanut-allergic children, despite strict avoidance. Epicutaneous immunotherapy (EPIT) with VIASKIN peanut patch (VP) in toddlers has been associated with reduced rates of reactions following APC, compared to placebo. Here we characterize reported APCs, regardless of whether an allergic reaction was triggered, through Year 2 of the EPITOPE open-label extension (OLE) trial.

EPITOPE, a 12-month, randomized, double-blind, placebo-controlled (DBPC) trial, assessed VP efficacy and safety in peanut-allergic toddlers aged 1 through 3 years. Eligible participants could enroll in the OLE for up to a total of 3 years of active treatment. APCs were collected prospectively and were analyzed longitudinally after 3 and 2 years of active treatment for VP and placebo-crossover participants, respectively. The associations between longer-term efficacy outcome and rate of APC events and related allergic reactions were examined.

Further increases in eliciting dose (ED) beyond Month 12 were observed following long-term active treatment in the OLE: in VP participants, the proportion with an ED ≥1,000 mg was 84.6% after 3 years; in placebo-crossover participants, the proportion with an ED ≥1,000 mg after 2 years was 67.7%. Participants reaching a higher ED were less likely to experience a reaction following APC; 23/40 (58%) participants with ED ≥1000 mg did not experience a reaction following APC versus 8/35 (23%) with ED <1000 mg who had no reaction. With increasing time on treatment, yearly rates of APC (with or without reaction) decreased, and the yearly event rate of APC-related reactions decreased by 3.8-fold (from 11.4 to 3.0) and 1.3-fold (from 6.0 to 4.5) for placebo-crossover and VP participants, respectively, between EPITOPE and the 2-year OLE. 

EPIT with VP has demonstrated reduced rates of APC-related reactions with further reductions observed as time on treatment and ED increase. These results suggest the potential of the VIASKIN peanut patch, if approved, to provide real-world effectiveness, including mitigating accidental peanut consumption reactions.