New results support safety of investigational ViaskinTM Peanut in children
Published: November 27, 2021
Peanut allergy is a leading cause of food allergy among children and, for most patients, is a lifelong condition. Peanut allergy can cause substantial anxiety for patients, families, and childcare and school personnel due to the fear of accidental exposures and the unpredictability of severe reactions. There are limited treatment options for patients, and the standard of care remains strict avoidance of peanut. Epicutaneous immunotherapy (EPIT) is a type of allergy treatment that aims to use the unique immune properties of the skin to safely build protection from peanut-induced allergic reactions while limiting peanut allergen absorption into the rest of the body. Viaskin Peanut, a form of EPIT for peanut allergy, is a proprietary patch containing 250 micrograms (µg) of peanut protein (equivalent to ~1/1000 of one peanut kernel) that is currently under investigation in clinical trials.
In a recent article in The Journal of Allergy and Clinical Immunology: In Practice, Pongracic et al described the results from the randomized, double-blind, placebo-controlled period of a Phase 3 clinical trial (REALISE) assessing the safety of Viaskin Peanut 250 µg. Peanut-allergic children aged 4 to 11 years were randomized to receive either Viaskin Peanut 250 µg or a placebo patch for 6 months. The study was designed to resemble the anticipated real-world use of Viaskin Peanut in routine clinical practice. Therefore, double-blind, placebo-controlled oral food challenges were not required in order to participate in the study, and instead, children were enrolled based on a convincing medical history of peanut allergy and supportive testing (skin prick test and blood test for peanut IgE). Of note, children with a history of anaphylaxis, including severe anaphylaxis, to peanut were not excluded from study participation. The safety of Viaskin Peanut was assessed by Investigators at each study visit by evaluating treatment-emergent adverse events (TEAEs), which are undesirable events that can potentially occur after starting patch treatment. TEAEs were evaluated according to their duration, severity, and treatment relatedness. In addition, 3 local skin reactions—itching, swelling, and redness—were recorded by parents using a daily diary.
The results of the REALISE study demonstrated that Viaskin Peanut 250 µg was well tolerated by peanut-allergic children. Overall, 393 children (Viaskin Peanut: n=294; placebo: n=99) were enrolled, of whom 383 (97.5%) completed the 6-month double-blind treatment period, with only 1.0% withdrawing from the study due to adverse events. The most common TEAEs reported were mild or moderate local skin reactions, which declined over time. During the study, the frequency of severe TEAEs was low (Viaskin Peanut: 1.4%; placebo: 1%), as were serious adverse events (Viaskin Peanut: 1%; placebo: 2%). TEAEs considered related to treatment were reported in 32% of Viaskin Peanut- treated children and 14.1% of placebo-treated children. Twelve (4.1%) participants experienced anaphylactic reactions considered related to treatment, none of which were severe; 7 (2.4%) of these participants were treated with epinephrine, and 2 participants discontinued treatment because of these events. No differences in safety were observed in the study between participants with or without a history of severe peanut anaphylaxis. The authors concluded that these results, which are consistent with those seen in previous clinical trials, demonstrate the safety, tolerability, and high adherence to treatment (applying the patch on a daily basis, as directed) associated with Viaskin Peanut. The results support its continued investigation as a potential treatment option for peanut allergy.
The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.