Data from Pharmawand - Curated by Marshall Pearce - Date added 21 November 2017
The REALISE double-blinded period compared the safety of treatment with Viaskin Peanut 250 µg versus placebo for six months. Patients who completed the blinded portion of the study will continue to receive active treatment for up to 36 months during an open-label extension, further studying the long-term safety and use of Viaskin Peanut in routine clinical practice.
The REALISE trial met its primary objective, demonstrating that Viaskin Peanut was well-tolerated with no new or unexpected adverse events. Based on preliminary analysis, a similar safety profile was observed in all patients included in the trial, regardless of history of severe anaphylaxis. The safety data reported will complete the Food and Drug Administration (FDA) safety database requirement for the Viaskin Peanut program in children four to 11 years of age. Results from this study, in addition to data from the PEPITES Phase III efficacy and safety trial, will form the basis for planned regulatory discussions in the United States, Europe and other countries for use of Viaskin Peanut in this patient population.
Results from this trial were comparable with outcomes from previous studies of Viaskin Peanut 250 ug. The most commonly reported adverse events were local application site reactions, that were mostly mild and moderate in nature. No imbalance in serious adverse events (SAEs) was observed in the trial, with 3 cases in 3 subjects in the active arm (1.0%), and 2 cases in 2 subjects in the placebo arm (2.0%); 1 case in 1 subject in the active arm was qualified by the investigator as moderate anaphylaxis probably related to treatment. The patient responded to standard outpatient therapy. In the six-month blinded period, the discontinuation rate was 2.5%, with a 1.0% dropout related to adverse events. Mean patient compliance was above 95%.
Comment: Viaskin is an electrostatic patch, which offers a convenient, self-administered, non-invasive immunotherapy to patients. Once applied on intact skin, Viaskin forms a condensation chamber, which hydrates the skin and solubilizes the antigen allowing it to penetrate the epidermis, where it is captured by Langerhans cells. Based on numerous scientific publications and research, DBV believes, this unique mechanism of action is safe and that it generates a strong and highly tolerogenic immune response. This epicutaneous immunotherapy method allows DBV to address severe food allergies, as well as unmet medical needs in other immunotherapy indications.