Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: REALISE Randomized Clinical Trial Results.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Pongracic Jacqueline A, Gagnon Rémi, Sussman Gordon, Siri Dareen, Oriel Roxanne C, Brown-Whitehorn Terri F, Green Todd D, Campbell Dianne E, Anvari Sara, Berger William E, Bird J Andrew, Chan Edmond S, Cheema Amarjit, Chinthrajah R Sharon, Chong Hey Jin, Dowling Paul J, Fineman Stanley M, Fleischer David M, Gonzalez-Reyes Erika, Kim Edwin H, Lanser Bruce J, MacGinnitie Andrew, Mehta Hemalini, Petroni Daniel, Rupp Ned, Schneider Lynda C, Scurlock Amy M, Sher Lawrence D, Shreffler Wayne G, Sindher Sayantani B, Stillerman Allan, Wood Robert, Yang William H, Bois Timothée, Sampson Hugh A, Bégin Philippe
Аннотация
OBJECTIVE: To examine the safety of VP250 in children, using a study design approximating potential real-world use.
METHODS: REAL LIfe Use and Safety of EPIT (REALISE) is a phase 3 multicenter study consisting of a 6-month, randomized, double-blind, placebo-controlled period followed by open-label active treatment. Children aged 4 to 11 years with physician diagnosis of peanut allergy received daily treatment with placebo (6 months) or VP250 (up to 36 months). Data from the 6-month, randomized, controlled phase of REALISE are reported.
RESULTS: Three hundred ninety-three children were randomized 3:1 to receive VP250 (n = 294) or placebo (n = 99) for 6 months; 284 (72.3%) children had a history of peanut anaphylaxis. According to parent diary, all participants receiving VP250 and 83.8% receiving placebo reported at least 1 episode of local skin reaction, with frequency decreasing over time. Only 4 participants (1.4%) receiving VP250 discontinued because of adverse events (AEs). Epinephrine was administered for allergic reactions attributed to VP250 in 7 children (2.4%), of whom 5 remained in the study; none involved severe anaphylaxis. Overall, AE rates were similar among participants with and without a history of peanut anaphylaxis.
CONCLUSIONS: In a study designed to mirror real-world use, VP250 was observed to be well tolerated in peanut-allergic children, consistent with previous phase 2b and 3 studies.