Long-Term Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: An Open-Label Active Treatment (REALISE Study).
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Pongracic Jacqueline A, Gagnon Rémi, Sussman Gordon, Siri Dareen, Oriel Roxanne C, Brown-Whitehorn Terri F, Anvari Sara, Berger William E, Bird J Andrew, Chan Edmond S, Chinthrajah R Sharon, Chong Hey 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, Wood Robert, Yang William H, Sampson Hugh A, Bois Timothée, Green Todd D, Campbell Dianne E, Bee Katharine J, Bégin Philippe
Аннотация
OBJECTIVE: This study assessed long-term safety of EPIT with VIASKIN peanut patch 250 μg (VP250) via an open-label extension of the REAL Life Use and Safety of EPIT (REALISE) trial.
METHODS: REALISE was a phase 3 trial in peanut-allergic children aged 4 through 11 years that included a 6-month, randomized, double-blind, placebo-controlled treatment phase, followed by an open-label, single-arm, active treatment period for up to 36 months.
RESULTS: Of the 392 participants (male 54.8%; median age 7.2 y) who received at least 1 dose of treatment, 77.8% completed the 36-month active treatment. Mean adherence to treatment was high at 96.4%. Most participants (98.7%) experienced at least 1 treatment-emergent adverse event (TEAE); the majority were mild or moderate and decreased in frequency and severity over time. Most participants (94.6%) experienced at least 1 treatment-related TEAE. Local skin reactions were the most common treatment-related TEAE with the incidence decreasing from year 1 (87.8%) to year 3 (19.2%). Serious treatment-related TEAEs were reported in 2 participants. No specific safety signals were identified in the 14 participants enrolled with a history of severe anaphylaxis (Anaphylaxis Staging System grade 3).
CONCLUSION: Consistent with previous phase 3 studies, long-term EPIT with VIASKIN peanut patch 250 μg was well tolerated with high adherence in peanut-allergic children aged 4 through 11 years (clinicaltrials.gov; NCT: NCT02916446).