Inmaculada Pérez-Rangel1, Pablo Rodríguez Del Río2, Carmelo Escudero2, Silvia Sánchez-García2, José Javier Sánchez-Hernández3, María Dolores Ibáñez4. 1. Allergy Department, Hospital Infantil Universitario Niño Jesús, Madrid, Spain. 2. Allergy Department, Hospital Infantil Universitario Niño Jesús, Madrid, Spain; Health Research Institute Princesa, Madrid, Spain. 3. Unidad de Investigación en Salud Pública, Monterrey, Mexico. 4. Allergy Department, Hospital Infantil Universitario Niño Jesús, Madrid, Spain; Health Research Institute Princesa, Madrid, Spain. Electronic address: mibanezs@salud.madrid.org.
Abstract
BACKGROUND: Egg oral immunotherapy is effective but time consuming. OBJECTIVE: To assess the efficacy and safety of egg rush oral immunotherapy (ROIT) with a targeted dose equivalent to a raw egg white. METHODS:Thirty-three persistent egg allergic children confirmed by double-blind, placebo-controlled food challenge (DBPCFC) were randomized to receive egg ROIT immediately after randomization (ROIT1 group), or to continue an egg avoidance diet for 5 months after randomization (control group [CG]). A 5-day build-up phase starting with the highest single tolerated dose at baseline DBPCFC was scheduled and several doses administered daily until achieving a dose of approximately 2,808 mg of egg white protein. In the maintenance phase, patients ate an undercooked egg every 48 hours for 5 months. The CG participants who failed the DBPCFC at 5 months began active treatment. Children from the ROIT1 group plus children from the CG who failed a second DBPCFC at 5 months and then received egg ROIT were randomized to the ROIT2 group. Adverse events (AEs) and immune marker evolution were recorded. RESULTS: A total of 17 (89%) of 19 children in the ROIT1 group and no CG patients were desensitized at 5 months (P < .001). A total of 31 (97%) of the 32 children in the ROIT2 group completed the build-up phase in a median of 3 days (range, 1-14 days), and 30 (94%) of 32 maintained desensitization at 5 months. From baseline to 5 months of treatment, skin prick test, specific IgE, and specific IgE/IgG4 ratio to egg fractions significantly decreased, whereas specific IgG4 increased. During the build-up phase, AEs occurred in 69% of patients (50% had ≤2 AEs) and 31% of doses (2% severe, 55% gastrointestinal). Lower threshold dose in the DBPCFC and higher egg white and ovalbumin specific IgE levels at baseline revealed an association with a higher rate of AEs. CONCLUSION: The proposed 5-day egg ROIT desensitized 94% of the allergic patients, with most AEs being mild or moderate.
RCT Entities:
BACKGROUND: Egg oral immunotherapy is effective but time consuming. OBJECTIVE: To assess the efficacy and safety of egg rush oral immunotherapy (ROIT) with a targeted dose equivalent to a raw egg white. METHODS: Thirty-three persistent egg allergic children confirmed by double-blind, placebo-controlled food challenge (DBPCFC) were randomized to receive egg ROIT immediately after randomization (ROIT1 group), or to continue an egg avoidance diet for 5 months after randomization (control group [CG]). A 5-day build-up phase starting with the highest single tolerated dose at baseline DBPCFC was scheduled and several doses administered daily until achieving a dose of approximately 2,808 mg of egg white protein. In the maintenance phase, patients ate an undercooked egg every 48 hours for 5 months. The CG participants who failed the DBPCFC at 5 months began active treatment. Children from the ROIT1 group plus children from the CG who failed a second DBPCFC at 5 months and then received egg ROIT were randomized to the ROIT2 group. Adverse events (AEs) and immune marker evolution were recorded. RESULTS: A total of 17 (89%) of 19 children in the ROIT1 group and no CG patients were desensitized at 5 months (P < .001). A total of 31 (97%) of the 32 children in the ROIT2 group completed the build-up phase in a median of 3 days (range, 1-14 days), and 30 (94%) of 32 maintained desensitization at 5 months. From baseline to 5 months of treatment, skin prick test, specific IgE, and specific IgE/IgG4 ratio to egg fractions significantly decreased, whereas specific IgG4 increased. During the build-up phase, AEs occurred in 69% of patients (50% had ≤2 AEs) and 31% of doses (2% severe, 55% gastrointestinal). Lower threshold dose in the DBPCFC and higher egg white and ovalbumin specific IgE levels at baseline revealed an association with a higher rate of AEs. CONCLUSION: The proposed 5-day egg ROIT desensitized 94% of the allergic patients, with most AEs being mild or moderate.
Authors: François Graham; Natacha Tardio; Louis Paradis; Anne Des Roches; Philippe Bégin Journal: Hum Vaccin Immunother Date: 2017-10-03 Impact factor: 3.452
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Authors: Debra de Silva; Pablo Rodríguez Del Río; Nicolette W de Jong; Ekaterina Khaleva; Chris Singh; Anna Nowak-Wegrzyn; Antonella Muraro; Philippe Begin; Giovanni Pajno; Alessandro Fiocchi; Angel Sanchez; Carla Jones; Caroline Nilsson; Carsten Bindslev-Jensen; Gary Wong; Hugh Sampson; Kirsten Beyer; Mary-Jane Marchisotto; Montserrat Fernandez Rivas; Rosan Meyer; Susanne Lau; Ulugbek Nurmatov; Graham Roberts Journal: Allergy Date: 2022-01-19 Impact factor: 14.710