Naoka Itoh-Nagato1, Yuzaburo Inoue2, Mizuho Nagao3, Takao Fujisawa3, Naoki Shimojo4, Tsutomu Iwata5. 1. Department of Pediatrics, Shimoshizu National Hospital, Chiba, Japan. 2. Department of Pediatrics, Eastern Chiba Medical Center, Chiba, Japan; Department of General Medical Science, Graduate School of Medicine, Chiba University, Chiba, Japan. Electronic address: yuzaburo@chiba-u.jp. 3. Allergy Center, Mie National Hospital, Mie, Japan. 4. Department of Pediatrics, Graduate School of Medicine, Chiba University, Chiba, Japan. 5. Allergy Center, Mie National Hospital, Mie, Japan; Department of Education for Childcare, Faculty of Child Studies, Tokyo Kasei University, Saitama, Japan.
Abstract
BACKGROUND:Patients with food allergies and their families have a significantly reduced health-related quality of life (QOL). METHODS: We performed a multicenter, randomized, parallel-group, delayed-start design study to clarify the efficacy and safety of rush oral immunotherapy (rOIT) and its impact on the participants' daily life and their guardians (UMIN000003943). Forty-five participants were randomly divided into an early-start group and a late-start group. The early-start group received rOIT for 3 months, while the late-start group continued the egg elimination diet (control). In the next stage, both groups received OIT until all participants had finished 12 months of maintenance OIT. RESULTS: The ratio of the participants in whom an increase of the TD was achieved in the first stage was significantly higher in the early-start group (87.0%), than in the late-start group (22.7%). The QOL of the guardians in the early-start group significantly improved after the first stage (65.2%), in comparison to the late-start group (31.8%). During 12 months of rOIT, the serum ovomucoid-specific IgE levels, the percentage of CD203c+ basophils upon stimulation with egg white, and the wheal size to egg white were decreased, while the serum ovomucoid-specific IgG4 levels were increased. However, approximately 80% of the participants in the early-start group showed an allergic reaction during the first stage of the study, whereas none of the patients in the late-start group experienced an allergic reaction. CONCLUSIONS: rOIT induced desensitization to egg and thus improved the QOL of guardians; however, the participants experienced frequent allergic reactions due to the treatment.
RCT Entities:
BACKGROUND:Patients with food allergies and their families have a significantly reduced health-related quality of life (QOL). METHODS: We performed a multicenter, randomized, parallel-group, delayed-start design study to clarify the efficacy and safety of rush oral immunotherapy (rOIT) and its impact on the participants' daily life and their guardians (UMIN000003943). Forty-five participants were randomly divided into an early-start group and a late-start group. The early-start group received rOIT for 3 months, while the late-start group continued the egg elimination diet (control). In the next stage, both groups received OIT until all participants had finished 12 months of maintenance OIT. RESULTS: The ratio of the participants in whom an increase of the TD was achieved in the first stage was significantly higher in the early-start group (87.0%), than in the late-start group (22.7%). The QOL of the guardians in the early-start group significantly improved after the first stage (65.2%), in comparison to the late-start group (31.8%). During 12 months of rOIT, the serum ovomucoid-specific IgE levels, the percentage of CD203c+ basophils upon stimulation with egg white, and the wheal size to egg white were decreased, while the serum ovomucoid-specific IgG4 levels were increased. However, approximately 80% of the participants in the early-start group showed an allergic reaction during the first stage of the study, whereas none of the patients in the late-start group experienced an allergic reaction. CONCLUSIONS: rOIT induced desensitization to egg and thus improved the QOL of guardians; however, the participants experienced frequent allergic reactions due to the treatment.
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
Authors: Antonella Muraro; Debra de Silva; Susanne Halken; Margitta Worm; Ekaterina Khaleva; Stefania Arasi; Audrey Dunn-Galvin; Bright I Nwaru; Nicolette W De Jong; Pablo Rodríguez Del Río; Paul J Turner; Pete Smith; Philippe Begin; Elizabeth Angier; Hasan Arshad; Barbara Ballmer-Weber; Kirsten Beyer; Carsten Bindslev-Jensen; Antonella Cianferoni; Céline Demoulin; Antoine Deschildre; Motohiro Ebisawa; Maria Montserrat Fernandez-Rivas; Alessandro Fiocchi; Bertine Flokstra-de Blok; Jennifer Gerdts; Josefine Gradman; Kate Grimshaw; Carla Jones; Susanne Lau; Richard Loh; Montserrat Alvaro Lozano; Mika Makela; Mary Jane Marchisotto; Rosan Meyer; Clare Mills; Caroline Nilsson; Anna Nowak-Wegrzyn; Ulugbek Nurmatov; Giovanni Pajno; Marcia Podestà; Lars K Poulsen; Hugh A Sampson; Angel Sanchez; Sabine Schnadt; Hania Szajewska; Ronald Van Ree; Carina Venter; Berber Vlieg-Boerstra; Amena Warner; Gary Wong; Robert Wood; Torsten Zuberbier; Graham Roberts Journal: World Allergy Organ J Date: 2022-09-07 Impact factor: 5.516