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Omalizumab Alleviates Anaphylactic Food Allergy in Children with Severe Asthma: A Real-Life Study
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  • Stefania Arasi,
  • Arianna Cafarotti,
  • Francesca Galletta,
  • Valentina Panetta,
  • Carla Riccardi,
  • Veronica Calandrelli,
  • Vincenzo Fierro,
  • Lamia Dahdah,
  • Maria Cristina Artesani,
  • Rocco Valluzzi,
  • Valentina Pecora,
  • Valeria Tallarico,
  • Giulio Dinardo,
  • Lucia Lo Scalzo,
  • Alessandro Fiocchi
Stefania Arasi
Ospedale Pediatrico Bambino Gesu
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Arianna Cafarotti
Ospedale Pediatrico Bambino Gesu
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Francesca Galletta
Ospedale Pediatrico Bambino Gesu
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Valentina Panetta
Assist Consulting Srl Roma
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Carla Riccardi
Ospedale Pediatrico Bambino Gesu
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Veronica Calandrelli
Ospedale Pediatrico Bambino Gesu
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Vincenzo Fierro
Ospedale Pediatrico Bambino Gesu
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Lamia Dahdah
Ospedale Pediatrico Bambino Gesu
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Maria Cristina Artesani
Ospedale Pediatrico Bambino Gesu
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Rocco Valluzzi
Ospedale Pediatrico Bambino Gesu
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Valentina Pecora
Ospedale Pediatrico Bambino Gesu
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Valeria Tallarico
Ospedale Pediatrico Bambino Gesu
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Giulio Dinardo
Ospedale Pediatrico Bambino Gesu
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Lucia Lo Scalzo
Ospedale Pediatrico Bambino Gesu
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Alessandro Fiocchi
Ospedale Pediatrico Bambino Gesu

Corresponding Author:alessandro.fiocchi@allegriallergia.net

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Abstract

Background: In Europe, Omalizumab (anti-IgE) is indicated for the treatment of moderate/severe asthma, but not for IgE-mediated food allergy (FA). Objective: We prospectively assessed the impact of Omalizumab for efficacy, safety, and quality of life (FA-QoL) in patients with moderate/severe asthma and history of anaphylaxis to peanut, tree nuts, fish, egg, milk, and/or wheat. Methods: Food-allergic children (6-18yrs) with moderate/severe asthma underwent oral food challenges (OFCs) to establish the threshold of reaction to the culprit food(s) at baseline (T0) and at four-month intervals (T1, T2, T3) during their first year of treatment with Omalizumab. We recorded the number and severity of food-allergic reactions, Asthma Control Test (ACT), FA-QoL, and total IgE. Results: In 65 patients allergic to 107 foods, the No Observed Adverse Events Level (NOAEL) at T1 increased: 243- and 488-fold for raw and baked milk, respectively; 172 and 134-fold for raw and baked egg; 245-fold for hazelnut; 55-fold for peanut; 31-fold for wheat, and 10-fold for fish. Full tolerance was achieved in 66.4% of OFCs at T1, 58.3% at T2, and 75% at T3. Ninety-five foods were liberalized ad libitum in the diet of 55 patients; the remaining 12 were introduced by 10 patients at least in traces. Throughout the study, 40/65 children got a free diet. ACT increased from 17 (Q1-Q3:15-17) to 23.6 (Q1-Q3:23-25). The FA-QoL score in children ≤ 12 years decreased from 4.63±0.74 to 2.02±1.13, in adolescents from 4.68±0.92 to 1.90±1.50. Conclusions: Omalizumab allows safe reintroduction of allergenic foods. Trial registration number: ClinicalTrials.gov, NCT06316414
05 Apr 2024Submitted to Allergy
05 Apr 2024Submission Checks Completed
05 Apr 2024Assigned to Editor
05 Apr 2024Review(s) Completed, Editorial Evaluation Pending
14 Jun 20241st Revision Received
03 Jul 2024Review(s) Completed, Editorial Evaluation Pending
08 Jul 2024Editorial Decision: Revise Minor
15 Jul 20242nd Revision Received
18 Jul 2024Assigned to Editor
18 Jul 2024Submission Checks Completed
18 Jul 2024Review(s) Completed, Editorial Evaluation Pending
27 Jul 2024Reviewer(s) Assigned
12 Aug 2024Editorial Decision: Revise Minor
16 Aug 20243rd Revision Received
19 Aug 2024Assigned to Editor
19 Aug 2024Submission Checks Completed
19 Aug 2024Review(s) Completed, Editorial Evaluation Pending
26 Aug 2024Editorial Decision: Accept