Omalizumab dose–related efficacy in a cohort of children with severe food allergy: OSAFA cohort

Omalizumab dose–related efficacy in a cohort of children with severe food allergy: OSAFA cohort | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL Allergy This is a preprint and has not been peer reviewed. Data may be preliminary. 31 March 2025 V1 Latest version Share on Omalizumab dose–related efficacy in a cohort of children with severe food allergy: OSAFA cohort Authors : Stefania Arasi 0000-0002-8135-0568 , Carol Bitetti , Lucia Lo Scalzo 0000-0001-9303-2551 [email protected] , Alessandra Spagnoli , Elena Fabrizi 0000-0003-3173-3533 , Alessandro Fiocchi 0000-0002-2549-0523 , and Arianna Cafarotti Authors Info & Affiliations https://doi.org/10.22541/au.174344110.08555315/v1 Published Journal of Allergy and Clinical Immunology Version of record Peer review timeline 418 views 289 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Background: We recently published on clinical efficacy of 1-year-long evaluation of 65 asthmatics with severe IgE-mediated food allergy (FA) under Omalizumab: Omalizumab is safe and able to increase reactivity threshold, allows safe food introduction, and improves quality of life (OSAFA-study, ClinicalTrials.gov, NCT06316414). Herein, we assess Omalizumab dose–related efficacy during the first year Omalizumab-treatment in achieving food desensitization in patients with severe FA. Methods: Children (6-18 years) with severe asthma and severe allergy to ≥ 1food allergen were screened. Oral food challenges (OFCs), skin prick test (SPT), complete blood count, chemistry, total and specific IgE were measured at baseline and at 12 months of Omalizumab. Results: 76 patients (previously published cohort plus 11 newly-enrolled patients) were included [OSAFA (Omalizumab in Severe Asthmatics with Food Allergy) study]. 69.7% were male; mean age (SD) 12.2 (4.19) years. 77.6% were allergic to 2+ foods. Total IgE median was 644 kU/L. After adjusting for confounders, such as age and gender, a significant association was observed between the achievement of desensitization and the dosage (mg/month) of Omalizumab (OR: 1.151, 95% CI:1. 066-1.258), while no significant effect was observed for total IgE levels at the baseline (OR: 0.999, 95% CI: 0.998-1.001). Conclusions: The findings of this study indicate that the efficacy of Omalizumab is independent, ceteris paribus , from total IgE levels, suggesting that body weight is the most appropriate parameter for calculating its dosage in the treatment of patients with severe FA. Supplementary Material File (figure 1.docx) Download 95.95 KB File (figure 2.docx) Download 219.02 KB File (figure 3.docx) Download 34.50 KB File (main manuscript.docx) Download 87.01 KB Information & Authors Information Version history V1 Version 1 31 March 2025 Peer review timeline Published Journal of Allergy and Clinical Immunology Version of Record 1 Feb 2025 Published Copyright This work is licensed under a Non Exclusive No Reuse License. Collection Allergy Keywords allergy treament anaphylaxis asthma biologics food allergy pediatrics Authors Affiliations Stefania Arasi 0000-0002-8135-0568 Ospedale Pediatrico Bambino Gesu IRCCS View all articles by this author Carol Bitetti Azienda Ospedaliera Regionale San Carlo View all articles by this author Lucia Lo Scalzo 0000-0001-9303-2551 [email protected] Ospedale Pediatrico Bambino Gesu IRCCS View all articles by this author Alessandra Spagnoli Universita degli Studi di Roma La Sapienza Dipartimento di Sanita Pubblica e Malattie Infettive View all articles by this author Elena Fabrizi 0000-0003-3173-3533 Universita degli Studi di Teramo Facolta di Scienze Politiche View all articles by this author Alessandro Fiocchi 0000-0002-2549-0523 Ospedale Pediatrico Bambino Gesu IRCCS View all articles by this author Arianna Cafarotti Ospedale Pediatrico Bambino Gesu IRCCS View all articles by this author Metrics & Citations Metrics Article Usage 418 views 289 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Stefania Arasi, Carol Bitetti, Lucia Lo Scalzo, et al. Omalizumab dose–related efficacy in a cohort of children with severe food allergy: OSAFA cohort. Authorea . 31 March 2025. DOI: https://doi.org/10.22541/au.174344110.08555315/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu . 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