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1. WAO consensus on DEfinition of Food Allergy SEverity (DEFASE)

Author

Stefania Arasi, MD, PhD, MSc, Ulugbek Nurmatov, MD, Audrey Dunn-Galvin, PhD, Graham Roberts, DM, Paul J. Turner, FRCPCH, PhD, Sayantani B. Shinder, MD, PhD, Ruchi Gupta, MD, MPh, Philippe Eigenmann, MD, Anna Nowak-Wegrzyn, MD, PhD, Ignacio J. Ansotegui, MD, PhD, Montserrat Fernandez Rivas, MD, Stavros Petrou, PhD, Luciana K. Tanno, MD, PhD, Marta Vazquez-Ortiz, MD, PhD, Brian Vickery, MD, PhD, Gary Wong, MD, FRCPC, Montserrat Alvaro-Lozano, MD, PhD, Miqdad Asaria, PhD, Philippe Begin, MD, MSc, Martin Bozzola, MD, Robert Boyle, MD, Helen Brough, MD, PhD, Victoria Cardona, MD, PhD, R. Sharon Chinthrajah, MD, PhD, Antonella Cianferoni, MD, Antoine Deschildre, MD, David Fleischer, MD, Flavio Gazzani, PhD, Jennifer Gerdts, Marilena Giannetti, PhD, Matthew Greenhawt, MD, MBA, MSc, Maria Antonieta Guzmán, MD, Elham Hossny, MD, PhD, FAAAAI, Paula Kauppi, MD, Carla Jones, Francesco Lucidi, PhD, Olga Patricia Monge Ortega, MD, PhD, Daniel Munblit, MD, PhD, Antonella Muraro, MD, Giovanni Pajno, MD, Marcia Podestà, Pablo Rodriguez del Rio, MD, PhD, Maria Said, Alexandra Santos, MD, MSc, MRCPCH, PGCAP, FHEA, PhD, Marcus Shaker, MD, Hania Szajewska, MD, PhD, Carina Venter, PhD, Cristopher Warren, PhD, Tonya Winders, Motohiro Ebisawa, MD, PhD, and Alessandro Fiocchi, MD

Subjects
Consensus, Definition, Food allergy, Severity, e-Delphi study, Immunologic diseases. Allergy, RC581-607
Abstract

Background: While several scoring systems for the severity of anaphylactic reactions have been developed, there is a lack of consensus on definition and categorisation of severity of food allergy disease as a whole. Aim: To develop an international consensus on the severity of food allergy (DEfinition of Food Allergy Severity, DEFASE) scoring system, to be used globally. Methods: Phase 1: We conducted a mixed-method systematic review (SR) of 11 databases for published and unpublished literature on severity of food allergy management and set up a panel of international experts. Phase 2: Based on our findings in Phase 1, we drafted statements for a two-round modified electronic Delphi (e-Delphi) survey. A purposefully selected multidisciplinary international expert panel on food allergy (n = 60) was identified and sent a structured questionnaire, including a set of statements on different domains of food allergy severity related to symptoms, health-related quality of life, and economic impact. Participants were asked to score their agreement on each statement on a 5-point Likert scale ranging from “strongly agree” to “strongly disagree”. Median scores and percentage agreements were calculated. Consensus was defined a priori as being achieved if 70% or more of panel members rated a statement as “strongly agree” to “agree” after the second round. Based on feedback, 2 additional online voting rounds were conducted. Results: We received responses from 92% of Delphi panel members in round 1 and 85% in round 2. Consensus was achieved on the overall score and in all of the 5 specific key domains as essential components of the DEFASE score. Conclusions: The DEFASE score is the first comprehensive grading of food allergy severity that considers not only the severity of a single reaction, but the whole disease spectrum. An international consensus has been achieved regarding a scoring system for food allergy disease. It offers an evaluation grid, which may help to rate the severity of food allergy. Phase 3 will involve validating the scoring system in research settings, and implementing it in clinical practice.

Published
2023
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2. IgE-immunoadsorption for severe allergy to multiple foods: A case series of five children

Author

Stefania Arasi, MD, PhD, MSC, Anna Lucia Piscitelli, MD, Arianna Cafarotti, MD, Beatrice Marziani, MD, Valentina Pecora, MD, Lamia Dahdah, MD, Giovanna Leone, MD, Giorgia Bracaglia, PhD, Ottavia Porzio, MD, Andrea Onetti Muda, MD, and Alessandro Fiocchi, MD

Subjects
Anti-IgE treatment, Children, IgE-immunoadsorption, Omalizumab, Severe food allergy, Immunologic diseases. Allergy, RC581-607
Abstract

Background: Children with severe food allergy may present high risk of fatal anaphylaxis and a highly impaired quality of life. Anti IgE-treatment has been shown to be a promising approach as monotherapy for severe allergy to multiple foods. However, very high serum total IgE levels may limit its use.This study aims to assess the efficacy of IgE-selective immunoadsorption (IgE-IA) on total IgE levels and threshold of reactivity to the culprit foods in children with history of severe anaphylaxis due to multiple foods and allergic comorbidities. Methods: In this single-center, prospective, open-label efficacy study we evaluated children with severe asthma, allergy to 2+foods and total IgE levels >2300 kUI/L. To establish the food reactivity threshold, each patient underwent oral food challenges (OFCs) before and after IgE-IA. Results: Five patients (4 males; age, 12.2 ± 5 years, mean ± SD) underwent an average of 3 (range 2–4) sessions of IgE-IA. Each session reduced IgE levels by a mean of 1958.87 kUI/L. After the IgE-IA cycle, serum total IgE dropped from 3948 ± 1652.7 (mean ± SD) to 360.8 ± 71.9 kUI/L (−10.9 folds; p = 0.01). The threshold of reactivity (No Observed Adverse Effect Level, NOAEL) tested at OFCs for the culprit foods (4 baked-milk + 2 baked-egg + 1 lentil + 2 hazelnut + 1 wheat) increased overall from 21.5 (median, IQR 1.5–82.6) protein milligrams to 1115 (837.2–4222.8) milligrams (p

Published
2023
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3. World Allergy Organization (WAO) Diagnosis and Rationale for Action against Cow's Milk Allergy (DRACMA) guideline update – XIII – Oral immunotherapy for CMA – Systematic review

Author

Antonio Bognanni, MD, Derek K. Chu, MD, Ramon T. Firmino, DDS, PhD, Stefania Arasi, PhD, MSc, Siw Waffenschmidt, Arnav Agarwal, MD, Piotr Dziechciarz, MD, PhD, Andrea Horvath, MD, PhD, Rime Jebai, MSc, MPH, Hanako Mihara, MD, MPH, Yetiani Roldan, MD, Maria Said, RN, Raanan Shamir, MD, PhD, Martin Bozzola, MD, Sami Bahna, MD, DrPH, Alessandro Fiocchi, MD, Susan Waserman, MD, MSc, Holger J. Schünemann, MD, MSc, PhD, Jan L. Brożek, MD, PhD, Ignacio J. Ansotegui, MD, PhD, Stefania Arasi, MD, PhD, Amal H. Assa'ad, MD, Sami L. Bahna, MD, DrPH, Roberto Berni Canani, MD, PhD, Jan Brozek, MD, PhD, Derek K. Chu, MD, PhD, Lamia Dahdah, MD, Christophe Dupont, MD, PhD, Motohiro Ebisawa, MD, PhD, Ramon Targino Firmino, MD, Elena Galli, MD, PhD, Rose Kamenwa, MD, Gideon Lack, MBBCh, Haiqi Li, MD, Alberto Martelli, MD, Anna H. Nowak-Wegrzyn, MD, PhD, Nikolaos G. Papadopoulos, MD, PhD, Ruby Pawankar, MD, PhD, Mario Sánchez-Borges, MD, Jonathan M. Spergel, MD, PhD, Hania Szajewska, MD, Luigi Terracciano, MD, Yvan Vandenplas, MD, PhD, Carina Venter, PhD, RD, Amena Warner, RN, SN (PG Dip), and GaryW.K. Wong, MD

Subjects
Milk allergy, Oral immunotherapy, Systematic review, Meta-analysis, GRADE, Immunologic diseases. Allergy, RC581-607
Abstract

Background: Allergy to cow's milk is the most common food allergy in infants and it is usually outgrown by 5 years of age. In some individuals it persists beyond early childhood. Oral immunotherapy (OIT, oral desensitization, specific oral tolerance induction) has been proposed as a promising therapeutic strategy for persistent IgE-mediated cow's milk allergy. We previously published the systematic review of OIT for cow's milk allergy (CMA) in 2010 as part of the World Allergy Organization (WAO) Diagnosis and Rationale for Action against Cow's Milk Allergy (DRACMA) Guidelines. Objective: To systematically synthesize the currently available evidence about OIT for IgE-mediated CMA and to inform the updated 2022 WAO guidelines. Methods: We searched the electronic databases including PubMed, Medline, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), and the websites of selected allergy organizations. We included all studies irrespective of the language of the original publication. The last search was conducted in February 2021. We registered the protocol on Open Science Framework (10.17605/OSF.IO/AH2DT). Results: We identified 2147 unique records published between 2010 and 2021, including 13 randomized trials and 109 observational studies addressing cow's milk OIT. We found low-certainty evidence that OIT with unheated cow's milk, compared to elimination diet alone, increased the likelihood of being able to consume ≥150 ml of cow's milk in controlled settings (risk ratio (RR): 12.3, 95% CI: 5.9 to 26.0; risk difference (RD): 25 more per 100, 95% CI 11 to 56) as well as accidently ingest a small amount (≥5 ml) of cow's milk (RR: 8.7, 95% CI: 4.7 to 16.1; RD: 25 more per 100, 95% CI 12 to 50). However, 2–8 weeks after discontinuation of a successful OIT, tolerance of cow's milk persisted in only 36% (range: 20%–91%) of patients. OIT increased the frequency of anaphylaxis (rate ratio: 60.0, 95% CI 15 to 244; rate difference 5 more anaphylactic reactions per 1 person per year, 95% CI: 4 to 6; moderate evidence) and the frequency of epinephrine use (rate ratio: 35.2, 95% CI: 9 to 136.5; rate difference 268 more events per 100 person-years, 95% CI: 203 to 333; high certainty). OIT also increased the risk of gastrointestinal symptoms (RR 6.9, 95% CI 1.6–30.9; RD 28 more per 100, CI 3 to 100) and respiratory symptoms (RR 49.0, 95% CI 3.12–770.6; RD 77 more per 100, CI 62 to 92), compared with avoidance diet alone. Single-arm observational studies showed that on average 6.9% of OIT patients (95% CI: 3.8%–10%) developed eosinophilic esophagitis (very low certainty evidence). We found 1 trial and 2 small case series of OIT with baked milk. Conclusions: Moderate certainty evidence shows that OIT with unheated cow's milk in patients with IgE-mediated CMA is associated with an increased probability of being able to drink milk and, at the same time, an increased risk of serious adverse effects.

Published
2022
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4. Managing food allergy: GA2LEN guideline 2022

Author

Antonella Muraro, MD, Debra de Silva, PhD, Susanne Halken, DM DMSc, Margitta Worm, MD∗, Ekaterina Khaleva, MD MSc, Stefania Arasi, MD PhD, Audrey Dunn-Galvin, PhD, Bright I. Nwaru, PhD, Nicolette W. De Jong, PhD, Pablo Rodríguez Del Río, MD PhD, Paul J. Turner, FRCPCH PhD, Pete Smith, FRACP PhD, Philippe Begin, MD MSc, Elizabeth Angier, MSc, Hasan Arshad, DM, Barbara Ballmer-Weber, PhD, Kirsten Beyer, MD, Carsten Bindslev-Jensen, MD PhD DSc, Antonella Cianferoni, MD PhD, Céline Demoulin, Antoine Deschildre, MD, Motohiro Ebisawa, MD PhD, Maria Montserrat Fernandez-Rivas, DM PhD, Alessandro Fiocchi, MD, Bertine Flokstra-de Blok, PhD, Jennifer Gerdts, Josefine Gradman, MD, Kate Grimshaw, PhD, Carla Jones, Susanne Lau, MD, Richard Loh, FRACP, Montserrat Alvaro Lozano, MD, Mika Makela, MD PhD, Mary Jane Marchisotto, Rosan Meyer, PhD, Clare Mills, PhD, Caroline Nilsson, MD PhD, Anna Nowak-Wegrzyn, MD PhD, Ulugbek Nurmatov, PhD, Giovanni Pajno, MD, Marcia Podestà, Lars K. Poulsen, PhD, Hugh A. Sampson, MD, Angel Sanchez, Sabine Schnadt, Hania Szajewska, MD, Ronald Van Ree, PhD, Carina Venter, PhD, Berber Vlieg-Boerstra, PhD, Amena Warner, Gary Wong, MD FRCPC, Robert Wood, MD, Torsten Zuberbier, MD, Graham Roberts, DM, Priya Bansal, Roberto Berni–Canani, Katharina Blumchen, Andreas Bonertz, Melisande Bourgoin-Heck, Ozlem Ceylon, Amandine Divaret-Chauveau, David Fleischer, Maximiliano Gomez, Marion Groetch, Domingo Barber Hernandez, Betina Hjorth, Lydia Collins Hussey, André C. Knulst, Agnes Leung, Douglas Mack, Vera Mahler, Francesca Mori, Leyla Namazova-Baranova, Kati Palosuo, Claudio Alberto Salvador Parisi, Antonio Carlos Pastorino, Odilija Rudzeviciene, Maria Said, Piotr Sawiec, Scott Sicherer, Sakura Sato, and Svitlana Zubchenko

Subjects
Food allergy, Food hypersensitivity, Children, Adolescent, Adults, Immunologic diseases. Allergy, RC581-607
Abstract

Food allergy affects approximately 2–4% of children and adults. This guideline provides recommendations for managing food allergy from the Global Allergy and Asthma European Network (GA2LEN). A multidisciplinary international Task Force developed the guideline using the Appraisal of Guidelines for Research and Evaluation (AGREE) II framework and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. We reviewed the latest available evidence as of April 2021 (161 studies) and created recommendations by balancing benefits, harms, feasibility, and patient and clinician experiences. We suggest that people diagnosed with food allergy avoid triggering allergens (low certainty evidence). We suggest that infants with cow's milk allergy who need a breastmilk alternative use either hypoallergenic extensively hydrolyzed cow's milk formula or an amino acid-based formula (moderate certainty). For selected children with peanut allergy, we recommend oral immunotherapy (high certainty), though epicutaneous immunotherapy might be considered depending on individual preferences and availability (moderate certainty). We suggest considering oral immunotherapy for children with persistent severe hen's egg or cow's milk allergy (moderate certainty). There are significant gaps in evidence about safety and effectiveness of the various strategies. Research is needed to determine the best approaches to education, how to predict the risk of severe reactions, whether immunotherapy is cost-effective and whether biological therapies are effective alone or combined with allergen immunotherapy.

Published
2022
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