GA2LEN ANACARE consensus statement: Potential of omalizumab in food allergy management
- PMID: 39506193
- PMCID: PMC11540805
- DOI: 10.1002/clt2.70002
GA2LEN ANACARE consensus statement: Potential of omalizumab in food allergy management
Abstract
Immunoglobulin E (IgE)-mediated food allergies are the most common type of food allergy, often causing rapid symptoms after exposure to allergens posing a serious health risk and a high impact on patient's and caregiver's quality of life. Omalizumab, a humanized anti-IgE monoclonal antibody, reduces allergic reactions by binding to circulating IgE. Omalizumab has been successfully used in allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic urticaria, and was recently approved for treating IgE-mediated food allergies by the US Food and Drug Administration (FDA). This GA2LEN ANACARE Consensus Statement presents our position on the use of omalizumab for treating IgE-mediated food allergies, based on a systematic review and meta-analysis, experience with use for other conditions, and expert consensus achieved via an eDelphi process. Following publication of the recent OUtMATCH study (stage 1) results and subsequent FDA approval, we propose that there is now sufficient evidence to recommend omalizumab as the only drug currently available that can mechanistically reduce IgE-mediated food allergic reactions. We acknowledge that the evidence does not reach the highest level of evidence which would be needed for a guideline recommendation.
Keywords: anaphylaxis; desensitization; food allergy; immunoglobulin E; omalizumab.
© 2024 The Author(s). Clinical and Translational Allergy published by John Wiley & Sons Ltd on behalf of European Academy of Allergy and Clinical Immunology.
Conflict of interest statement
Torsten Zuberbier reports honoraria for lectures from Amgen, AstraZeneca, AbbVie, ALK ‐Abelló, Almirall, Astellas, Bayer Health Care, Bencard, Berlin Chemie, FAES Farma, HAL Allergie GmbH, Henkel, Kryolan, Leti, L'Oreal, Meda, Menarini, Merck Sharp and Dohme, Novartis, Nuocor, Pfizer, Sanofi, Stallergenes, Takeda, Teva, UCB, and Uriach; Fees for industry consulting were received from Abivax, Almirall, ,Bluprint, Celldex, Celltrion, Novartis, and Sanofi; in addition he declares non‐paid organizational affiliations: Committee member, “Allergic Rhinitis and its Impact on Asthma” (ARIA), Member of the Board, German Society for Allergy and Clinical Immunology (DGAKI), Head, European Center for Allergy Research Foundation (ECARF), President, Global Allergy and Asthma Excellence Network (GA2LEN), and Member, Committee on Allergy Diagnosis and Molecular Allergology, World Allergy Organisation (WAO). Antonella Muraro reports speaker's fees from Viatris, DVB Technologies, Aimmune, Novartis, and Nestle Health Sciences, and is a non‐paid committee member of “GA2LEN Executive Committee” and “GA2LEN ANACare Steering Committee.” Ulugbek Nurmatov declares no conflict of interest. Stefania Arasi reports contracts from Bambino Gesu’ Children Research Hospital, speaker's fees from Ulrich and DBV, participation on the advisory board for Novartis and AIMMUNE, and is a non‐paid committee member of EAACI. Katarina Stevanovic declares no conflicts of interest. Aikaterini Anagnostou reports consulting fees from Novartis, Genentech, ALK; speaker's fees from EPG Health, MJH, Adelphi, Aimmune Therapeutics, Genentech, FARE, Medscape, Innovation horizons; travel fee support from Novartis, Medscape, multiple allergy societies, and participation on advisory boards for Ready set food, Novartis, Genentech, and Bryn. Roberta Bonaguro declares no conflicts of interest. Sharon Chinthrajah reports grants from Consortium for Food Allergy Research (CoFAR), National Institute of Allergy and Infectious Disease (NIAID), Food Allergy Research and Education (FARE); is an advisory board member for Alladapt Immunotherapeutics, Novartis, Allergenis, Intrommune Therapeutics, Phylaxis, Genentech, and Blueprint Therapeutics; is a stockholder of Intrommune Therapeutics. Gideon Lack reports grants from the National Institute of Allergy and Infectious Diseases (NIAID, NIH) and National Peanut Boards (NPB); consulting fees from Novartis, DBV Technologies, Reckitt Mead Johnson, and ALK Abello; speaker's fees from DBV Technologies, Aimmune, and EPG Health; and is a shareholder of DBV Technologies and Mighty MissionMe. Alessandro Fiocchi reports grants from Novartis, Ferrero, Sanofi, Stallergenes, Danone, and Aimmune; consulting fees from Abbott and Ferrero; speaker's fees from Sanofi; and non‐paid committee member of World Allergy Organization (WAO) and American Academy of Allergy Asthma and Immunology (AAAAI). Thuy‐My Le reports speaker's fees from Thermofisher and Abbvie. Paul Turner reports grants from the Medical Research Council, Food Standards Agency, JM Charitable Foundation, National Institute for Health and Care Research (NIHR)–Imperial Biomedical Research Center, outside the submitted work, and personal fees from the UK Food Standards Agency, DBV Technologies, Aimmune Therapeutics, Allergenis, and ILSI Europe outside the submitted work. Montserrat Alvaro Lozano declares no conflict of interest. Elizabeth Angier reports support for travel expenses and honoraria from Gp Lecture; is a non‐paid member of Primary Care group members BSACI, Anapyhylaxis UK, and Allergy UK. Simona Barni reports speaker's fees from Nutricia and Sanofi. Phillippe Bégin reports payments to institutions for clinical trials from Novartis, DBV Technologies, and Sanofi; consulting fees from ALK, Novartis, DBV Technologies, and Pfizer; and speaker's fees from ALK and Novartis. Barbara Balmer‐Webber reports consulting fees from ALK, Novartis, Sanofi, and Allergopharma; speaker's fees from Thermo Fisher, Novartis, Sanofi, and Menarini. Victoria Cardona declares no conflicts of interest. Carsten Bindslev‐Jensen reports grant from Novartis and consulting fees from ALK Abello and Novartis. Antonella Cianferoni declares no conflicts of interest. Nicolette de Jong declares no conflicts of interest. Debra de Silva declares no conflicts of interest. Antoine Deschildre reports consulting fees from Novartis, ALK, GSK, Sanofi, Regeneron, Aimmune Therapeutics, Nestlé Health Science, Stallergènes‐Greer, Viatris, Celltryon; speaker's fees from Novartis, ALK, GSK, Sanofi, Aimmune Therapeutics, DBV Technologies, Nestlé Health Science, Viatris; travel costs support from ALK, Sanofi, Stallergenes Greer, Novartis, Astra‐Zeneca, Aimmune Therapeutics, Celltryon; participation on a data safety monitoring board for the BOOM study. Audry Dunn Galvin reports consulting fees from Novartis; speaker's fees from Novartis and DBV, support for travel costs from Novartis and DVB, and is a non‐paid member of GA2LEN and Anaphylaxis Ireland. Motohiro Ebisawa reports consulting fees from Novartis, ARS‐Pharmaceuticals, and Sanofi; speaker's fees from Viatris. David M. Fleischer reports grants to institutions from ARS‐Pharmaceuticals and DBV Technologies; Royalties from UpToDate; consulting fees from Genentech, ARS‐Pharmaceuticals, Bryn Pharma, DBV Technologies, and Nasus Pharma; speaker's fees from Genentech; and is a nonpaid member of AAAAI Division Director's Committee, National Peanut Board Medical Advisory Council, Food Allergy and Anaphylaxis Connection Team Medical Advisory Board; and stock owner of Grow Happy. Jennifer Gerdts reports on her honorarium as a member of the Novartis Global Patient Advisory Group. Mattia Giovannini reports speaker's fees from Sanofi. Josephine Gradman declares no conflicts of interest. Sussanne Halken reports speaker's fees from ALK Nordic, Nestlé Purino, and Abigo and personal honoraria as a member of an independent data monitoring committee for Stallergenes. Syed Hasan Arshad reports a grant from the Natasha Allergy Research Foundation. Ekaterina Khaleva declares no conflicts of interest. Susanne Lau reports grant to institution for clinical trial from DBV; speaker's fees from Sanofi‐Aventis and DBV, travel costs support from DBV and Allergopharma, and advisory board honoraria from Sanofi Aventis, DBV, and Leo Pharma. Richard Loh declares no conflicts of interest. Mika J. Mäkelä declares no conflicts of interest. Mary Jane Marchisotto declares no conflicts of interest. Laura Morandini declares no conflicts of interest. Charlotte G. Mortz reports research grants from Novartis. Caroline Nilsson reports grants to institutions from Aimmune Therapeutics and grants for material in a study from Thermo Fisher; speaker's fees from ALK, Thermo Fisher, and GSK; and is a member of the advisory board for Aimmune Therapeutics. Anna Nowak‐Wegrzyn reports speaker's fees from Genentech. Marcia Podesta reports grants from DBV Technologies, Viatris, and Novartis and is a non‐paid member of the Food Allergy Italia, GA2LEN ANAcare Patient's Advocates Team, EACCI Patient Organisation Committee, EACCI Ethics Committee, FAO WHO Codex Alimentarius Commission, and EAACI food allergy‐related task forces and guideline groups. Lars K. Poulson declares no conflict of interest. Graham Roberts reports grants from the National Institutes of Health Research, National Institute of Health, and Action Medical Research; consulting fees from ALK‐Abello, Thermo Fisher, and Astra Zeneca; and is the president of the British Society of Allergy and Clinical Immunology. Pablo Rodrguez del Ro reports a grant from Aimmune Therapeutics, DBV, FAES, and Novartis; speaker's fees from GSK, FAES, Novartis, ALK‐Abelló, LETI, Sanofi, Stallergenes, DBV, EPG‐Health, and Roxall. Hugh A. Sampson report grants for research to institution from National Institutes of Health (NIAID), Food Allergy Research and Education (FARE), and Allergenis; textbook royalties from Wiley/Blackwell and Elsevier; consulting fees from DBV Technologies, N‐Fold LLC, Alpina Biotechnology, Siolta Therapeutics, and AbbVie; honoraria from AAAAI and ACAAI; travel costs support from AAAAI and DBV Technologies, institutional patents for Peptides And Methods For Detecting Egg Allergies, Peptides And Methods For Detecting Peanut Allergies, Methods for characterizing antibody binding affinity and epitope diversity in food allergy, Compounds, extracts and methods from Chinese medicinal herb Sophora flavescens that inhibit airway contractions; stockholder of DBV Technologies and N‐Fold LLC. Angel Sanchez reports consulting fees from Aimmune Therapeutics; fees for participation on the Global Food Allergy Council 2022/2023 by Novartis. Sabine Schnadt declares no conflicts of interest. Peter K. Smith reports grants paid to institutions from Sanofi and GSK; honoraria from Viatris and Novartis; and is a non‐paid member of the AusEE patient group advisory board. Hania Szajewska reports honoraria from Arla, BioGaia, Biocodex, Danone, Dicofarm, Nestlé, NNI, Nutricia, Mead Johnson, and Novalac. Natasa Teovska Mitrevska reports declare no conflict of interest. Alice Toniolo declares no conflicts of interest. Carina Venter reports honoraria from Dannone, Reckitt, Neste Nutrition Institute, and Abbott; research grant to institution from Reckitt; and is a stockholder of Growhappy. Amena Warner reports employment by the patient charity Allergy UK. Gary W. K. Wong reports that he is a non‐paid president of the Hong Kong Institute of Allergy. Robert Wood reports grants from Aimmune, ALK, DBV, Genentech, Novartis, NIH, Siolta, and Aravax and consulting fees from Genentech. Margitta Worm reports consulting fees from Novartis Pharma GmbH, Sanofi‐Aventis Deutschland GmbH, DBV Technologies S.A, Aimmune Therapeutics UK Limited, Leo Pharma GmbH, AstraZenceca GmbH, ALK‐Abelló Arzneimittel GmbH, Lilly Deutschland GmbH, Kymab Limited, Amgen GmbH, Abbvie Deutschland GmbH and Co. KG, Pfizer Pharma GmbH, Mylan Germany GmbH (A Viatris Company), Boehringer Ingelheim Pharma GmbH and Co. KG, GlaxoSmithKline GmbH and Co. KG, Almirall S. A., Amgen GmbH, Pfizer Deutschland GmbH, Bristol‐Myers Squibb GmbH and Co. KGaA and FomF GmbH; honoraria from Novartis Pharma GmbH, Sanofi‐Aventis Deutschland GmbH, DBV Technologies S.A, Aimmune Therapeutics UK Limited, Leo Pharma GmbH, AstraZenceca GmbH, ALK‐Abelló Arzneimittel GmbH, Lilly Deutschland GmbH, Kymab Limited, Amgen GmbH, Abbvie Deutschland GmbH and Co. KG, Pfizer Pharma GmbH, Mylan Germany GmbH (A Viatris Company), Boehringer Ingelheim Pharma GmbH and Co. KG, GlaxoSmithKline GmbH and Co. KG, Almirall S. A., Amgen GmbH, Pfizer Deutschland GmbH, Bristol‐Myers Squibb GmbH and Co. KGaA and FomF GmbH.
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