GA2LEN ANACARE consensus statement: Potential of omalizumab in food allergy management

Torsten Zuberbier; Antonella Muraro; Ulugbek Nurmatov; Stefania Arasi; Katarina Stevanovic; Aikaterini Anagnostou; Roberta Bonaguro; Sharon Chinthrajah; Gideon Lack; Alessandro Fiocchi; Thuy-My Le; Paul Turner; Montserrat Alvaro Lozano; Elizabeth Angier; Simona Barni; Phillippe Bégin; Barbara Ballmer-Weber; Victoria Cardona; Carsten Bindslev-Jensen; Antonella Cianferoni; Nicolette de Jong; Debra de Silva; Antoine Deschildre; Audrey Dunn Galvin; Motohiro Ebisawa; David M Fleischer; Jennifer Gerdts; Mattia Giovannini; Josefine Gradman; Susanne Halken; Syed Hasan Arshad; Ekaterina Khaleva; Susanne Lau; Richard Loh; Mika J Mäkelä; Mary Jane Marchisotto; Laura Morandini; Charlotte G Mortz; Caroline Nilsson; Anna Nowak-Wegrzyn; Marcia Podestà; Lars K Poulsen; Graham Roberts; Pablo Rodríguez Del Río; Hugh A Sampson; Angel Sánchez; Sabine Schnadt; Peter K Smith; Hania Szajewska; Natasa Teovska Mitrevska; Alice Toniolo; Carina Venter; Amena Warner; Gary W K Wong; Robert Wood; Margitta Worm

doi:10.1002/clt2.70002

GA²LEN ANACARE consensus statement: Potential of omalizumab in food allergy management

Clin Transl Allergy. 2024 Nov;14(11):e70002. doi: 10.1002/clt2.70002.

Authors

Torsten Zuberbier^{1

2}, Antonella Muraro³, Ulugbek Nurmatov⁴, Stefania Arasi⁵, Katarina Stevanovic^{1

2}, Aikaterini Anagnostou⁶, Roberta Bonaguro³, Sharon Chinthrajah⁷, Gideon Lack^{8

9

10}, Alessandro Fiocchi⁵, Thuy-My Le^{11

12}, Paul Turner¹³, Montserrat Alvaro Lozano^{14

15

16}, Elizabeth Angier¹⁷, Simona Barni¹⁸, Phillippe Bégin^{19

20}, Barbara Ballmer-Weber^{21

22}, Victoria Cardona²³, Carsten Bindslev-Jensen²⁴, Antonella Cianferoni²⁵, Nicolette de Jong²⁶, Debra de Silva²⁷, Antoine Deschildre²⁸, Audrey Dunn Galvin²⁹, Motohiro Ebisawa³⁰, David M Fleischer³¹, Jennifer Gerdts³², Mattia Giovannini¹⁸, Josefine Gradman³³, Susanne Halken³³, Syed Hasan Arshad^{34

35

36}, Ekaterina Khaleva³⁷, Susanne Lau³⁸, Richard Loh^{39

40

41}, Mika J Mäkelä⁴², Mary Jane Marchisotto⁴³, Laura Morandini³, Charlotte G Mortz²⁴, Caroline Nilsson^{44

45}, Anna Nowak-Wegrzyn^{46

47}, Marcia Podestà⁴⁸, Lars K Poulsen⁴⁹, Graham Roberts^{50

51

52}, Pablo Rodríguez Del Río⁵³, Hugh A Sampson⁵⁴, Angel Sánchez⁵⁵, Sabine Schnadt⁵⁶, Peter K Smith⁵⁷, Hania Szajewska⁵⁸, Natasa Teovska Mitrevska^{59

60}, Alice Toniolo³, Carina Venter³², Amena Warner⁶¹, Gary W K Wong⁶², Robert Wood⁶³, Margitta Worm⁶⁴

Affiliations

¹ Institute of Allergology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
² Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany.
³ Food Allergy Referral Centre, Department of Women and Children Health, Padua University Hospital, Padua, Italy.
⁴ Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.
⁵ Allergy Unit, Pediatric Hospital Bambino Gesù IRCCS, Rome, Italy.
⁶ Department of Pediatrics, Division of Allergy and Immunology, Baylor College of Medicine, Houston, Texas, USA.
⁷ Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford, California, USA.
⁸ Paediatric Allergy, King's College London, London, UK.
⁹ Department of Women and Children's Health/Peter Gorer, Department of Immunobiology, School of Life Course and Population Sciences, King's College London, London, UK.
¹⁰ Evelina London Children's Hospital, Guy's and St. Thomas' NHS Foundation Trust, London, UK.
¹¹ Department of Dermatology/Allergology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
¹² Centre of Translational Immunology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
¹³ Imperial College London, London, UK.
¹⁴ Pediatric Allergy and Clinical Immunology Department, Hospital Sant Joan de Déu, Barcelona, Spain.
¹⁵ Institut de Recerca Sant Joan de Déu, Barcelona, Spain.
¹⁶ Universitat de Barcelona, Barcelona, Spain.
¹⁷ Primary Care, Population Science and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK.
¹⁸ Allergy Unit, Meyer Children's Hospital IRCCS, Florence, Italy.
¹⁹ Section of Allergy and Clinical Immunology, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada.
²⁰ Department of Medicine, Section of Allergy and Clinical Immunology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.
²¹ Clinic for Dermatology and Allergology, St. Gallen, Switzerland.
²² Department of Dermatology, University Hospital Zurich, Zurich, Switzerland.
²³ Allergy Section, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
²⁴ Department of Dermatology and Allergy Centre, Odense Research Centre for Anaphylaxis (ORCA), Odense University Hospital, University of Southern Denmark, Odense, Denmark.
²⁵ Allergy and Immunology Division, Perelman School of Medicine, The Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
²⁶ Internal Medicine, Allergology & Clinical Immunology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.
²⁷ The Evidence Centre, London, UK.
²⁸ University Lille, INSERM Unit 1019, CNRS UMR 9017, CHU Lille, Institut Pasteur de Lille, Center for Infection and Immunity of Lille, Lille, France.
²⁹ Allergy Research Group, University College Cork, Cork, Ireland.
³⁰ Clinical Research Center for Allergy and Rheumatology, NHO Sagamihara National Hospital, Kanagawa, Japan.
³¹ University of Colorado Denver School of Medicine, Children's Hospital Colorado, Aurora, Colorado, USA.
³² Food Allergy Canada, Toronto, Ontario, Canada.
³³ Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense, Denmark.
³⁴ Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
³⁵ David Hide Asthma and Allergy Research Centre, Isle of Wight, UK.
³⁶ NIHR Southampton Biomedical Research Centre, Southampton General Hospital, Southampton, UK.
³⁷ Faculty of Medicine, University of Southampton, Southampton, UK.
³⁸ Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.
³⁹ Medical School, The University of Western Australia, Perth, Western Australia, Australia.
⁴⁰ Perth Children's Hospital, Perth, Western Australia, Australia.
⁴¹ Australasian Society of Clinical Immunology and Allergy (ASCIA), Sydney, Western Australia, Australia.
⁴² Skin and Allergy Hospital, Helsinki University Central Hospital and University of Helsinki, Helsinki, Finland.
⁴³ MJM Advisory, New York, New York, USA.
⁴⁴ Department of Clinical Science and Education, Karolinska Institutet, Stockholm, Sweden.
⁴⁵ Sachs Children and Youth Hospital, South Hospital, Stockholm, Sweden.
⁴⁶ Department of Pediatrics, Hassenfeld Children's Hospital, NYU Grossman School of Medicine, New York City, New York, USA.
⁴⁷ Department of Pediatrics, Gastroenterology and Nutrition, Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland.
⁴⁸ EFA - European Federation of Allergy and Airways Diseases Patients' Associations, Brussels, Belgium.
⁴⁹ Allergy Clinic, Copenhagen University Hospital at Herlev-Gentofte, Copenhagen, Denmark.
⁵⁰ Department of Paediatric Allergy and Respiratory Medicine, University of Southampton, Southampton, UK.
⁵¹ NIHR Southampton Biomedical Research Centre, Southampton, UK.
⁵² David Hide Asthma and Allergy Centre, St Mary Hospital, Isle of Wight, UK.
⁵³ Hospital Infantil Universitario Niño Jesús, Madrid, Spain.
⁵⁴ Division of Allergy and Immunology, Department of Pediatrics, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
⁵⁵ AEPNAA Spanish Association of People with Food and Latex Allergy, Madrid, Spain.
⁵⁶ German Allergy and Asthma Association (DAAB), Mönchengladbach, Germany.
⁵⁷ Griffith University School of Medicine, Gold Coast, Queensland, Australia.
⁵⁸ Department of Paediatrics, Medical University of Warsaw, Warszawa, Poland.
⁵⁹ Dermatology Department, Remedika General Hospital, Skopje, North Macedonia.
⁶⁰ Department of Dermatology, International Balkan University, Skopje, North Macedonia.
⁶¹ Allergy UK, London, UK.
⁶² Chinese University of Hong Kong, Hong Kong, Hong Kong.
⁶³ Department of Pediatrics, John Hopkins University School of Medicine, Baltimore, Maryland, USA.
⁶⁴ Division of Allergy and Immunology, Department of Dermatology, Allergy and Venerology, Charité Universitätsmedizin Berlin, Berlin, Germany.

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.

Publication types

Review

Grants and funding

Novartis Pharma