Evaluation of clinical outcomes of efficacy in food allergen immunotherapy trials, COFAITH EAACI task force
Por:
Rodríguez Del Río P, Alvaro-Lozano M, Arasi S, Bazire R, Escudero C, Patel N, Mónica Paola Sandoval Ruballos, Vazquez-Ortiz M, Nowak-Wegrzyn A, Blümchen K, Dunn Galvin A, Deschildre A, Greenhawt M, Schnadt S, Riggioni C, Remington BC, Turner P and Fernandez Rivas M
Publicada:
1 abr 2024
Ahead of Print:
1 ene 2024
Resumen:
Food allergy is a global public health problem that until recent years lacked any aetiological treatment supported by academy, industry and regulators. Food immunotherapy (AIT) is an evolving treatment option, supported by clinical practice and industry trial data. Recent AIT meta-analyses have highlighted the difficulty in pooling safety and efficacy data from AIT trials, due to secondary heterogeneity in the study. An EAACI task force (CO-FAITH) initiated by the Paediatric Section was created to focus on AIT efficacy outcomes for milk, egg and peanut allergy rather than in trial results. A systematic search and a narrative review of AIT controlled clinical trials and large case series was conducted. A total of 63 manuscripts met inclusion criteria, corresponding to 23, 21 and 22 studies of milk, egg and peanut AIT, respectively. The most common AIT efficacy outcome was desensitization, mostly defined as tolerating a maintenance phase dose, or reaching a particular dose upon successful exit oral food challenge (OFC). However, a large degree of heterogeneity was identified regarding the dose quantity defining this outcome. Sustained unresponsiveness and patient-reported outcomes (e.g. quality of life) were explored less frequently, and to date have been most rigorously described for peanut AIT versus other allergens. Change in allergen threshold assessed by OFC remains the most common efficacy measure, but OFC methods suffer from heterogeneity and methodological disparity. This review has identified multiple heterogeneous outcomes related to measuring the efficacy of AIT. Efforts to better standardize and harmonize which outcomes, and how to measure them must be carried out to help in the clinical development of safe and efficacious food allergy treatments.
Filiaciones:
Rodríguez Del Río P:
Allergy Department, Hospital Infantil Universitario Niño Jesús, Madrid, Spain
FibHNJ, ARADyAL-RETICs RD16 /0006/0026 Instituto de Salud Carlos III, Madrid, Spain
IIS La Princesa, Madrid, Spain
Alvaro-Lozano M:
Pediatric Allergy and Clinical Immunology Department, Hospital Sant Joan de Déu, Barcelona, Spain
Institut de Recerca Sant Joan de Déu, Barcelona, Spain
Universitat de Barcelona, Barcelona, Spain
Arasi S:
Translational Research in Paediatric Specialities Area, Division of Allergy, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy
Bazire R:
Allergy Department, Hospital Infantil Universitario Niño Jesús, Madrid, Spain
FibHNJ, ARADyAL-RETICs RD16 /0006/0026 Instituto de Salud Carlos III, Madrid, Spain
IIS La Princesa, Madrid, Spain
Escudero C:
Allergy Department, Hospital Infantil Universitario Niño Jesús, Madrid, Spain
FibHNJ, ARADyAL-RETICs RD16 /0006/0026 Instituto de Salud Carlos III, Madrid, Spain
IIS La Princesa, Madrid, Spain
Patel N:
National Heart & Lung Institute, Imperial College London, London, UK
Mónica Paola Sandoval Ruballos:
Pediatric Allergy and Clinical Immunology Department, Hospital Sant Joan de Déu, Barcelona, Spain
Vazquez-Ortiz M:
National Heart & Lung Institute, Imperial College London, London, UK
Nowak-Wegrzyn A:
Department of Pediatrics, Hassenfeld Children's Hospital, NYU Grossman School of Medicine, New York City, New York, USA
Department of Pediatrics, Gastroenterology and Nutrition, Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland
Blümchen K:
Division of Pneumology, Allergology and Cystic Fibrosis, Department of Paediatric and Adolescent Medicine, University Hospital Frankfurt, Goethe University, Frankfurt, Germany
Dunn Galvin A:
University College Cork, Cork, Ireland
Deschildre A:
Pediatric Pulmonology and Allergy Department, CHU Lille, Univ. Lille, Hôpital Jeanne de Flandre, Lille, France
Greenhawt M:
Section of Allergy and Immunology, Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, Aurura, Colorado, USA
Schnadt S:
German Allergy and Asthma Association (DAAB), Mönchengladbach, Germany
Riggioni C:
Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore City, Singapore
Khoo Teck Puat-National University Children's Medical Institute, National University Hospital, National University Health System, Singapore City, Singapore
Remington BC:
Food Allergy Research and Resource Program, Department of Food Science and Technology, University of Nebraska, Lincoln, Nebraska, USA
Remington Consulting Group B.V, Utrecht, The Netherlands
Turner P:
National Heart & Lung Institute, Imperial College London, London, UK
Fernandez Rivas M:
Allergy Department, Hospital Clínico San Carlos, Facultad de Medicina, Universidad Complutense (UCM), IdISSC, ARADyAL, Madrid, Spain
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