Journal
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
Volume 149, Issue 6, Pages 2166-+Publisher
MOSBY-ELSEVIER
DOI: 10.1016/j.jaci.2021.12.789
Keywords
Food allergy; grading; anaphylaxis; severity scale; CoFAR; oral food challenge; oral immunotherapy
Categories
Funding
- National Institutes of Health [5UM1AI130839, 5UM2AI130836]
- Consortium for Food Allergy Research
- National Institute of Allergy and Infectious Diseases (NIAID) , Food Allergy Research & Education (FARE) , Aimmune, DBV Technologies
- Regeneron
- Genentech
- NIAID
- FARE
- Aimmune Therapeutics, Inc, DBV Technologies, Inc
- Genentech, Inc
- Aimmune Therapeutics, Inc
- Regeneron Pharmaceuticals, Inc
- Astellas Pharma, Inc
- Aimmune Therapeutics, DBV Technologies, Duke Clinical Research Institute
- Nutricia
- Jubilant Hollister-Stier, Belhaven Biopharma
- HAL Allergy, and Allergy Therapeutics
- National Institutes of Health (NIH) /NIAID
- National Center for Complementary and Integrative Health (NIH/NCCIH)
- WallaceResearch Foundation
- HAL Allergy
- American Academy of Allergy
- Sanofi
- Novartis
- Aimmune Therapeutics, DBV Technologies
- GlaxoSmithKline
- NIH/NIAID
- US NIH
- Aimmune, DBV Technologies
Ask authors/readers for more resources
Immunotherapy for food allergy is promising, but adverse events and their severity during treatment are not standardized. This study developed a revised grading scale to categorize and assess adverse allergic reactions in food allergy clinical trials. The use of this revised scale would allow for better data aggregation and safety comparisons.
Background: Immunotherapy is promising as an efficacious treatment for food allergy. Other food allergy treatments are also under development. However, adverse allergic events during treatment, as well as during oral food challenges, are common and reporting is not standardized. Objective: A more nuanced grading scale is needed to create a comprehensive and universal system to categorize adverse events and their severity for food allergy clinical trials. Methods: Starting with the 2012 Consortium for Food Allergy Research (CoFAR) Grading Scale and the World Allergy Organization Grading System, we developed the CoFAR Grading Scale for Systemic Allergic Reactions, Version 3.0, in collaboration with industry partners with expert opinion. Results: The revised CoFAR Grading Scale for Systemic Allergic Reactions has 5 levels of increasing severity, ranging from generalized urticaria, localized angioedema, rhinitis, and abdominal pain (grade 1) to death (grade 5). Systemic reactions are further categorized within each grade by relevant organ system. Mild, single-system reactions are differentiated from mild, multisystem reactions. Lower respiratory tract symptoms are graded on the basis of response to therapy; those that are refractory to standard treatment (eg, requiring >3 doses of intramuscular epinephrine, continuous intravenous epinephrine infusion, and continuous albuterol nebulization) and respiratory compromise requiring mechanical ventilation are classified as grade 4, life-threatening reactions. Conclusions: Universal and consistent use of the revised CoFAR Grading Scale beyond the CoFAR centers would allow for better data aggregation and safety comparisons in clinical trials for food allergy. (J Allergy Clin Immunol 2022;149:2166-70.)
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