R Sharon Chinthrajah1, Stacie M Jones2, Edwin H Kim3, Scott H Sicherer4, Wayne Shreffler5, Bruce J Lanser6, Negin Atri7, Denise C Babineau8, Daniel C Adelman9, Ahmar Iqbal10, Susan L Limb11, Amanda K Rudman Spergel7, Alkis Togias7, Robert A Wood12. 1. Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford University, Stanford, Calif. Electronic address: schinths@stanford.edu. 2. University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark. 3. Division of Pediatric Allergy and Immunology, Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC. 4. Elliot and Roslyn Jaffe Food Allergy Institute, Division of Allergy and Immunology, Kravis Children's Hospital, Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY. 5. Department of Pediatrics, Massachusetts General Hospital and Harvard Medical School, Boston, Mass. 6. Department of Pediatrics, National Jewish Health, Denver, Colo. 7. Division of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Md. 8. Rho, Inc, Durham, NC. 9. Department of Medicine, Allergy/Immunology, University of California, San Francisco, Calif. 10. Medical Affairs, Genentech/Roche, South San Francisco, Calif. 11. 4D Molecular Therapeutics, Emeryville, Calif. 12. Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Md.
Abstract
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.
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.
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