@article{7d12963568b7408fafdcab1072a05c3f,
title = "Updating the CoFAR Grading Scale for Systemic Allergic Reactions in Food Allergy",
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.",
keywords = "CoFAR, Food allergy, anaphylaxis, grading, oral food challenge, oral immunotherapy, severity scale",
author = "Chinthrajah, {R. Sharon} and Jones, {Stacie M.} and Kim, {Edwin H.} and Sicherer, {Scott H.} and Wayne Shreffler and Lanser, {Bruce J.} and Negin Atri and Babineau, {Denise C.} and Adelman, {Daniel C.} and Ahmar Iqbal and Limb, {Susan L.} and {Rudman Spergel}, {Amanda K.} and Alkis Togias and Wood, {Robert A.}",
note = "Funding Information: This work was supported by the National Institutes of Health (grant nos. 5UM1AI130839 and 5UM2AI130836). Disclosure of potential conflict of interest: R. S. Chinthrajah receives grant support from the Consortium for Food Allergy Research (CoFAR), the National Institute of Allergy and Infectious Diseases (NIAID), Food Allergy Research & Education (FARE), Aimmune, DBV Technologies, Astellas, Novartis, and Regeneron, and is an advisory board member for Alladapt Immunotherapeutics, Novartis, Sanofi, and Genentech. S. M. Jones reports grants to her institution from the NIAID and from FARE; clinical trials funding to her institution from Aimmune Therapeutics, Inc, DBV Technologies, Inc, Regeneron Pharmaceuticals, Inc, Astellas Pharma, Inc, and Genentech, Inc; and personal fees from Aimmune Therapeutics, Inc, as a member of the Scientific Advisory Board and Food and Drug Administration advisory consultant, from Regeneron Pharmaceuticals, Inc, as a research advisory consultant, and from Astellas Pharma, Inc, as scientific advisory consultant. E. H. Kim reports medical advisory board membership with DBV Technologies, Kenota Health, and Ukko, Inc; consultancy with Aimmune Therapeutics, DBV Technologies, Duke Clinical Research Institute, ALK, AllerGenis, Nutricia, Jubilant Hollister-Stier, Belhaven Biopharma, HAL Allergy, and Allergy Therapeutics; and receives grant support to his institution from the National Institutes of Health (NIH)/NIAID, the National Center for Complementary and Integrative Health (NIH/NCCIH), FARE, and the Wallace Research Foundation. S. H. Sicherer reports royalty payments from UpToDate and from Johns Hopkins University Press; grants to his institution from the NIAID, from FARE, and from HAL Allergy; and personal fees from the American Academy of Allergy, Asthma & Immunology as Deputy Editor of the Journal of Allergy and Clinical Immunology: In Practice, outside of the submitted work. W. Shreffler reports grants to his institution from the NIAID and from FARE; clinical trials funding to his institution from Aimmune Therapeutics, Inc, DBV Technologies, Inc, Regeneron Pharmaceuticals, Inc, Astellas Pharma, Inc, and Genentech, Inc; and personal fees from Aimmune Therapeutics, Inc, as a member of the Scientific Advisory Board and from Regeneron Pharmaceuticals, Inc, Sanofi, and Novartis as a scientific advisory consultant. B. J. Lanser reports grants and personal fees from Aimmune Therapeutics, DBV Technologies, and Genentech; grants from Regeneron; personal fees from Allergenis, Hycor, and GlaxoSmithKline; and grant support to his institution from the NIH/NIAID. D. C. Adelman was employed by Aimmune Therapeutics, Inc, and receives personal fees from Aimmune Therapeutics, Inc, as a member of the Scientific Advisory Board, and from IgGenix, Inc, as a research advisor. A. Iqbal is employed by Genentech. S. L. Limb was employed by Genentech. R. A. Wood reports grants from the US NIH, Astellas, Aimmune, DBV Technologies, Genentech, Sanofi, and Regeneron, and personal fees from UpToDate. The rest of the authors declare that they have no relevant conflicts of interest. A. K. R. Spergel, N. Atri, and A. Togias{\textquoteright} coauthorship of this publication does not necessarily constitute endorsement by the NIAID, the NIH, or any other agency of the US government. Funding Information: This work was supported by the National Institutes of Health (grant nos. 5UM1AI130839 and 5UM2AI130836 ). Publisher Copyright: {\textcopyright} 2022",
year = "2022",
month = jun,
doi = "10.1016/j.jaci.2021.12.789",
language = "English",
volume = "149",
pages = "2166--2170.e1",
journal = "Journal of Allergy and Clinical Immunology",
issn = "0091-6749",
publisher = "Mosby Inc.",
number = "6",
}