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Updating the CoFAR Grading Scale for Systemic Allergic Reactions in Food Allergy
R Sharon Chinthrajah1, Stacie M Jones2, Edwin H Kim3
1Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford University, Stanford, Calif.
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.
Insights
A new grading scale standardizes adverse event reporting in food allergy clinical trials. This system improves data aggregation and safety comparisons for immunotherapy and other treatments.
Area of Science:
- Allergy and Immunology
- Clinical Trials
- Drug Safety
Background:
- Immunotherapy shows promise for treating food allergies, with other treatments also in development.
- Adverse allergic events are common during food allergy treatments and oral food challenges.
- Current reporting of adverse events lacks standardization, hindering data comparison.
Purpose of the Study:
- To develop a comprehensive and universal grading scale for adverse events in food allergy clinical trials.
- To address the need for a more nuanced system to categorize the severity of adverse events.
Main Methods:
- The revised scale was developed collaboratively with industry partners and expert opinion.
- It builds upon the 2012 Consortium for Food Allergy Research (CoFAR) Grading Scale and the World Allergy Organization Grading System.
- The process involved refining existing scales to create version 3.0.
Main Results:
- The CoFAR Grading Scale for Systemic Allergic Reactions, Version 3.0, features 5 severity levels (Grade 1 to Grade 5).
- Reactions are categorized by organ system within each grade, differentiating single-system from multisystem reactions.
- Life-threatening reactions (Grade 4) include refractory lower respiratory symptoms requiring advanced interventions, and respiratory compromise necessitating mechanical ventilation.
Conclusions:
- Consistent application of the revised CoFAR Grading Scale across multiple centers is recommended.
- This standardization will facilitate improved data aggregation and safety comparisons in food allergy clinical trials.
- Wider adoption beyond CoFAR centers is crucial for advancing research and patient safety.
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