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Updated: Nov 1, 2025

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Published on: May 31, 2021
Urticaria: The 1-1-1 Criterion for Optimized Risk Stratification in β-Lactam Allergy Delabeling
Vito Sabato1, Francesco Gaeta2, Rocco Luigi Valluzzi3
1Department of Immunology, Allergology and Rheumatology, University of Antwerp, Antwerp University Hospital, Antwerpen, Belgium; Allergology Unit, AZ Jan Palfijn, Ghent, Belgium; Infla-Med Centre of Excellence, University of Antwerp, Antwerpen, Belgium.
Background:
A spurious label of β-lactam allergy compromises antibiotic stewardship. Delabeling protocols based on direct challenges (ie, not preceded by allergy tests) can be applied in low-risk patients.
Objective:
This study aims at determining the significance of the characteristics of urticaria in the risk stratification for delabeling.
Methods:
The characteristics of urticarial eruptions that had occurred during therapeutic courses with a β-lactam, namely the time interval between the exposure and onset, the dose (first or subsequent) after which urticaria appeared, and the duration of the eruption, were correlated to the results of a systematic allergy workup (skin tests, specific IgE measurements, and challenges). Data from 410 patients enrolled in 3 allergy centers (Rome and Troina, Italy, and Antwerp, Belgium) were analyzed. A multivariable logistic regression was performed, which included appearance within 1 hour after the first dose and regression within 1 day: a model that can be summarized as the "1-1-1" urticaria criterion.
Results:
An urticarial eruption that had appeared within 1 hour after the first dose and had regressed within 1 day was more frequently reported in the group with a positive allergy workup, with odds ratios of 17 (95% confidence interval [CI]: 9-31), 11 (95% CI: 6-20), and 48 (95% CI: 14-157), respectively (P < .005). The 1-1-1 criterion displayed a sensitivity and specificity of 85%, and a negative predictive value and a positive predictive value of 80% and 90%, respectively.
Conclusion:
Patients with urticaria meeting the 1-1-1 criterion should be considered at high risk and referred for an allergy workup with skin testing and specific IgE measurement before challenging.
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