Brittany Stevenson1, Michelle Trevenen2, Elizabeth Klinken1, William Smith3, Carlo Yuson3, Constance Katelaris4, Fiona Perram4, Pamela Burton4, James Yun5, Fenfen Cai6, Sara Barnes7, Kymble Spriggs8, Samar Ojaimi9, Raymond Mullins10, Sam Salman11, Patricia Martinez12, Kevin Murray13, Michaela Lucas14. 1. Department of Immunology, Sir Charles Gairdner Hospital, Perth, WA, Australia; Department of Immunology, Fiona Stanley Hospital, Perth, WA, Australia; Department of Immunology, PathWest Laboratory Medicine, Perth, WA, Australia. 2. Centre for Applied Statistics, The University of Western Australia, Perth, WA, Australia. 3. AllergySA, Beulah Park, Adelaide, SA, Australia; Clinical Immunology and Allergy, Royal Adelaide Hospital, Adelaide, SA, Australia. 4. Immunology/Allergy Unit, Campbelltown Hospital, Campbelltown, NSW, Australia. 5. Immunology and Rheumatology, Nepean Hospital, Sydney, NSW, Australia. 6. St Vincent's Hospital, Sydney, NSW, Australia. 7. Department of Allergy/Immunology, Monash Health, Melbourne, VIC, Australia. 8. Department of Allergy/Immunology, Monash Health, Melbourne, VIC, Australia; Melbourne Medical School, The University of Melbourne, Melbourne, VIC, Australia. 9. Department of Allergy/Immunology, Monash Health, Melbourne, VIC, Australia; Centre of Inflammatory Diseases, Monash University, Melbourne, VIC, Australia. 10. John James Medical Centre, Canberra, ACT, Australia. 11. Department of Immunology, Sir Charles Gairdner Hospital, Perth, WA, Australia; Department of Immunology, Fiona Stanley Hospital, Perth, WA, Australia; Department of Immunology, PathWest Laboratory Medicine, Perth, WA, Australia; School of Medicine, The University of Western Australia, Perth, WA, Australia. 12. Department of Immunology, Fiona Stanley Hospital, Perth, WA, Australia; Department of Immunology, PathWest Laboratory Medicine, Perth, WA, Australia; School of Medicine, The University of Western Australia, Perth, WA, Australia. 13. School of Population and Global Health, University of Western Australia, Perth, WA, Australia. 14. Department of Immunology, Sir Charles Gairdner Hospital, Perth, WA, Australia; Department of Immunology, PathWest Laboratory Medicine, Perth, WA, Australia; School of Medicine, The University of Western Australia, Perth, WA, Australia. Electronic address: michaela.lucas@health.wa.gov.au.
Abstract
BACKGROUND: Recent single-center studies promote oral penicillin challenges, without skin testing, in patients with low risk/likelihood of true allergy. However, how best to define a low-risk penicillin allergy history is uncertain. OBJECTIVE: To statistically determine an optimal low-risk definition, to select patients for safe outpatient penicillin challenges, without skin testing. METHODS: In a multicenter Australian study (February 2016 to May 2018), testing strategy (skin test and/or oral penicillin challenge) and outcomes were retrospectively collected for all penicillin-allergic patients. Statistical modeling was performed with 8 low-risk definitions, to determine an optimal low-risk definition. RESULTS: A total of 447 subjects (mean age, 45.3 years; 63.8% females) were analyzed. A history of benign, immediate, or delayed rash, more than 1 year before review, was the optimal low-risk definition. A total of 244 of 447 (54.6%) patients met this definition, of which 97.1% tolerated a 1- or 2-dose penicillin challenge, with no anaphylaxis in those who reacted. Of 203 patients designated higher risk, 54 (26.6%) had their allergy confirmed by skin test (n = 45) or challenge (n = 9). CONCLUSIONS: History of penicillin-associated rash (without angioedema, mucosal ulceration, or systemic involvement), more than 1 year ago, is sufficient to select a patient for a direct oral penicillin challenge. This large multicenter study demonstrates that this approach appears safe, and risk is comparable to that in other procedures being performed in primary care in Australia. The higher risk patients are more likely to benefit from skin testing. This simple risk-based delabeling strategy could potentially be used by nonallergists, leading to more efficient penicillin allergy delabeling service provision.
BACKGROUND: Recent single-center studies promote oral penicillin challenges, without skin testing, in patients with low risk/likelihood of true allergy. However, how best to define a low-risk penicillinallergy history is uncertain. OBJECTIVE: To statistically determine an optimal low-risk definition, to select patients for safe outpatientpenicillin challenges, without skin testing. METHODS: In a multicenter Australian study (February 2016 to May 2018), testing strategy (skin test and/or oral penicillin challenge) and outcomes were retrospectively collected for all penicillin-allergic patients. Statistical modeling was performed with 8 low-risk definitions, to determine an optimal low-risk definition. RESULTS: A total of 447 subjects (mean age, 45.3 years; 63.8% females) were analyzed. A history of benign, immediate, or delayed rash, more than 1 year before review, was the optimal low-risk definition. A total of 244 of 447 (54.6%) patients met this definition, of which 97.1% tolerated a 1- or 2-dose penicillin challenge, with no anaphylaxis in those who reacted. Of 203 patients designated higher risk, 54 (26.6%) had their allergy confirmed by skin test (n = 45) or challenge (n = 9). CONCLUSIONS: History of penicillin-associated rash (without angioedema, mucosal ulceration, or systemic involvement), more than 1 year ago, is sufficient to select a patient for a direct oral penicillin challenge. This large multicenter study demonstrates that this approach appears safe, and risk is comparable to that in other procedures being performed in primary care in Australia. The higher risk patients are more likely to benefit from skin testing. This simple risk-based delabeling strategy could potentially be used by nonallergists, leading to more efficient penicillinallergy delabeling service provision.
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