Melissa Iammatteo1, Santiago Alvarez Arango2, Denisa Ferastraoaru1, Nadeem Akbar3, Andrew Y Lee3, Hillel W Cohen4, Elina Jerschow5. 1. Division of Allergy and Immunology, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY. 2. Division of Allergy and Clinical Immunology, Johns Hopkins Hospital, Baltimore, Md. 3. Department of Otorhinolaryngology, Montefiore Medical Center, Bronx, NY. 4. Department of Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY. 5. Division of Allergy and Immunology, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY. Electronic address: Elina.Jerschow@einstein.yu.edu.
Abstract
BACKGROUND: Unconfirmed penicillin allergy poses substantial public health consequences. The most widely accepted protocol to evaluate penicillin allergy is skin testing followed by an amoxicillin challenge. OBJECTIVE: To evaluate the safety of direct oral graded challenges to amoxicillin. METHODS: A prospective single-blind clinical trial with historical controls of patients ≥7 years old with historical non-life-threatening reactions to penicillin was conducted. Patients received placebo followed by a 2-step graded challenge to amoxicillin. The allergic reaction rate was compared with the rate observed in our previous study that included skin testing and with the currently reported penicillin allergy prevalence in the US population. RESULTS: Of the 155 participants who completed an amoxicillin challenge, 120 patients (77.4%) experienced no reaction whereas 31 patients (20%) experienced nonallergic reactions to either placebo (n = 16) or amoxicillin (n = 15). Four patients (2.6%) developed mild allergic reactions. Significantly (P = .03) fewer patients (4 of 155, 2.6%, 95% confidence interval [CI]: 1.0%, 6.5%) were determined to be allergic compared with 14 of 170 subjects (8.2%, 95% CI: 5.0%, 13.4%) in our previous study where patients were determined to be allergic based on either positive skin tests (n = 11) or allergic challenge reactions after negative skin tests (n = 3). This 2.6% reaction rate was also significantly less than the 10% reported US prevalence of penicillin allergy (P = .003). CONCLUSIONS: Placebo-controlled oral graded challenges to amoxicillin without prior skin testing may be safe for patients ≥7 years old with non-life-threatening historical reactions to penicillin. Amoxicillin can be tolerated by the majority of patients with self-reported penicillin allergy.
BACKGROUND: Unconfirmed penicillinallergy poses substantial public health consequences. The most widely accepted protocol to evaluate penicillinallergy is skin testing followed by an amoxicillin challenge. OBJECTIVE: To evaluate the safety of direct oral graded challenges to amoxicillin. METHODS: A prospective single-blind clinical trial with historical controls of patients ≥7 years old with historical non-life-threatening reactions to penicillin was conducted. Patients received placebo followed by a 2-step graded challenge to amoxicillin. The allergic reaction rate was compared with the rate observed in our previous study that included skin testing and with the currently reported penicillinallergy prevalence in the US population. RESULTS: Of the 155 participants who completed an amoxicillin challenge, 120 patients (77.4%) experienced no reaction whereas 31 patients (20%) experienced nonallergic reactions to either placebo (n = 16) or amoxicillin (n = 15). Four patients (2.6%) developed mild allergic reactions. Significantly (P = .03) fewer patients (4 of 155, 2.6%, 95% confidence interval [CI]: 1.0%, 6.5%) were determined to be allergic compared with 14 of 170 subjects (8.2%, 95% CI: 5.0%, 13.4%) in our previous study where patients were determined to be allergic based on either positive skin tests (n = 11) or allergic challenge reactions after negative skin tests (n = 3). This 2.6% reaction rate was also significantly less than the 10% reported US prevalence of penicillinallergy (P = .003). CONCLUSIONS: Placebo-controlled oral graded challenges to amoxicillin without prior skin testing may be safe for patients ≥7 years old with non-life-threatening historical reactions to penicillin. Amoxicillin can be tolerated by the majority of patients with self-reported penicillinallergy.
Authors: Rashmeet Bhogal; Abid Hussain; Ariyur Balaji; William H Bermingham; John F Marriott; Mamidipudi T Krishna Journal: Int J Clin Pharm Date: 2021-01-13
Authors: Cosby A Stone; Jason Trubiano; David T Coleman; Christine R F Rukasin; Elizabeth J Phillips Journal: Allergy Date: 2019-05-26 Impact factor: 13.146
Authors: Mary L Staicu; David Vyles; Erica S Shenoy; Cosby A Stone; Taylor Banks; Kristin S Alvarez; Kimberly G Blumenthal Journal: J Allergy Clin Immunol Pract Date: 2020-10
Authors: Kimberly G Blumenthal; Emily M Huebner; Xiaoqing Fu; Yu Li; Gita Bhattacharya; Amy S Levin; Christian M Mancini; Benjamin R Slawski; Aleena Banerji Journal: J Allergy Clin Immunol Pract Date: 2019-04-11
Authors: Kyra Y L Chua; Sara Vogrin; Susan Bury; Abby Douglas; Natasha E Holmes; Nixon Tan; Natasha K Brusco; Rebecca Hall; Belinda Lambros; Jacinta Lean; Wendy Stevenson; Misha Devchand; Kent Garrett; Karin Thursky; M Lindsay Grayson; Monica A Slavin; Elizabeth J Phillips; Jason A Trubiano Journal: Clin Infect Dis Date: 2021-08-02 Impact factor: 9.079