"Preliminary Results Comparing Outpatient Oral Graded Challenges to Pen" by Syed Shahzad Mustafa, Kelly Conn et al.
 

Preliminary Results Comparing Outpatient Oral Graded Challenges to Penicillin Skin Testing

Document Type

Conference Proceeding

Publication Date

2-2019

Abstract

Rationale

Graded challenges (GC) may be as safe as penicillin skin testing (PST) in low risk patients. We designed a longitudinal, non-inferiority trial to evaluate PST followed by an amoxicillin challenge compared to a 2-step GC to amoxicillin without PST.

Methods

Penicillin allergy histories were reviewed in all patients presenting to an allergy/immunology practice from 4/2018 onward. Patients >5 years old (y/o) with a cutaneous-only or unknown reaction (> 1 year ago for ages 5-17, > 10 years ago for 18+) were randomized 1:1 to PST or GC. All children <5 y/o underwent graded challenge and patients with extra-cutaneous reaction histories underwent PST. All groups were monitored 30 minutes after amoxicillin administration for reactions. Preliminary descriptive results are reported using means (SD) and percentages.

Results

Penicillin allergy was reported in 256/1622 (15.8%) patients, 139 consented to further evaluation. 13/256 (5.1%) patients <5 y/o underwent direct challenge; all were negative. 10/256 (3.9%) patients with angioedema and/or extra-cutaneous symptoms underwent PST; 1/10 patients had positive PST. A total of 116 patients were randomized to GC (49.1%) or PST (50.9%). SPT was negative in 53/59 (89.8%) patients. All 53 patients had a negative amoxicillin challenge. GC was negative in 56/57 (98.2%) patients. Average time for patients undergoing PST was 72.7 (± 5.2) minutes, and 68.4 (± 13.6) minutes for patients undergoing GC.

Conclusions

Preliminary results demonstrate a low reaction rate among GC patients. Future non-inferiority analysis upon completion of this trial may provide foundational evidence for use of GC instead of PST in low risk patients.

Comments

Presented at the American Academy of Allergy, Asthma, and Immunology Annual Meeting. San Francisco, CA. February 22-25, 2019.

Abstract published in: Journal of Clinical Immunology; 143 (2).

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