Patient recruitment, screening, and eligibility.
infection, IgE-mediated allergy, hepatitis
ALLERGY, CARDIOVASCULAR DISEASE, CEREBROVASCULAR ACCIDENT, BLEEDING DISORDER, INFECTION, HEPATITIS
Eligible patients were 18 years of age or older at screening with a history of an IgE-mediated allergy to peanut. Patients were required to have a positive skin puncture test to peanut extract and an objective clinical reaction to cumulative dose of 1,044 mg of peanut protein or less during baseline OFC. Key exclusion criteria included: cardiovascular disease or prior cerebrovascular accident; active infection; history of bleeding disorder or receiving anticoagulants; any immunomodulatory therapies or oral corticosteroids within 1 month before study participation; active infection or latent hepatitis; use of strong CYP3A4 inducers or inhibitors; and pregnancy or nursing. Patients were also excluded if they had ever received peanut immunotherapy or omalizumab. Complete eligibility criteria are listed in Patients were recruited from the Johns Hopkins University Allergy and Clinical Immunology outpatient clinic and through IRB-approved advertising on social media. Patients who responded to advertisements were initially screened by telephone to determine eligibility. If determined eligible, patients were consented by teleconference before visit 1 in compliance with FDA 21 CFR Part 11.