EVALUATION OF PRODROMAL SYMPTOMS CONCURRENT WITH HEREDITARY ANGIOEDEMA THERAPY.

RATIONALE: There is sparse literature regarding prodromal symptoms associated with hereditary angioedema (HAE). Most literature is based on case series or random surveys that are confounded by recall bias and self-selection bias. The aim of our study was to inquire about prodromal symptoms at the time of treatment of HAE exacerbations to reduce this bias. METHODS: A survey was administered to subjects with HAE enrolled in the phase 3 open label extension study of human pasteurized C1 esterase inhibitor concentrate (C1-INH). Evaluation of prodromal symptoms was one of the primary objectives of this survey. This was recorded via computer or interactive voice response service each time a subject had an HAE exacerbation and was treated with C1-INH. Descriptive statistics were employed to evaluate the responses. IRB approval was obtained. RESULTS: To date 27 subjects have been enrolled in this ongoing study at 7 sites in USA and Canada. A total of 273 treatments with C1-INH were administered. Prodromal symptoms were reported in 48.35%. The most commonly reported prodromal symptoms across all types of attacks were: fatigue (27.83%), nausea (19.41%), and flu-like symptoms (13.19%). Other prodromal symptoms included: bowel movement change (7.33%), abdominal rumbling (5.86%), urticaria-like skin eruptions (6.54%), non-itchy rash with pale centers (5.38%) and tingling (3.30%). CONCLUSIONS: Practitioners should be aware that non-specific and variable symptoms might represent the prodrome of an HAE exacerbation. They should educate their patients to seek medical attention promptly to decrease the morbidity and mortality associated with HAE exacerbations.