Methods: Patient characteristics and icatibant-treatment outcomes were recorded at clinic visits. Descriptive retrospective analyses by gender were performed on data collected from July 2009–April 2015.
Results: At IOS entry, 596 patients (353 female, 59.2%) reported BL data. Icatibant was used to treat 2245 angioedema attacks in 415 patients with 240 females (57.8%) reporting 1419 attacks (63.2%). Females reported a significantly higher annual attack frequency at BL (median: 7.5 vs 6.3; p=0.025) and more frequent abdominal and multiple location attacks. Complete treatment outcome data were available for 219 patients who had 831 attacks, including 136 females (62.1%) who had 481 attacks (57.9%). Respectively, the median time to icatibant administration in females vs males was 2.0 vs 1.0 hours (p=0.075), the median time to symptom resolution was 5.0 vs 6.5 hours (p=0.882) and the median attack duration was 10.0 vs 8.3 hours (p=0.420). For attacks treated with a single icatibant injection, C1 INH rescue use was higher in males (13.3%) than females (5.9%).
Conclusions: Female HAE I/II patients enrolled in IOS reported significantly more annual angioedema attacks at IOS entry than male patients. No significant gender difference in icatibant treatment outcome was observed in this real-world observational study, however male patients used C1 INH more frequently as rescue medication.