Methods: IOS is conducted at 47 centers in 11 countries. Patient characteristics and icatibant treatment outcomes were recorded at clinic visits. Descriptive retrospective analyses were performed on data collected from July 2009–July 2014.
Results: Icatibant was used to treat 1716 angioedema attacks in 353 patients with type I or II HAE. Mean age at enrollment was 41.1 years (range 16.5–79.0), and 60.2% of patients were female. Proportions of very mild/mild, moderate, and severe/very severe attacks were 8.4%, 29.8%, and 61.8%, respectively (N=1545 attacks). Of attacks with anatomical location data (N=1682), 56.8% affected the abdomen, 40.4% affected the skin, and 6.8% affected the larynx. Most icatibant injections were self-administered (N=1289/1585 attacks; 81.3%). Median time to icatibant administration was 1.0 hour (N=794 attacks). Median time to symptom resolution was 4.9 hours (N=860 attacks). Median attack duration was 7.0 hours (N=692 attacks). Icatibant was well tolerated, with no unexpected safety outcomes.
Conclusions: IOS has accumulated a large database of patients with HAE, providing insight into the characteristics of this rare disease. In addition, treatment outcomes of icatibant in the real world were consistent with those from the Phase III studies.