1072 The Icatibant Outcome Survey: More Than 1500 Icatibant-Treated Attacks in Patients with Type I or II Hereditary Angioedema

Wednesday, 14 October 2015
Hall D1 Foyer (Floor 3) (Coex Convention Center)

Marcus Maurer , Dermatology and Allergology, CharitÚ - Universitńtsmedizin Berlin, Berlin, Germany

Teresa Caballero , Hospital La Paz Institute for Health Research (IdiPaz), Biomedical Research Network on Rare Diseases (CIBERER, U754), Madrid, Spain

Werner Aberer , Department of Dermatology and Venereology, Medical University of Graz, Graz, Austria

Andrea Zanichelli , Dipartimento Di Scienze Biomediche e Cliniche Luigi Sacco, UniversitÓ Degli Studi Di Milano-Ospedale Luigi Sacco, Milano, Italy

Laurence Bouillet , National Reference Centre for Angioedema, Internal Medicine Department, Grenoble University Hospital, Grenoble, France

Vincent Fabien , Shire, Zug, Switzerland

Hilary Longhurst , Department of Immunology, Barts Health NHS Trust, London, United Kingdom

Background: Icatibant is a bradykinin B2 receptor antagonist used to treat attacks of hereditary angioedema (HAE) due to C1-inhibitor deficiency in adults. The Icatibant Outcome Survey (IOS; NCT01034969) is an international observational study monitoring the safety and effectiveness of icatibant in a real-world setting. Here we report data from the first 1716 icatibant-treated attacks in patients with HAE type I or II.

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.