Hereditary angioedema (HAE) is a life-threatening disorder characterized by recurrent angioedema. Icatibant, a subcutaneous bradykinin-B2-receptor antagonist, is an effective on-demand therapy. Data outside the United States (US) suggest that self-administration is well-tolerated and patient-preferred compared to administration by healthcare professionals at medical facilities (HCP-administration) [Aberer 2014, Fernandez-de-Rojas 2015].
Subjects ≥ 18 years old with HAE Type I or II were enrolled in a prospective, multi-center study in the US evaluating icatibant self-administration for HAE attacks. The first two attacks were treated at medical facilities. Subjects were instructed on self-administration during icatibant treatment for the second attack. Subjects self-administered icatibant at home for all subsequent attacks. Patient characteristics, timing of attack and icatibant treatment, initial improvement of symptoms, and complete symptom resolution were evaluated.
Nineteen patients received icatibant for 78 distinct HAE attacks. HAE attack duration (attack onset to complete symptom resolution) was significantly shorter with self-administration (n=49, 377±73 minutes) than HCP-administration (n=29, 735±133 minutes, p=0.003). Median time to treatment was significantly shorter with self-administration (30±33 minutes) than HCP-administration (167±93 minutes, p=0.01). Time from icatibant injection to initial symptom improvement and complete symptom resolution were comparable between self-administration and HCP-administration. Improvements in Visual Analogue Score and Patient Symptom Score from pre-treatment to 4 hours post-injection were also comparable. There were no serious adverse events (AEs) related to icatibant or discontinuations due to AEs with self-administration or HCP-administration.
Icatibant self-administration was comparable to HCP-administration in a prospective, multi-center study, shortening HAE attack duration with no difference in safety or treatment outcomes.