Phase IV EMPOWER study of Takhzyro shows efficacy and safety in Hereditary Angioedema.
Takeda presented four abstracts including interim real-world data from the observational Phase IV EMPOWER study of Takhzyro (lanadelumab) as a treatment for people with Hereditary Angioedema (HAE) Type I or II in North America, as well as findings from a post-hoc analysis of the HELP Open Label Extension study of long-term safety and efficacy of Takhzyro in HAE patients 12 years of age and older at the American Academy of Allergy, Asthma and Immunology (AAAAI) 78th Annual Meeting.
Key findings from the data presentations include: Improvements among new users and sustained outcomes in established users were reported in scores of the Angioedema Quality of Life Questionnaire (AE-QOL), Angioedema Control Test (AECT), and the Treatment Satisfaction Questionnaire for Medication (TSQM-9) when collected every three months, as presented in the EMPOWER IA2 Patient-Reported Outcomes interim data presentation. An average of 1 in 5 established Takhzyro users were able to extend treatment from every 2 weeks to 4 weeks as shown in interim data shared in the EMPOWER IA2 Treatment Patterns and Subgroups presentation. Interim real-world data showed marked attack rate reduction of 83% and no new safety signals based on patient self-reporting reduced attack rates in the EMPOWER IA2 Effectiveness and Safety presentation. A post-hoc analysis of HELP and HELP OLE showed that reduction of attack rates with Takhzyro were similar for patients previously on androgen treatments as they were for the wider treatment population in these studies in the Switch from Androgens to Takhzyro in HELP 03 and HELP 04.
The observational Phase IV EMPOWER study, evaluating real-world HAE attack rates before and after treatment with Takhzyro in patients with HAE types I and II, is ongoing. Full results of the EMPOWER study are expected to be published in 2024. HELP OLE is a completed Phase III study of the safety and efficacy of Takhzyro in patients previously treated with androgens and other therapies for long-term prophylaxis prior to transitioning to Takhzyro.
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