− Interim Real-World Data from Phase 4 EMPOWER Study Show Attack Rate Reduction and Improvement in Treatment Satisfaction and Other Patient-Reported Outcome Scores1
− Interim Patient-Reported Outcomes Showed a Reduction of Monthly Attack Rates in New Users and Showed Sustained Angioedema Control in Established Users Over Twelve-Months Using the Angioedema Control Test (AECT)1,2,3
− Attack Rate Reduction in Patients Previously on Androgen Treatments Consistent with Study Population in Phase 3 HELP OLE Based on Post-Hoc Analysis4
Takeda presented four abstracts including interim real-world data from the observational Phase 4 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.
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“A big challenge for HAE patients is the unpredictability of attacks and the impact that the attacks have on quality of life. We are encouraged by the initial results of the EMPOWER study, along with the additional evidence presented in the HELP Open Label Extension,” said Associate Professor Paula Busse, MD, Division of Allergy and Clinical Immunology, Icahn School of Medicine at Mount Sinai in New York, NY USA. “Data from both studies show that lanadelumab had marked reduction in attack rates, and that angioedema control was sustained for 12 months.”
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.1
- 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.3
- 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.2
- 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 04.4
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“We are pleased to see the real-world data from EMPOWER show improvements in angioedema control and treatment satisfaction. These interim results provide a better understanding of the overall patient experience with TAKHZYRO,” said Neil Inhaber, MD, Head, Rare Genetics and Hematology, Global Medical Affairs, Takeda. “With more than a decade of experience and innovation for patients with this devastating condition, Takeda remains committed to continuing our unwavering support for the HAE community.”
The observational Phase 4 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 3 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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