D84.1
Conditions
Interventions
Group 1: Patients with type 1 or type 2 HAE who initiate treatment with lanadelumab according to the current product labelling, a documented history of = 24 attacks in the year prior to enrollment and
Sponsors
Takeda GmbH
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: - Confirmed diagnosis of HAE Type 1/2. - Voluntarily provision of written, signed, and dated (personally or via a legally authorized representative) informed consent to participate in the study. - Initiation of treatment with lanadelumab in accordance with current product labelling. - Documented history of = 24 attacks in the year prior to enrollment AND baseline AE-QoL Score of = 30 points. - 12 years or older.
Exclusion criteria
Exclusion criteria: - Inability to provide written, signed, and dated informed consent. - Documented history of > 24 confirmed HAE attacks/year in the year prior to study enrollment OR baseline AE-QoL Score of < 30 points. - Participation in the study ruled out by the treating physician/investigator. - Pregnant or breastfeeding. - Current or planned participation in interventional studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of lanadelumab to significantly improve health-related quality of life in HAE patients with less frequent HAE attacks, measured via the Angioedema Quality of Life Questionnaire (AE-QoL) and its minimal clinically important difference (MCID) of 6 points in the total score. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Effectiveness of lanadelumab q4w dosing interval compared to non-q4w dosing intervals; - Effectiveness of lanadelumab in reducing HAE attack frequency in real-world clinical practice. | — |
Countries
Germany
Contacts
Public ContactVeronika Garus
Sacura GmbH
Outcome results
None listed