A Study in Teenagers and Adults With Hereditary Angioedema (HAE) Type I or Type II Who Use Lanadelumab as Long-Term Prophylaxis

Study Overview
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Brief Summary
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The main aims of this study are to learn how many people with HAE Type I or Type II are attack-free when treated with lanadelumab in real life. This includes the number of people that are attack-free when lanadelumab is given every 2 and every 4 weeks. This study is about collecting existing data only; participants will not receive lanadelumab as part of this study. No new information will be collected during this study. Only data already available at the participant's doctor's office will be reviewed and collected for this study. Participants do not need to visit their doctor in addition to their normal visits.

Official Title
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Retrospective, Observational Chart Review Study Evaluating Clinical Effectiveness and Disease/Treatment Management Among Patients Who Initiated Long-term Prophylaxis With Takhzyro® in a Real-world Setting

Conditions
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Hereditary Angioedema (HAE)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is aged >= 12 years at the time of the last documented HAE attack in the eligibility period. Participant has a physician-confirmed diagnosis (or confirmation in medical records) of HAE type I or type II. Participant had initiated LTP with lanadelumab during the eligibility period. Participant provides informed consent or assent prior to the initiation of any study procedures (where required by local regulations). Exclusion Criteria: Participant was enrolled in a therapeutic investigational drug or device trial during the observation period. Participant without documented HAE attacks in the pre-index period and/or without available participant diary or systematic documentation of HAE attacks in the medical records during the post index period.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants With Hereditary Angioedema<br>Participants with HAE type I or type II who had initiated long-term prophylaxis (LTP) treatment with lanadelumab which was administered every two weeks (Q2W) or every four weeks (Q4W) or every six weeks (Q6W) or every eight weeks (Q8W) in accordance to Summary of Product Characteristics (SmPC), during a routine clinical setting will be followed up to 38 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Are Free of Hereditary Angioedema (HAE) Attacks Treated With Lanadelumab | Percentage of participants who are free of HAE attacks will be reported. A HAE attack is defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). | Up to Month 12 | 
| Percentage of Participants Who Are Free of HAE Attacks Treated With Lanadelumab Administered Every Two Weeks | Percentage of participants who are free of HAE attacks treated with lanadelumab which was administered every two weeks will be reported. | Up to Month 12 | 
| Percentage of Participants Who Are Free of HAE Attacks Treated With Lanadelumab Administered Every Four Weeks | Percentage of participants who are free of HAE attacks treated with lanadelumab which was administered every four weeks will be reported. | Up to Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Specific HAE Attack Occurrence | Percentage of participants with specific HAE attack occurrence (e.g. attacks of specific localization, attacks requiring on-demand medication, life-threatening attacks) will be reported. | Up to Month 12 | 
| Percentage of Participants Who are Free of HAE Attacks Relative to Prior Treatment | Percentage of participants who are free of HAE attacks relative to prior treatment (e.g. prior prophylaxis treatment or on-demand medications) among participants treated with lanadelumab will be reported. | Up to Month 12 | 
| Number of Participants Characterized With Every Four Weeks Adjustment | Number of participants will be characterized with every four weeks adjustment (e.g. weight, age, duration of disease, history of life-threating attacks, length of attack-free interval during lanadelumab treatment) will be reported. | Every 4 weeks from start of treatment (Up to Month 12) | 
| Number of Participants Characterized Based on Primary Reasons for Down Titration | Number of participants will be characterized based on primary reasons for down titration will be reported. | Up to Month 12 |