A Study in Adults With Hereditary Angioedema (HAE) Who Currently Receive Icatibant at Home
Study Details
Study Description
Brief Summary
The main aim of this study is to describe the treatment patterns, characteristics and outcomes of people with HAE who are currently receiving icatibant in the homecare setting in the United Kingdom (UK).
Participants will be treated with icatibant according to their routine practice via homecare service for icatibant within the UK. Data will be directly collected from participants via study diaries and questionnaires. Participants will be contacted approximately every 90 days during study duration (this can occur via phone or as a face-to-face visit).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HAE Participants Adult participants with a diagnosis of HAE who are receiving treatment according to routine clinical practice and prescribed all treatments in accordance with the approved marketing authorization will be enrolled in this study. Data will be directly collected from participants via patient reported diaries and paper- based and/or electronic homecare records as appropriate for UK participants using homecare services for icatibant. No study specific intervention will be administered in this study. |
Other: No Intervention
No Intervention will be administered in this study.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Treated with Icatibant in the Homecare Setting who Were Receiving Prophylaxis Treatment at Index [Up to 12 months from Index (day of the first homecare telephonic consultation/visit)]
- Number of Participants Treated with Icatibant in the Homecare Setting in Each Prophylactic Treatment Type [Up to 12 months from Index (day of the first homecare telephonic consultation/visit)]
Secondary Outcome Measures
- Number of Participants Categorized by Their Demographic Characteristics [Baseline Period [3 months prior to Index (day of the first homecare telephonic consultation/visit)]]
Demographic characteristics will include age at index (categories: 18-29, 30-39, 40-49, 50-59, 60+ years), sex (male, female, non-binary), and ethnic group.
- Number of Participants Categorized by Their Clinical Characteristics [At Index (day of the first homecare telephonic consultation/visit)]
Clinical characteristics will include patient reported HAE type (Type I or Type II), categories of duration (participant's self-administration of icatibant at home and time since HAE diagnosis) at index, comorbidities, prior HAE related concomitant medication details, categories of details of deaths during the study observation period.
- Rate of New HAE Attacks [Up to 12 months from Index (day of the first homecare telephonic consultation/visit)]
Rate of new HAE attacks and rate of new HAE attacks that required treatment in homecare setting will be recorded as number of HAE attacks per participant per month. Data would be reported for pre-defined time-period categories as follows: between index to month 3, between month 3 to 6, month 6 to 9 and month 9 to 12.
- Frequency of Visits to Accident and Emergency Services Related to an HAE Attack [Up to 12 months from Index (day of the first homecare telephonic consultation/visit)]
Frequency of visits to Accident and Emergency Services related to an HAE attack will be defined as number of visits to Accidents and Emergency Services during pre-defined time period. Data would be reported for pre-defined time-period categories as follows: between index to month 3, between month 3 to 6, month 6 to 9 and month 9 to 12.
- Time from the Start of Each HAE Attack to Administration of Icatibant in the Homecare Setting [Up to 12 months from Index (day of the first homecare telephonic consultation/visit)]
The summary data for time (in hours) from the start of each HAE attack to administration of icatibant in the homecare setting will be reported.
- Frequency of Icatibant Administration Following Start of Each HAE Attack [Up to 12 months from Index (day of the first homecare telephonic consultation/visit)]
The summary data for number of icatibant administration following start of each HAE attack during the predefined time period will be reported.
- Number of Participants by Treatment Patterns [Up to 12 months from Index (day of the first homecare telephonic consultation/visit)]
Treatment patterns will include assessment of number of participants by treatment dose received for HAE attack and average dose per participant received post-index.
- Number of Participants by Treatment Management Patterns [Up to 12 months from Index (day of the first homecare telephonic consultation/visit)]
Treatment management patterns will include assessment of number of participants by discontinuations of icatibant treatment and reasons for discontinuation (this would be assessed for participants who received prophylaxis treatment during the study), number of face-to-face and telephone-based homecare consultations.
- EQ-5D-5L Score [Up to 12 months from Index (day of the first homecare telephonic consultation/visit)]
The EQ-5D-5L questionnaire will be used to record impact of HAE on participant's quality-of-life (QoL). The EQ-5D-5L is a descriptive system of Health-Related Quality-of-Life (HRQoL) states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take 1 of 5 responses. The responses record 5 levels of severity [no problems, slight problems, moderate problems, severe problems, and extreme problems] within a particular dimension. The scores will be the sum of scores from each dimension and can range from 5 (no problems) to 25 (extreme problems).
- HAE-QoL Total Score [Up to 12 months from Index (day of the first homecare telephonic consultation/visit)]
The Hereditary Angioedema Quality of Life (HAE-QoL) includes 25 items and 7 dimensions: treatment difficulties, physical functioning and health, disease-related stigma, emotional role and social functioning, concern about offspring, perceived control over illness, and mental health. Raw scores from each domain will be linearly transformed to a total score of 0 to 100, with higher scores indicating a stronger impairment.
- Angioedema Control Test (AECT) Total Score [Up to 12 months from Index (day of the first homecare telephonic consultation/visit)]
The AECT is used to assess participants with recurrent angioedema. The test uses a questionnaire with 4 items, each of which has 5 options and is used to measure the participant's current disease control. HAE control score will be recorded with 5 levels of answers [1=very often, 2=often, 3=sometimes, 4=seldom, 5=not at all] to the following questions: 1) In the last 3 months, how often have you had angioedema? 2) In the last 3 months, how much has your QoL been affected by angioedema? 3) In the last 3 months, how much has the unpredictability of your angioedema bothered you? 4) In the last 3 months, how well has your angioedema been controlled by your therapy? The total scores are the sum of individual scores from 4 items and will range from 4 (Very often) to 20 (not at all). Higher scores will indicate no recurrence.
Eligibility Criteria
Criteria
Inclusion Criteria
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Participants self-administering or receiving care assisted administration of icatibant treatment for patient confirmed diagnosis of HAE Type I or II in the homecare setting
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Participants who are able and willing to complete the study questionnaires
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Participants who are willing to be visited or contacted by a member of the homecare or research team at pre-arranged intervals in order to complete questionnaires
Exclusion Criteria
- Participants who have received icatibant as an investigational medicine as part of a clinical trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sciensus | London | United Kingdom | W2 6LA |
Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TAK-667-4002
- MACS-2021-061502