A Study in Male and Female Adult Patients With Atopic Dermatitis Treated With Dupilumab in Taiwan
Investigating Treatment Patterns in Adult Atopic Dermatitis Patients
Study Overview
Primary objective:
To characterize the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment for adult AD patients, who are eligible for dupilumab reimbursement in Taiwan (e.g., used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching).
Secondary objectives:
- To characterize the adult AD patients, who are eligible for dupilumab reimbursement in Taiwan, with respect to their a) medical history, b) socio-demographic, c) disease characteristics, d) comorbid with type 2 diseases [e.g., Asthma, Chronic rhinosinusitis with nasal polyp (CRSwNP)], and e) prior and concomitant treatments of atopic dermatitis
- To assess the effectiveness and safety of dupilumab in adult atopic dermatitis patients, who are eligible for dupilumab reimbursement in Taiwan
- To assess comorbid atopic conditions and effects of dupilumab treatment for comorbid atopic conditions in adult patients, who are eligible for dupilumab reimbursement in Taiwan
- To evaluate the correlation of patient reported outcome [Atopic Dermatitis Control Tool (ADCT)] and physician assessment [Eczema Area and Severity Index (EASI)] from the recruited subjects
Study Details
1 year
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Atopic Dermatitis
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
- Male or female, 18 years or older at the baseline visit
- Initiating treatment with dupilumab for AD, who are eligible for dupilumab reimbursement according to the country-specific prescribing information
Note: Patients, who are diagnosed with AD more than 6 months, Eczema Area and Severity Index (EASI) more than or equals to 20. body surface area (of AD involvement) (BSA) more than or equals to 30% and IGA=3-4, may be eligible if they have already initiated treatment with:
- Phototherapy (psoralen + ultraviolet light A (PUVA) or narrow-band ultraviolet B (nb-UVB) twice a week) more than 3 months, and,
- Two different immunosuppressants (methotrexate, azathioprine, or cyclosporine) more
than 3 months respectively before their enrollment in the registry.
- Provided signed informed consent
Exclusion Criteria:
- Any condition that, in the opinion of the Investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from adequately completing the schedule of visits and assessments
- Patients currently participating in any interventional clinical trial which modifies patient care
- Patients who have a contraindication to dupilumab according to the country-specific prescribing information
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
This study investigates the treatment patterns in adult patients with atopic dermatitis (AD) in Taiwan. The purpose of this study is to understand how treatments like phototherapy and immunosuppressants are used before starting treatment with an investigational medication in patients eligible for reimbursement in Taiwan. It will look at the reasons for starting new treatments, the combination of therapies used, and how long treatments last before they are changed or stopped.
Participants in this study will undergo various assessments to gather information about their medical history, socio-demographic details, and disease characteristics. The study will also evaluate the effectiveness and safety of the investigational medication and its effects on related conditions such as asthma and chronic rhinosinusitis. Data will be collected through patient-reported outcomes and physician assessments to better understand the correlation between different measures of disease control.
- Who can participate: Adults aged 18 years or older who are starting treatment with an investigational medication for atopic dermatitis and eligible for reimbursement in Taiwan can participate. Participants must have a history of atopic dermatitis for more than 6 months and meet criteria related to disease severity and prior treatments.
- Study details: Participants will be required to provide informed consent and will undergo assessments related to their medical history and disease characteristics. They will also be monitored for the effectiveness and safety of the investigational medication. The study will collect data through both patient-reported outcomes and physician assessments.
- Study timelines: The study will last 1 year.
