A Study in Male and Female Adult Patients With Atopic Dermatitis Treated With Dupilumab in Taiwan

Brief description of study

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

Detailed description of study

1 year

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: Atopic Dermatitis
Age: 18 Years
Gender: Male or Female

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:
          1. Phototherapy (psoralen + ultraviolet light A (PUVA) or narrow-band ultraviolet B
             (nb-UVB) twice a week) more than 3 months, and,
          2. 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.

Updated on 27 Jul 2022 . Study ID: NCT05442645

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