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

Study Overview
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Brief Summary
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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
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1 year

Official Title
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Observational Study of Atopic Dermatitis Patients Treated With Dupilumab in Taiwan

Conditions
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Atopic Dermatitis

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 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 AD<br>Male or female, 18 years or older at the baseline visit initiated treatment with dupilumab for AD, who are eligible for dupilumab reimbursement according to the country-specific prescribing information | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Used regimens |  | At baseline (Day 1) | 
| Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Reason for initiation of new treatments |  | At baseline (Day 1) | 
| Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Concomitant therapies |  | At baseline (Day 1) | 
| Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Treatment durations |  | At baseline (Day 1) | 
| Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Reasons for discontinuation and/or switching |  | At baseline (Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of the patients who receive dupilumab for AD: Medical history |  | At baseline (Day 1) | 
| Characterization of the patients who receive dupilumab for AD: Socio-demographic data |  | At baseline (Day 1) | 
| Characterization of the patients who receive dupilumab for AD: Prior and concomitant treatments of AD; percentage who were on dupilumab at the baseline/enrollment visit (Visit 1) |  | At baseline (Day 1) | 
| Characterization of the patients who receive dupilumab for AD: Reason for initiation of dupilumab |  | At baseline (Day 1) | 
| Characterization of the patients who receive dupilumab for AD: Baseline assessments of comorbid conditions (Asthma Control Questionnaire (ACQ-5)) |  | At baseline (Day 1) | 
| Characterization of the patients who receive dupilumab for AD: Baseline assessments of comorbid conditions (22-item Sino-Nasal Outcome Test (SNOT-22)) |  | At baseline (Day 1) | 
| Characterization of real-world use patterns of dupilumab for AD: Dupilumab dose regimens used over the study, and the duration with each regimen |  | Up to 12 months | 
| Characterization of real-world use patterns of dupilumab for AD: Percentage of patients whose dose (either the frequency of the strength) increased from starting regimen and reasons; percentage whose dose decreased from the starting regimen and reasons |  | Up to 12 months | 
| Characterization of real-world use patterns of dupilumab for AD: Percent discontinuing dupilumab, including temporary or permanent discontinuation; reasons for discontinuation |  | Up to 12 months | 
| Characterization of real-world use patterns of dupilumab for AD: Longest duration of use |  | Up to 12 months | 
| Characterization of real-world use patterns of dupilumab for AD: Number of gaps in dupilumab treatment and longest gap length |  | Up to 12 months | 
| Characterization of real-world use patterns of dupilumab for AD: Concomitant therapies taken for AD |  | Up to 12 months | 
| Effectiveness of dupilumab: change from baseline in Eczema Area and Severity Index (EASI) |  | Day 0, Months 3, 6, 9 and 12 | 
| Effectiveness of dupilumab: change from baseline in body surface area (of AD involvement) (BSA) |  | Day 0, Months 3, 6, 9 and 12 | 
| Effectiveness of dupilumab: change from baseline in Investigator global assessment scale (IGA) |  | Day 0, Months 3, 6, 9 and 12 | 
| Effectiveness of dupilumab: change from baseline in Scoring of Atopic Dermatitis (SCORAD) |  | Day 0, Months 3, 6, 9 and 12 | 
| Effectiveness of dupilumab: change from baseline in Patient-Oriented Eczema Measure (POEM) |  | Day 0, Months 3, 6, 9 and 12 | 
| Effectiveness of dupilumab: change from baseline in Atopic Dermatitis Control Tools (ADCT) |  | Day 0, Months 3, 6, 9 and 12 | 
| Effectiveness of dupilumab: change from baseline in Pruritus Numerical Rating Scale (NRS) |  | Day 0, Months 3, 6, 9 and 12 | 
| Effectiveness of dupilumab: change from baseline in Sleep NRS |  | Day 0, Months 3, 6, 9 and 12 | 
| Effectiveness of dupilumab: change from baseline in Dermatology Life Quality Index (DLQI) |  | Day 0, Months 3, 6, 9 and 12 | 
| Effectiveness of dupilumab in relevant comorbid conditions: change in Juniper Asthma Control Questionnaire (ACQ-5) from the first reported time point of Asthma |  | Day 0 to Month 12 | 
| Effectiveness of dupilumab in relevant comorbid conditions: change in 22-item Sino-Nasal Outcome Test (SNOT-22) from the first reported time point of Asthma |  | Day 0 to Month 12 | 
| Percentage of participants reporting that their comorbid condition got better, and the percentage reporting their condition got worse at each follow-up visit by each specific condition (other than asthma and allergic rhinitis) |  | Day 0 to Month 12 | 
| Safety: Number of patients with at least 1 adverse event (AE) |  | Day 0 to Month 12 | 
| Safety: Annualized event rates of AEs |  | Day 0 to Month 12 |