Study of Patients Receiving DUPIXENT® for Atopic Dermatitis (AD)

Study Overview
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Brief Summary
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A long-term observational registry in patients with atopic dermatitis (AD) initiating treatment with DUPIXENT® (dupilumab)

Detailed Description
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This is a prospective observational study conducted to (1) characterize the patients who receive DUPIXENT® for AD in a real world setting with respect to their medical history, socio-demographic and disease characteristics, and prior and concomitant treatments of AD; (2) characterize real world use patterns of DUPIXENT® for AD (eg, most commonly used regimens by line of therapy, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching); (3) assess the long-term effectiveness of DUPIXENT® in AD patients in a real world setting; (4) assess comorbid atopic conditions, patterns of use and effects of treatment in comorbid atopic conditions in patients who receive DUPIXENT® for AD; and (5) collect safety data on study participants

Official Title
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A Prospective Observational Study of Patients Receiving DUPIXENT® for Atopic Dermatitis

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Drug: Dupilumab


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Male or female, 12 years of age or older at the baseline visit. NOTE: Adolescent patients (at least 12 years old, but less than 18 years) are eligible in the US or Canada only after DUPIXENT receives the respective country's regulatory approval for use in this age group. Initiating treatment with DUPIXENT® as standard-of-care for AD according to the country-specific prescribing information (Note: Participants will be screened when they received their initial prescription for DUPIXENT®). Willing and able to comply with study-related activities. Able to understand and complete study-related questionnaires. Provide signed informed consent or parental/legal guardian consent plus patient assent, where applicable. Key Exclusion Criteria: Patients who have a contraindication to the drug according to the country-specific prescribing information label. 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 co-morbidities that can predictably prevent the patient from adequately completing the schedule of visits and assessments. Prior use of dupilumab within 6 months of the screening visit, or within 6 months of the baseline visit if screening and baseline occur on the same day. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

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

| Intervention/Treatment |
| --- |
|Drug: Dupilumab|Dupixent 1 dose at Baseline required for eligibility; otherwise, no therapeutic intervention required during the course of the study. In addition to (or substituting for) DUPIXENT®, participants may receive marketed drugs as deemed necessary by their physicians for the treatment of AD or comorbid conditions.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Registry Assessment: Baseline Characteristics | Medical history | At baseline (day when DUPIXENT treatment is initiated) | 
| Registry Assessment: Baseline Characteristic | Socio-demographics | At baseline (day when DUPIXENT treatment is initiated) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Registry (Physician) Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis | Percentage of BSA affected by AD assessed for each major section of the body | Baseline to month 60 | 
| Registry (Physician) Assessment: Eczema Area and Severity Index (EASI) | Measure used in clinical practice and clinical trials to assess the severity and extent of AD | Baseline to month 60 | 
| Registry (Physician) Assessment: Overall Disease Severity scale | Questionnaire used to characterizing the severity of AD on a 4-point scale (0=No disease, 1=Minimal disease, 2=Mild disease, 3=Moderate disease, 4=Severe disease) | Baseline to month 60 | 
| Registry (Participant) Assessment: Patient Oriented Eczema Measure | Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults | Baseline to month 60 | 
| Registry (Participant) Assessment: Pruritus Numerical Rating Scales (NRS) | Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale. | Baseline to month 60 | 
| Registry (Participant) Assessment: Skin Pain or Soreness NRS | Individual NRS used to rate skin pain and soreness using a 0 to 10 NRS | Baseline to month 60 | 
| Registry (Participant) Assessment: Skin Feeling Hot NRS | Individual NRS used to rate the sensation of skin feeling hot (burning sensation) using a 0 to 10 NRS | Baseline to month 60 | 
| Registry (Participant) Assessment: Skin Sensitivity NRS | Individual NRS used to rate skin sensitivity using a 0 to 10 NRS | Baseline to month 60 | 
| Registry (Participant) Assessment: Sleep Disturbance NRS | Individual NRS used to report the severity of their sleep disturbance using a 0 to 10 NRS | Baseline to month 60 | 
| Registry (Participant) Assessment: Global Assessment of Atopic Dermatitis scale | Rate of overall well-being on a 5-point scale. | Baseline to month 60 | 
| Registry (Participant) Assessment: Dermatology Life Quality Index (DLQI) | Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL) in adults | Baseline to month 60 | 
| Registry (Participant) Assessment: Children's Dermatology Life Quality Index (CDLQI) | Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on QOL in pediatrics. | Baseline to month 60 | 
| Registry (Participant) Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD) | Questionnaire to assess the impact of AD on productivity. | Baseline to month 60 | 
| Registry (Participant) Assessment: Health Care Resource Utilization Questionnaire | Questionnaire regarding hospitalization, or emergency room/ urgent care center visits due to AD. | Baseline to month 60 | 
| Registry (Participant) Assessment: Dermatitis Family Impact Questionnaire | Questionnaire to assess the impact of atopic eczema on the QOL of the parents and family members of affected children. | Baseline to month 60 | 
| Registry (Participant) Assessment: Missed School Days | Questionnaire to assess the number of missed school days since the last study assessment of adolescent patients (aged ≥ 12 to < 18 years) who are enrolled in school. | Baseline to month 60 | 
| Registry (Participant) Assessment: Juniper Asthma Control Questionnaire (ACQ-5) | 5-question version of questionnaire to evaluate asthma control in registry patients with comorbid asthma. | Baseline to month 60 | 
| Registry (Participant) Assessment: Allergic Rhinitis Visual Analog Scale (AR-VAS) | Questionnaire used as a validated measuring instrument for the documentation of symptoms and therapy monitoring in AR. | Baseline to month 60 | 
| Registry (Participant) Assessment: Changes in Concurrent Conditions | Rate of change in any other condition(s) (other than eczema, asthma, and allergic symptoms) on a 2-point scale (Better or Worse). | Baseline to month 60 | 
| Registry (Participant) Assessment: Overall Health State | Rate of overall state of health on a 5-point scale (Poor, Fair, Good, Very Good or Excellent). | Baseline to month 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eczema