Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis (AD)

Study Overview
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Brief Summary
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Primary Objective: To characterize the patients who receive Dupixent® (dupilumab) 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 Secondary Objectives: To characterize real-world use patterns of Dupixent® for AD (eg, used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching) To assess the long-term effectiveness of Dupixent® in AD patients in a real-world setting To assess comorbid atopic conditions and effects of treatment in comorbid atopic conditions in patients who receive Dupixent® for AD To collect safety data on study participants

Detailed Description
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Participants enrolled in the study will be followed for 5 years.

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 SAR231893 (REGN668)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 12 years or older at the baseline visit. Note: Adolescent participants (at least 12 years old, but less than 18 years) are eligible only after Dupixent® receives the respective country's regulatory approval for use in this age group; Initiating treatment with Dupixent® for AD according to the country-specific prescribing information. Note: Participants may be eligible if they have already initiated treatment with Dupixent® for AD within 6 months before their enrollment in the registry, provided that all core baseline data required (Eczema Area and Severity Index [EASI], Scoring of Atopic Dermatitis [SCORAD], body surface area [of AD involvement] [BSA], Patient-Oriented Eczema Measure [POEM], and Dermatology Life Quality Index [DLQI]) by the registry protocol were captured at the time of initiating Dupixent® treatment and are available for entry in the registry database Able to understand and complete study-related questionnaires Provide signed informed consent or parental/legally acceptable representative consent and/or patient assent where applicable Exclusion Criteria: Participants 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 participant patient from adequately completing the schedule of visits and assessments Patients currently participating in any interventional clinical trial which modifies patient care Prior use of Dupixent® within 6 months of the screening visit, or within 6 months of the baseline visit if screening and baseline occur on the same day The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with AD<br>Adult and adolescent participants with AD initiating treatment with Dupixent® for AD according to the country-specific prescribing information, as part of their usual care as determined by their physician | Drug: Dupilumab SAR231893 (REGN668)<br>* Pharmaceutical form: solution for injection Route of administration: subcutaneous injection<br>* Other names: Dupixent®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Characteristics: Medical history |  | Baseline to Month 60 | 
| Baseline Characteristics: Socio-demographics |  | Baseline to Month 60 | 
| Baseline Characteristics: Disease characteristics |  | Baseline to Month 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Physician Assessment: Scoring of Atopic Dermatitis (SCORAD) | Measure used in clinical practice and clinical trials to standardize the evaluation of the severity and extent of AD | Baseline to Month 60 | 
| Participant Assessment: Patient Oriented Eczema Measure (POEM) | Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults | Baseline to Month 60 | 
| Participant Assessment: Pruritus Numerical Rating Scale (NRS) | Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale | Baseline to Month 60 | 
| 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 | 
| 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 | 
| Participant Assessment: Skin Sensitivity NRS | Individual NRS used to rate skin sensitivity using a 0 to 10 NRS | Baseline to Month 60 | 
| 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 | 
| Participant Assessment: Dermatology Life Quality Index (DLQI) for adults and Children Dermatology Life Quality Index (CDLQI) for adolescents | Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL) | Baseline to Month 60 | 
| Participant Assessment: Juniper Asthma Control Questionnaire (ACQ-5) | Questionnaire to evaluate asthma control in participants with comorbid asthma | Baseline to Month 60 | 
| Participant Assessment: Allergic Rhinitis-Visual Analog Scale (AR-VAS) | Instrument for the documentation of symptoms and therapy monitoring in allergic rhinitis | Baseline to Month 60 | 
| Participant Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD) for adults and Work Productivity and Activity Impairment Questionnaire+Classroom Impairment Questions for AD (WPAI-CIQ-AD) for adolescents | Questionnaire to assess the impact of AD on productivity | Baseline to Month 60 | 
| Participant Assessment: Health Care Resource Utilization Questionnaire | Questionnaire regarding hospitalization, or emergency room/urgent care center visits due to AD | Baseline to Month 60 | 
| Participant Assessment: 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9) | Instrument to measure treatment satisfaction | Baseline to Month 60 | 
| Adverse events (AEs) | Number of participants with at least 1 AE | Baseline to Month 60 | 
| Participant Assessment: Atopic Dermatitis Control Tool (ADCT) to be collected optionally | Questionnaire related with Atopic dermatitis control | Baseline to Month 60 |