Dermatitis, Atopic
Conditions
Keywords
Eczema
Brief summary
A long-term observational registry in patients with atopic dermatitis (AD) initiating treatment with DUPIXENT® (dupilumab)
Detailed description
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
Interventions
DRUGDupilumab
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.
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Registry Assessment: Baseline Characteristics | At baseline (day when DUPIXENT treatment is initiated) | Medical history |
| Registry Assessment: Baseline Characteristic | At baseline (day when DUPIXENT treatment is initiated) | Socio-demographics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Registry (Physician) Assessment: Overall Disease Severity scale | Baseline to month 60 | 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) |
| Registry (Participant) Assessment: Patient Oriented Eczema Measure | Baseline to month 60 | Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults |
| Registry (Participant) Assessment: Pruritus Numerical Rating Scales (NRS) | Baseline to month 60 | Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale. |
| Registry (Participant) Assessment: Skin Pain or Soreness NRS | Baseline to month 60 | Individual NRS used to rate skin pain and soreness using a 0 to 10 NRS |
| Registry (Participant) Assessment: Skin Feeling Hot NRS | Baseline to month 60 | Individual NRS used to rate the sensation of skin feeling hot (burning sensation) using a 0 to 10 NRS |
| Registry (Participant) Assessment: Skin Sensitivity NRS | Baseline to month 60 | Individual NRS used to rate skin sensitivity using a 0 to 10 NRS |
| Registry (Participant) Assessment: Sleep Disturbance NRS | Baseline to month 60 | Individual NRS used to report the severity of their sleep disturbance using a 0 to 10 NRS |
| Registry (Participant) Assessment: Global Assessment of Atopic Dermatitis scale | Baseline to month 60 | Rate of overall well-being on a 5-point scale. |
| Registry (Participant) Assessment: Dermatology Life Quality Index (DLQI) | Baseline to month 60 | 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 |
| Registry (Physician) Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis | Baseline to month 60 | Percentage of BSA affected by AD assessed for each major section of the body |
| Registry (Participant) Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD) | Baseline to month 60 | Questionnaire to assess the impact of AD on productivity. |
| Registry (Participant) Assessment: Health Care Resource Utilization Questionnaire | Baseline to month 60 | Questionnaire regarding hospitalization, or emergency room/ urgent care center visits due to AD. |
| Registry (Participant) Assessment: Dermatitis Family Impact Questionnaire | Baseline to month 60 | Questionnaire to assess the impact of atopic eczema on the QOL of the parents and family members of affected children. |
| Registry (Participant) Assessment: Missed School Days | Baseline to month 60 | 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. |
| Registry (Participant) Assessment: Juniper Asthma Control Questionnaire (ACQ-5) | Baseline to month 60 | 5-question version of questionnaire to evaluate asthma control in registry patients with comorbid asthma. |
| Registry (Participant) Assessment: Allergic Rhinitis Visual Analog Scale (AR-VAS) | Baseline to month 60 | Questionnaire used as a validated measuring instrument for the documentation of symptoms and therapy monitoring in AR. |
| Registry (Participant) Assessment: Changes in Concurrent Conditions | Baseline to month 60 | Rate of change in any other condition(s) (other than eczema, asthma, and allergic symptoms) on a 2-point scale (Better or Worse). |
| Registry (Participant) Assessment: Overall Health State | Baseline to month 60 | Rate of overall state of health on a 5-point scale (Poor, Fair, Good, Very Good or Excellent). |
| Registry (Participant) Assessment: Children's Dermatology Life Quality Index (CDLQI) | Baseline to month 60 | Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on QOL in pediatrics. |
| Registry (Physician) Assessment: Eczema Area and Severity Index (EASI) | Baseline to month 60 | Measure used in clinical practice and clinical trials to assess the severity and extent of AD |
Countries
Canada, United States
Outcome results
None listed