Real-world Effectiveness Study of Long-term Treatment With Dupilumab in Participants ≥6 Years With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— PROTYPE2  

Official title:

Prospective, Non-interventional, Observational Study for Multi-dimensional Assessment of Signs, Symptoms, Quality of Life and Disease Control of Long-term Treatment With Dupilumab in Patients With Atopic Dermatitis (≥6 Years)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06039241
• Other study ID #: OBS17251
• Secondary ID: U1111-1293-5998
• Status: Recruiting
• Start date: March 7, 2023
• Est. completion date: March 8, 2027

Study information

• Verified date: March 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free for US & Can
• Phone: 1800633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a Prospective, non-interventional (NIS) observational study in patients (≥6 years) with atopic dermatitis (AD) receiving dupilumab for the prospective evaluation of signs and symptoms, quality of life and disease control. The aim of this NIS is the characterization of the AD patient population in Germany, receiving dupilumab under everyday conditions in terms of their medical history, socio-demographic and disease-related characteristics, associated atopic comorbidities and type 2 inflammation diseases, concomitant therapy as well as previous systemic and ongoing AD treatments. In addition to the therapeutic response rate at Month 6, the long-term efficacy of dupilumab at Month 12 and Month 24 will be assessed by additional outcomes by measuring disease control in AD patients using questionnaires such as Atopic Dermatitis Control Tool (ADCT) and Recap of Atopic Eczema (RECAP). In addition, this NIS aims to assess the dosing pattern of dupilumab for AD, including variations in dosing regimen, reason for dupilumab treatment initiation or discontinuation, or change in therapy and concomitant therapies and duration of treatment. In addition, the effect of dupilumab in adult and pediatric AD patients with associated atopic comorbidities or type-2 inflammation diseases are observed, which corresponds to the clinical care situation. Finally, this NIS aims to collect long-term safety data in adult, adolescent and pediatric AD patients treated with dupilumab. Individual observation period is 2 years or until dupilumab is discontinued. Visits will be scheduled according to standard of care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: March 8, 2027
• Est. primary completion date: March 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Patients are at least 6 years of age at the baseline visit. - Initial treatment with dupilumab was initiated in adults and adolescents 12 years of age and older with moderate to severe AD, or in children 6 to 11 years of age with severe AD according to the Summary of Product Characteristics. - Patients or their guardians are able to understand and complete the study-related questionnaires. - Signing a written informed consent form by the patients before the initiation of documentation within the framework of this NIS or informed consent of parents/guardian, if applicable.

Exclusion Criteria:

• Patients who have a contraindication for dupilumab based on the current Summary of Product Characteristics. - Patients who have already been treated with dupilumab for more than 7 days. - Any acute or chronic diseases, which, in the opinion of the attending physician, would impair the patient's ability to complete questionnaires or participate in this study or could affect the interpretation of the results. - Participation in an ongoing interventional or observational study, which, in the opinion of the attending physician, could affect the assessment of the current study. "The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial."

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
Germany	Investigational Site Number: 061	Aachen
Germany	Investigational Site Number: 092	Ahaus
Germany	Investigational Site Number: 066	Andernach
Germany	Investigational Site Number: 002	Berlin
Germany	Investigational Site Number: 003	Berlin
Germany	Investigational Site Number: 004	Berlin
Germany	Investigational Site Number: 073	Berlin
Germany	Investigational Site Number: 077	Berlin
Germany	Investigational Site Number: 174	Berlin
Germany	Investigational Site Number: 176	Berlin
Germany	Investigational Site Number: 059	Braunschweig
Germany	Investigational Site Number: 057	Buxtehude
Germany	Investigational Site Number: 028	Chemnitz
Germany	Investigational Site Number: 026	Dresden
Germany	Investigational Site Number: 072	Dresden
Germany	Investigational Site Number: 032	Düren
Germany	Investigational Site Number: 043	Erlangen
Germany	Investigational Site Number: 064	Essen
Germany	Investigational Site Number: 184	Friedberg
Germany	Investigational Site Number: 055	Gera
Germany	Investigational Site Number: 007	Gießen
Germany	Investigational Site Number: 031	Gladbeck
Germany	Investigational Site Number: 078	Göttingen
Germany	Investigational Site Number: 020	Hamburg
Germany	Investigational Site Number: 086	Hamburg
Germany	Investigational Site Number: 087	Hamburg
Germany	Investigational Site Number: 088	Hamburg
Germany	Investigational Site Number: 169	Heidelberg
Germany	Investigational Site Number: 053	Heilbad Heiligenstadt
Germany	Investigational Site Number: 063	Jülich
Germany	Investigational Site Number: 186	Karlsruhe
Germany	Investigational Site Number: 016	Kiel
Germany	Investigational Site Number: 017	Kiel
Germany	Investigational Site Number: 069	Köln
Germany	Investigational Site Number: 183	Landsberg
Germany	Investigational Site Number: 038	Langenau
Germany	Investigational Site Number: 179	Leipzig
Germany	Investigational Site Number: 014	Mainz
Germany	Investigational Site Number: 178	Mainz
Germany	Investigational Site Number: 185	Mainz
Germany	Investigational Site Number: 013	Mannheim
Germany	Investigational Site Number: 018	Mölln
Germany	Investigational Site Number: 035	Mönchengladbach
Germany	Investigational Site Number: 050	München
Germany	Investigational Site Number: 076	Neubrandenburg
Germany	Investigational Site Number: 042	Nürnberg
Germany	Investigational Site Number: 045	Nürnberg
Germany	Investigational Site Number: 024	Oelde
Germany	Investigational Site Number: 082	Potsdam
Germany	Investigational Site Number: 172	Remscheid
Germany	Investigational Site Number: 177	Rostock
Germany	Investigational Site Number: 047	Wasserburg
Germany	Investigational Site Number: 019	Wismar
Germany	Investigational Site Number: 168	Wittlich
Germany	Investigational Site Number: 193	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who maintain Eczema Area and Severity Index (EASI) = 7 OR peak pruritus Numerical Rating Scale (NRS) = 4 OR Dermatology Life Quality Index (DLQI) = 5	EASI is a Measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity. DLQI is a questionaire with a score system of 0 to 30 the high score is indicative of poor QoL	From Month 6 to Month 12
Primary	Mean percent change from baseline in Atopic Dermatitis Control Tools (ADCT) score (=12 years)	Atopic dermatitis control tool (ADCT) is a validated, brief and easy scored tool designed to evaluate patient-perceived control of atopic dermatitis, to foster communication between patients and their physicians and help appropriate decision- making. ADCT questionnaire assess patient-self-perceived control of their AD with a total score from 0 to 24; higher scores indicate lower AD control. ADCT is a questionnaire to assess patient-self-perceived control of their AD with a total score from 0 to 24; higher scores indicate lower AD control.	From baseline to Week 52
Primary	Mean percent change from baseline in Recap of atopic eczema (RECAP) score (6-11 years)	Recap of atopic eczema (RECAP) is a seven-item questionnaire designed to capture the experience of eczema control in all ages and eczema severities. Patient's who turn 12 years during the course of study will continue to complete RECAP.	From baseline to Week 52
Secondary	Incidence of treatment emergent adverse events (TEAEs) during the observation period	Treatment emergent AEs and SAEs reported	From baseline up to 24 months
Secondary	Incidence of dupilumab-related TEAEs during the observation period.	Treatment emergent AEs and SAEs reported	From baseline up to 24 months
Secondary	Event rate (per patient year) by type of TEAEs during the observation period.		From baseline up to 24 months
Secondary	Event rate (per patient year) by type of dupilumab related TEAEs during the observational period		From Baseline up to 24 months
Secondary	Treating physician reported effectiveness data: Change from baseline in IGA score after 6, 12, and 24 months dupilumab therapy	The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity	From baseline up to 24 months
Secondary	Treating physician reported effectiveness data.: Number of patients achieving EASI-75 (improvement in EASI score from baseline of = 75%) after 6, 12 and 24 months of dupilumab therapy	EASI is a Measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI score is used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders are the participants who achieved =75% improvement from baseline.	From baseline up to 24 months
Secondary	Treating physician reported effectiveness data: Absolute change from baseline in EASI score after 6, 12 and 24 months of dupilumab therapy	EASI is a Measure used in clinical practice and clinical trials to assess the severity and extent of AD, The EASI score is used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD	From baseline up to 24 months
Secondary	Treating physician reported effectiveness data: Percentage change from baseline in EASI score after 6, 12, and 24 months of dupilumab therapy	EASI is a Measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI score is used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.	From baseline up to 24 months
Secondary	Treating physician reported effectiveness data: Absolute change from baseline in IGA score after 6, 12, and 24 months of dupilumab therapy	The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.	From baseline up to 24 months
Secondary	Treating physician reported effectiveness data: Change from baseline in body surface area (BSA) after 6, 12, and 24 months of dupilumab therapy	Affected body surface area is measured.	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on quality of life (QoL) data: Mean absolute change from baseline in Atopic Dermatitis Control Test (ADCT) score after 3, 6, 9, 15, 18, and 24 months of dupilumab therapy	ADCT is a validated, brief and easy scored tool designed to evaluate patient-perceived control of atopic dermatitis, to foster communication between patients and their physicians and help appropriate decision making. The ADCT is a 6-item patient-reported outcomes instrument with a 7-day recall period to measure AD disease control. Total score ranges from 0 to 24.	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in ADCT score after 3, 6, 9, 15, 18, and 24 months of dupilumab therapy	ADCT is a validated, brief and easy scored tool designed to evaluate patient-perceived control of atopic dermatitis, to foster communication between patients and their physicians and help appropriate decision-making. The ADCT is a 6-item patient-reported outcomes instrument with a 7-day recall period to measure AD disease control. Total score ranges from 0 to 24.	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Recap of atopic eczema (RECAP) score after 3, 6, 9, 15, 18, and 24 months of dupilumab therapy	Recap of atopic eczema (RECAP) is a seven-item questionnaire designed to capture the experience of eczema control in all ages and eczema severities. The RECAP can range from 0 to 28, where a lower score indicates a better outcome.	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in RECAP score after 3, 6, 9, 15, 18, and 24 months of dupilumab therapy	RECAP is a seven-item questionnaire designed to capture the experience of eczema control in all ages and eczema severities. The RECAP can range from 0 to 28, where a lower score indicates a better outcome.	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Patient Oriented Eczema Measure (POEM) score after 6, 12, and 24 months of dupilumab therapy	POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28, the higher score indicating higher severity.	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in POEM score after 6, 12, and 24 months of dupilumab therapy	POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28, the higher score indicating higher severity.	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Dermatology Life Quality Index/Children's Dermatology Life Quality Index (DLQI/CDLQI) score after 6, 12, and 24 months of dupilumab therapy.	The Dermatology Quality of Life Index (DLQI) is a 10-item questionnaire to measure dermatology specific quality of life (QoL). The DLQI is designed for use in adults (patient's = 16 years of age) and the CDLQI for patients < 16 years of age. Each question is scored on a four-point Likert scale.The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in Dermatology Life Quality Index (DLQI)/Children's Dermatology Life Quality Index (CDLQI) score after 6, 12, and 24 months of dupilumab therapy	The Dermatology Quality of Life Index (DLQI) is a 10-item questionnaire to measure dermatology specific quality of life (QoL). The DLQI is designed for use in adults (patient's = 16 years of age) and the CDLQI for patients < 16 years of age. Each question is scored on a four-point Likert scale.The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: Mean Absolute Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance score after 6, 12, and 24 months of dupilumab therapy.	Patient-Reported Outcomes Measurement Information System® (PROMIS®) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS® Sleep Disturbance Scale was developed to assess self-reported perceptions of sleep quality, sleep depth, and any perceived difficulties related to getting and staying asleep over a 7-day period. Response options for the sleep quality item range from: "Very poor (1)" to "Very good (5)" or from "Not at all (1)" to "Very much (5).	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: Mean Percent Change from baseline in PROMIS sleep disturbance score after 6, 12, and 24 months of dupilumab therapy	Patient-Reported Outcomes Measurement Information System® (PROMIS®) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS® Sleep Disturbance Scale was developed to assess self-reported perceptions of sleep quality, sleep depth, and any perceived difficulties related to getting and staying asleep over a 7-day period. Response options for the sleep quality item range from: "Very poor (1)" to "Very good (5)" or from "Not at all (1)" to "Very much (5).	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in At baseline Questionnaire on Experience with Skin complaints (QES) score after 6, 12, and 24 months of dupilumab therapy	The Questionnaire on Experience with Skin Complaints (QES) [8] is a fully standardized self-rating instrument that focuses on the feelings of stigmatization of patients with different skin diseases and the coping with the stigma experience.	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in At baseline Questionnaire on Experience with Skin complaints (QES) score after 6, 12, and 24 months of dupilumab therapy	The Questionnaire on Experience with Skin Complaints (QES) [8] is a fully standardized self-rating instrument that focuses on the feelings of stigmatization of patients with different skin diseases and the coping with the stigma experience.	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Patient Global Assessment (PtGA) score after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy	The Global Patient Assessment is a 2-component questionnaire on symptom severity and the patient's overall satisfaction with their treatment.	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in Patient Global Assessment (PtGA) score after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy	The Global Patient Assessment is a 2-component questionnaire on symptom severity and the patient's overall satisfaction with their treatment	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: : Mean percent change from baseline in Asthma control questionnaire-5 (ACQ-5)-Scores, assessed only in patients with co-existing Asthma after 3, 6, 9,12, 15, 18, and 24 months of dupilumab therapy	The ACQ-5 assesses asthma control using the 5-item ACQ-5 questionnaire.	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Asthma control questionnaire-5 (ACQ-5)-Scores, assessed only in patients with co-existing Asthma) after 3, 6, 9,12, 15, 18, and 24 months of dupilumab therapy	The ACQ-5 assesses asthma control using the 5-item ACQ-5 questionnaire.	From baseline up to 24 months
Secondary	Mean absolute change from baseline in Allergic Visual analogue Scales ([Allergic-VAS] only patients with co-existing overall allergic symptoms) after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy	Patient reported effectiveness and impact on QoL data: will be assessed. Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. VAS is usually a horizontal 100 mm long scale with two opposing descriptors at its end points. The lower numbers indicate less severity, and the higher numbers indicate greater severity.	From baseline up to 24 months
Secondary	Mean percent change from baseline in Allergic Visual Analogue Scales ([Allergic-VAS] only patients with co-existing overall allergic symptoms) after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy	Patient reported effectiveness and impact on QoL data: will be assessed. Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. VAS is usually a horizontal 100 mm long scale with two opposing descriptors at its end points. The lower numbers indicate less severity, and the higher numbers indicate greater severity.	From Baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in MACVIA-ARIA Sentinel Network Rhinitis Visual Analog Score (MASK-Rhinitis VAS score).	Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. VAS is usually a horizontal 100 mm long scale with two opposing descriptors at its end points. The lower numbers indicate less severity, and the higher numbers indicate greater severity.	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in MACVIA-ARIA Sentinel Network Rhinitis Visual Analog Score (MASK-Rhinitis VAS score)	Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. VAS is usually a horizontal 100 mm long scale with two opposing descriptors at its end points. The lower numbers indicate less severity, and the higher numbers indicate greater severity.	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in MACVIA-ARIA Sentinel Network conjunctivitis Visual Analog Score (MASK-conjunctivitis VAS score), after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy.	Only assessed in patients with co-existing allergic conjunctivitis. Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. VAS is usually a horizontal 100 mm long scale with two opposing descriptors at its end points. The lower numbers indicate less severity, and the higher numbers indicate greater severity.	From baseline up to 24 months
Secondary	Mean percent change from baseline in MACVIA-ARIA Sentinel Network conjunctivitis Visual Analog Score (MASK-conjunctivitis VAS score) after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy	Only assessed in patients with co-existing allergic conjunctivitis. Patient reported effectiveness and impact on QoL data: will be aVisual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. VAS is usually a horizontal 100 mm long scale with two opposing descriptors at its end points. The lower numbers indicate less severity, and the higher numbers indicate greater severity.	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Sinus Control Test (SCT) score, only assessed in patients with co-existing chronic rhinosinusitis after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy	The SCT involves four questions, three of which are answered using a 5-point Likert scale and one dichotomous question. The SCT total score is used to categorize patient control status into three groups: controlled (total score 0-3), partially controlled (total score 4-11), and uncontrolled (total score 12-16).	From baseline up to 24 months
Secondary	Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in SCT score, only assessed in patients with co-existing chronic rhinosinusitis after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy	The SCT involves four questions, three of which are answered using a 5-point Likert scale and one dichotomous question. The SCT total score is used to categorize patient control status into three groups: controlled (total score 0-3), partially controlled (total score 4-11), and uncontrolled (total score 12-16).	From baseline up to 24 months
Secondary	Patient and treatment characteristics reported by the physician or patient: Socio -demographic data		At baseline
Secondary	Patient and treatment characteristics reported by the physician or patient: Medical history of disease		At baseline
Secondary	Patient and treatment characteristics reported by the physician or patient: Comorbidities/smoker status/alcohol usage		At baseline
Secondary	Patient and treatment characteristics reported by the physician or patient: Prior systemic AD treatment (including balneophototherapy and/or UV therapy)		At baseline
Secondary	Patient and treatment characteristics reported by the physician or patient: Current topical and/or systemic AD treatment of the last 4 weeks before baseline visit (dosage, type)		At baseline
Secondary	Patient and treatment characteristics reported by the physician or patient: Current treatment for co-existing type 2 inflammatory and atopic diseases	Data reported for dosage and type of current treatment for co-existing type 2 inflammatory and atopic diseases.	At baseline
Secondary	Patient and treatment characteristics reported by the physician or patient: Reasons for initiating dupilumab treatment		At baseline
Secondary	Patient and treatment characteristics reported by the physician or patient: Reasons for discontinuation of dupilumab treatment (if the discontinuation was before end of study)	Reasons for discontinuation of dupilumab treatment (if the discontinuation was before end of study) will be collected at the discontinuation visit.	Up to 24 months
Secondary	Patient and treatment characteristics reported by the physician or patient: Number of sick-leave days away from work/school due to AD		From baseline up to 24 months
Secondary	Patient and treatment characteristics reported by the physician or patient: Number of medical appointments due to AD		From baseline up to 24 months
Secondary	Patient and treatment characteristics reported by the physician or patient: Number of visits to alternative practitioners and complementary care physicians		From baseline upto 24 months
Secondary	Patient and treatment characteristics reported by the physician or patient: Cost of non-reimbursable supplementary therapy [€/month]		From baseline up to 24 months