Study in Paediatric Patients With Atopic Dermatitis Treated With Dupilumab in Spain (PROADAP)

Prospective, Observational, Longitudinal Study in Paediatric Patients With AD, Treated With Dupilumab in Spain

This is a multicentre, prospective, non-interventional study that aims to describe the treatment patterns of in Atopic dermatitis (AD) patients aged 6 months to 11 years old in Spain: patients' characteristics, disease characteristics, prior treatments for and treatment prescription modalities. As well as to document the real-world effectiveness and safety of dupilumab during the two years of follow up. No diagnostic or therapeutic intervention outside of routine clinical practice will be applied.

Study Overview

• Status: Not yet recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Dupilumab

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Trial Transparency email recommended (Toll free for US & Canada); Phone Number: option 6 800-633-1610; Email: contact-us@sanofi.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients aged 6 months to 11 years old at baseline and initiating Dupilumab for their Severe Atopic dermatitis (AD) in Spain.

Description

Inclusion Criteria:

• Male or female aged 6 months to 11 years old at baseline.
• Patients with severe Atopic dermatitis (AD) according to the investigator's assessment.
• Patients initiating dupilumab (in those patients initiated retrospectively 2 months before the start of the study, the baseline information must be correctly filled out in the medical records).
• Signed informed consent by the parent/legally acceptable representative and assent by the patient appropriate to the patient's age.

Exclusion Criteria:

• Patients who are participating in an interventional clinical trial that modifies patient care.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dupilumab; The information will be collected during consultation as part of the patient's usual follow-up.	Drug: Dupilumab; This study will not administer any treatment, only observe the treatment as prescribed in real world-clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Age		At baseline
Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Gender		At baseline
Characteristic of pediatric patients initiating treatment with dupilumab for Severe AD:Body mass index (BMI)		At baseline
Medical history characteristics of pediatric patients initiating treatment with dupilumab for Severe AD	Including course of AD, recent AD treatment history, family history.	At baseline
Medical history of atopic comorbidities	Selected atopic comorbidities over time will be reported.	At baseline
Medical history of non-atopic diseases		At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of real-world treatment patterns: Dupilumab dosage		From baseline up to 24 months
Description of real-world treatment patterns: Dupilumab frequency of administration		From baseline up to 24 months
Description of real-world treatment patterns: Dupilumab reason for discontinuation	Reason for discontinuation will be reported if applicable.	From baseline up to 24 months
Description of real-world treatment patterns (other treatments): Other type of treatment	In case of receiving other treatments for AD, topical or systemic.	From baseline up to 24 months
Description of real-world treatment patterns (other treatments): Name of treatment	In case of receiving other treatments for AD, topical or systemic.	From baseline up to 24 months
Description of real-world treatment patterns (other treatments): Duration of treatment	In case of receiving other treatments for AD, topical or systemic.	From baseline up to 24 months
Description of real-world treatment patterns (other treatments): Reason for discontinuation (if applicable)	In case of receiving other treatments for AD, topical or systemic. Reason for discontinuation will be reported if applicable.	From baseline up to 24 months
Participant-caregiver assessment: Change from baseline in the Children's Dermatology Life Quality Index score	The Children's Dermatology Life Quality Index (cDLQI) it is a 10-item questionnaire that assesses six different aspects that may affect quality of life, including symptoms and feelings, daily activities, leisure, work and school performance, personal relationships, and treatment. Each of the 10 questions is scored from 0 (not at all) to 3 (very much) and the overall cDLQI is calculated by summing the score of each question, resulting in a total score between 0-30. The higher the score, the more quality of life is impaired.	From baseline up to 24 months
Participant-caregiver assessment: Change from baseline in the Infant's Dermatology Life Quality Index score	The Infant Dermatology Quality of Life Index (iDLQI) contains 10 questions and a response scale divided into four boxes. Each box gives a point between 0 and 3. The lower number is understood as the most positive for the participant. The index is filled out by a parent to a participating child between the ages of 0 to 5 years. Points from each question are added together and the end-sum represents the score. The sum score can be between 0 and 30. The higher the score the worse the assumed quality of life.	From baseline up to 24 months
Participant-caregiver assessment: Change from baseline in the Dermatitis Family Impact (DFI) questionnaire	The DFI is a 10-item disease specific questionnaire assessing the impact of having a child with AD on family Quality of Life (QoL). The DFI questions are scored ranging from 0 to 3, and the total DFI score ranges from 0 to 30. The time frame of reference is the past week, and a higher DFI score indicates greater impairment in family QoL as affected by AD.	From baseline up to 24 months
Participant-caregiver assessment: Change from baseline in the patient's Worst Itch Numerical Rating Scale (WI-NRS)	WI-NRS is a validated measure of itch severity. Patients will be asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicate more severity.	From baseline up to 24 months
Caregiver assessment: Change from baseline in the patient's Worst Itch Scale Numerical Rating Scale (WSI-NRS)	The WSI-NRS is a single-item caregiver-reported. The caregivers describe their child "scratch" or "itch" in the AD-affected area by using numeric response options (0: no scratching/itching to 10: worst scratching/itching). Higher scores indicate more severity.	From baseline up to 24 months
Physician assessment: Change from baseline in the eczema severity using the Eczema Area and Severity Index (EASI)	The EASI is calculated by summing 4 separate scores of the (1) head/neck, (2) upper extremities, (3) trunk, and (4) lower extremities. For each of the 4 anatomical regions, the score formula is SxAxM ["S" is the congregate score from the severity of 4 signs: erythema, oedema/papulation, excoriation, and lichenification graded on a discrete scale from 0 to 3, where 0 = absent, 1 = mild, 2 = moderate, and 3 = severe, giving S a maximum of 12. "A" represents the area to which AD affects the body, yielding a maximum of 6 points: 0 = 0%, 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, and 6 = 90-100%. "M" is a multiplier, which is 0.1, 0.2, 0.3, and 0.4, respectively, for the region affected in those ≥8 years and 0.2, 0.2, 0.3, and 0.3, respectively, for those <8 years. The final EASI score is calculated based on the sum of the scores from the 4 anatomical regions. A higher score means higher AD severity. Scores range from 0 (no disease) to 72 (maximal disease severity).	From baseline up to 24 months
Physician assessment: Percent change from beseline in the Body Surface Area (BSA) (%) affected by AD	BSA affected by AD disease will be assessed for each major section of the body (head, neck, anterior trunk, back, upper limbs, lower limbs, and genitals). It will be reported as a percentage of all major body sections combined.	From baseline up to 24 months
Physician assessment: Change in Proportion of patients with Validated Investigator's Global Assessment (IGA)	The IGA is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).	From baseline up to 24 months
Physician assessment: Change from baseline in Biomarkers	Biomarker analysis will be performed, if available, in routine clinical practice and at routine visits	From baseline up to 24 months
Number of Adverse Events (AE) / Serious Adverse Events (SAE) / Adverse Event of Special Interest (AESI)	The number of events and the percentage of patients who had at least one event will be described.	From date of signed ICF, up to 24 months
Health Care Resource Utilization (HCRU) Questionnaire	Health care resource utilization may include hospitalizations (including length of stay), outpatient visits, urgent care or emergency room visits.	From baseline up to 24 months

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: OBS18427; U1111-1306-7579 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org