A Study to Assess the Disease Control of Moderate to Severe Atopic Dermatitis in Male and Female Participants of Atleast 12 Years Old Receiving Dupilumab Injections in Gulf Countries

Sanofi187 enrolled

Overview

Primary objective: To assess the disease control of moderate to severe atopic dermatitis in patients aged 12 years and above treated with dupilumab therapy using Atopic Dermatitis Control Tool (ADCT) after 24 weeks of treatment. Secondary objectives: * To figure the proportion of patients with reduction of ADCT score by 5 points after 4, 12, and 24 weeks of treatment. * To figure the proportion of patients with ADCT score less than 7 at weeks 4, 12, and 24. * Assess the effectiveness of dupilumab in moderate to severe atopic dermatitis (AD) patients, using the severity score as routine practice SCORing Atopic Dermatitis (SCORAD). * To describe comorbidities related to type 2 inflammation. * To characterize the safety profile of dupilumab in the local Gulf population. * To evaluate treatment satisfaction in the local Gulf population.

24 weeks

Study Type

OBSERVATIONAL

Enrollment

187

Conditions

Dermatitis Atopic

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Having moderate to severe atopic dermatitis: * Moderate atopic dermatitis is defined at screening and baseline as i) Atopic dermatitis body surface area (BSA) involvement ≥10%; and ii) Pruritus numerical rating scale (NRS) ≥3, Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline, Investigator's Global Assessment (IGA)=3, or SCORing Atopic Dermatitis (SCORAD) is between 25 and 50. * Severe atopic dermatitis is defined at screening and baseline as i) Atopic dermatitis BSA involvement ≥10%; ii) Eczema Area and Severity Index (EASI) score ≥20; iii) Investigator's Global Assessment (IGA) score = 4, or SCORAD ≥50. * Initiating dupilumab therapy within 30 days of enrollment, according to the treating physician's decision independently of study participation. * Participants and/or his legally approved representatives (LAR, in case of minor subject) agrees to sign an informed consent or an assent. * Age of 12 years or above. Exclusion Criteria: * Participation in another trial. * Pregnancy or lactating or planning/intending to be pregnant in the next 6 months. * Presence of active chronic or acute infection requiring systemic treatment * Diagnosed active endoparasites infection, or suspected high risk of infection. * Human immunodeficiency virus (HIV), hepatitis B or C, malignancy, or other concomitant illnesses. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Outcomes

Primary Outcomes

Percentage of patients achieving an Atopic Dermatitis Control Tool (ADCT) score less than 7 (defined as in control according to ADCT)

ADCT is a questionnaire to assess patient-self-perceived control of their atopic dermatitis (AD) with a total score from 0 to 24; higher scores indicate lower AD control.

Time frame: At week 24

Secondary Outcomes

Percentages (%) of patients achieving a reduction of 5 points from baseline in ADCT

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.

Time frame: At weeks 4, 12, and 24

Percentages (%) of patients with ADCT score less than 7

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.

Time frame: At weeks 4 and 12

Percentages (%) for patients achieving 50% and 75% reduction from baseline in SCORAD score (SCORAD-50 and SCORAD-75)

SCORAD is used to assess the extent and severity of AD. Extent and severity of AD as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease).

Time frame: At week 24

Mean change in SCORAD

Time frame: From baseline (week 0) to week 24

Number of patients with at least one type-2 inflammation comorbidity

Comorbidities related to type-2 inflammation as (allergic rhinitis, bronchial asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis).