Drug Survival of Target Therapies in Atopic Dermatitis

Recruiting

• Conditions: Atopic Dermatitis

• Registration Number: NCT06882148
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

This is an observational study with drug to evaluate the drug survival of approved target therapies in atopic dermatitis. Patients affected by moderate-severe atopic dermatitis who will start therapy with approved target drugs (dupilumab, tralokinumab, upadacitinib, abrocitinib, baricitinib) for AD will be enrolled. Patients already on therapy with these drugs will also be included.

During the baseline and follow up visits, clinical and demographic data will be collected, according to ordinary clinical practice. Current or retrospective disease severity scores will also be collected.

Among the main: Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Dermatology Life Quality Index (DLQI), Pruritus Numerical Rating Scale (NRS pruritus), Sleep Numerical Rating Scale (NRS sleep), Patient Oriented Eczema Measure (POEM).

Detailed Description

Atopic dermatitis (AD) is a chronic, inflammatory skin disease with a prevalence of 10% in adults and 20% in children. It is of primary importance to select the best treatment option as as relapses occur quickly after discontinuation.

Drug survival rate reflects efficacy, tolerability, and safety of a drug, influencing disease management and healthcare costs. AD treatment has been revolutionized by new treatments that include monoclonal antibodies (dupilumab, tralokinumab) and JAK inhibitors (abrocitinib, baricitinib, upadacitinib).

This observational study evaluates the 12-month drug survival of these approved treatments in moderate-to-severe atopic dermatitis, assessing their safety. The study also aims to evaluate the relationship between drug survival and clinical, laboratory, and pharmacological factors.

Patients affected by moderate-severe atopic dermatitis who will start therapy with approved target drugs (dupilumab, tralokinumab, upadacitinib, abrocitinib, baricitinib) for AD will be enrolled. Patients already on therapy with these drugs will also be included.

During the baseline and follow up visits, clinical and demographic data will be collected, according to ordinary clinical practice. Current or retrospective disease severity scores will also be collected.

Among the main: Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Dermatology Life Quality Index (DLQI), Pruritus Numerical Rating Scale (NRS pruritus), Sleep Numerical Rating Scale (NRS sleep), Patient Oriented Eczema Measure (POEM).

Study Timeline

• Study First Submitted: 2023-10-10
• Study Start: 2023-10-12
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-10-30
• Study Completion: 2028-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1167

Inclusion Criteria

• Age 18 years or older
• Diagnosed with moderate-to-severe atopic dermatitis (EASI>24)
• Undergoing therapy (retrospective cohort) or undertaking systemic therapy with a biological drug or small molecules
• (for retrospective data) presence of at least one follow-up visit after the start of treatment for which clinical and demographic data were collected at baseline and follow-up visits.
• Signature of informed consent to the study and to the processing of personal data for the research

Exclusion Criteria

• Patients under 18 years of age
• Patients who have undergone systemic therapy with a biological drug or small molecules for whom the start date of treatment is not available and/or no clinical-demographic data were collected at baseline and at follow-up visits.
• Absence of informed consent to the study and processing of personal data for research purposes.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
drug survival evaluation	1 year	evaluate the 12-month drug survival rate, for each of the 5 biological drugs/small molecules under study.

Secondary Outcome Measures

Name	Time	Method
drug survival related to safety	through study completion, an average of 3 year	Number of participants with treatment-related adverse events
relationship between drug survival and clinical data	through study completion, an average of 3 year	Evaluate the relationship between drug survival and clinical, laboratory and pharmacological determinants.

Trial Locations

Locations (1)

fondazione policlinico universitario agostino gemelli IRCCS; 🇮🇹 Rome, Italy