Drug Survival of Target Therapies in Atopic Dermatitis

NCT ID: NCT06882148

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1167 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-12
• Study Completion Date: 2028-10-30

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).

Conditions

Atopic Dermatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

target therapies (biological drug, small molecules)

describe the drug sruvival rate of the different approved drugs

Intervention Type: DRUG

Other Intervention Names

selective drugs

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ketty Peris, Prof

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

fondazione policlinico universitario agostino gemelli IRCCS

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

ketty peris, Prof

Role: CONTACT

ketty.peris@unicatt.it

+390630155284

Facility Contacts

ketty peris fondazione policlinico universitario agostino gemelli IRCCS, professor

Role: primary

ketty.peris@unicatt.it

063015 85284

Other Identifiers

5909

Identifier Type: -

Identifier Source: org_study_id