Drug Survival of Target Therapies in Atopic Dermatitis

Phase

N/A

Condition

Dermatitis, Atopic

Rash

Hives (Urticaria)

Treatment

target therapies (biological drug, small molecules)

Clinical Study ID

NCT06882148

5909

Ages > 18
All Genders

Study 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).

Eligibility Criteria

Inclusion

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 abiological drug or small molecules
(for retrospective data) presence of at least one follow-up visit after the start oftreatment for which clinical and demographic data were collected at baseline andfollow-up visits.
Signature of informed consent to the study and to the processing of personal datafor the research

Exclusion

Exclusion Criteria:

Patients under 18 years of age
Patients who have undergone systemic therapy with a biological drug or smallmolecules for whom the start date of treatment is not available and/or noclinical-demographic data were collected at baseline and at follow-up visits.
Absence of informed consent to the study and processing of personal data forresearch purposes.

Study Design

target therapies (biological drug, small molecules)

October 12, 2023

October 30, 2028

Study 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.

Connect with a study center

fondazione policlinico universitario agostino gemelli IRCCS
Rome, 00168
Italy
Active - Recruiting

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