Drug Survival of Target Therapies in Atopic Dermatitis (VADRUDA)

Evaluation of Drug Survival of Target Therapies in Atopic Dermatitis

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).

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: target therapies (biological drug, small molecules)

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 Type: Observational
• Enrollment (Estimated): 1167

Contacts and Locations

• Study Contact: Name: ketty peris, Prof; Phone Number: +390630155284; Email: ketty.peris@unicatt.it

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Contact: ketty peris fondazione policlinico universitario agostino gemelli IRCCS, professor; Phone Number: 063015 85284; Email: ketty.peris@unicatt.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients affected by moderate-severe atopic dermatitis undergoing target therapies for AD (upadacitinib, baricitinib, abrocitinib, dupilumab, tralokinumab)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Ketty Peris, Prof, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2028

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: 5909

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No