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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).
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| target therapies (biological drug, small molecules) | Drug | describe the drug sruvival rate of the different approved drugs |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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patients affected by moderate-severe atopic dermatitis undergoing target therapies for AD (upadacitinib, baricitinib, abrocitinib, dupilumab, tralokinumab)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ketty peris, Prof | Contact | +390630155284 | ketty.peris@unicatt.it |
| Name | Affiliation | Role |
|---|---|---|
| Ketty Peris, Prof | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| fondazione policlinico universitario agostino gemelli IRCCS | Recruiting | Rome | 00168 | Italy |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D001688 | Biological Products |
| ID | Term |
|---|---|
| D045424 | Complex Mixtures |
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Evaluate the relationship between drug survival and clinical, laboratory and pharmacological determinants.
| through study completion, an average of 3 year |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |