atopic dermatitis, eczema
Conditions
Interventions
Patients will be treated with 
lebrikizumab 
 
(Ebglyss®) according to SmPC in routine clinical practice settings, during the 24-month study observation period. Concomitant treatments for AD are allowed during the study observation period, per leb
Sponsors
Almirall
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult (=18 years) male or female patients with diagnosis of moderate-to-severe Atopic dermatitis.Adult patients prescribed lebrikizumab as part of routine/usual care to manage their moderate-to-severe Atopic dermatitis.Willingness and ability to participate in the study; patients must give their written consent to participate.
Exclusion criteria
Exclusion criteria: Hypersensitivity to the active substances or to any of the excipients of lebrikizumab (Ebglyss®).Patients with pre-existing helminth infections. These patients should be treated for helminth infection before starting lebrikizumab therapy.Concomitant use of live and live attenuated vaccines.Pregnant women, except when the potential benefit justifies the potential risk.Patients included in a clinical trial at baseline or at any time during the planned study period.Patients unable to comply with the requirements of the study or who, in the opinion of the study physician, should not participate in the study.Patients for whom medical chart is inaccessible to physicians to complete baseline data collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is to assess overall health-related well-being (evaluated through WHO-5 scores) in patients with moderate-to-severe AD treated with lebrikizumab from baseline and throughout the study observation period. Absolute measures and change from baseline (CFB) will be assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinician effectiveness evaluation of lebrikizumab using EASI overall score and by region as well as overall IGA score at baseline and throughout the study observation period. Proportion of patients with overall EASI score reduction from baseline (by 50% (EASI50), 75% (EASI75), 90% (EASI90) and 100% (EASI100)) will be evaluated throughout the study observation period. Proportion of patients with absolute EASI score =7 will be evaluated throughout the study observation period. Proportion of patients with overall IGA-AD score of 0 [clear] or 1 [almost clear] at each visit, and CFB will also be evaluated throughout the study observation period.Disease control evaluated through the Patient Oriented Eczema Measure (POEM) score, and the disease related NRS: pruritus score, skin pain score, fatigue score, and sleep quality score at baseline and during the study observation period. Absolute measures and CFB will be assessed.Adverse event reporting by reporting Incidence of all (S)AEs, (S)ADRs, maternal/paternal pregnancy exposure and other special situations during study observation period. | — |
Countries
Austria, Belgium, Czech Republic, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom
Contacts
Public ContactSN Narayanan
Avant Health
Outcome results
None listed