A European multicenter, observational study to understand how the use of lebrikizumab affects health-related well-being and disease symptoms in patients with moderate-to-severe atopic dermatitis (ADTrust).

Atopic dermatitis (AD) affects many aspects of life, making daily well-being a key treatment goal. However, comprehensive well-being assessments remain limited in AD care. The Global Atopic Dermatitis Atlas advocates a holistic approach to empower AD patients to manage their condition and achieve life goals. A multidimensional assessment of patient burden, combining traditional and new tools, can better capture patient experiences and life improvements due to new treatments. Lebrikizumab has demonstrated sustained efficacy and safety up to 52 weeks in phase 3 trials, with additional support from a 2-year extension study. This ADTrust study, a real-world evaluation of lebrikizumab’s long-term benefits on multiple aspects of patient’s lives, could strengthen this treatment’s value for patients and clinicians, further supporting its role in moderate-to-severe AD treatment.

Primary objective:

• To assess the long-term effect of treatment with lebrikizumab on the overall well-being in patients with moderate-to-severe AD using the WHO-5 questionnaire.

Secondary objectives:

• To assess the clinical effectiveness of lebrikizumab over two years, as measured using EASI, and IGA.
• To assess the long-term effect of the treatment with lebrikizumab on disease symptomatology, as measured using POEM, Pruritus Numerical Rating Scale (NRS), Skin pain NRS , fatigue NRS, and sleep quality scale
• To assess safety and tolerability of lebrikizumab in routine clinical practice (up to 24 months of treatment).

This is a European, prospective, observational, multicentre study in patients with moderate to severe AD treated with lebrikizumab (Ebglyss®) under real-life conditions.

It is planned to include approximately 1000 adult AD patients from up to 150 sites from the following countries: Austria, Belgium, Czech Republic, Denmark, France, Germany, Italy, Ireland, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom. In this study, lebrikizumab will be prescribed according to Summary of Product Characteristics (SmPC). Special care must be taken that the decision to prescribe the treatment will be made independently and prior to the decision to include the patient in the study. To guarantee that the study does not modify the habits of prescribing the drug under study, during a usual care visit, following a routine clinical practice decision concerning the atopic dermatitis treatment, if the patient is prescribed Ebglyss® per clinical judgment, before the patient completes the usual care visit, the site investigator or the study coordinator shall approach the patient with an invitation to consider ADTrust study. If the patient consents to participate, the patient is included in the study, and baseline visit procedures are performed. No additional diagnostic or monitoring procedures will be applied to the patients. Assessments aligned with those usually performed in the routine clinical practice are planned.  A follow-up of up to 24 months for each patient will be performed.

Data will be mainly collected at study inclusion (Baseline Visit) and at approximately 16 weeks, 24 weeks, 52 weeks, 78 weeks, and 104 weeks after baseline. Thus, a total follow-up of up to 24 months for each recruited patient will be performed. Patients will also be invited to voluntarily complete a brief outcomes diary every 4 weeks, as feasible. Partner/relative of patients will be invited to complete a brief online survey following patient’s study visits. The study will be implemented over a period of 6 years, across the planned countries.

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 lebrikizumab SmPC. 

There are no known medical risks associated with participating in this study. You may not benefit from participating in this study. However, participation would greatly help people with atopic dermatitis (eczema) in the future and advance research in this area.