The main purpose of this study is to evaluate the impact of lebrikizumab treatment on the overall well-being of adult participants with moderate-to-severe AD in real-world clinical practice settings across Europe, as measured using validated 5-item World Health Organization Well-being Index (WHO-5) and to investigate effectiveness and safety of lebrikizumab, treatment satisfaction, and long-term effect of lebrikizumab treatment on participants in terms of disease symptomatology/control, fatigue, work impairment, patient's relationship with their skin, and overall QOL among adult participants.
Study Type
OBSERVATIONAL
Enrollment
1,000
This is non-interventional study.
Aarhus University Hospital
Aarhus, Denmark, Denmark
RECRUITINGAbsolute Measures in the Overall Health-related Well-being Index Evaluated Through World Health Organization (WHO-5) Score Throughout the Study Observation Period
The WHO-5 item well-being index is a generic global rating scale measuring subjective well-being and contains positively phrased items. The respondent is asked to rate how well each of the 5 items applies to him or her when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The raw score therefore theoretically ranges from 0 (absence of well-being) to 25 (maximal well-being). To standardize the score on a scale from 0 (absent) to 100 (maximal), it is recommended to multiply the raw score by 4.
Time frame: Baseline up to Week 104
Change From Baseline in the Overall Health-related Well-being Index Evaluated Through WHO-5 Score Throughout the Study Observation Period
The WHO-5 item well-being index is a generic global rating scale measuring subjective well-being and contains positively phrased items. The respondent is asked to rate how well each of the 5 items applies to him or her when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The raw score therefore theoretically ranges from 0 (absence of well-being) to 25 (maximal well-being). To standardize the score on a scale from 0 (absent) to 100 (maximal), it is recommended to multiply the raw score by 4.
Time frame: Baseline up to Week 104
Percentage of Participants with 50 Percent (%) or Greater Reduction From Baseline in Overall Eczema Area and Severity Index (EASI) Score (EASI50) Throughout the Study Observation Period
The EASI is used to assess the severity and extent of AD; The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranging from 0 to 72 where 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe, with higher values indicating more severe and or extensive disease. EASI 50 is defined as 50% or greater reduction from baseline in the EASI score.
Time frame: Baseline up to Week 104
Percentage of Participants with 75% or Greater Reduction From Baseline in Overall EASI Score (EASI75) Throughout the Study Observation Period
The EASI is used to assess the severity and extent of AD; The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranging from 0 to 72 where 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe, with higher values indicating more severe and or extensive disease. EASI75 is defined as 75% or greater reduction from baseline in the EASI score.
Time frame: Baseline up to Week 104
Percentage of Participants with 90% or Greater Reduction From Baseline in Overall EASI Score (EASI90) Throughout the Study Observation Period
The EASI is used to assess the severity and extent of AD; The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranging from 0 to 72 where 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe, with higher values indicating more severe and or extensive disease. EASI 90 is defined as 90% or greater reduction from baseline in the EASI score.
Time frame: Baseline up to Week 104
Percentage of Participants with 100% Reduction From Baseline in Overall EASI Score (EASI100) Throughout the Study Observation Period
The EASI is used to assess the severity and extent of AD; The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranging from 0 to 72 where 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe, with higher values indicating more severe and or extensive disease. EASI100 is defined as 100% reduction from baseline in the EASI score.
Time frame: Baseline up to Week 104
Percentage of Participants With Absolute EASI Score Less than or Equal (<=) to 7 Throughout the Study Observation Period
The EASI is used to assess the severity and extent of AD; The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranging from 0 to 72 where 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe, with higher values indicating more severe and or extensive disease.
Time frame: Baseline up to Week 104
Percentage of Participants with Overall Investigator Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) Throughout the Study Observation Period
The IGA is an instrument used to globally rate the severity of the participants AD. It is based on a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe), and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point. The score is based on an overall assessment of the degree of erythema, induration/papulation, lichenification, and oozing/crusting.
Time frame: Baseline up to Week 104
Absolute Measures in Overall IGA Score Throughout the Study Observation Period
The IGA is an instrument used to globally rate the severity of the participants AD. It is based on a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe), and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point. The score is based on an overall assessment of the degree of erythema, induration/papulation, lichenification, and oozing/crusting.
Time frame: Baseline up to Week 104
Change from Baseline in Overall IGA Score Throughout the Study Observation Period
The IGA is an instrument used to globally rate the severity of the participants AD. It is based on a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe), and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point. The score is based on an overall assessment of the degree of erythema, induration/papulation, lichenification, and oozing/crusting.
Time frame: Baseline up to Week 104
Absolute Measures in Patient-Oriented Eczema Measure (POEM) Score Throughout the Study Observation Period
The POEM is a 7-item, validated, questionnaire used by the participants to assess disease symptoms over the last week. The participants will be asked to respond to 7 questions on skin dryness, itching, flaking, cracking, sleep disturbance, bleeding and weeping. All 7 answers carry equal weight with a total possible score from 0 to 28 (answers scored as: No days=0; 1- 2 days = 1; 3-4 days = 2; 5-6 days = 3; everyday = 4). A high score is indicative of severe atopic dermatitis
Time frame: Baseline up to Week 104
Change From Baseline in POEM Score Throughout the Study Observation Period
The POEM is a 7-item, validated, questionnaire used by the participants to assess disease symptoms over the last week. The participants will be asked to respond to 7 questions on skin dryness, itching, flaking, cracking, sleep disturbance, bleeding and weeping. All 7 answers carry equal weight with a total possible score from 0 to 28 (answers scored as: No days=0; 1- 2 days = 1; 3-4 days = 2; 5-6 days = 3; everyday = 4). A high score is indicative of severe atopic dermatitis
Time frame: Baseline up to Week 104
Absolute Measures in Pruritus Numerical Rating Scale (NRS) Score Throughout the Study Observation Period
Pruritus NRS is a self-administered scale to assess participants worst level of itching on the skin (in the last 24 hours) experienced due to atopic dermatitis. The scale has a single-item that describes the worst level of itching on the skin due to atopic dermatitis in the last 24 hours on an 11-point scale anchored at 0 (no itching) and 10 (worst itching imaginable).
Time frame: Baseline up to Week 104
Change From Baseline in Pruritus NRS Score Throughout the Study Observation Period
Pruritus NRS is a self-administered scale to assess participants worst level of itching on the skin (in the last 24 hours) experienced due to atopic dermatitis. The scale has a single-item that describes the worst level of itching on the skin due to atopic dermatitis in the last 24 hours on an 11-point scale anchored at 0 (no itching) and 10 (worst itching imaginable).
Time frame: Baseline up to Week 104
Absolute Measures in Skin Pain NRS Score Throughout the Study Observation Period
Skin pain NRS is a self-administered scale to assess participants worst level of skin pain (in the last 24 hours) experienced due to atopic dermatitis. The scale has a single-item that describes the worst level of skin pain due to atopic dermatitis in the last 24 hours on an 11-point scale anchored at 0 (no skin pain) and 10 (worst skin pain imaginable).
Time frame: Baseline up to Week 104
Change From Baseline in Skin Pain NRS Score Throughout the Study Observation Period
Skin pain NRS is a self-administered scale to assess participants worst level of skin pain (in the last 24 hours) experienced due to atopic dermatitis. The scale has a single-item that describes the worst level of skin pain due to atopic dermatitis in the last 24 hours on an 11-point scale anchored at 0 (no skin pain) and 10 (worst skin pain imaginable).
Time frame: Baseline up to Week 104
Absolute Measures in Fatigue NRS Score Throughout the Study Observation Period
Fatigue NRS is a self-administered scale to assess participants worst level fatigue (in the last 24 hours) experienced due to atopic dermatitis. The scale has a single-item that describes the worst level of fatigue due to atopic dermatitis in the last 24 hours on an 11-point scale anchored at 0 (no fatigue) and 10 (worst fatigue imaginable).
Time frame: Baseline up to Week 104
Change From Baseline in Fatigue NRS Score Throughout the Study Observation Period
Fatigue NRS is a self-administered scale to assess participants worst level fatigue (in the last 24 hours) experienced due to atopic dermatitis. The scale has a single-item that describes the worst level of fatigue due to atopic dermatitis in the last 24 hours on an 11-point scale anchored at 0 (no fatigue) and 10 (worst fatigue imaginable).
Time frame: Baseline up to Week 104
Absolute Measures in Sleep Quality Scale Throughout the Study Observation Period
Sleep quality scale is a self-administered scale to assess participants overall sleep quality, in terms of the extent to which itching interfered with their sleep last night. The scale has a single-item that describes the interference of itching on sleep last night on an 11-point scale anchored at 0 (no interference) and 10 (unable to sleep at all).
Time frame: Baseline up to Week 104
Change From Baseline in Sleep Quality Scale Throughout the Study Observation Period
Sleep quality scale is a self-administered scale to assess participants overall sleep quality, in terms of the extent to which itching interfered with their sleep last night. The scale has a single-item that describes the interference of itching on sleep last night on an 11-point scale anchored at 0 (no interference) and 10 (unable to sleep at all).
Time frame: Baseline up to Week 104
Number of Participants With Adverse Events (AEs), Serious AEs, Adverse Drug Reactions (ADRs) and Serious ADRs Throughout the Study Observation Period
An AE is any untoward medical occurrence in a study participant who has been administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. An ADR is defined as a response to a medicinal product which is noxious and unintended. Response in this context means that there is a reasonable suspected causal relationship between the medicinal product and the adverse event. An AE or ADR is serious (SAE / SADR) as per following categories: death, is life-threatening, requires in-patient hospitalization or prolongs existing hospitalization, results in persistent or significant disability or incapacity, congenital anomaly or birth defect, or any other medically important event.
Time frame: Baseline up to Week 104
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