Atopic Dermatitis, Eczema
Conditions
Brief summary
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.
Interventions
OTHERNo Intervention
This is non-interventional study.
Sponsors
Almirall, S.A.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (greater than or equal to \[\>=\] 18 years) male or female participants with diagnosis of moderate-to-severe Atopic dermatitis. * Adult participants prescribed lebrikizumab as part of routine/usual care to manage their moderate-to severe Atopic dermatitis. * Willingness and ability to participate in the study; participants must give their written consent to participate.
Exclusion criteria
* Hypersensitivity to the active substances or to any of the excipients of lebrikizumab (Ebglyss®). * Participants with pre-existing helminth infections. These participants 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. * Participants included in a clinical trial at baseline or at any time during the planned study period. * Participants unable to comply with the requirements of the study or who, in the opinion of the study physician, should not participate in the study. * Participants for whom medical chart is inaccessible to physicians to complete baseline data collection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Measures in the Overall Health-related Well-being Index Evaluated Through World Health Organization (WHO-5) Score Throughout the Study Observation Period | Baseline up to Week 104 | 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. |
| Change From Baseline in the Overall Health-related Well-being Index Evaluated Through WHO-5 Score Throughout the Study Observation Period | Baseline up to Week 104 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with 90% or Greater Reduction From Baseline in Overall EASI Score (EASI90) Throughout the Study Observation Period | Baseline up to Week 104 | 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. |
| Percentage of Participants with 100% Reduction From Baseline in Overall EASI Score (EASI100) Throughout the Study Observation Period | Baseline up to Week 104 | 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. |
| Percentage of Participants With Absolute EASI Score Less than or Equal (<=) to 7 Throughout the Study Observation Period | Baseline up to Week 104 | 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. |
| Percentage of Participants with Overall Investigator Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) Throughout the Study Observation Period | Baseline up to Week 104 | 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. |
| Absolute Measures in Overall IGA Score Throughout the Study Observation Period | Baseline up to Week 104 | 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. |
| Change from Baseline in Overall IGA Score Throughout the Study Observation Period | Baseline up to Week 104 | 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. |
| Absolute Measures in Patient-Oriented Eczema Measure (POEM) Score Throughout the Study Observation Period | Baseline up to Week 104 | 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 |
| Change From Baseline in POEM Score Throughout the Study Observation Period | Baseline up to Week 104 | 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 |
| 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 | Baseline up to Week 104 | 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. |
| Change From Baseline in Pruritus NRS Score Throughout the Study Observation Period | Baseline up to Week 104 | 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). |
| Absolute Measures in Skin Pain NRS Score Throughout the Study Observation Period | Baseline up to Week 104 | 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). |
| Change From Baseline in Skin Pain NRS Score Throughout the Study Observation Period | Baseline up to Week 104 | 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). |
| Absolute Measures in Fatigue NRS Score Throughout the Study Observation Period | Baseline up to Week 104 | 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). |
| Change From Baseline in Fatigue NRS Score Throughout the Study Observation Period | Baseline up to Week 104 | 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). |
| Absolute Measures in Sleep Quality Scale Throughout the Study Observation Period | Baseline up to Week 104 | 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). |
| Change From Baseline in Sleep Quality Scale Throughout the Study Observation Period | Baseline up to Week 104 | 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). |
| Number of Participants With Adverse Events (AEs), Serious AEs, Adverse Drug Reactions (ADRs) and Serious ADRs Throughout the Study Observation Period | Baseline up to Week 104 | 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. |
| Absolute Measures in Pruritus Numerical Rating Scale (NRS) Score Throughout the Study Observation Period | Baseline up to Week 104 | 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). |
| Percentage of Participants with 75% or Greater Reduction From Baseline in Overall EASI Score (EASI75) Throughout the Study Observation Period | Baseline up to Week 104 | 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. |
Countries
Denmark
Contacts
Primary ContactÈric Massana
Outcome results
None listed