A Study to Assess Disease Activity in Adolescent and Adult Participants With Atopic Dermatitis Who Receive Oral Upadacitinib Tablets in a Real-World Setting

Study Overview
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Brief Summary
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Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study will assess the real-world effectiveness of upadacitinib on early and sustained response along adolescent and adult participants with AD. This study also aims to understand upadacitinib utilization patterns in real-world clinical practice. Upadacitinib (RINVOQ) is approved in the EU for the treatment of moderate to severe AD in adults and adolescents 12 years and older who are candidates for systemic therapy. Approximately 772 adolescent and adult participants with AD will be enrolled at up to 200 sites in Germany. Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population, and indication. The overall duration of the study is approximately 2 years. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

Official Title
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Non-Interventional, Prospective Observational Cohort Study to Investigate the Effectiveness and Sustained Disease Control of an Upadacitinib Therapy in Moderate to Severe Atopic Dermatitis Patients Over Two Years

Conditions
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Atopic Dermatitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body weight >=30 kg at baseline for participants between >=12 and <18 years of age. Physician confirmed diagnosis of moderate to severe atopic dermatitis at the time of enrollment. Upadacitinib initiated as per the local label. The decision to prescribe upadacitinib must have been made prior to and independently of study participation. Medical and medication history available at least for the last 6 months. Exclusion Criteria: - Current participation in interventional research (note: this does not include non-interventional, post-marketing observational studies, or registry participation).

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants Receiving Upadacitinib<br>Participants receiving upadacitinib for moderate to severe atopic dermatitis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Disease Control Defined by Atopic Dermatitis Control Tool (ADCT) Total Score <7 Points | The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control. | Month 3 | 
| Percentage of Participants Achieving Disease Control Defined by ADCT Total Score <7 Points Among Participants Who Achieved Disease Control at Month 3 | The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control. | Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Disease Control Defined by ADCT Total Score <7 Points | The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control. | Up to 24 Months | 
| Percentage of Participants with An ADCT Total Score Reduction >=5 from Baseline | The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control. | Up to 24 Months | 
| Percentage of Participants Achieving Disease Control as Defined by ADCT Item 4 (Sleep Problems) <1 Point and All Other Items <2 Points | The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control. | Up to 24 Months | 
| Percentage of Participants Achieving Disease Control as Defined by ADCT Total Score <7 Points at Month 3 and Maintaining Disease Control | The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control. | Up to 21 Months (Excluding Month 3 - Primary Endpoint) | 
| Absolute Score for ADCT Total Score | The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control. | Up to 24 Months | 
| Absolute Change from Baseline for ADCT Total Score | The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control. | Up to 24 Months | 
| Time to Achieve ADCT Total Score Reduction >=5 Points from Baseline | The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control. | Up to 24 Months | 
| Time to Achieve Disease Control as Defined by ADCT Total Score <7 Points | The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control. | Up to 24 Months | 
| Percent Change from Baseline for ADCT Total Score | The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control. | Up to 24 Months | 
| Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 50 | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of 0 (absent) through 3 (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0). | Up to 24 Months | 
| Percentage of Participants Achieving EASI 75 | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of 0 (absent) through 3 (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0). | Up to 24 Months | 
| Percentage of Participants Achieving EASI 90 | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of 0 (absent) through 3 (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0). | Up to 24 Months | 
| Percentage of Participants Achieving EASI 100 | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of 0 (absent) through 3 (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0). | Up to 24 Months | 
| Percentage of Participants Achieving Absolute EASI <=7 | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of 0 (absent) through 3 (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0). | Up to 24 Months | 
| Absolute Score for EASI | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of 0 (absent) through 3 (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0). | Up to 24 Months | 
| Absolute Change from Baseline for EASI | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of 0 (absent) through 3 (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0). | Up to 24 Months | 
| Percent Change from Baseline for EASI | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of 0 (absent) through 3 (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0). | Up to 24 Months | 
| Time to Achieve EASI 50 | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of 0 (absent) through 3 (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0). | Up to 24 Months | 
| Time to Achieve EASI 75 | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of 0 (absent) through 3 (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0). | Up to 24 Months | 
| Time to Achieve EASI 90 | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of 0 (absent) through 3 (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0). | Up to 24 Months | 
| Time to Achieve EASI 100 | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of 0 (absent) through 3 (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0). | Up to 24 Months | 
| Time to Achieve Absolute EASI <=7 | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of 0 (absent) through 3 (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0). | Up to 24 Months | 
| Percentage of Participants Achieving EASI 50 in the Head and/or Neck Body Region | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of 0 (absent) through 3 (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0). | Up to 24 Months | 
| Percentage of Participants Achieving EASI 75 in the Head and/or Neck Body Region | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of 0 (absent) through 3 (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0). | Up to 24 Months | 
| Percentage of Participants Achieving EASI 90 in the Head and/or Neck Body Region | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of 0 (absent) through 3 (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0). | Up to 24 Months | 
| Percentage of Participants Achieving EASI 100 in the Head and/or Neck Body Region | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of 0 (absent) through 3 (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0). | Up to 24 Months | 
| Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) <=1 | vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification. | Up to 24 Months | 
| Percentage of Participants Achieving Worst Pruritus Numerical Rating Scale (WP-NRS) <=1 | WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch. | Up to 24 Months | 
| Percentage of Participants Achieving WP-NRS <=3 | WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch. | Up to 24 Months | 
| Percentage of Participants Achieving a WP-NRS Reduction >=4 from Baseline | WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch. | Up to 24 Months | 
| Absolute Score for WP-NRS | WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch. | Up to 24 Months | 
| Absolute Change from Baseline for WP-NRS | WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch. | Up to 24 Months | 
| Percent Change from Baseline for WP-NRS | WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch. | Up to 24 Months | 
| Time to Achieve WP-NRS <=1 | WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch. | Up to 24 Months | 
| Absolute Change from Baseline for SCORAD Sleep VAS | The sleep VAS is one component from the SCORAD test that measures the intensity of sleeplessness during a three day or night recall period. The test uses a VAS scale of 0 to 10 with 0 being no sleeplessness and 10 being worst imaginable sleeplessness. | Up to 24 Months | 
| Absolute Score for Score Atopic Dermatitis (SCORAD) Sleep Visual Analog Scale (VAS) | The sleep VAS is one component from the SCORAD test that measures the intensity of sleeplessness during a three day or night recall period. The test uses a VAS scale of 0 to 10 with 0 being no sleeplessness and 10 being worst imaginable sleeplessness. | Up to 24 Months | 
| Percent Change from Baseline for SCORAD Sleep VAS | The sleep VAS is one component from the SCORAD test that measures the intensity of sleeplessness during a three day or night recall period. The test uses a VAS scale of 0 to 10 with 0 being no sleeplessness and 10 being worst imaginable sleeplessness. | Up to 24 Months | 
| Percentage of Participants Achieving Dermatology Life Quality Index (DLQI)/Children's Dermatology Life Quality Index (cDLQI) <=1 | DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used. | Up to 24 Months | 
| Percentage of Participants Achieving DLQI/cDLQI <=5 | DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used. | Up to 24 Months | 
| Percentage of Participants Achieving DLQI/cDLQI Reduction >=4 from Baseline | DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used. | Up to 24 Months | 
| Absolute Score for DLQI/cDLQI | DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used. | Up to 24 Months | 
| Absolute Change from Baseline for DLQI/cDLQI | DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used. | Up to 24 Months | 
| Percent Change from Baseline for DLQI/cDLQI | DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used. | Up to 24 Months | 
| Time to Achieve DLQI/cDLQI <=1 | DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used. | Up to 24 Months | 
| Absolute Score for Hospital Anxiety and Depression Scale for Anxiety (HADS-A) | The HADS is a 14-item self-report scale, It contains two 7-item scales: one for anxiety (HADS-A) and one for depression (HADS-D). Each HADS item is rated on a 4-point Likert-type scale with total scores on each subscale ranging from 0 to 21, and with higher scores corresponding to greater respective symptom severity. | Up to 24 Months | 
| Absolute Change from Baseline for HADS-A | The HADS is a 14-item self-report scale, It contains two 7-item scales: one for anxiety (HADS-A) and one for depression (HADS-D). Each HADS item is rated on a 4-point Likert-type scale with total scores on each subscale ranging from 0 to 21, and with higher scores corresponding to greater respective symptom severity. | Up to 24 Months | 
| Percent Change from Baseline for HADS-A | The HADS is a 14-item self-report scale, It contains two 7-item scales: one for anxiety (HADS-A) and one for depression (HADS-D). Each HADS item is rated on a 4-point Likert-type scale with total scores on each subscale ranging from 0 to 21, and with higher scores corresponding to greater respective symptom severity. | Up to 24 Months | 
| Absolute Score for Hospital Anxiety and Depression Scale for Depression (HADS-D) | The HADS is a 14-item self-report scale, It contains two 7-item scales: one for anxiety (HADS-A) and one for depression (HADS-D). Each HADS item is rated on a 4-point Likert-type scale with total scores on each subscale ranging from 0 to 21, and with higher scores corresponding to greater respective symptom severity. | Up to 24 Months | 
| Absolute Change from Baseline for HADS-D | The HADS is a 14-item self-report scale, It contains two 7-item scales: one for anxiety (HADS-A) and one for depression (HADS-D). Each HADS item is rated on a 4-point Likert-type scale with total scores on each subscale ranging from 0 to 21, and with higher scores corresponding to greater respective symptom severity. | Up to 24 Months | 
| Percent Change from Baseline for HADS-D | The HADS is a 14-item self-report scale, It contains two 7-item scales: one for anxiety (HADS-A) and one for depression (HADS-D). Each HADS item is rated on a 4-point Likert-type scale with total scores on each subscale ranging from 0 to 21, and with higher scores corresponding to greater respective symptom severity. | Up to 24 Months | 
| Absolute Score for Stigmatization (6-Item Stigmatization Scale) | The scale consists of 6 items that address the feeling of stigmatization because of this condition. The participants respond to each item by 0 (not at all), 1 (sometimes), 2 (very often), or 3 (always). The sum of the responses to the 6 items generates a score ranging from 0 to 18 with higher scores corresponding to a higher feeling of stigmatization. | Up to 24 Months | 
| Absolute Change from Baseline for Stigmatization (6-Item Stigmatization Scale) | The scale consists of 6 items that address the feeling of stigmatization because of this condition. The participants respond to each item by 0 (not at all), 1 (sometimes), 2 (very often), or 3 (always). The sum of the responses to the 6 items generates a score ranging from 0 to 18 with higher scores corresponding to a higher feeling of stigmatization. | Up to 24 Months | 
| Percent Change from Baseline for Stigmatization (6-Item Stigmatization Scale) | The scale consists of 6 items that address the feeling of stigmatization because of this condition. The participants respond to each item by 0 (not at all), 1 (sometimes), 2 (very often), or 3 (always). The sum of the responses to the 6 items generates a score ranging from 0 to 18 with higher scores corresponding to a higher feeling of stigmatization. | Up to 24 Months | 
| Absolute Score for Asthma Control Test (ACT) in Participants Having a Confirmed Diagnosis of Asthma at Baseline | The ACT consists of 5 simple questions regarding the patients' asthma symptom burden. For each question there is a range from 1 to 5. A lower score indicates lower asthma control. | Up to 24 Months | 
| Absolute Change from Baseline in ACT in Participants Having a Confirmed Diagnosis of Asthma at Baseline | The ACT consists of 5 simple questions regarding the patients' asthma symptom burden. For each question there is a range from 1 to 5. A lower score indicates lower asthma control. | Up to 24 Months | 
| Percent Change from Baseline in ACT in Participants Having a Confirmed Diagnosis of Asthma at Baseline | The ACT consists of 5 simple questions regarding the patients' asthma symptom burden. For each question there is a range from 1 to 5. A lower score indicates lower asthma control. | Up to 24 Months | 
| Percentage of Participants Achieving Absolute Score >=20 for ACT in Participants Having a Confirmed Diagnosis of Asthma at Baseline | The ACT consists of 5 simple questions regarding the patients' asthma symptom burden. For each question there is a range from 1 to 5. A lower score indicates lower asthma control. | Up to 24 Months | 
| Percentage of Participants Starting on Upadacitinib 15 mg or 30 mg | Percentage of participants initiating upadacitinib at 15 mg or 30 mg with rationale. | Baseline | 
| Percentage of Participants with Modification of Upadacitinib Therapy, Timing of Modifications, and Reasons for Modifications | This includes change in upadacitinib dose with rationale, e.g., dose change, temporary or permanent discontinuation. | 24 Months | 
| Percentage of Participants with Modification of Concomitant AD Therapy, Timing of Modifications, and Reasons for Modifications | This includes change in concomitant AD therapy with rationale, e.g., adding or removing or changing dose of topical corticosteroids/topical calcineurin inhibitors. | 24 Months | 
| Absolute Score for Skin Pain on the Atopic Dermatitis Symptom Scale (ADerm-SS) | Skin pain and skin cracking are assessed by a one item test from the ADERM-SS to measure the intensity of skin pain/skin cracking during the past 24 hours. The test uses a scale of 0 to 10, with 0 being no skin pain/no skin cracking and 10 bring the worst imaginable skin pain/worst imaginable skin cracking. | Up to 24 Months | 
| Percent Change from Baseline for Skin Pain on the ADerm-SS | Skin pain and skin cracking are assessed by a one item test from the ADERM-SS to measure the intensity of skin pain/skin cracking during the past 24 hours. The test uses a scale of 0 to 10, with 0 being no skin pain/no skin cracking and 10 bring the worst imaginable skin pain/worst imaginable skin cracking. | Up to 24 Months | 
| Absolute Change from Baseline for Skin Pain on the ADerm-SS | Skin pain and skin cracking are assessed by a one item test from the ADERM-SS to measure the intensity of skin pain/skin cracking during the past 24 hours. The test uses a scale of 0 to 10, with 0 being no skin pain/no skin cracking and 10 bring the worst imaginable skin pain/worst imaginable skin cracking. | Up to 24 Months | 
| Absolute Score for Skin Cracking on the ADerm-SS | Skin pain and skin cracking are assessed by a one item test from the ADERM-SS to measure the intensity of skin pain/skin cracking during the past 24 hours. The test uses a scale of 0 to 10, with 0 being no skin pain/no skin cracking and 10 bring the worst imaginable skin pain/worst imaginable skin cracking. | Up to 24 Months | 
| Absolute Change from Baseline for Skin Cracking on the ADerm-SS | Skin pain and skin cracking are assessed by a one item test from the ADERM-SS to measure the intensity of skin pain/skin cracking during the past 24 hours. The test uses a scale of 0 to 10, with 0 being no skin pain/no skin cracking and 10 bring the worst imaginable skin pain/worst imaginable skin cracking. | Up to 24 Months | 
| Percent Change from Baseline for Skin Cracking on the ADerm-SS | Skin pain and skin cracking are assessed by a one item test from the ADERM-SS to measure the intensity of skin pain/skin cracking during the past 24 hours. The test uses a scale of 0 to 10, with 0 being no skin pain/no skin cracking and 10 bring the worst imaginable skin pain/worst imaginable skin cracking. | Up to 24 Months | 
| Absolute Score for Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) of Hand Eczema | The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. It consists of a 5-point scale used by the investigator to measure the severity of disease ranging from 0 - Clear to 4 - Severe. | Up to 24 Months | 
| Absolute Change from Baseline for vIGA-AD of Hand Eczema | The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. It consists of a 5-point scale used by the investigator to measure the severity of disease ranging from 0 - Clear to 4 - Severe. | Up to 24 Months | 
| Percent Change from Baseline for vIGA-AD of Hand Eczema | The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. It consists of a 5-point scale used by the investigator to measure the severity of disease ranging from 0 - Clear to 4 - Severe. | Up to 24 Months | 
| Absolute Score for vIGA-AD of Facial Eczema | The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. It consists of a 5-point scale used by the investigator to measure the severity of disease ranging from 0 - Clear to 4 - Severe. | Up to 24 Months | 
| Absolute Change from Baseline for vIGA-AD of Facial Eczema | The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. It consists of a 5-point scale used by the investigator to measure the severity of disease ranging from 0 - Clear to 4 - Severe. | Up to 24 Months | 
| Percent Change from Baseline for vIGA-AD of Facial Eczema | The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. It consists of a 5-point scale used by the investigator to measure the severity of disease ranging from 0 - Clear to 4 - Severe. | Up to 24 Months | 
| Absolute Score for Pruritis (5-D Pruritis Scale) | The 5-D pruritis scale is a brief but multidimensional questionnaire for the quantification of pruritis that is sensitive to change over time. The five dimensions are degree, duration, direction, disability and distribution. The duration, degree and direction domains each include one item, while the disability domain has four items. All items on the first four domains are measured on a five-point Likert scales. The scores of each of the five domains are achieved separately and then summed together to obtain a total 5-D score. 5-D scores can potentially range between 5 (no pruritis) and 25 (most severe pruritis). | Up to 24 Months | 
| Absolute Change from Baseline for Pruritis (5-D Pruritis Scale) | The 5-D pruritis scale is a brief but multidimensional questionnaire for the quantification of pruritis that is sensitive to change over time. The five dimensions are degree, duration, direction, disability and distribution. The duration, degree and direction domains each include one item, while the disability domain has four items. All items on the first four domains are measured on a five-point Likert scales. The scores of each of the five domains are achieved separately and then summed together to obtain a total 5-D score. 5-D scores can potentially range between 5 (no pruritis) and 25 (most severe pruritis). | Up to 24 Months | 
| Percent Change from Baseline for Pruritis (5-D Pruritis Scale) | The 5-D pruritis scale is a brief but multidimensional questionnaire for the quantification of pruritis that is sensitive to change over time. The five dimensions are degree, duration, direction, disability and distribution. The duration, degree and direction domains each include one item, while the disability domain has four items. All items on the first four domains are measured on a five-point Likert scales. The scores of each of the five domains are achieved separately and then summed together to obtain a total 5-D score. 5-D scores can potentially range between 5 (no pruritis) and 25 (most severe pruritis). | Up to 24 Months | 
| Absolute Score for Flare Frequency | Flare frequency is assessed by acquiring information about the number of flares in the last six months before baseline. During the study the patient is asked about number of flares since the last visit. Additionally, the presence of a current flare is assessed at each visit. | Up to 24 Months | 
| Absolute Change from Baseline for Flare Frequency | Flare frequency is assessed by acquiring information about the number of flares in the last six months before baseline. During the study the patient is asked about number of flares since the last visit. Additionally, the presence of a current flare is assessed at each visit. | Up to 24 Months | 
| Percent Change from Baseline for Flare Frequency | Flare frequency is assessed by acquiring information about the number of flares in the last six months before baseline. During the study the patient is asked about number of flares since the last visit. Additionally, the presence of a current flare is assessed at each visit. | Up to 24 Months | 
| Absolute Score for Flare Duration | Flare frequency is assessed by acquiring information about the number of flares in the last six months before baseline. During the study the patient is asked about number of flares since the last visit. The mean duration of the flares is also documented. Additionally, the presence of a current flare is assessed at each visit. | Up to 24 Months | 
| Absolute Change from Baseline for Flare Duration | Flare frequency is assessed by acquiring information about the number of flares in the last six months before baseline. During the study the patient is asked about number of flares since the last visit. The mean duration of the flares is also documented. Additionally, the presence of a current flare is assessed at each visit. | Up to 24 Months | 
| Percent Change from Baseline for Flare Duration | Flare frequency is assessed by acquiring information about the number of flares in the last six months before baseline. During the study the patient is asked about number of flares since the last visit. The mean duration of the flares is also documented. Additionally, the presence of a current flare is assessed at each visit. | Up to 24 Months | 
| Absolute Score for Patient Self-Reported Global Assessment of Disease Severity (PtGA) | Patients assess the overall severity of their disease by a five-point assessment scale (clear, mild, moderate, severe, or very severe, [0-4]), with higher scores corresponding to greater severity. | Up to 24 Months | 
| Absolute Change from Baseline for PtGA | Patients assess the overall severity of their disease by a five-point assessment scale (clear, mild, moderate, severe, or very severe, [0-4]), with higher scores corresponding to greater severity. | Up to 24 Months | 
| Percent Change from Baseline for PtGA | Patients assess the overall severity of their disease by a five-point assessment scale (clear, mild, moderate, severe, or very severe, [0-4]), with higher scores corresponding to greater severity. | Up to 24 Months | 
| Percentage of Participants Achieving PtGA <=2 | Patients assess the overall severity of their disease by a five-point assessment scale (clear, mild, moderate, severe, or very severe, [0-4]), with higher scores corresponding to greater severity. | Up to 24 Months | 
| Percentage of Participants Achieving PtGA Reduction >=1 from Baseline | Patients assess the overall severity of their disease by a five-point assessment scale (clear, mild, moderate, severe, or very severe, [0-4]), with higher scores corresponding to greater severity. | Up to 24 Months | 
| Incidence and Type of Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug but within 30 days after the last dose of study drug. | Up to 24 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis (AD), Upadacitinib, RINVOQ