Registry for Systemic Eczema Treatments

Study Overview
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Brief Summary
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The Registry for Systemic Eczema Therapies (RESET) registry is a database and biospecimen repository for patients with pediatric-onset atopic dermatitis (AD) who have used or will initiate any systemic treatment(s) for AD. The goal of the registry is to enable more efficient research recruitment and data collection as well as timely notification to enrollees about newly FDA-approved treatments for AD.

Detailed Description
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The purpose of the Registry for Systemic Eczema Therapies (RESET) registry is to serve as a database and biospecimen repository of patients with pediatric-onset atopic dermatitis (AD), also known as eczema. This registry seeks to enroll patients with AD who have used or will initiate any systemic treatment(s) for AD. Such a registry will allow investigators to identify patients who are potentially eligible for AD research protocols, including observational studies or clinical trials. The registry will also prospectively collect data that would then serve as a resource for studying a variety of questions surrounding systemic therapy use in patients with AD, for example comparing the effectiveness of treatments or examining treatment effects on patient-reported outcomes. Moreover, the registry would permit safety monitoring of systemic AD medications, as it would include both patients receiving traditional systemic agents with well-known side effect profiles and patients receiving more novel systemic agents with under-characterized side effect profiles. Finally, this registry would allow for the identification of patients with moderate-to-severe AD who may be eligible to receive and benefit from the rapidly expanding number of U.S. Food and Drug Administration (FDA)-approved systemic therapies for AD.

Official Title
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Registry for Systemic Eczema Treatments

Conditions
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Atopic Dermatitis

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age <26 years old Current physician diagnosis of atopic dermatitis Provide signed informed consent if ≥ 18 years old Provide signed informed consent by parent or legal guardian (if <18 years old) and informed assent if applicable Subject and/or parent/legal guardian is willing to be contacted in the future by study staff Seen for clinical care at Johns Hopkins since 1/1/2017 Previously on, currently on, or planning to initiate (within next 6 months) a systemic AD therapy Exclusion criteria: Age ≥26 years old at the time of registry enrollment Does not speak English If <18 years old, has a primary caretaker who does not speak English If <18 years old, parent/legal guardian is unwilling to sign the written informed consent Is a foster child Has not received clinical care at Johns Hopkins since 1/1/2017

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 26 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 |
| --- | --- |
| Methotrexate<br>Participants who have received methotrexate for atopic dermatitis. | |
| Cyclosporine<br>Participants who have received cyclosporine for atopic dermatitis. | |
| Mycophenolate mofetil<br>Participants who have received mycophenolate mofetil for atopic dermatitis. | |
| Azathioprine<br>Participants who have received azathioprine for atopic dermatitis. | |
| Dupilumab<br>Participants who have received dupilumab for atopic dermatitis. | |
| Tralokinumab<br>Participants who have received tralokinumab for atopic dermatitis. | |
| Upadacitinib<br>Participants who have received upadacitinib for atopic dermatitis. | |
| Abrocitinib<br>Participants who have received abrocitinib for atopic dermatitis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment effectiveness as assessed by the change in Investigator's Global Assessment (IGA) Scores | To evaluate the clinical effectiveness of systemic treatments for atopic dermatitis according to IGA through periodic electronic medical record (EMR) review. The IGA is a physician-reported atopic dermatitis severity score. IGA is the global clinical assessment scale to determine severity of AD and clinical response to treatment on a static 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on the degree of erythema and papulation/infiltration. The IGA score ranges from 0 to 4. Higher scores indicate greater severity of AD. | 3 years | 
| Treatment effectiveness as assessed by the change in Eczema Area and Severity Index (EASI) Scores | To evaluate the clinical effectiveness of systemic treatments for atopic dermatitis according to EASI through periodic electronic medical record (EMR) review. The EASI score is a physician-reported atopic dermatitis severity score. EASI is used to evaluate severity of AD based on AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) is scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. The total EASI score ranges from 0 to 72. Higher scores indicate greater severity of AD. | 3 years | 
| Treatment effectiveness as assessed by the change in Patient Oriented Eczema Measure (POEM) Scores | To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to a POEM score. The POEM score is a patient-reported AD severity score. The POEM is a 7-item questionnaire to assess disease symptoms in children and adults with AD. It is composed of 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on symptom frequency during the past week (0 = 'no days', 1 = '1 to 2 days', 2 = '3 to 4 days', 3 = '5 to 6' days, and 4 = 'every day'). The total POEM score ranges from 0 to 28. Higher scores indicate more severe disease and poor quality of life. | Quarterly from baseline to 3 years | 
| Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Itch questionnaire score | To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Itch questionnaire. The PROMIS Itch questionnaire measures the extent to which patients experience problems with itchiness over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; and 5 = Almost Always). Higher scores reflect greater severity of experienced itch symptoms. | Quarterly from baseline to 3 years | 
| Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety questionnaire score | To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Anxiety questionnaire. The PROMIS Anxiety questionnaire measures the extent to which patients experience problems with anxiety over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Almost never; 3 = Sometimes; 4 = Often; and 5 = Almost Always). The questionnaire includes fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), social/separation anxiety (fear or distress when separating from caregivers), and somatic symptoms related to arousal (racing heart, dizziness). Higher scores reflect greater severity of experienced anxiety symptoms. | Quarterly from baseline to 3 years | 
| Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Problem questionnaire score | To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Sleep Problem/Health questionnaires. The PROMIS Sleep Problem questionnaire measures the extent to which patients experience problems with sleep over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Almost never; 3 = Sometimes; 4 = Almost always; and 5 = Always). The sleep problems contain sleep disturbances (sleep quality, sleep onset, sleep continuity) and sleep-related impairment (perceptions of sleepiness during usual awake hours and reported impairments during the day associated with sleep problems or daytime sleepiness). Higher scores reflect greater severity of sleep problems. | Quarterly from baseline to 3 years | 
| Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms questionnaire score | To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Depressive Symptoms questionnaire. The PROMIS Depressive Symptoms questionnaire measures the extent to which patients experience problems with depression over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Almost never; 3 = Sometimes; 4 = Almost Always; and 5 = Always). The depressive symptoms include negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation); decreased positive affect, anhedonia (loss of interest, inability to engage in play), and engagement. Higher scores reflect greater severity of experienced depressive symptoms. | Quarterly from baseline to 3 years | 
| Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function questionnaire score | To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Cognitive Function questionnaire. The PROMIS Cognitive Function questionnaire measures the extent to which patients experience problems with cognitive function over the past 4 weeks using a 5-point Likert scale (1 = All of the time; 2 = Most of the time; 3 = Some of the time; 4 = A little of the time; and 5 = None of the time). The questionnaire includes difficulties in cognitive abilities (e.g., memory, attention, and decision making), and difficulties in the application of such abilities to everyday tasks (e.g., planning, organizing, calculating, remembering, and learning). Lower scores reflect greater impact on cognitive function. | Quarterly from baseline to 3 years | 
| Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire score | To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Global Health questionnaire. The PROMIS Global Health questionnaire measures the extent to which patients experience problems with global health in general using a 5-point Likert scale (1 = Poor; 2 = Fair; 3 = Good; 4 = Fair; and 5 = Excellent). The questionnaire includes an overall evaluation of physical, mental health, and social health. Higher scores reflect a lower quality of global health. | Quarterly from baseline to 3 years | 
| Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity questionnaire score | To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Pain Intensity questionnaire. The PROMIS Pain Intensity questionnaire measures the intensity of patients' pain due to their AD over the past 7 days using a 10 point scale, with 0 indicating No Pain and 10 indicating the worst pain possible. Higher raw scores reflect greater severity of experienced pain due to AD. | Quarterly from baseline to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of discontinuation or dose de-escalation of systemic treatment | To assess rates of discontinuation or dose de-escalation per systemic treatment (e.g. dupilumab, tralokinumab, upadacitinib and abrocitinib) in patients with well-controlled atopic dermatitis | 3 years | 
| Adverse effects of systemic treatments for atopic dermatitis | To collect data on adverse effects of systemic treatments for AD (e.g. conjunctivitis, injection site reaction, renal or liver impairment, cardiovascular events, malignancy, infection, etc.) to assess the safety of each systemic treatment. | 3 years |