An Observational Study of Upadacitinib to Assess Change in Disease Activity in Canadian Adult Participants With Moderate-to-Severe Atopic Dermatitis Who Are Inadequate Responders To or Discontinuing Dupilumab (CAN UpTIMISE)

CANadian Effectiveness of UPadacitinib in Adult Moderate-to-severe aTopIc derMatitis Patients Who Are Inadequate Responders to Dupilumab or diScontinuing Dupilumab Due to safEty/Tolerability Reasons: The CAN UpTIMISE Study

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 adult participants with moderate-to-severe AD who are inadequate responders to dupilumab or who are discontinuing from dupilumab due to safety/tolerability reasons. This study also aims to understand upadacitinib utilization patterns in real-world clinical practice.

In Canada, upadacitinib is indicated for the treatment of adults and adolescents 12 years of age and older with refractory moderate to severe atopic dermatitis (AD) who are not adequately controlled with a systemic treatment (e.g., steroid or biologic) or when use of those therapies is inadvisable. CAN UpTIMISE will enroll approximately 100 adult participants, 18 years of age and above, with moderate-to-severe AD who are inadequate responders to dupilumab or are discontinuing from dupilumab from up to 25 sites in Canada.

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 4 Months.

Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, using questionnaires, and reporting potential side-effects.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis

• Study Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute - Blackfoot Trail /ID# 246344
    • Calgary, Alberta, Canada, T2W 4X9
      • Laser Rejuvenation Clinics Inc. /ID# 255303
    • Calgary, Alberta, Canada, T3K 6B8
      • Rejuvenation Dermatology Clinic Calgary North /ID# 255623
    • Edmonton, Alberta, Canada, T5J 3S9
      • Rejuvenation Dermatology - Edmonton Downtown /ID# 246298
    • Edmonton, Alberta, Canada, T5K 2V4
      • Stratica Medical /ID# 254940
    • Edmonton, Alberta, Canada, T5N 1L5
      • Rejuvaderm /ID# 255850
    • Edmonton, Alberta, Canada, T6X 0N9
      • Alpha Clinic Research Inc. /ID# 248015
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-ho Hong Medical Inc. /ID# 246841
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Nova Scotia Health /ID# 248136
  • Ontario
    • London, Ontario, Canada, N6A 5R9
      • Fiona Lovegrove Medicine Professional Corporation /ID# 255784
    • Markham, Ontario, Canada, L3P 1X2
      • Lynde Institute for Dermatology /ID# 246341
    • Niagara Falls, Ontario, Canada, L2H 1H5
      • Allergy Research Canada Inc. /ID# 251916
    • Peterborough, Ontario, Canada, K9J 5K2
      • SKiN Centre for Dermatology /ID# 246291
    • Richmond Hill, Ontario, Canada, L4B 1L1
      • York Dermatology Clinic and Research Centre /ID# 246921
    • Toronto, Ontario, Canada, M3B 0A7
      • Canadian Dermatology Centre /ID# 246334
    • Toronto, Ontario, Canada, M4C 1L1
      • FACET Dermatology /ID# 254914
    • Toronto, Ontario, Canada, M5A 3R6
      • AvantDerm, Toronto, CA /ID# 250941
    • Toronto, Ontario, Canada, M5G 1E2
      • Evidence based medical educator Inc. /ID# 246687
  • Quebec
    • Drummondville, Quebec, Canada, J2B 5L4
      • Dr. Isabelle Delorme Inc. /ID# 246296
    • Laval, Quebec, Canada, H7N 6L2
      • Clinique D /ID# 247330
    • Laval, Quebec, Canada, H7P 4K7
      • Roula Rassi MD Inc /ID# 252563
    • Quebec City, Quebec, Canada, G1W 4R4
      • Centre de Recherche St-Louis /ID# 252223
    • Québec, Quebec, Canada, G1V 4T3
      • Diex Recherche Québec Inc. /ID# 247696
    • Saint-Jerome, Quebec, Canada, J7Z 7E2
      • Dre Angelique Gagne-Henley M.D. inc. /ID# 246457
    • Verdun, Quebec, Canada, H4G 3E7
      • Sima Recherche inc. /ID# 248338

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with moderate-to-severe Atopic Dermatitis who are inadequate responders to dupilumab or are discontinuing from dupilumab due to safety/tolerability reasons.

Description

Inclusion Criteria:

• Able to give written informed consent before starting any study-related assessments
• Diagnosis of moderate or severe AD, as per investigator's judgement
• Initiating upadacitinib treatment, as per the local label, and where decision to treat with upadacitinib must have been made with the participant, prior to and independently of enrolment in the study

• Previous treatment with dupilumab for AD, as the most recent systemic therapy, and who is either or:

  • i. sub-optimally controlled as per investigator judgement, after at least 16 weeks of dupilumab treatment, with or without additional AD therapies, at time of baseline visit.
  • ii. discontinuing dupilumab due to safety/tolerability reason(s) as per investigator judgement at the baseline visit
• Availability of medication history during the past 4 weeks prior to baseline visit

Exclusion Criteria:

• Previous treatment with any systemic JAKi including upadacitinib, or any investigational drug of chemical or biologic nature within 4 weeks or five half-lives of the drug (whichever is longer) prior to and at the time of the baseline visit
• Currently enrolled in an interventional clinical study, or within the last 30 days or five-half lives of being administered an investigational drug, whichever is longer, prior to baseline visit. Participation in other observational studies or registries is acceptable.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants Receiving Upadacitinib; Participants receiving upadacitinib for moderate to severe atopic dermatitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 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.	Month 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving vlGA-AD of 0 or 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 2 Months
Percentage of Participants Achieving vlGA-AD of ≥ 2 at baseline reaching a vIGA-AD score of 0 or 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 4 Months
Percentage of Participants with a vIGA score 0 or 1 at Baseline Maintaining a vIGA-AD score 0 or 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.	From Baseline to Month 4
Percentage of Participants with an Eczema Area and Severity Index (EASI) score corresponding to, at least, mild disease (≥1.1) at baseline achieving an absolute EASI score corresponding to clear or almost clear disease (<1.1)	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	Up to 4 Months
Percentage of Participants with an EASI score corresponding to, at least, moderate disease (≥7.1) at baseline achieving an absolute EASI score corresponding to mild disease (<7.1)	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	Up to 4 Months
Absolute mean EASI score	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	Up to 4 Months
Percent change in EASI score from baseline	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	Up to 4 Months
Mean change in EASI score from baseline	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	Up to 4 Months
Percent change in EASI score by body region (head and neck region, trunk [including genitals], upper limbs, and lower limbs [including buttocks])	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	Up to 4 Months
Mean change in EASI score by body region (head and neck region, trunk [including genitals], upper limbs, and lower limbs [including buttocks])	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	Up to 4 Months
Percent change in Worst pruritus numerical rating scale (WP-NRS) score 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 4 Months
Mean change in WP-NRS score 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 4 Months
Percentage of Participants with WP-NRS >2 at baseline achieving a WP-NRS score of 0 or 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 4 Months
Percentage of Participants achieving Dermatology Life Quality Index (DLQI) score of 0 or 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.	Up to 4 Months
Percentage of Participants with a baseline DLQI score ≥ 2 (at least small effect on participant's quality of life) achieving a DLQI score of 0 or 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.	Up to 4 Months
Absolute mean DLQI scores	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.	Up to 4 Months
Percent change in DLQI score 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.	Up to 4 Months
Mean change in DLQI score 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.	Up to 4 Months
Absolute mean Patient Oriented Eczema Measurement (POEM) score	The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Participants respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID.	Up to 4 Months
Percent change in POEM score from baseline	The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Participants respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID.	Up to 4 Months
Mean change in POEM score from baseline	The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Participants respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID.	Up to 4 Months
Percentage of Participants with a baseline POEM score ≥ 4 achieving an improvement (reduction) in POEM ≥ 4 at Month 4	The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Participants respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID.	Up to 4 Months
Percentage of Participants achieving a POEM score of ≤2 among participants with POEM >2 at baseline	The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Participants respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID.	Up to 4 Months
Percent change in Body surface area (BSA) score from baseline	The investigator selects the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus five digits is assumed to be approximately equivalent to 1%. Measurement of the total area of involvement by the investigator is aided by imagining if scattered plaques were moved so that they were next to each other and then estimating the total area involved. Published score bands: 0% (clear), 0.1-15.9% (mild), 16.0-39.9% (moderate), 40-100% (severe).	Up to 4 Months
Mean change in BSA score from baseline	The investigator selects the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus five digits is assumed to be approximately equivalent to 1%. Measurement of the total area of involvement by the investigator is aided by imagining if scattered plaques were moved so that they were next to each other and then estimating the total area involved. Published score bands: 0% (clear), 0.1-15.9% (mild), 16.0-39.9% (moderate), 40-100% (severe).	Up to 4 Months
Percentage of Participants who are "Very much improved" or "Much improved" on the Patient Global Impression of Change (PGIC)	The PGIC ask participants to rate the overall change in their AD symptoms using a 7-point response scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. PGIC score ranges from 1 to 7 with lower score desirable.	Up to 4 Months
Percentage of Participants who report symptoms to be "Minimal" or "Absent" on the Patient Global Impression of Severity (PGIS)	The PGIS ask participants to describe the severity of their AD symptoms at the present time using a 7-point response scale: 0= Absent, 1 = Minimal, 2 = Mild, 3 = Moderate, 4= Moderately Severe, 5 = Severe, 6 = Very Severe.	Up to 4 Months
Percentage of Participants who report symptoms to be "Very satisfied" or "Extremely satisfied" on the Patient Global Impression of Treatment (PGIT)	PGIT-AD is a single item participant self-administered instrument designed to assess participant satisfaction or dissatisfaction with their current treatment for atopic dermatitis based on the following question: "Overall, how satisfied or dissatisfied are you with your current treatment for atopic dermatitis?". Response options range from 1 (extremely dissatisfied) to 7 (extremely satisfied).	Up to 4 Months
Number of participants who used concomitant AD medications along with upadacitinib since last visit	Number of participants who used concomitant AD medications since last visit.	Up to 4 Months

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Clinical Study Report Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): August 15, 2024
• Study Completion (Actual): August 15, 2024

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Upadacitinib; Atopic Dermatitis (AD); RINVOQ
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: P23-106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No