Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis, Upadacitinib, Biologics
Brief summary
Atopic dermatitis (AD) is a common, chronic, inflammatory skin disease with a significant impact on patients' health-related quality of life. In addition to skin lesions, patients often experience pruritis, often at night, which can result in scratching and frequent sleep disturbances. These impacts can subsequently contribute to mental health problems and diminished quality of life. This study aims to evaluate the real-world effectiveness of upadacitinib for the achievement of minimal disease activity and optimal treatment targets in relation to biological treatments in adults with moderate-to-severe atopic dermatitis. This is a prospective, observational, cohort study to evaluate the effectiveness of upadacitinib and biologics in participants with moderate-to-severe atopic dermatitis. Upadacitinib is an approved selective and reversible JAK inhibitor for the treatment of atopic dermatitis. This study is non-interventional and observational in design. Participants will be prescribed either upadacitinib or an approved biologic treatment for AD as per local country label and prescribing guidelines by their physician independent of study participation. Adult participants with moderate-to-severe AD who are biologic-naive or biologic-experienced will be enrolled. Around 900 participants will be enrolled in the study at multiple sites worldwide. The study will follow participants for 48 weeks with recommended assessments. The treatment regimen, including route, form, and frequency, will be determined by the physician's usual clinical practice and local prescribing guidelines. There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Physician confirmed diagnosis of moderate-to-severe AD validated Investigator's Global Assessment (vIGA-AD ≥ 3) with onset of symptoms ≥ 1 year prior to baseline * Biologic-naive or biologic-experienced (use of a biologic treatment for AD within 2 years prior to the baseline visit) * Participants initiating upadacitinib or an approved biologic treatment for AD per local label and local prescription guidelines * Participants who are willing and able to complete the patient reported questionnaires * Participants must voluntarily sign and date an informed consent form approved by an IEC/IRB prior to inclusion in this study (as per local regulations).
Exclusion criteria
* Participation in any interventional trial or observational study (not restricted to AD). Participation in a registry is permitted. * Prior use of the AD treatment being evaluated in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Minimal Disease Activity (MDA) | At Week 16 | Achievement of MDA defined as Eczema Area and Severity Index (EASI ≤ 3) and Worst Pruritus Numerical Rating Scale (WP-NRS) 0/1. The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD: Clear=0, Almost clear=0.1-1.0, Mild=1.1-7.0, Moderate=7.1-21.0, Severe=21.1-50.0, Very severe=50.1-72.0 Worst Pruritus NRS (WP-NRS) is a validated single self-reported measure where patients rate the worst level of itching they have experienced over the past 24 hours on a scale from 0 (no itching) to 10 (worst itching imaginable) |
Contacts
CONTACTMeerat Oza
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed