Atopic Dermatitis
Conditions
Keywords
observational, target trial emulation, dupilumab, upadacitinib
Brief summary
The goal is the replication of the primary outcome (EASI 75 at week 16) of the Heads Up trial (Blauvelt, A, Teixeira, H, Simpson, E et al (2021) doi:10.1001/jamadermatol.2021.3023) and the evaluation of the patient reported outcomes (POEM, DLQI and RECAP) in a head-to-head comparison of upadacitinib versus dupilumab treatment in moderate-to-severe atopic dermatitis (AD).
Detailed description
Atopic dermatitis (AD) is an inflammatory, multifactorial skin disease characterized by eczematous skin lesions, severe itching, and negative consequences on quality of life. The goal of this study is the replication of the primary outcome (Eczema Area and Severity Index (EASI) 75 at week 16) of the Heads Up trial and the evaluation of the patient reported outcomes (Patient-oriented Eczema Measure (POEM), Dermatologic Quality of Life Index (DLQI) and Recap of Atopic Eczema (RECAP)) that were not assessed in the Heads Up trial but are part of the recommendations by the Harmonising Outcome Measures for Eczema (HOME) initiative (Williams, HC, Schmitt, J, Thomas, KS et al (2022) doi:10.1016\\j.jaci.2022.03.017) regarding core outcome sets in atopic dermatitis clinical trials. The core outcome set as defined by HOME encompasses the following domains (core outcome instruments): clinical signs (EASI), patient-reported symptoms (POEM and Peak Itch), long term control (RECAP) and quality of life (DLQI). The data basis is the TREATgermany registry (https://treatgermany.org/). TREATgermany is a national clinical registry for patients with moderate to severe AD. The physician and patient-reported outcomes are collected in about 60 clinics and private practices during routine care. Data of more than 2,400 patients is currently documented.
Interventions
DRUGUpadacitinib
30 mg tablet daily
BIOLOGICALDupilumab
300 mg injection every other week
Sponsors
Technische Universität Dresden
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic AD with onset of symptoms at least 3 years prior to baseline * Meets UK working party criteria * EASI score ≥ 16 * ≥ 10% body surface area (BSA) of AD involvement at baseline ("therapy start") visit
Exclusion criteria
* contraindications according to upadacitinib or dupilumab labeling
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| POEM | baseline to month 6 | Mean POEM change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EASI | from baseline to month 6 | Mean EASI change |
| NRS Itch (past 3 days) | from baseline to month 6 | Mean NRS Itch (past 3 days) change |
| EASI 75 | from baseline to month 6 | EASI 75 change |
| DLQI | from baseline to month 6 | Mean DLQI change |
| RECAP | from baseline to month 6 | Mean RECAP change |
| NRS sleeping problems (past 3 days) | from baseline to month 6 | Mean NRS sleeping problems (past 3 days) change |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORJochen M Schmitt
Center for Evidence-based Healthcare, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden
Outcome results
None listed