Lead Investigator: Junko Takeshita, University of Pennsylvania
Title of Proposal Research: Evaluating Racial and Ethnic Differences in the Quality-of-Life Impact of Atopic Dermatitis
Vivli Data Request: 7597
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Atopic dermatitis (AD) is a common, chronic inflammatory skin disease that affects approximately 9.6 million U.S. children and about 7.3% of US adults. The condition is characterized by eczematous lesions, itch, and skin pain. AD negatively impacts patient’s mood, sleep, and school/work productivity and imparts a significant burden on overall quality-of-life (QoL). The health related QoL burden of AD is similar to or higher than other chronic conditions, including the QoL burden of psoriasis, another chronic inflammatory skin disease. Previous studies have found that the QoL impact of psoriasis differs by race/ethnicity, as racial/ethnic minorities with psoriasis report worse QoL due to their skin disease than White adults, independent of disease severity. However, it is unknown if this same disparity exists among patients with AD. Unpublished data has shown that among AD patients with high levels of anxiety or depression, QoL scores are worse among non-Hispanic Black vs. non-Hispanic White adults. However, a larger, more diverse patient population with a higher AD disease burden is needed to further elucidate these racial/ethnic differences in QoL. Our study will analyze anonymized, participant-level baseline data from phase 3 clinical trials for atopic dermatitis to evaluate the association between participant race/ethnicity and QoL. The clinical trial population is ideal for this analysis as QoL information is routinely collected in clinical trials and the study participants typically have more severe disease with a greater impact on their QoL. We will use the Dermatology Life Quality Index (DLQI) to measure QoL in adults (>=16 years) and the Children’s Dermatology Life Quality Index (CDLQI) to measure QoL in children (4-16 years), with the aim of determining whether DLQI/CDLQI scores differ by race/ethnicity among patients with AD. It is important that these differences are accurately defined so that we can work to eliminate the health disparities that affect patients with AD.
Requested Studies:
SOLO 1 (Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis)
Data Contributor: Regeneron
Study ID: NCT02277743
SOLO 2 (Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis)
Data Contributor: Regeneron
Study ID: NCT02277769
LIBERTY AD CHRONOS (Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis)
Data Contributor: Regeneron
Study ID: NCT02260986
LIBERTY AD PEDS (Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD))
Data Contributor: Regeneron
Study ID: NCT03345914
LIBERTY AD ADOL (Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis)
Data Contributor: Regeneron
Study ID: NCT03054428
Data Request ID: 00007597
AD-301 A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF AN2728 TOPICAL OINTMENT, 2% IN CHILDREN, ADOLESCENTS, AND ADULTS (AGES 2 YEARS AND OLDER) WITH ATOPIC DERMATITIS
Data Contributor: Pfizer Inc.
Study ID: NCT02118766
ADD-302 A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF AN2728 TOPICAL OINTMENT, 2% IN CHILDREN, ADOLESCENTS, AND ADULTS (AGES 2 YEARS AND OLDER) WITH ATOPIC DERMATITIS
Data Contributor: Pfizer Inc.
Study ID: NCT02118792
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis
Data Contributor: Lilly
Study ID: NCT03435081
Sponsor ID: 17049