Burden of Chronic Hand Eczema: A Snapshot of Patient Reported Outcomes Collected at Screening in a Phase 2B Trial with Delgocitinib
Author(s)
ABSTRACT WITHDRAWN
OBJECTIVES: Chronic hand eczema (CHE) is a burdensome multifactorial inflammatory skin disorder. Here we describe the burden of CHE, by disease severity, on patients’ quality of life using two patient reported outcomes (PROs) completed at screening: (1) Dermatology Life Quality Index (DLQI); and (2) EuroQoL 5-dimension health questionnaire 5-level (EQ-5D-5L). METHODS: Cross-sectional estimates of PROs were collected at screening in a phase 2b dose ranging trial (NCT03683719) of screened subjects with CHE (no screening failures on IC3-CHE disease definition). Estimate were collected before discontinuation of therapy ongoing at screening and initiation of investigational medical product. The PROs assessing disease burden (DLQI, EQ-5D-5L) were stratified by patient disease severity using the Investigator’s Global Assessment for CHE (IGA-CHE). RESULTS: Among patients completing the DLQI at screening (n=294), the mean total score (SD) was 10.8(6.8) indicating a very large effect on patients’ lives per category definitions of the instrument. The DLQI domain with the greatest impact was skin feeling itchy, sore, painful, or stinging (2.1(0.8)). Those with severe (n=50, IGA-CHE=4) and moderate (n=150, IGA=3) CHE perceived a very large effect of CHE on their lives (16.8(6.6) and 10.5(6.3), respectively). Those with mild CHE (n=92, IGA=2) reported a moderate effect of CHE on their quality of life (8.1(5.8)). The mean total EQ-5D-5L index score for patients at screening (n=293) was 0.7(0.2) and VAS score was 72.7(19.3). Those with severe CHE (n=50) had the lowest EQ-5D-5L index and VAS scores (0.5(0.3) and 61.5(23.0), respectively). The EQ-5D-5L index and VAS scores were similar between those with mild (n=92) and moderate (n=149) CHE (mild: 0.8(0.2) and 75(18.7); moderate: 0.7(0.2) and 75(17.1)). CONCLUSIONS: More severe CHE is associated with lower quality of life and greater impacts on patients’ lives. These findings highlight the burden of CHE and the necessity for safe and efficacious treatment.
Conference/Value in Health Info
2021-11, ISPOR Europe 2021, Copenhagen, Denmark
Value in Health, Volume 24, Issue 12, S2 (December 2021)
Code
POSA375
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Specific Disease