Burden of Chronic Hand Eczema: A Snapshot of Patient Reported Outcomes Collected at Screening in a Phase 2B Trial with Delgocitinib
Author(s)
Buhl T1, Bauer A2, Thyssen JP3, Apol E4, Hagen BF5, Agner T3
1University Medical Center Göttingen, Göttingen, Germany, 2University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany, 3Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark, 4LEO Pharma, Ballerup, 84, Denmark, 5LEO Pharma A/S, Ballerup, Denmark
Presentation Documents
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
2022-05, ISPOR 2022, Washington, DC, USA
Value in Health, Volume 25, Issue 6, S1 (June 2022)
Code
PCR178
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas