Atopic dermatitis (AD) and chronic hand eczema (CHE)—both often simply referred to as eczema—are among the most common dermatologic diseases. These conditions cause significant patient burden related to constant, intense itching, visible skin effects, impaired ability to interact with others and—particularly for CHE—ability to perform work functions. Patients often experience these chronic conditions at the same time.
Researchers from Leo Pharma and RTI Health Solutions performed a structured literature review to explore the assessment of key symptoms and their impact in AD and CHE. The goal was to identify patient-reported outcome measures (PROMs) currently in use and explore gaps in these measures as well as gaps in the assessment of the conditions in clinical trials.
Researchers found that although measurement of key symptoms via PROMs is on the rise, the determination in clinical trials of whether a treatment works is generally based on a clinician-reported outcome measure.
Lead author Amy Barrett said, “Going forward, clinical trials should include key endpoint measures that assess how patients experience and value changes in symptoms. Doing this will incorporate important patient-centered information being requested and prioritized by regulatory agencies.”
Regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), are indeed increasingly accepting patient-reported outcomes to support label claims for eczema therapies.
Patient-Reported Outcome Measures Reviewed
Four relevant PROMs were identified and reviewed:
- Dermatology Life Quality Index (DLQI) -- a measure of health-related quality of life (HRQOL) in people with dermatologic conditions
- Pruritus/Itch Numeric Rating Scale (NRS) -- a measure of itch severity
- Patient-Oriented Eczema Measure (POEM) -- a measure of AD symptoms and sleep disturbance
- Quality of Life in Hand Eczema Questionnaire (QOLHEQ) -- a measure of CHE symptoms and HRQOL
Read the full study here: