OBJECTIVES: PROs and ObsROs are used to define endpoints that describe how patients feel or function. When PROs and ObsROs are appropriately developed, they can increase the efficiency and clinical relevance of clinical trials. AD is a chronic, itchy, inflammatory skin disorder affecting both children and adults. The objective of this landscape assessment was to identify the most commonly used PRO and ObsRO measures in clinical trials of adult patients with AD.

METHODS: A search was conducted in ClinicalTrials.gov to identify phase 3, interventional trials of adult patients (aged 18-65) with AD in North America and Europe. Clinical trials initiated between 2015 and 2018 were included. Recruiting and completed studies were assessed. The eligible clinical trials were evaluated to identify PROs and ObsROs among primary and secondary endpoints. Composite measures that included other types of clinical outcome assessments, such as clinical-reported outcome (ClinRO) measures or performance outcome (PerfO) measures were not included in the analysis. Instruments that could not be confirmed as a validated PRO or ObsRO were also excluded.

RESULTS: Our search identified 16 eligible studies. Of those studies, 8 included PRO- or ObsRO-related secondary endpoints. No studies included PRO- or ObsRO-related primary endpoints. The most commonly used PROs were the Itch or Pruritus Numeric Rating Scale (NRS) (8 studies), the Dermatology Life Quality Index (DLQI) (6 studies), and the Hospital Anxiety Depression Scale (HADS) (5 studies). The Patient Oriented Eczema Measure (POEM), a composite ObsRO and PRO measure, was identified in 6 studies.

CONCLUSIONS: While PRO and ObsRO measures are being used occasionally in AD clinical trials, no recent studies have used validated measures designed specifically for patients with AD. Based on this research, there appears to be a lack of comprehensive AD-specific PRO and ObsRO measures, and future research should focus on the development of such measures.