Severity bands for atopic dermatitis measures: Analysis from adult dupilumab randomized clinical trials

Abstract Background Numeric measures of atopic dermatitis (AD) disease severity are translated into severity bands to describe disease burden. Severity bands for clinician‐reported outcomes (ClinROs), such as SCORing Atopic Dermatitis (SCORAD) and the Eczema Area and Severity Index (EASI), and patient‐reported outcomes (PROs), such as the Dermatology Life Quality Index (DLQI), Patient‐Oriented Eczema Measure (POEM) and SCORAD Sleep Loss and Pruritus Visual Analog Scales (VAS), are clinically meaningful tools for physicians and patients. Objectives To develop severity bands for AD measures using a large data set from global, randomized, placebo‐controlled clinical trials of dupilumab in adults with moderate‐to‐severe AD. Methods Disease severity data from 2822 adults and approximately 30,000 visits (excluding first visit) from five clinical trials were pooled. ClinROs and PROs were anchored to 5‐level Investigator's Global Assessment and Patient Global Assessment of Disease Status questionnaires, respectively, based on correlation strength. Means (via spline regression), frequencies, medians and modes were used to select thresholds for five severity categories for each outcome measure. Goodness‐of‐fit and concordance were calculated using R 2 and weighted κ ‐coefficients. Results All measures demonstrated high goodness‐of‐fit, and most demonstrated high concordance with the respective anchors ( R 2 : 0.981–0.999; quadratic weighted κ ‐coefficients: 0.207–0.831). PROs showed reasonable agreement with previously published bands, while ClinROs displayed severity strata that differed from previously published bands. For the first time, severity bands for SCORAD Sleep Loss VAS were assessed. Conclusions This severity bands analysis of ClinROs and PROs using a substantial, global, clinical trial data set of adults with moderate‐to‐severe AD, which included utilizing frequency crossover and spline regression as novel methodologies, may aid in the interpretation of AD disease severity and stratification in adult clinical trial settings. In agreement with other diseases, quality of life moderately correlates with clinical measures of severity. Further validation will provide additional insight for clinical practice applications.