Do Atopic Dermatitis Patient-Reported Outcomes Correlate With Validated Investigator Global Assessment? Insights From TARGET-AD Registry.

Challenge

Patient-reported outcomes in AD are increasingly required for drug approval, but the degree to which validated PRO instruments—including POEM and DLQI—correlate with clinician-assessed disease severity (vIGA-AD) in real-world practice had not been established, creating uncertainty about whether PROs can serve as stand-alone endpoints.

Solution

The TARGET-DERM AD registry was used to assess the correlation between vIGA-AD scores and PRO measures (POEM, DLQI/CDLQI) across the full spectrum of AD severity, using regression analyses to characterize the strength and directionality of the vIGA-AD/PRO relationship.

Impact

Demonstrating strong correlation between clinician-assessed vIGA-AD and patient-reported outcomes validates PRO instruments as meaningful reflections of clinical reality, supporting their use as primary or co-primary endpoints in AD registration trials and strengthening the regulatory acceptability of PRO-based label claims.