Patient reported burden is associated with clinician-reported severity in alopecia areata: Real world insights from TARGET-DERM AA

AA-specific PRO instruments had been developed, but whether patient-reported disease burden—as measured by AAPPO and PROMIS anxiety/depression—correlates meaningfully with clinician-assessed severity (CGI-AA, SALT) in real-world US/Canadian practice had not been established, creating uncertainty about PRO validity for regulatory purposes.

The TARGET-DERM AA registry was used to assess Spearman correlations and regression-based associations between clinician-reported AA severity measures and patient-reported AAPPO and PROMIS outcomes at enrollment, characterizing the degree of agreement between the clinician and patient perspectives.

Establishing that patient-reported AA burden correlates significantly with clinician-reported severity provides the convergent validity evidence required for regulatory acceptance of AAPPO as a primary or co-primary endpoint in AA trials, directly supporting the use of PROs in JAK inhibitor label submissions.

Clinician-PRO concordance validation for AA regulatory endpoint strategy, AAPPO convergent validity evidence supporting PRO-based label claims in AA drug development, Real-world PRO instrument validation for AA regulatory submissions