PSYCHOMETRIC EVALUATION OF SKINDEX-16 AA, THE ALOPECIA AREATA SYMPTOM IMPACT SCALE (AASIS), AND THE SCALP HAIR ASSESSMENT PATIENT-REPORTED OUTCOME (PRO) IN ADULTS AND ADOLESCENTS WITH SEVERE ALOPECIA AREATA
Author(s)
Leila Asfour, MD1, Ahmed M. Soliman, MS, PhD2, Shanshan Qin, PhD3, James Twiss, PhD4, Dane Korver, BS5, Lynda Doward, MSc6, Ellie Julian, MS7, Andreas Lazar, MD8, Thierry Passeron, MD, PhD9, Arash Mostaghimi, MD10;
1Chelsea and Westminster NHS Foundation Trust, London, United Kingdom, 2AbbVie Inc., Vernon Hills, IL, USA, 3RTI- Health Solutions, Research Triangle Park, NC, USA, 4RTI- Health Solutions, Manchester, United Kingdom, 5RTI- Health Solutions, Durham, NC, USA, 6RTI- Health Solutions, Vice President, European Head, Patient-Centered Outcomes, Manchester, United Kingdom, 7Abbvie, BROOKLYN, NY, USA, 8AbbVie, North Chicago, IL, USA, 9University Côte d’Azur; University Hospital of Nice, Nice, France, 10Brigham & Women's Hospital, Harvard Medical School, Boston, MA, USA
1Chelsea and Westminster NHS Foundation Trust, London, United Kingdom, 2AbbVie Inc., Vernon Hills, IL, USA, 3RTI- Health Solutions, Research Triangle Park, NC, USA, 4RTI- Health Solutions, Manchester, United Kingdom, 5RTI- Health Solutions, Durham, NC, USA, 6RTI- Health Solutions, Vice President, European Head, Patient-Centered Outcomes, Manchester, United Kingdom, 7Abbvie, BROOKLYN, NY, USA, 8AbbVie, North Chicago, IL, USA, 9University Côte d’Azur; University Hospital of Nice, Nice, France, 10Brigham & Women's Hospital, Harvard Medical School, Boston, MA, USA
OBJECTIVES: Skindex-16 AA (Emotions, Functioning), Alopecia Areata Symptom Impact Scale (AASIS) (Interference, Symptoms), and Scalp Hair Assessment Patient-Reported Outcome (PRO) are important PRO measures for alopecia areata (AA), yet evidence for their psychometric performance is limited. This study evaluated psychometric properties and estimated meaningful within-patient change (MWPC) thresholds for these PRO scores.
METHODS: Analyses used baseline to Week 24 data from a phase 3 upadacitinib trial for severe AA (NCT06012240; Up‑AA). Floor and ceiling effects were examined at baseline. Test-retest reliability (intraclass correlation coefficients [ICCs]) was assessed using Week 8 and 12 data in patients with stable Patient Global Impression of Severity of AA (PaGIS-AA). Correlational analyses and between-group comparisons were conducted for scores at baseline and Week 24, and changes from baseline to Week 24. MWPC thresholds were estimated using anchor- and distribution-based methods.
RESULTS: Data sample comprised 1,399 patients (1,281 adults; 118 adolescents; overall 59% female; median age 35 years). Baseline ceiling effects were minimal (<20%), except for AASIS Interference in adolescents (25.6%). Test-retest ICCs generally exceeded 0.70: Skindex-16 AA Emotions (0.85 adults, 0.88 adolescents), Functioning (0.84, 0.89); AASIS Interference (0.83, 0.88), Symptoms (0.77, 0.63); and Scalp Hair Assessment PRO (0.67, 0.74). In adults at Week 24, most target PRO scores showed moderate-to-strong correlations (|r|≥0.30) with PaGIS-AA and Severity of Alopecia Tool (SALT). Most scores significantly distinguished PaGIS-AA groups at baseline and Week 24 in adults (P<0.01), and most PRO change scores significantly distinguished between PaGIS-AA response groups (improved/no change/worsened) from baseline to Week 24 in adults and adolescents (P<0.01). Estimated MWPC thresholds for the overall sample based on 1-category improvement on PaGIS-AA were −19.0 (Emotions), −13.3 (Functioning), and −1.3 (Interference and Symptoms).
CONCLUSIONS: All 5 scores exhibit adequate psychometric properties and confirm their suitability as fit-for-purpose measures in clinical trials of adults and adolescents with severe AA.
METHODS: Analyses used baseline to Week 24 data from a phase 3 upadacitinib trial for severe AA (NCT06012240; Up‑AA). Floor and ceiling effects were examined at baseline. Test-retest reliability (intraclass correlation coefficients [ICCs]) was assessed using Week 8 and 12 data in patients with stable Patient Global Impression of Severity of AA (PaGIS-AA). Correlational analyses and between-group comparisons were conducted for scores at baseline and Week 24, and changes from baseline to Week 24. MWPC thresholds were estimated using anchor- and distribution-based methods.
RESULTS: Data sample comprised 1,399 patients (1,281 adults; 118 adolescents; overall 59% female; median age 35 years). Baseline ceiling effects were minimal (<20%), except for AASIS Interference in adolescents (25.6%). Test-retest ICCs generally exceeded 0.70: Skindex-16 AA Emotions (0.85 adults, 0.88 adolescents), Functioning (0.84, 0.89); AASIS Interference (0.83, 0.88), Symptoms (0.77, 0.63); and Scalp Hair Assessment PRO (0.67, 0.74). In adults at Week 24, most target PRO scores showed moderate-to-strong correlations (|r|≥0.30) with PaGIS-AA and Severity of Alopecia Tool (SALT). Most scores significantly distinguished PaGIS-AA groups at baseline and Week 24 in adults (P<0.01), and most PRO change scores significantly distinguished between PaGIS-AA response groups (improved/no change/worsened) from baseline to Week 24 in adults and adolescents (P<0.01). Estimated MWPC thresholds for the overall sample based on 1-category improvement on PaGIS-AA were −19.0 (Emotions), −13.3 (Functioning), and −1.3 (Interference and Symptoms).
CONCLUSIONS: All 5 scores exhibit adequate psychometric properties and confirm their suitability as fit-for-purpose measures in clinical trials of adults and adolescents with severe AA.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PCR30
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
SDC: Sensory System Disorders (Ear, Eye, Dental, Skin)