PSYCHOMETRIC PERFORMANCE OF EQ-5D-5L INDEX IN ADULTS AND ADOLESCENTS WITH SEVERE ALOPECIA AREATA: EVIDENCE FROM PHASE III TRIAL DATA
Author(s)
Leila Asfour, MD1, Ahmed M. Soliman, MS, PhD2, Shanshan Qin, PhD3, James Twiss, PhD4, Courtney Levy, PhD4, Lynda Doward, MSc4, Ellie Julian, MS2, Henrique Teixeira, MBA2, Arash Mostaghimi, MD, MPH5, Thierry Passeron, MD, PhD6;
1Chelsea and Westminster NHS Foundation Trust, London, United Kingdom, 2AbbVie Inc., North Chicago, IL, USA, 3RTI Health Solutions, Durham, NC, USA, 4RTI Health Solutions, Manchester, United Kingdom, 5Brigham and Women's Hospital, Boston, MA, USA, 6Department of Dermatology, Université Côte D’Azur, Centre Hospitalier Universitaire Nice, Nice, France
1Chelsea and Westminster NHS Foundation Trust, London, United Kingdom, 2AbbVie Inc., North Chicago, IL, USA, 3RTI Health Solutions, Durham, NC, USA, 4RTI Health Solutions, Manchester, United Kingdom, 5Brigham and Women's Hospital, Boston, MA, USA, 6Department of Dermatology, Université Côte D’Azur, Centre Hospitalier Universitaire Nice, Nice, France
OBJECTIVES: Alopecia areata (AA) is a non-scarring hair loss disease that negatively impacts health-related quality of life (HRQoL). The EuroQoL-5-Dimension-5-Level (EQ-5D-5L) is widely used to assess HRQoL and support health technology assessment. This study evaluates the psychometric performance of EQ-5D-5L index (based on UK value set) in adults and adolescents with severe AA.
METHODS: Data were from a Phase III upadacitinib trial (NCT06012240; Up-AA), in patients aged ≥12-<64 years (United States: ≥18 years) with severe AA (Severity of Alopecia Tool [SALT] score ≥50). EQ-5D-5L index scores were reported at baseline and Week 24. Test-retest intraclass correlation coefficients (ICC) were calculated in patients with consistent Patient Global Impression of AA Severity (PaGIS-AA) scores at Weeks 8 and 12. Spearman’s rank correlation coefficients with AA-specific clinical outcomes were evaluated at baseline and Week 24.
RESULTS: The sample comprised 1399 patients (1281 adults; 118 adolescents; 59% female; median age 35 years). Mean (SD) baseline EQ-5D-5L index scores were high (adults and adolescents: 0.9 [0.1]) and 38.9% of adults and 46.2% of adolescents had the best score of 1, indicating substantial ceiling effects. Therefore, despite improvement in AA-specific outcomes during the study, all patients showed limited mean (SD) EQ-5D-5L improvement from baseline to Week 24 (0.0 [0.1]). Overall test-retest ICC (95% CI) was 0.76 (0.73-0.79), exceeding the common criterion of 0.70. At baseline in adults, correlations between EQ-5D-5L and physician-GIS-AA (0.04), PaGIS-AA (-0.01), Scalp Hair Assessment (0.04), patient-reported outcomes for eyebrows (0.00) and eyelashes (-0.02), and SALT score (0.07) were small or negligible. Results were similar in adolescents and at Week 24.
CONCLUSIONS: Despite acceptable test-retest reliability, EQ-5D-5L index scores showed substantial ceiling effects, poor sensitivity to change, and weak correlations with AA-specific outcomes. Therefore, EQ-5D-5L may not have adequate sensitivity to measure HRQoL burden and clinical responses in patients with severe AA.
METHODS: Data were from a Phase III upadacitinib trial (NCT06012240; Up-AA), in patients aged ≥12-<64 years (United States: ≥18 years) with severe AA (Severity of Alopecia Tool [SALT] score ≥50). EQ-5D-5L index scores were reported at baseline and Week 24. Test-retest intraclass correlation coefficients (ICC) were calculated in patients with consistent Patient Global Impression of AA Severity (PaGIS-AA) scores at Weeks 8 and 12. Spearman’s rank correlation coefficients with AA-specific clinical outcomes were evaluated at baseline and Week 24.
RESULTS: The sample comprised 1399 patients (1281 adults; 118 adolescents; 59% female; median age 35 years). Mean (SD) baseline EQ-5D-5L index scores were high (adults and adolescents: 0.9 [0.1]) and 38.9% of adults and 46.2% of adolescents had the best score of 1, indicating substantial ceiling effects. Therefore, despite improvement in AA-specific outcomes during the study, all patients showed limited mean (SD) EQ-5D-5L improvement from baseline to Week 24 (0.0 [0.1]). Overall test-retest ICC (95% CI) was 0.76 (0.73-0.79), exceeding the common criterion of 0.70. At baseline in adults, correlations between EQ-5D-5L and physician-GIS-AA (0.04), PaGIS-AA (-0.01), Scalp Hair Assessment (0.04), patient-reported outcomes for eyebrows (0.00) and eyelashes (-0.02), and SALT score (0.07) were small or negligible. Results were similar in adolescents and at Week 24.
CONCLUSIONS: Despite acceptable test-retest reliability, EQ-5D-5L index scores showed substantial ceiling effects, poor sensitivity to change, and weak correlations with AA-specific outcomes. Therefore, EQ-5D-5L may not have adequate sensitivity to measure HRQoL burden and clinical responses in patients with severe AA.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
MSR123
Topic
Methodological & Statistical Research
Topic Subcategory
PRO & Related Methods
Disease
SDC: Sensory System Disorders (Ear, Eye, Dental, Skin)