Real-world assessment of disease characteristics and clinical outcomes in alopecia areata in a global noninterventional observational cohort (ADAAGIO)

Abstract

Background Limited evidence exists on prevailing treatments, disease characteristics and real-world outcomes of patients with alopecia areata (AA), particularly for those with >= 50% scalp hair loss (SHL) managed in clinical settings outside the USA. Objective To provide evidence on disease characteristics, clinical management and outcomes of patients with AA with >= 50% SHL from real-world practice settings in Europe. Methods The Assessment of real-world Disease characteristics and outcomes in Alopecia Areata in a Global non-Interventional Observational cohort (ADAAGIO) study was a retrospective chart review study in the UK, France, Spain and Germany. Adults and adolescents with >= 50% SHL were included. The first clinical observation of >= 50% SHL defined the study index date (2015-2019). Patients had >= 6 months of follow-up from index. Analyses were descriptive. The primary endpoint was the absolute Severity of Alopecia Tool (SALT) score, assessed longitudinally. Other endpoints included change in SALT score from baseline, and sustained SALT <= 20, defined as time to achieving SALT <= 20 without regression to SALT > 30 within 6 months, and sustained SALT <= 20 was assessed via inverse probability of censoring weighting (IPCW)-adjusted Kaplan-Meier estimation. Results In total, 741 patients were included [median age at index: 27 years (range 12-81); 52.6% (390/741) female]. The mean SALT score at index was 63.5 (SD 15.6); 80.2% (594/741) had patchy AA and 19.8% (147/741) had alopecia totalis or universalis. Topical corticosteroids were the most common treatment post-index, with 55.6% (412/741) receiving >= 1 course with a median cumulative exposure of 4 months. Systemic and intralesional corticosteroids [44.1% (327/741) and 22.5% (167/741), respectively], Systemic and intralesional corticosteroids [44.1% (327/741) and 22.5% (167/741), respectively], systemic were also common. The mean absolute SALT reduction at 12 months post-index was -44.6% (SD 37.3%). However, at 12 months, based on IPCW-adjusted estimation, few patients (10.6%) achieved SALT <= 20 that was sustained for >= 6 months. Conclusions Although patients in this study experienced substantial absolute SALT score reductions, few achieved and sustained SALT <= 20. These findings highlight the potential suboptimal effectiveness of the varied treatments. What is already known about this topic? center dot Alopecia areata (AA) is a sometimes chronic and relapsing autoimmune disease characterized by nonscarring hair loss affecting people of all ages, races/ethnicities and sexes. center dot AA prevalence has been estimated at 0.58%, and the disease carries significant clinical burden and psychosocial impacts. center dot A range of medications with varying efficacy are used to treat AA, but there is no consensus standard of care. What does this study add? center dot This study provides updated evidence on real-world disease characteristics, treatment patterns and clinical outcomes in patients with AA with >= 50% scalp hair loss (SHL) in Europe in the period around which three novel AA treatments (baricitinib, ritlecitinib, deuruxolitinib) were first approved. center dot Although patients experienced substantial Severity of Alopecia Tool (SALT) score reductions, few achieved and sustained SALT <= 20, highlighting potential suboptimal effectiveness of treatments used in patients with AA with >= 50% SHL.