Analysis of alopecia areata surveys suggests a threshold for improved patient-reported outcomes

Abstract

Summary Background Although alopecia areata (AA) greatly impacts patients’ quality of life (QoL), there is no adequate validation of AA‐targeted QoL surveys in clinical trials, hindering sufficient representation of patient‐reported outcomes. Objectives Better understanding of patient‐reported outcomes may guide treatment goals and future clinical trials. Methods In a recent randomized controlled trial testing dupilumab in AA, patients were administered the Alopecia Areata Quality of Life Index (AA‐QLI) and the Alopecia Areata Symptom Impact Scale (AASIS) surveys, specifically evaluating QoL in patients with AA. An in‐depth analysis was performed to assess the utility of these questionnaires in this patient population, both at baseline and after treatment, and to determine a threshold for improved patient‐reported outcomes. Results While AASIS correlated with baseline Severity of Alopecia Tool (SALT) scores and with therapeutic response, AA‐QLI showed no correlation with AA severity before or after treatment. Itch strongly correlated with serum IgE levels across both surveys. Using various approaches to estimate a discriminative threshold for decreased impact of AA on QoL (by AASIS) following treatment, a SALT score of 20 points or less post‐treatment was associated with improved patient‐reported outcomes, including both AA‐related symptoms and items within the daily activities/feelings domain such as ‘feeling sad’ and ‘feeling anxious or worry’. Conclusions AASIS is better than AA‐QLI to assess patient‐reported outcomes. SALT ≤ 20 following treatment should be considered as a threshold for meaningful therapeutic outcome and as a clinical endpoint in future clinical trials for AA. What is already known about this topic? Alopecia areata greatly compromises quality of life, and affected patients have increased prevalences of depression, anxiety and social phobia. Despite the significant negative impact of the disease on patients’ wellbeing, validation of targeted questionnaires in alopecia areata is lacking, and a therapeutic response threshold for improved patient‐reported outcomes is unknown. What does this study add? This study investigated the utility of two different alopecia areata‐targeted questionnaires – Alopecia Areata Quality of Life Index and Alopecia Areata Symptom Impact Scale (AASIS) – in a clinical trial setting. AASIS was found to correlate strongly with alopecia areata severity and clinical response. What are the clinical implications of this work? Patients with ≤ 20% scalp hair loss after treatment reported improvement in multiple quality‐of‐life items, suggesting this as a meaningful therapeutic outcome that may guide clinicians and improve the development of future clinical trials.

Alopecia areata: What's new in the diagnosis and treatment with JAK inhibitors?

“…21 The AA Symptom Impact Scale (AASIS) was developed as a valid and reliable measure of AA symptoms and their impact on functioning, 22 and was suggested to be better than the AA Quality of Life Index for assessing patient-reported outcomes. 23 A Global Registry of AA Disease Severity and Treatment Safety (GRASS) was developed to identify the core domains required for AA registries. 24…”

“…The AA Disease Severity Scale, with three severity grades and four additional clinical features (eyebrow and eyelash involvement, treatment‐refractory disease, and psychosocial impact), was proposed 21 . The AA Symptom Impact Scale (AASIS) was developed as a valid and reliable measure of AA symptoms and their impact on functioning, 22 and was suggested to be better than the AA Quality of Life Index for assessing patient‐reported outcomes 23 …”

Scalp biomarkers during dupilumab treatment support Th2 pathway pathogenicity in alopecia areata

“…1 The pathogenesis of AA is not fully understood, 2 hindering the development of specific therapeutics. Thus, despite the great burden of AA on patients' well-being 3 and the increased prevalence of associated anxiety, depression, and even suicidal ideation, [4][5][6][7] treatment options are limited and only baricitinib has been recently FDA-approved for moderate to severe AA. 8 Alopecia areata is induced by a chain of events initiated by an unknown trigger, leading to compromised immune privilege of the hair follicle.…”