Improvement in health‐related quality of life and symptoms of anxiety and depression in patients with alopecia areata randomized to baricitinib or placebo: Results from two international randomized controlled trials

Abstract Background Alopecia areata (AA) is an autoimmune hair loss disorder associated with high rates of emotional and psychosocial distress. Baricitinib, an oral selective Janus kinase (JAK) 1 and JAK 2 inhibitor, was superior to placebo with respect to hair regrowth in two phase 3 trials involving 1200 adults with severe AA (≥50% of scalp hair loss). Objectives This analysis investigated the evolution of health‐related quality of life (HRQoL) and symptoms of anxiety and depression after treatment with baricitinib in severe AA. Methods Patients were randomized to placebo, baricitinib 2‐mg, or baricitinib 4‐mg. Improvements in HRQoL and psychological burden were measured using Skindex‐16 AA and Hospital Anxiety and Depression Scales (HADS‐A and HADS‐D), respectively. Changes from baseline through Week 36 were analyzed using analysis of covariance with modified last observation carried forward for missing data. Proportion of patients with baseline HADS score ≥8 that shifted to <8 (normal) was analyzed at Week 36 using logistic regression with nonresponder imputation. Results At Week 36, patients receiving baricitinib 2‐mg and 4‐mg reported significant improvements versus placebo in Skindex‐16 AA symptoms (2‐mg: −2.80 and 4‐mg: −2.53), functioning (2‐mg: −14.02 and 4‐mg: −17.14), and emotions (2‐mg: −20.42 and 4‐mg: −24.11) domain scores. In comparison to placebo, patients receiving baricitinib 2‐mg and 4‐mg experienced significant reductions in HADS‐A (2‐mg:‐0.96 and 4‐mg:‐1.04) and HADS‐D (2‐mg: −0.30 and 4‐mg: −0.33) scores after 36 weeks. More patients on baricitinib shifted from a score ≥8 to <8 for anxiety (2‐mg: 33% and 4‐mg: 39%) and depression (2‐mg: 34% and 4‐mg: 45%) but results were generally not significant. Conclusions In two large trials, greater improvements in HRQoL and symptoms of anxiety and depression were observed after treatment with baricitinib 2‐mg and 4‐mg compared to placebo. These results support that hair regrowth has a positive impact on HRQoL and psychological burden in severe AA.