Quality of life, sleep, and psychological well-being in chronic spontaneous urticaria patients receiving omalizumab: a case–control study

Chronic spontaneous urticaria (CSU) impacts both physical and mental well-being, causing distress and sleep disturbances. While omalizumab reduces disease activity, its effects on mental health and quality of life remain unclear. This study assesses the psychosocial burden and sleep disturbances in CSU patients receiving omalizumab compared to healthy controls and explores their relationship with disease parameters. This case––control study included 210 CSU patients receiving omalizumab for at least three months and 210 age- and sex-matched healthy controls. Disease severity was assessed using the Urticaria Activity Score over 7 Days (UAS7) and Urticaria Control Test (UCT), while quality of life was evaluated with the Chronic Urticaria Quality of Life Questionnaire (CU-Q₂oL). Psychological distress and sleep disturbances were measured using validated scales, including the Perceived Stress Scale (PSS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Pittsburgh Sleep Quality Index (PSQI), and Epworth Sleepiness Scale (ESS). CSU patients had significantly higher scores for perceived stress, depression, anxiety, and daytime sleepiness compared to controls (p < 0.001). Patients with a good response to omalizumab also showed significantly higher psychological distress and poorer sleep quality than controls (p < 0.001). Omalizumab response was good in 29.5%, moderate in 38.6%, and limited in 31.9% of patients. Despite treatment, 32.9% reported no change in quality of life, while 35.7% had mild and 31.4% had moderate improvement. A history of atopic disease was present in 55.7% of patients, who had significantly higher daytime sleepiness scores than those without (p = 0.045). In CSU patients, while omalizumab improves symptoms and quality of life, psychological distress persists in substantial subsets, highlighting the need to address mental health and lifestyle factors.