Objectives: Chronic spontaneous urticaria (CSU) is a debilitating disorder that compromises quality of life. American and European treatment guidelines recommend the use of omalizumab in patients unresponsive to H1-antihistamines. Here we describe real-world effectiveness outcomes for patients with CSU treated with omalizumab in clinical practice.

Methods: The Adelphi Disease Specific Programme™ (cross-sectional survey; United States; Q4:2020-Q3:2021) collected data on patients with CSU by physician survey (n=49 dermatologists; n=46 allergists; actively treating CSU), physician-reported patient records (n=443 dermatologists; n=420 allergists), and patient (≥18years) self-completed questionnaires (n=291). We describe outcomes for patients with moderate-severe CSU currently treated with omalizumab (n=242) and patients with moderate-severe CSU, currently unresponsive to standard of care and not treated with omalizumab (non-omalizumab; n=205).

Results: Patients currently treated with omalizumab were slighter older (mean 44.0 vs 36.5 years), had been diagnosed with CSU for a longer duration than non-omalizumab patients (mean 3.9 vs 1.3 years), and had a median time from diagnosis to first omalizumab prescription of 34.2 weeks. Severity of CSU improved following omalizumab treatment (from 56%/42% moderate/severe before initiation to 76%/20%/4% mild/moderate/severe). Physician-reported disease control was better for omalizumab patients (87%/11%/2% improving/same/worsening) compared with non-omalizumab patients (21%/72%/6% improving/same/worsening), and most omalizumab patients were currently non-symptomatic (76% vs. 27% for non-omalizumab). Patient-reported outcomes (PROs) and satisfaction with treatment was better for omalizumab compared with non-omalizumab (n=95 omalizumab, n=62 non-omalizumab; 99% vs 52% satisfied; PROs - Dermatology Life Quality Index mean score 2.3 vs 8.7; Jenkins Sleep Evaluation mean score 3.1 vs 5.5; Work Productivity and Activity Impairment overall mean score 8.9 vs 33.3).

Conclusions: This real-world data collected from physicians and patients highlights the benefits, better HrQoL and functionality, of omalizumab treatment for CSU. However, despite CSU severity patients did not begin omalizumab until ~8 months after their diagnosis, which represents a significant delay in guideline-recommended treatment.