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Omalizumab Treatment Is Effective for Patients with Chronic Spontaneous Urticaria Despite Delay in Treatment Initiation: A Real-World Study

Speaker(s)

Rajput Y1, Thomas C2, Hetherington J3, Hoskin B3, Wrest E3, Holden M4, Bernstein JA5
1Genentech, South San Francisco, CA, USA, 2University of South Florida, Tampa, FL, USA, 3Adelphi Real World, Bollington, UK, 4Genentech, Inc., South San Francisco, CA, USA, 5University of Cincinnati College of Medicine, Cincinnati, OH, USA

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.

Code

RWD59

Topic

Patient-Centered Research, Real World Data & Information Systems

Topic Subcategory

Distributed Data & Research Networks, Patient-reported Outcomes & Quality of Life Outcomes

Disease

Drugs