C33-06 Real-world Evidence: Assessing Baseline Characteristics and 1-year Outcomes in GINA 3 Asthma Patients With and Without Exacerbations

Abstract Rationale Despite use of available therapies, many patients with asthma across the spectrum of disease severity remain uncontrolled. In this real-world study, we present the baseline characteristics and 1-year outcomes of asthma patients on GINA Step 3 therapies to better understand the disease trajectory of patients with mild-to-moderate asthma. Methods Patients with a diagnosis of asthma on GINA Step 3 therapy during the 365-day baseline period (N = 57,594) were identified for inclusion in the study using electronic health record data from TriNetX Dataworks, USA Network. GINA 3 patients were categorized into three groups at baseline: (1) asthma worsening with exacerbations (qualifying events: asthma inpatient care, urgent care, or emergency room visit; oral corticosteroid OCS prescription for ≥3 days within 7 days of asthma-related outpatient visit or systemic steroid prescription after asthma-related outpatient visit); (2) asthma worsening without exacerbations (qualifying events: GINA step-up during baseline; ≥3 short-acting beta-agonist (SABA) prescription fills; asthma symptoms; OCS prescription for 3 days, ≥2 asthma outpatient visits, and no Group 1 qualifying events); and (3) controlled asthma (no Group 1 or 2 qualifying events). Baseline characteristics and 1-year outcomes were evaluated. Results During the 1-year baseline period, 28.8% of GINA 3 patients experienced asthma worsening with exacerbations (Group 1), 59.6% experienced asthma worsening without exacerbations (Group 2), and 11.6% had controlled asthma (Group 3) (Figure). Group 1 patients were more likely to have comorbidities and leukotriene receptor antagonist use than Group 2 or 3. The most prevalent baseline qualifying events were having an inpatient asthma encounter (Group 1) and having ≥3 SABA inhaler prescription fills (Group 2). Groups 1, 2, and 3 were 70.7%, 66.5%, and 65.2% female, respectively. During the 1-year follow-up period, 34.7% of GINA 3 patients in Group 1 at baseline continued to experience asthma with exacerbations, whereas 42.4% experienced asthma worsening without exacerbations and 22.9% achieved asthma control. Among Group 2 patients, 9.3% experienced exacerbations, 66.6% continued to experience asthma worsening without exacerbations, and 24.2% achieved control. In Group 3, 5.7% experienced asthma with exacerbations, 41.8% experienced asthma worsening without exacerbations, and 52.5% maintained asthma control. Conclusions This real-world study demonstrates that a high proportion of patients on GINA 3 therapies experience asthma worsening with or without exacerbations and are likely to remain uncontrolled at 1 year. This highlights the future risk of disease progression and an unmet need for better asthma control even among patients who are considered to have milder disease. This abstract is funded by: Sanofi