Abstract Rationale Despite the availability of novel biologic therapies over the past decade, exacerbation burden remains high suggesting limited real-world impact. Limited effect may be due to biologics not being delivered to the patient populations most responsible for the exacerbation burden. Understanding where this burden lies is essential to identify gaps in care and assess the disconnect between therapeutic innovation and outcomes. Here we demonstrate the proportion of adult U.S. asthma patients experiencing moderate to severe exacerbations by treatment cohort (biologic vs. non-biologic). Methods Adult patients with a prior diagnosis of asthma and a claim for treatment with controller medications (from July 1, 2022, to June 30, 2024) per GINA guidelines were identified in HealthVerity data. Follow-up began the day after the index date (index date= first asthma prescription for controller medications within the study window) and continued for 12 months We estimated the occurrence of moderate (based on outpatient visits) and severe exacerbations (based on ER, inpatient and steroid use), as well as any exacerbations (moderate or severe) by treatment cohort. Results 1.22 million patients with at least one prescription for any asthma medication during the study period were identified. Among these, 17.5% (N = 214,181) received a controller medication and met all other study eligibility criteria (Figure 1A). The non-biologic and biologic cohort comprised of 205,281 and 8,900 patients respectively. The proportion of patients with at least one exacerbation was 3.2% among non-biologic users and 2.4% among biologic users. Similarly, when outcomes were analyzed by exacerbation severity, non-biologic users had a higher proportion of patients with at least one severe exacerbation (2.4% and 1.7%) and at least one moderate exacerbation (0.8% and 0.7%) compared to biologic users (Figure 2B). Conclusions This study demonstrated that a small proportion of patients with asthma are on guideline recommended controller medication treatments. At the population level, patients on non-biologic treatments have a higher burden of asthma exacerbations than patients on biologic treatments. The modest impact of biologics of reducing exacerbations likely reflects their use in only a small subset of the asthma population who have failed all prior lines of treatment. To meaningfully reduce exacerbations at a population level, new treatments must target a broader spectrum of asthma patients. Figure B Figure 1. Distribution by GINA treatment groups (2 to 4) and exacerbation burden by biologics versus non-biologic users This abstract is funded by: Gilead Sciences
Gupta et al. (Fri,) studied this question.