D1.171 - Real-World Exacerbation Outcomes After AIR Therapy Rescue Implementation: Toward a SABA-Free Era

Short-acting beta2-agonist (SABA) overreliance is linked to poor asthma outcomes. We evaluated real-world outcomes after a system-level transition from SABA reliever strategies to inhaled corticosteroid–formoterol anti-inflammatory reliever (AIR) and maintenance-and-reliever therapy (MART) in children and adolescents with mild-to-moderate asthma.

Single-center retrospective cohort study using a clinical registry. Patients aged 4–18 years with physician-diagnosed asthma (GINA steps I–III) were included. Two temporal cohorts were compared: historical SABA era (2018–2019) and contemporary SABA-free era (2024–2025) implementing budesonide–formoterol as AIR (steps I–II) and/or MART (step III). Follow-up was up to 12 months from the first visit documenting reliever strategy. The primary endpoint was annualized severe exacerbation rate (systemic corticosteroids, generally ≥3 days). Secondary outcomes included total exacerbations, ≥1 severe exacerbation, hospitalization days, Asthma Control Test (ACT), and time to first exacerbation. Inverse probability of treatment weighting (IPTW) was used to balance baseline covariates.

We included 7,400 patients (3,200 SABA era; 4,200 SABA-free era); median follow-up was 365 days. After IPTW, covariate balance was excellent (standardized mean differences ≈0.00–0.01). Severe exacerbation rates were lower in the SABA-free era (0.070 vs 0.118 events/patient-year; incidence rate ratio [IRR] 0.59, 95% CI 0.52–0.66; p<0.001). Total exacerbations decreased (0.37 vs 0.61 events/patient-year; IRR 0.61, 95% CI 0.57–0.65; p<0.001). Risk of ≥1 severe exacerbation was reduced (6.21% vs 9.83%; risk ratio 0.63, 95% CI 0.56–0.71; p<0.001; number needed to treat 28). Hospitalization days were fewer (IRR 0.57, 95% CI 0.49–0.66; p<0.001) and ACT improved modestly (+1.21 points, 95% CI 1.09–1.33; p<0.001). Event-free survival for any exacerbation at day 365 was 75.5% vs 65.3%.

In routine pediatric care, transitioning to budesonide–formoterol-based AIR/MART within guideline-based maintenance therapy was associated with fewer exacerbations, lower severe exacerbation risk, reduced hospitalization days, and improved asthma control compared with a historical SABA-based reliever paradigm.