Albuterol-budesonide rescue inhaler in patients>=18 years with moderate to-severe asthma: post-hoc analysis of mandala

IntroductionIn the Phase 3 MANDALA study (NCT03769090), as-needed albuterol-budesonide 180/160μg significantly reduced severe exacerbation risk by 27% versus albuterol 180μg in patients ≥12 years with moderate-to-severe asthma on inhaled corticosteroid (ICS)-containing maintenance therapy. Albuterol-budesonide 180/160µg inhaler received FDA approval in January 2023 for as-needed treatment or prevention of bronchoconstriction and to reduce exacerbation risk in patients ≥18 years with asthma. Here, we present MANDALA efficacy and safety data for the adult subpopulation.MethodsPrimary and secondary endpoints from MANDALA were analyzed post hoc for the subpopulation of patients ≥18 years randomized to as-needed albuterol-budesonide 180/160μg (n=979) or albuterol 180μg (n=980).ResultsAlbuterol-budesonide reduced severe exacerbation risk, as measured by time to first severe exacerbation (primary endpoint), by 28% (HR 0.72; 95% CI 0.60, 0.86; p<0.001), annualized severe exacerbation rate by 24% (p=0.008), and mean annualized total SCS exposure by 32% (p=0.001) versus albuterol (Table). A numerically lower proportion of patients treated with albuterol-budesonide versus albuterol had a severe exacerbation requiring hospitalization (0.9% vs 1.5%) or an urgent care or emergency department visit (4.5% vs 6.1%). Asthma Control Questionnaire and Asthma Quality of Life Questionnaire responder rates at Week 24 showed that the odds of clinically meaningful improvements were nominally higher with albuterol-budesonide versus albuterol (Table). The proportion of patients with AEs/SAEs was similar across treatment arms.ConclusionsIn post hoc analyses, as-needed albuterol-budesonide 180/160µg resulted in a reduction in severe exacerbation risk and resultant SCS use compared with albuterol 180µg in adults with moderate-to-severe asthma.