Abstract Rationale Patients with asthma that is uncontrolled on medium/high-dose ICS-LABA therapy have a high disease burden. Real-world longitudinal data on the evolution in their medication usage and asthma control status over time can inform clinical practice, highlight residual burden, and guide better therapeutic strategies. Methods This study analyzed patients with physician-diagnosed asthma from the NOVELTY study, a global, prospective observational cohort (18 countries; 3-year follow-up). Patients were aged ≥12 years with uncontrolled asthma at baseline (defined as Asthma Control Test ACT 20 or ≥ 1 severe exacerbation in the previous year) despite taking medium/high-dose ICS-LABA. Patients taking LAMA or biologic treatment at baseline were excluded. Assessments were performed annually, including clinical measurements, patient-reported outcomes, comorbidity and biomarker profiling, and medication tracking. Longitudinal asthma control status (symptom control ACT and/or severe exacerbations) was assessed, and medication patterns were visualized with Sankey diagrams. Results Of 1,102 patients with asthma receiving medium/high-dose ICS-LABA and with available lung function, exacerbation, and ACT data, 610 (55%) patients met the criteria for uncontrolled asthma (n = 296 49% had ACT 20 only; n = 150 25% had ≥1 exacerbation only; n = 164 27% had both). The median age was 53 years (IQR 40-66), 67% were female, and mean BMI was 29 kg/m². Treatment patterns over time for all patients are shown in the Figure. Among patients with available medication data (n = 433), 87% remained on medium/high-dose ICS-LABA at year 1, 77% at year 2, and 73% at year 3. Similarly, the proportions remaining specifically on high-dose ICS-LABA were above 85% at year 1 and declined to 73% by year 3. Cumulatively, 11%, 15%, and 16% had biologics and/or LAMA added by year 1, 2, and 3, respectively. Among patients with non-missing data across all timepoints (n = 228), asthma remained uncontrolled in 70% at years 1 and 2; at year 3, 60% still had uncontrolled asthma. Of the patients with uncontrolled asthma at year 1 (n = 297), year 2 (n = 236), and year 3 (n = 194), 50%, 48%, and 48%, respectively, had ACT scores 20 only; 30%, 27%, and 30% had ≥1 exacerbation only; and 20%, 26%, and 22% had both. Conclusions This study showed that for a majority of patients with uncontrolled asthma, it remained uncontrolled over three years of follow-up, despite predominant and sustained use of medium/high-dose ICS-LABA. These findings highlight the need for ongoing monitoring and consideration of targeted or add-on therapies in this high-risk population. This abstract is funded by: AstraZeneca
Reddel et al. (Fri,) studied this question.