Abstract Rationale The dose of inhaled corticosteroids (ICS) is traditionally increased after an asthma exacerbation, but there is limited evidence of added benefit. We investigated whether stepping up to high-dose (HD) ICS/long-acting β2-agonist (LABA) post-exacerbation reduces future exacerbation risk in patients in Japan with asthma in a real-world setting. Methods This was a retrospective cohort study using data from the DeSC Healthcare, Inc. administrative claims database in Japan (October 2015 to May 2024). We included patients with asthma, aged ≥15 years, with ≥2 ICS/LABA prescriptions within a year, who experienced a severe exacerbation while receiving medium dose (MD) ICS/LABA (issued in the prior 3 months), and remained on MD or stepped up to HD ICS/LABA within the following 3 months. Index was the date of earliest MD or HD ICS/LABA prescription post-exacerbation. Patients with a record of COPD and other comorbidities treated with systemic corticosteroids, and those with concomitant HD ICS/LABA in the 12 months pre-index, were excluded. Inverse probability of treatment weighting (IPTW) using propensity scores was used for confounder adjustment. We compared annualized asthma exacerbation rate (AAER) and time to subsequent exacerbation for those who stepped up to high-dose (MD-HD) compared with those who remained on medium-dose ICS/LABA (MD-MD) using negative binomial regression and Cox proportional hazards regression, respectively. Follow-up began 1 day after the index date and ended at the earliest occurrence of an outcome or censoring event. Results Overall, 2,111 and 20,238 patients were included in the MD-HD and MD-MD groups, respectively. Most were female (MD-HD: 70.3%; MD-MD: 67.2%), the mean (SD) age was 60 years (MD-HD: 61 (19); MD-MD: 67 (17)), and 40% of patients in both groups experienced ≥2 severe exacerbations in the 12-months pre-index (MD-HD: 42.8%; MD-MD: 41.0%). Compared with the MD-MD group, the MD-HD group was associated with a higher 95% CI AAER (0.71 0.69, 0.73 vs 0.51 0.51, 0.52) and shorter median 95% CI time-to-exacerbation (504 460, 579 vs 1021 973, 1073 days) (Figure). The median follow-up was 2.20 years in the MD-MD group and 2.50 years in the MD-HD group. A similar pattern was noted when follow-up was restricted to a maximum of 12 months. Conclusions Following a severe exacerbation, stepping up from MD to HD ICS/LABA was not associated with benefit in preventing future exacerbations compared to remaining on MD. Other treatment strategies may prove to be better options in patients with persistent asthma. This abstract is funded by: AstraZeneca
Zhang et al. (Fri,) studied this question.