Impact of COVID-19 measures on exacerbation rates and healthcare visits in US asthma patients.

Objective: To compare exacerbation rates and healthcare resource utilization (HCRU) in real-world patients in the United States who had moderate-to-severe asthma on medium- or high-dose inhaled corticosteroid/long-acting ß2-agonist therapy at different stages before and after the pandemic. Methods: This noninterventional, retrospective study described demographics, exacerbations, HCRU, and medication use in patients from a US-wide healthcare claims database in 4 consecutive years anchored around March 15, 2020 (start date of the first emergency health measures against coronavirus disease 2019 [COVID-19], or the first lockdown, in the United States, termed "restriction onset" hereafter). Four cohorts of patients potentially eligible for moderate-to-severe asthma clinical trials at the beginning (index) of each of four 1-year periods (March 15, 2018, 2019, 2020, 2021, respectively) were built. Exacerbations, healthcare visits, and asthma medication use were counted in the 1-year period after the index for each cohort. Results: The prevalence of patients with one or more exacerbation per year decreased by 10.00% in the first year after the restriction onset compared with the year before and attenuated over time to 6.37% in the second year. The proportion of inpatient, emergency department, and physician's office visits remained stable over the time periods evaluated for all patients and those patients who experienced one or more exacerbations. Asthma treatment of patients who experienced one or more exacerbations also remained stable over the 4 years. Conclusion: The effect of COVID-19 public health measures on asthma exacerbation rates might have affected clinical trials being run during this period and should be considered in their analysis. Asthma clinical trials run under pandemic hygiene restrictions should consider lower exacerbation frequency in their study design, while treatment and healthcare visits seem unchanged.

Real-World Frequency and Management of Ocular Adverse Events in Eyes with Neovascular Age-Related Macular Degeneration Treated with Brolucizumab.

INTRODUCTION: Intraocular inflammation (IOI)-related adverse events (AEs) that may result in severe vision loss have been associated with the anti-vascular endothelial growth factor brolucizumab. In this study, we investigate the timing, management and resolution of IOI-related AEs in a large cohort of patients treated with at least one injection of brolucizumab in routine clinical practice. METHODS: Retrospective review of medical records from patients with neovascular age-related macular degeneration treated with ≥ 1 brolucizumab injection between October 2019 and November 2021 at the Retina Associates of Cleveland, Inc. clinics. RESULTS: Of the 482 eyes included in the study, IOI-related AEs occurred in 22 (4.6%) eyes. Four (0.8%) eyes developed retinal vasculitis (RV) and of these, 2 (0.4%) had concomitant retinal vascular occlusion (RO). Most eyes [14/22 (64%)] developed the AE within 3 months and 4/22 (18%) within 3-6 months of the first brolucizumab injection. The median [interquartile range (IQR)] time from the last brolucizumab injection to development of the IOI-related AE was 13 (4-34) days. At the time of event, 3 (0.6%) eyes with IOI (no RV/RO) developed severe vision loss of ≥ 30 ETDRS letters, and a further 5 (1.0%) eyes (1 with IOI + RV, 1 with IOI + RV + RO) developed moderate vision loss of ≥ 15 letters compared with their last visual acuity (VA) prior to the AE. The median (IQR) vision loss was -6.8 (-19.9, -0.0) letters. Taking the best VA at either 3 or 6 months after AE resolution (or stability for occlusive events), VA decreased by ≥ 5 letters compared with prior to the AE in 3 (14%) of the 22 affected eyes, and was preserved (< 5-letter loss) in 18 (82%) eyes. CONCLUSIONS: In this real-world study, most IOI-related AEs occurred early after brolucizumab treatment initiation. With appropriate monitoring and management of IOI-related AEs, vision loss associated with brolucizumab may be limited.