ABSTRACT
INTRODUCTION: To assess real-world safety outcomes for adults with neovascular age-related macular degeneration (nAMD) treated with brolucizumab from the US-based IRIS® (Intelligent Research in Sight) Registry. METHODS: In this retrospective study, 18,312 eyes (15,998 patients) treated with ≥ 1 intravitreal brolucizumab injections between 8 October 2019 (US launch date for brolucizumab) and 7 October 2021 were followed up for ≤ 2 years after first injection (index date). The study assessed the predefined incident ocular adverse events of intraocular inflammation (IOI), retinal vasculitis (RV), and retinal vascular occlusion (RO). RESULTS: Overall, 614/18,312 eyes (3.4%) experienced any IOI, RV, and/or RO event. Median (interquartile range [IQR]) time to an event was 84 (42-167) days; 77.4% of events (475/614) occurred within 6 months after index date. Median (IQR) number of brolucizumab injections before an event was 2 (1-4). For eyes with an adverse event and visual acuity (VA) data (n = 406), median (IQR) change in Early Treatment of Diabetic Retinopathy Study (ETDRS) letters from pre-event VA was 0 (- 7 to + 5) at the 6-month follow-up; 50 eyes (12.3%) had a VA loss of 10 or more ETDRS letters. Risk of an event (hazard ratio [95% confidence interval]) was decreased in eyes from male patients (0.61 [0.53-0.71]), from older patients (0.83 [0.76-0.90]), from treatment-naive patients (0.51 [0.38-0.69]), and from patients who started brolucizumab in the second year after launch (0.68 [0.53-0.86] vs. first year). CONCLUSION: In this large real-world brolucizumab safety study, 3.4% of eyes experienced an IOI, RV, and/or RO event. Among eyes that experienced an adverse event for which VA data were available, median ETDRS vision change was 0 letters (IQR - 7 to + 5).
ABSTRACT
Background: Patients with COPD often develop other morbidities, suggesting a systemic component to this disease. This retrospective non-interventional cohort study investigated relationships between multimorbidities in COPD and their impact on COPD exacerbations and COPD-related healthcare resource utilization (HCRU) using real-world evidence from Optum's de-identified Clinformatics® Data Mart Database. Methods: Demographic and clinical characteristics were assessed. Overall comorbidity burden and proportion of individuals with gastroesophageal reflux disease (GERD), diabetes or osteoporosis/osteopenia were compared in age-matched COPD versus non-COPD cohorts using descriptive statistics. COPD exacerbations and COPD-related HCRU (hospitalizations and emergency room visits) were compared between age-matched cohorts of COPD patients with and without specific common morbidities (GERD, diabetes and osteoporosis/osteopenia). Additional weight-matching was performed for matched cohorts of COPD patients with and without diabetes, and with and without osteoporosis/osteopenia. Follow-up period was five years. Results: Age-matched cohorts with and without COPD each comprised 158,106 patients. Morbidities were more common in the COPD cohort than the cohort without COPD (GERD: 44.9% vs 27.8%; diabetes: 40.8% vs 31.1%; osteoporosis/osteopenia: 18.8% vs 14.1%, respectively). Compared with matched cohorts with COPD only, cohorts of COPD patients with either GERD, diabetes or osteoporosis/osteopenia, experienced increased risk of severe exacerbations (odds ratio [OR]=1.819, OR=1.119 and OR=1.373, respectively), moderate exacerbations (OR=1.699, OR=1.102 and OR=1.322, respectively) or any exacerbations OR=1.848, OR=1.099 and OR=1.384, respectively, p<0.001 for all comparisons and increased risk of COPD-related HCRU (ER visits: OR=1.983, OR=1.098 and OR=1.343, respectively; Hospitalization visits: OR=2.222, OR=1.26 and OR=1.368, respectively; p<0.001 for all comparisons). Conclusion: These real-world data confirm that GERD, diabetes, and osteoporosis are common morbidities in patients with COPD and, moreover, that they affect frequency of exacerbation and HCRU. Determining and addressing the mechanisms behind the systemic effects of COPD may be beneficial for COPD patients and may also help reduce COPD exacerbations.