Safety outcomes of brolucizumab in neovascular age-related macular degeneration
JAMA — Khanani AM, Zarbin MA, Barakat MR, et al. | January 24, 2022
In patients with neovascular age-related macular degeneration (AMD) treated with brolucizumab, the incidence rate for any form of intraocular inflammation (IOI) and/or retinal vascular occlusion (RO) was about 2.4% in this study. A history of IOI and/or RO was identified to be a main risk factor for IOI and/or RO following brolucizumab treatment initiation. These early results explore potential risk factors for inflammation-linked adverse events that could develop after real-world treatment with brolucizumab.
In this cohort study, the incidence rates and risk factors for IOI and/or RO post-brolucizumab treatment were assessed in patients with neovascular AMD treated with brolucizumab.
From the Intelligent Research in Sight (IRIS) Registry and Komodo Health database, a total of 10,654 and 11,161 eyes were included, respectively, with median follow-up times of 97 and 95 days.
Overall incidence of IOI and/or RO was estimated to be 2.4% and 2.4% for the IRIS and Komodo groups, respectively, and retinal vasculitis and/or RO, 0.6% (59 of 10,654 eyes and 63 of 11,161 eyes), respectively.
An elevated risk rate (8.7% and 10.6%) for an IOI and/or RO event in the 6 months after the first brolucizumab treatment was observed in patients with a history of IOI and/or RO in the 12 months before brolucizumab initiation, vs patients without prior IOI and/or RO (2.0% in both data sets).
Women were found to have an increased estimated incidence rate (2.9% and 3.0%) vs men (1.3% and 1.4%), but this risk was not as large as that of a prior IOI and/or RO.