Safety Outcomes of Brolucizumab in Neovascular Age-Related Macular Degeneration: Results from the IRIS Registry and Komodo Healthcare Map

Arshad M. Khanani, Marco A. Zarbin, Mark R. Barakat, Thomas A. Albini, Peter K. Kaiser, B. Guruprasad, Neetu Agashivala, Justin S. Yu, Charles C. Wykoff, Mathew W. Maccumber

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2 Scopus citations

Abstract

Importance: Limited data exist on the real-world safety outcomes of patients with neovascular age-related macular degeneration treated with brolucizumab (Beovu). Objective: To determine the real-world incidence of intraocular inflammation (IOI), including retinal vasculitis (RV) and/or retinal vascular occlusion (RO), for patients with neovascular age-related macular degeneration who underwent brolucizumab treatment. Additionally, potential risk factors associated with these adverse events were evaluated. Design, Setting, and Participants: This cohort study included patients with neovascular age-related macular degeneration in the Intelligent Research in Sight (IRIS) Registry and Komodo Healthcare Map. Patients initiating and receiving 1 or more brolucizumab injections from October 8, 2019, to June 5, 2020, with up to 6 months of follow-up were included. Intervention: Brolucizumab injections. Main Outcome and Measures: Incidence of IOI (including RV) and/or RO and RV and/or RO and risk stratification for the identified risk factors. Results: Of 10654 and 11161 included eyes (from the IRIS Registry and Komodo Health database, respectively), the median follow-up times were 97 and 95 days. Most eyes switched from another anti-vascular endothelial growth factor agent (9686 of 10654 [90.9%] and 10487 of 11161 [94.0%], respectively), most commonly aflibercept (7160 of 9686 [73.9%] and 7156 of 10487 [68.2%]), and most were from women (6105 of 10654 [57.3%] and 6452 of 11161 [57.8%]). The overall incidence of IOI and/or RO was 2.4% (255 of 10654 eyes) and 2.4% (268 of 11161 eyes) for the IRIS and Komodo groups, respectively, and RV and/or RO, 0.6% (59 of 10654 eyes and 63 of 11161 eyes), respectively. Patients with a history of IOI and/or RO in the 12 months before brolucizumab initiation had an increased observed risk rate (8.7% [95% CI, 6.0%-11.4%] and 10.6% [95% CI, 7.5%-13.7%]) for an IOI and/or RO event in the 6 months following the first brolucizumab treatment compared with patients without prior IOI and/or RO (2.0% in both data sets). There was an increased estimated incidence rate in women (2.9% [95% CI, 2.5%-3.3%] and 3.0% [95% CI, 2.6%-3.4%]) compared with men (1.3% [95% CI, 1.0%-1.7%] and 1.4% [95% CI, 1.0%-1.7%]), but this risk was not as large as that of a prior IOI and/or RO. Similar findings were observed for patients with RV and/or RO events. Conclusions and Relevance: The incidence rate of IOI and/or RO was approximately 2.4%. Patient eyes with IOI and/or RO in the 12 months prior to first brolucizumab injection had the highest observed risk rate for IOI and/or RO in the early months after the first brolucizumab treatment. However, given study limitations, the identified risk factors cannot be used as predictors of IOI and/or RO events, and causality with brolucizumab cannot be assessed..

Original languageEnglish (US)
Pages (from-to)20-28
Number of pages9
JournalJAMA Ophthalmology
Volume140
Issue number1
DOIs
StatePublished - Jan 2022

ASJC Scopus subject areas

  • Ophthalmology

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