Abstract
Purpose :
Uncertainty exists regarding the safety of intravitreal brolucizumab (IVB) in patients with nAMD post hoc clinical trials. We performed a retrospective clinical analysis to investigate the relative risk of adverse events and adjunctive treatment costs in a year-long cohort study designed to analyze pre-treated anti-VEGF eyes that converted to IVB.
Methods :
We performed a chart review of 144 patients (64 male, mean age 77.6±11.8) who received treatment between 10/1/2019-12/4/2020. Qualifying criteria were: IVB initiated between 11/2019-4/2020 and previous anti-VEGF treatment. Random selection of 155 patients (mean age 82.14 ± 9.8) treated with intravitreal aflibercept (IVA) for nAMD at the same institution in this time period was used for comparison. Patients underwent eye exams aided by optical coherence tomography. Additional diagnostics were given upon clinical judgment. Adverse events were classified as Uveitis, Retinal Artery Occlusion (RAO), or Anterior chamber inflammation (ACI). Number of follow-ups and associated healthcare expenditures were used to assess costs. Key outcome measure for safety evaluation was best-corrected visual acuity (BCVA).
Results :
Total of 16 eyes (11.1%) with IVB had adverse events versus 1 uveitis case in the IVA group (0.64%). Eyes that switched to IVB were significant for higher inflammatory rates (p< 0.0001) with relative risk of 17.2 compared to IVA. Of the IVB events, 4.9% were Uveitis, 2.8% RAO, and 4.2% ACI. Mean baseline ETDRS letters was 52.58 vs 45.37 at the last examination with an overall decreased BCVA (-7.20 ETDRS). BCVA ± 2 lines were maintained in 68.8% of patients at the last exam. Total treatment costs were $14,128 to $1,336 in IVA. On average, the adjunct cost was $883 per patient on IVB.
Conclusions :
Use of IVB was significant for increased risks versus IVA in eyes with prior anti-VEGF. With $883 per event added to the marketed q12W cost, IVB is still cost efficient by $3237 versus an q8W IVA regimen in 1 year. While lower costs make IVB an attractive alternative for nAMD treatment, increased risks compounded by higher individual treatment costs is dramatic compared to IVA. Additional follow-ups with potential irreversible vision loss increase patient burden and warrant extra caution with IVB use. Prospective study >1 year would aid this evaluation.
This is a 2021 ARVO Annual Meeting abstract.