Brolucizumab—early real-world experience: BREW study

Sharma, Ashish; Kumar, Nilesh; Parachuri, Nikulaa; Sadda, Srinivas R; Corradetti, Giulia; Heier, Jeffrey S.; Chin, Adam T; Boyer, David S.; Dayani, Pouya N.; Arepalli, Sruthi; Kaiser, Peter K.

doi:10.1038/s41433-020-1111-x

Cited by 60 publications

(93 citation statements)

References 5 publications

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“…However, only limited data of its use in a real-world setting are available to date. 16 17 20-22 Herein, we report early experiences with brolucizumab use in clinical routine in a single centre in Europe following approval in February 2020 (SHIFT study). Our findings indicate that initiation of intravitreal brolucizumab therapy in previously treated patients with nAMD (switch) may be an option in particular with regard to the morphological effects in recalcitrant cases who previously received multiple anti-VEGF injections without satisfactory resolution of fluid in various anatomical compartments.…”

Section: Discussionmentioning

confidence: 99%

“…During the entire observation period, patients treated with brolucizumab were seen across a mean follow-up of 16…”

Section: Study Cohortmentioning

confidence: 99%

“…Regarding the time of IOI development, four patients developed signs of IOI after the first brolucizumab injection with occurrence of first symptoms after a mean of 19.0±6.5 (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25) days. Medical attention was sought after a mean of 23.8±6.4 (13-29) days after injection.…”

Section: Adverse Eventsmentioning

confidence: 99%

“…13 Post hoc analyses demonstrated overall favourable anatomical effects. [16][17][18] However, safety signals have been reported in both RCTs and postmarketing reports, which included the occurrence of intraocular inflammation (IOI) and retinal vasculitis with or without occlusion. 13 18-25 The aim of the SHIFT study was to report early real-world experiences in a single European clinical centre of brolucizumab treatment for nAMD with regard to both functional and anatomical disease control as well as adverse effects following approval in February 2020 in Europe.…”

Section: Introductionmentioning

confidence: 99%

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Short-term real-world outcomes following intravitreal brolucizumab for neovascular AMD: SHIFT study

et al. 2021

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BackgroundBrolucizumab has recently been approved in Europe as a novel treatment for patients with neovascular age-related macular degeneration (nAMD). We report on early experiences with real-world outcomes of switch to brolucizumab therapy in previously anti-vascular endothelial growth factor (anti-VEGF)-treated patients.MethodsPatients with recalcitrant nAMD were switched to brolucizumab therapy. Functional and structural parameters 4 weeks after first brolucizumab injection were evaluated including best-corrected visual acuity (BCVA (logMAR)), foveal centre point (FCP (µm)), central subfield retinal thickness (CSRT (µm)) and macular volume (mm³).ResultsSixty-three eyes of 57 patients with nAMD (52.6% females) with a mean (±SD) age of 79.5±6.7 years were included. Mean change of BCVA was −0.02±0.13 logMAR (p=0.322). Significant reductions were recorded for FCP with a mean (±SD) change of −66.79±72.64 µm, −66.76±60.71 µm for CSRT and −0.27±0.24 mm³ for macular volume (all p<0.001). Intraocular inflammation was observed in seven eyes of seven patients, including one case of retinal vasculitis without occlusion.ConclusionsThe results of the SHIFT study indicate that switch to brolucizumab may represent a treatment option in patients with nAMD poorly responsive to other anti-VEGF agents. Further long-term analyses appear prudent to assess efficacy and safety of brolucizumab in a routine clinical setting.

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Section: Discussionmentioning

confidence: 99%

“…During the entire observation period, patients treated with brolucizumab were seen across a mean follow-up of 16…”

Section: Study Cohortmentioning

confidence: 99%

Section: Adverse Eventsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Short-term real-world outcomes following intravitreal brolucizumab for neovascular AMD: SHIFT study

et al. 2021

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“…The hope that brolucizumab might more effectively achieve disease stability in the subset of eyes which cannot be extended to 8 or more weeks under their current anti-VEGF therapy led to switching to brolucizumab with the aim of reducing the treatment burden in many cases upon its approval. Recent studies showed a short-term reduction of foveal thickness 4–8 weeks after switching to brolucizumab in eyes with active nAMD despite the consequent anti-VEGF treatment every 4–8 weeks, indicating its superior efficacy regarding anatomic criteria [ 5 , 6 , 7 ]. Adding to this short-term experience, the aim of this study was to evaluate the functional and anatomic outcomes after switch to brolucizumab over 6 months in eyes with active nAMD under treatment intervals of ≤6 weeks with other anti-VEGF agents.…”

Section: Introductionmentioning

confidence: 99%

Switching to Brolucizumab in Neovascular Age-Related Macular Degeneration Incompletely Responsive to Ranibizumab or Aflibercept: Real-Life 6 Month Outcomes

Haensli

Pfister

Garweg

2021

JCM

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Purpose: The aim of this study was to evaluate the effect of switching treatment in eyes with neovascular age-related macular degeneration (nAMD) and treatment intervals of ≤6 weeks to brolucizumab. Methods: In this prospective series, eyes with persisting retinal fluid under aflibercept or ranibizumab every 4–6 weeks were switched to brolucizumab. Visual acuity (BCVA), reading acuity (RA), treatment intervals, central subfield thickness (CST), and the presence of intra- and subretinal fluid were recorded over 6 months. Results: Seven of 12 eyes completed the 6 month follow-up and received 4.4 ± 0.5 brolucizumab injections within 28.0 ± 2.8 weeks. Treatment intervals increased from 5.3 ± 0.9 weeks to 9.0 ± 2.8 weeks (95% confidence interval of extension (CI): 1.6 to 5.9). BCVA improved from 67.8 ± 7.2 to 72.2 ± 7.5 (95% CI: −0.3 to 9.1) ETDRS letters, RA improved from 0.48 ± 0.15 to 0.31 ± 0.17 LogRAD (95% CI: 0.03 to 0.25), and CST improved from 422.1 ± 97.3 to 353.6 ± 100.9 µm (95% CI: −19.9 to 157.1). Treatment was terminated early in five eyes (two intraocular inflammations with vascular occlusion without vision loss, one stroke, and two changes in the treatment plan). Conclusions: Improvement in visual performance and longer treatment intervals in our series over 6 months indicate the potential of brolucizumab to reduce the treatment burden in nAMD, while two instances of intraocular inflammation were encountered.

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Early Experience With Brolucizumab Treatment of Neovascular Age-Related Macular Degeneration

et al. 2021

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IMPORTANCEOutcome data are limited regarding early experience with brolucizumab, the most recently approved anti-vascular endothelial growth factor (VEGF) agent for the treatment of neovascular age-related macular degeneration (nAMD).OBJECTIVE To report clinical outcomes after intravitreous injection (IVI) of brolucizumab, 6 mg, for nAMD. DESIGN, SETTING, AND PARTICIPANTSThis retrospective case series conducted at 15 private or academic ophthalmological centers in the United States included all consecutive patients with eyes treated with brolucizumab by 6 retina specialists between October 17, 2019, and April 1, 2020. EXPOSURES Treatment with brolucizumab IVI, 6 mg. MAIN OUTCOMES AND MEASURES Change in mean visual acuity (VA) and optical coherence tomography parameters, including mean central subfield thickness and presence or absence of subretinal and/or intraretinal fluid. Secondary outcomes included ocular and systemic safety. RESULTS A total of 172 eyes from 152 patients (87 women [57.2%]; mean [SD] age, 80.0 [8.0] years) were included. Most eyes (166 [96.5%]) were not treatment naive, and 65.7% of these eyes (109 of 166) were switched from the prior anti-VEGF agent because of persistent fluid detected on optical coherence tomography scans. Study eyes received a mean (SD) of 1.46 (0.62) brolucizumab IVIs. The mean (SD) VA prior to starting brolucizumab was a 64.1 (15.9) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (Snellen equivalent, 20/50) and was a 63.3 (17.2) ETDRS letter score (Snellen equivalent, 20/63) at the last study evaluation (mean difference, 0.8; 95% CI, −2.7 to 4.3; P = .65). When analyzed by number of brolucizumab IVIs, the presence or absence of fluid prior to starting brolucizumab, or the presence or absence of intraocular inflammation after receiving brolucizumab, there was no difference in mean VA prior to starting brolucizumab compared with after brolucizumab IVIs or at the final study evaluation. The mean (SD) central subfield thickness in all eyes prior to starting brolucizumab was 296.7 (88.0) μm and was 269.8 (66.5) μm at the last study examination (mean difference, 26.9 μm; 95% CI, 9.0-44.7 μm; P = .003). Intraocular inflammation was reported in 14 eyes (8.1%) and was self-limited and resolved without treatment in almost half those eyes (n = 6). One previously reported eye (0.6%) had occlusive retinal vasculitis and severe loss of vision. CONCLUSIONS AND RELEVANCEIn this analysis of brolucizumab IVI for nAMD, VA remained stable, with a reduction in central subfield thickness. Intraocular inflammation events ranged from mild with spontaneous resolution to severe occlusive retinal vasculitis in 1 eye.

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Brolucizumab—early real-world experience: BREW study

Cited by 60 publications

References 5 publications

Short-term real-world outcomes following intravitreal brolucizumab for neovascular AMD: SHIFT study

Short-term real-world outcomes following intravitreal brolucizumab for neovascular AMD: SHIFT study

Switching to Brolucizumab in Neovascular Age-Related Macular Degeneration Incompletely Responsive to Ranibizumab or Aflibercept: Real-Life 6 Month Outcomes

Early Experience With Brolucizumab Treatment of Neovascular Age-Related Macular Degeneration

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