Efficacy and safety of brolucizumab in age-related macular degeneration: A systematic review of real-world studies.

Abstract

Intravitreally injected anti-vascular endothelial growth factor (anti-VEGF) agents are first-line treatment for neovascular age-related macular degeneration (nAMD). Phase 3 trials demonstrated non-inferiority of anti-VEGF therapy with brolucizumab compared with aflibercept in best corrected visual acuity (BCVA) gains, with superior anatomical outcomes after brolucizumab. The purpose of the review was to summarize real-world efficacy and safety data on brolucizumab in patients with nAMD. The review protocol was registered with PROSPERO (ID: CRD42021290530). We conducted systematic searches in Embase, Medline and key ophthalmology congress websites (19 October 2021). Original reports of efficacy and/or safety in patients receiving brolucizumab to treat nAMD in clinical practice were eligible. The descriptive summary includes reports describing at least 10 brolucizumab-treated eyes. In total, 2907 brolucizumab-treated eyes from 26 studies were included. Outcomes were available for treatment-naive eyes (six studies), eyes switched to brolucizumab from other anti-VEGFs (16 studies), and/or treatment-naive and switch eyes combined (eight studies). Follow-up time points ranged from 4 weeks to 1 year post-brolucizumab initiation. For BCVA, significant improvements compared with brolucizumab initiation were reported in four of six studies in treatment-naive eyes (mean BCVA improvement, range: +3.7 to +11.9 Early Treatment Diabetic Retinopathy Study [ETDRS] letters) and in three of 12 studies in switch eyes (range: +9.0 to +15 ETDRS letters) (all p < 0.05); remaining studies reported no significant post-brolucizumab BCVA changes. For central subfield thickness (CST), improvements post-brolucizumab initiation were reported in all six studies in treatment-naive eyes (mean CST improvement, range: -113.4 to -150.1 μm) and in eight of 11 studies in switch eyes (range: -26 to -185.7 μm) (all p < 0.05). The 14 studies reporting on intraretinal, subretinal and/or total fluid observed improvements post-brolucizumab initiation. The four studies comparing treatment intervals observed extension of the interval between injections after switching to brolucizumab from other anti-VEGFs. Incidence of intraocular inflammation ranged from 0% to 19%. In conclusion, real-world efficacy and safety data concur with brolucizumab pivotal trials. Additionally, reduction of disease activity in anti-VEGF switch eyes was demonstrated by fluid reduction and/or visual acuity gain, along with prolongation of the interval between injections.

• Authors: Caroline R Baumal, Torben Lykke Sørensen, Helene Karcher, Rita L Freitas, Anja Becher, Sébastien Balez, Andreas Clemens, Michael Singer, Laurent Kodjikian
• Journal: Acta ophthalmologica (Acta Ophthalmol) Vol. 101 Issue 2 Pg. 123-139 (Mar 2023) ISSN: 1755-3768 [Electronic] England
• PMID: 36117281 (Publication Type: Systematic Review, Journal Article, Review)
• Copyright: © 2022 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.

Chemical References

• brolucizumab
• Ranibizumab
• Angiogenesis Inhibitors
• Vascular Endothelial Growth Factor A
• Receptors, Vascular Endothelial Growth Factor
• Recombinant Fusion Proteins

Topics

• Humans
• Ranibizumab (therapeutic use)
• Angiogenesis Inhibitors (therapeutic use)
• Vascular Endothelial Growth Factor A
• Intravitreal Injections
• Macular Degeneration (drug therapy)
• Receptors, Vascular Endothelial Growth Factor (therapeutic use)
• Diabetic Retinopathy (drug therapy)
• Recombinant Fusion Proteins (therapeutic use)
• Wet Macular Degeneration (diagnosis, drug therapy)