Safety Outcomes of Brolucizumab in Neovascular Age-Related Macular Degeneration

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

doi:10.1001/jamaophthalmol.2021.4585

Cited by 82 publications

(102 citation statements)

References 22 publications

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“…The most dreaded manifestation of brolucizumab-associated inflammation is an occlusive retinal vasculitis leading to severe vision loss. 18 The American Society of Retina Specialists Research and Safety in Therapeutics Committee reported that 92% of retinal vasculitis cases after brolucizumab administration were associated with other signs of intraocular inflammation. 19 We observed inflammation in a total of 11 of 51 eyes (22%), including retinal vasculitis in 1 eye.…”

Section: Discussionmentioning

confidence: 99%

Short-Term Outcomes After Interim Treatment With Brolucizumab

Awh¹,

Davis²,

Thomas

et al. 2022

Retina

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Purpose: To examine outcomes of eyes with neovascular age-related macular degeneration that were switched to brolucizumab because of an unsatisfactory response to bevacizumab, ranibizumab, and/or aflibercept and then switched back because of the presence or risk of intraocular inflammation.Methods: Retrospective case series of 51 eyes. Visual acuity and retinal anatomy on optical coherence tomography were recorded at the first brolucizumab injection (T1), the final brolucizumab injection (T2), and 6 months following the final brolucizumab injection (T3).Results: At T2, 41 eyes (41/51%, 80%) had decreased subretinal fluid (31 eyes), intraretinal fluid (12 eyes), or pigment epithelial detachment height (12 eyes). At T3, decreased subretinal fluid was sustained in 17 eyes (17/31%, 55%), decreased intraretinal fluid was sustained in eight eyes (8/12%, 67%), and decreased pigment epithelial detachment height was sustained in eight eyes (8/12%, 67%). Mean logarithm of the minimum angle of resolution visual acuity at T1, T2, and T3 was 0.396 (20/50), 0.441 (20/ 55), and 0.468 (20/59), respectively. During the brolucizumab treatment period, 11 eyes (11/51%, 22%) developed intraocular inflammation, including one case of retinal vasculitis.Conclusion: Interim treatment with brolucizumab resulted in anatomical improvements in 41 eyes (41/51%, 80%) that were maintained in 22 of these eyes (22/41%, 54%) for at least 6 months after switching back to the original anti-vascular endothelial growth factor therapeutic. There were no corresponding significant changes in visual acuity.

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Section: Discussionmentioning

confidence: 99%

Short-Term Outcomes After Interim Treatment With Brolucizumab

Awh¹,

Davis²,

Thomas

et al. 2022

Retina

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“…Following its commercial release in 2019, a number of reports of IOI and occlusive retinal vasculitis (RV) surfaced. The incidence (2.4% for both 21 ) and severity (mean of 20/243 visual acuity at final follow up 22 ) of RV in particular represented a new complication that had not previously been observed. Most cases occurred in the first 6 months of treatment and involved the arteries (91%) 22 .…”

mentioning

confidence: 89%

Anti‐vascular endothelial growth factor for neovascular age‐related macular degeneration in 2022: Same, same but different

Fung

2022

Clinical Exper Ophthalmology

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“…A recent cohort study of patients from the Intelligent Research in Sight (IRIS) Registry (US eye disease database) and Komodo Healthcare Map (US claims database) has examined real-world evidence of IOI, including retinal vasculitis (RV) and/or retinal vascular occlusion (RO) in patients with nAMD who received brolucizumab treatment between October 8, 2019, and June 5, 2020 [ 52 ]. The analysis include over 21,000 treated eyes, with the majority being switched from another anti-VEGF therapy [ 52 ]. In this cohort analysis, the overall incidence of IOI and/or RO was 2.4% in each registry.…”

Section: Risk Vs Benefit Considerationsmentioning

confidence: 99%

“…In this cohort analysis, the overall incidence of IOI and/or RO was 2.4% in each registry. Also of note is that patients with a history of IOI and/or RO in the preceding 12 months 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) [ 52 ]. However, due to the nature of the design of the studies, there are limitations to using the analysis of the risk factors as predictors of the rates of IOI and/or RO events [ 32 , 52 ].…”

Section: Risk Vs Benefit Considerationsmentioning

confidence: 99%

The changing landscape for the management of patients with neovascular AMD: brolucizumab in clinical practice

Pearce

Amoaku

Bailey

et al. 2022

Eye

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Untreated neovascular age-related macular degeneration (nAMD) can lead to severe and permanent visual impairment. The chronic nature of the disease can have a significant impact on patients’ quality of life and an economic and time burden on medical retina (MR) services, with the care need outweighing the growth of resources that clinical services can access. The introduction of a new treatment into clinical services can be challenging, especially for services that are already under capacity constraints. Guidance for practical implementation is therefore helpful. Roundtable meetings, facilitated by Novartis UK, between a working group of MR experts with experience of leading and managing NHS retinal services in the intravitreal era were conducted between 2020 and 2021. These meetings explored various aspects and challenges of introducing a new anti-vascular endothelial growth factor (VEGF) therapy to the UK medical retina services. Provision of clear expert recommendations and practical guidance nationally, that can be adapted locally as required to support clinicians and healthcare professionals (HCPs), is valuable in supporting the introduction of a new anti-VEGF therapy within the NHS environment. The experts provide ophthalmologic HCPs with a collation of insights and recommendations to support the introduction and delivery of brolucizumab in their local service in the face of current and projected growth in demand for retina care.

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Safety Outcomes of Brolucizumab in Neovascular Age-Related Macular Degeneration

Cited by 82 publications

References 22 publications

Short-Term Outcomes After Interim Treatment With Brolucizumab

Short-Term Outcomes After Interim Treatment With Brolucizumab

Anti‐vascular endothelial growth factor for neovascular age‐related macular degeneration in 2022: Same, same but different

The changing landscape for the management of patients with neovascular AMD: brolucizumab in clinical practice

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