Biomarkers in Early Response to Brolucizumab on Pigment Epithelium Detachment Associated with Exudative Age-Related Macular Degeneration

Rispoli, Marco; Eandi, Chiara M; Antonio, Luca Di; Kilian, Raphael; Montesel, Andrea; Savastano, Maria Cristina

doi:10.3390/biomedicines9060668

Cited by 17 publications

(31 citation statements)

References 49 publications

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“…From the 45 real-world studies (50 reports) for inclusion, 26 studies (31 reports) described at least 10 brolucizumab-treated eyes, and are thus included in the main descriptive summary (Tables 1-3; Tables S1-S3) (Abdin et al, 2021;Aziz et al, 2021;Baumal et al, 2020;Bilgic, Kodjikian, March de Ribot, et al, 2021;Bilgic, Kodjikian, Srivastava, et al, 2021;Book et al, 2022;Bulirsch et al, 2022;Chakraborty et al, 2021;Cristian et al, 2021;Enríquez et al, 2021;Fossataro et al, 2021;Fukuda et al, 2021;Haensli et al, 2021aHaensli et al, , 2021bHamou et al, 2021;Hussain, 2021;Kilani et al, 2021;Maruko et al, 2021;Matsumoto et al, 2021;Montesel et al, 2021;Rave et al, 2021;Reyes-Capo et al, 2021;Rispoli et al, 2021;Sharma, Kumar, et al, 2021;Sharma, Rave, et al, 2021;Sudhalkar et al, 2021;Walter & Saba, 2021aWitkin et al, 2020Witkin et al, , 2021. A further 19 studies (19 reports) describing fewer than 10 brolucizumab-treated eyes are included in Table S4.…”

Section: Search Resultsmentioning

confidence: 99%

“…Information was limited as to how events were defined and how patients were monitored during follow-up. Six studies reported no adverse events occurring during follow-up (Bilgic, Kodjikian, Srivastava, et al, 2021;Fossataro et al, 2021;Hussain, 2021;Reyes-Capo et al, 2021;Rispoli et al, 2021;Sharma, Kumar, et al, 2021). For three studies, ocular adverse events were an inclusion criterion (Baumal et al, 2020;Witkin et al, 2020Witkin et al, , 2021.…”

Section: Safety Outcomesmentioning

confidence: 99%

See 1 more Smart Citation

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

Baumal

Sørensen

Karcher

et al. 2022

Acta Ophthalmologica

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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 EarlyTreatment 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.

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Section: Search Resultsmentioning

confidence: 99%

Section: Safety Outcomesmentioning

confidence: 99%

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

Baumal

Sørensen

Karcher

et al. 2022

Acta Ophthalmologica

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“…The response at 1 month after brolucizumab treatment is important to predict the prognosis. A previous study of exudative AMD reported that the PED height was significantly reduced within 1 month after the first brolucizumab injection [27]. It is speculated that one month could be enough to see the responsiveness of brolucizumab.…”

Section: Discussionmentioning

confidence: 95%

Response to brolucizumab treatment for refractory serous pigment epithelial detachment secondary to polypoidal choroidal vasculopathy

et al. 2022

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Purpose To report the efficacy and safety of brolucizumab in the treatment of refractory serous pigment epithelial detachment (PED) secondary to polypoidal choroidal vasculopathy (PCV). Methods Twenty-six eyes of 26 patients were included. Intravitreal brolucizumab 6.0 mg was administered, followed by pro re nata (PRN) retreatment at monthly follow-ups. All patients underwent spectralis domain optical coherence tomography (SD-OCT), fluorescein angiography, and indocyanine green angiography before the first brolucizumab injection. SD-OCT was repeated at follow-up visits. The height and width of the serous PEDs, measured using SD-OCT, were analyzed. Results The number of previous anti-VEGF injections was 12.3 ± 15.0. During brolucizumab treatment, anatomical improvement was achieved and maintained in the height and width of the PEDs (p < 0.05). However, the visual outcome did not improve significantly (p > 0.05). A good response was achieved in 69.2% of eyes at 1 month and at the last visit. Relapse and complete resolution were observed in 27.8 and 23.1% of patients, respectively. The number of brolucizumab injections was 2.00 ± 0.85. Intraocular inflammation, vascular obstruction, and retinal pigment epithelial tears were not observed. Conclusion Intravitreal brolucizumab may be an effective and safe treatment option for refractory serous PEDs in patients with PCV.

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“…Brolucizumab, an anti-vascular endothelial growth factor (anti-VEGF) for intravitreal injections (IVI), is the newest drug of its kind to be commercially available in the United States. [1][2][3] This drug, a humanized single-cell chain antibody fragment, constrains VEGF-A attachment to VEGFR1 and VEGFR2, two VEGF receptors. After three monthly loading IVI of both brolucizumab 6mg/0.05mL dosed at 8 or 12 weeks and aflibercept 2mg/0.05mL dosed at 8 weeks, two separate Phase III clinical trials [HAWK (NCT02307682) and HARRIER (NCT02434328)] showed that brolucizumab was non-inferior to the comparative agent in terms of visual acuity for treatment-naïve neovascular age-related macular degeneration (AMD).…”

Section: Introductionmentioning

confidence: 99%

Brolucizumab: Evaluation of Compassionate Use of a Complex Anti-VEGF Therapy

Murray¹,

Gold²,

Latiff³

et al. 2021

OPTH

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Objective: To report a consecutive series of compassionate, off-label use of intravitreal brolucizumab as a rescue therapy for complex, non-responsive macular edema. This report delineates primary diagnosis, indications for treatment, adverse events, and visual and anatomic outcomes after intravitreal brolucizumab. Methods: A retrospective review of a consecutive clinical case series of 110 eyes treated with intravitreal brolucizumab between January 1st and March 1st. 2020. All patients were included if they received intravitreal brolucizumab in an off-label delivery and had ongoing macular edema in the setting of prior, multiple intravitreal anti-VEGF and/or intravitreal triamcinolone acetonide. All patients had spectral domain OCT documented before, at the time of, and in serial follow-up after intravitreal brolucizumab. Results: Ninety-eight of 98 patients had marked decrease in macular edema. Indications for treatment were assigned to the primary etiologic diagnosis leading to the macular edema secondary to radiation retinopathy, complex epiretinal membrane, or complex diabetic retinopathy. In this series, sdOCT central point thickness decreased by an average of 71.5 microns, subretinal fluid resolved, and visual acuity was improved in 40% (greater than two Snellen lines) and stable in 60% (within two Snellen lines). No patient experienced a severe adverse event to specifically include vitritis and/or vasculitis. Conclusion:In this series, brolucizumab intravitreal injection was associated with significant improvement in macular edema in each diagnostic category. No serious complications to treatment were found in this series. Brolucizumab, though associated with known intraocular inflammation and vasculitis, demonstrated marked benefit in these complex eyes previously unresponsive to aggressive intravitreal pharmacotherapy.

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Biomarkers in Early Response to Brolucizumab on Pigment Epithelium Detachment Associated with Exudative Age-Related Macular Degeneration

Cited by 17 publications

References 49 publications

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

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

Response to brolucizumab treatment for refractory serous pigment epithelial detachment secondary to polypoidal choroidal vasculopathy

Brolucizumab: Evaluation of Compassionate Use of a Complex Anti-VEGF Therapy

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