First Year Real Life Experience With Intravitreal Brolucizumab for Treatment of Refractory Neovascular Age-Related Macular Degeneration

Abdin, Alaa Din; Al-Jundi, Wissam; Jawhari, Khalil M El; Suffo, Shady; Weinstein, Isabel; Seitz, Berthold

doi:10.3389/fphar.2022.860784

Cited by 22 publications

(25 citation statements)

References 35 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%

“…Ten of the 12 studies included statistical testing for the switch subgroups. Three studies reported significant improvements in mean BCVA in switch eyes, with improvements of +10.4 ETDRS letters (p = 0.014) in Bilgic, Kodjikian, March de Ribot, et al (2021) and +9.0 ETDRS letters (p < 0.001) in Chakraborty et al (2021), although in one study that included several follow-ups, by Abdin et al (2021), improvements were reported as significant at 16 weeks (+15 ETDRS letters, p = 0.03) but Note: All applicable information was reported when available. Empty cells containing only dashes indicate that the information was not reported or is not applicable.…”

Section: Anti-vegf Switch Eyesmentioning

confidence: 99%

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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: Anti-vegf Switch Eyesmentioning

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 majority of studies regarding real-world use of brolucizumab focused on switch therapy setting, which was not investigated in registrative trials, and reported variable results in visual outcomes [25, 27, 28, 31]. Strikingly, even in patients previously treated with other anti-VEGFs, our research highlighted an improvement in VA in a remarkable percentage of eyes (56%), with mean improvement from 41.9 ± 6.7 letters at baseline to 52.6 ± 5.3 letters ( p < 0.0001).…”

Section: Discussionmentioning

confidence: 99%

Brolucizumab for Wet Age-Related Macular Degeneration: One-Year Real-World Experience from a Tertiary Center

Scupola¹,

Carlà²,

Boselli³

et al. 2023

Ophthalmologica

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Introduction To explore the early efficacy and safety of treatment with intravitreal injections of brolucizumab in patients presenting neovascular age-related macular degeneration (nAMD) in a real-world setting. Methods This retrospective study included 194 eyes of 180 patients with nAMD treated with standard 6-mg intravitreal injections (IVTs) of brolucizumab in our clinic between 11 March 2021 and 15 June 2022. Both treatment-naive (33 eyes) and switch-therapy patients (161 eyes) were included in the study. Best corrected visual acuity (BCVA), central subfield thickness (CST), retinal fluid distribution (classified as intraretinal, IRF; subretinal, SRF; under the pigmented epithelium, sRPEF), treatment intervals and adverse event rates were collected for analysis. Results Average follow-up time was 37.2±16.6 weeks. Mean baseline BCVA were 38.1±4.5 and 41.9±6.7 letters in the treatment-naive and switch-therapy groups, with a final gain of 16.0±4.9 (p<0.0001) and 10.7±5.9 (p<0.0001) letters in the two groups, respectively. Throughout the study period, CST significantly decreased in both treatment-naïve (from 352.0±129.4 to 284.2±93.8 µm; p=0.0015) and switch-therapy (from 369.9±140.5 to 307.4±123.5 µm; p<0.0001). Significant fluid control rates were achieved at the end of the study period (45% and 27% eyes were completely free-of-fluid in naïve and switch groups, respectively). Five eyes (2.6%) developed adverse events with different grades of intraocular inflammation (IOI) and visual outcomes. Conclusion Brolucizumab IVTs showed a very good anatomical and functional outcomes in both naive and switch patients in this real-world experience. Nevertheless, even showing a favorable risk/benefit profile, clinicians should be aware of the possibility of a small rate of complications.

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“…Zubricky et al concluded that previously treated patients switching to brolucizumab were able to extend their intervals by approximately 4 weeks [12]. Abdin et al showed that patients with refractory nAMD who switched to brolucizumab reduced their annual injection number per eye by three injections in a small sample (n = 21 eyes) which further indicates interval extensions with brolucizumab [21]. Therefore, clinical trials and results from other real-world evidence studies indicate that results seen in REALIZE may be attributable to a better fluid response to brolucizumab compared to other anti-VEGF drugs [14,15].…”

Section: Discussionmentioning

confidence: 99%

The Treatment Patterns with Brolucizumab in Germany (REALIZE) Study: A Retrospective Cohort Study Based on Longitudinal Prescription Data

et al. 2022

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Introduction: This study describes real-world treatment patterns in Germany for brolucizumab, an anti-vascular endothelial growth factor (anti-VEGF) therapy for neovascular agerelated macular degeneration (nAMD). Methods: This single-arm retrospective cohort study used German patient-level prescription data. Patients aged C 50 years, who received C 1 brolucizumab prescription in one eye only (unilateral) and had a minimum of 12 months follow-up were included. Three cohorts were defined from the overall population: anti-VEGF treatment-naive patients (''treatment-naive''); anti-VEGF treatment-experienced patients (''treatment-experienced''); and of the treatment-experienced cohort, patients persistent on brolucizumab for 12 months (''treatment-experienced persistent''), i.e. who received C 2 brolucizumab injections and did not discontinue or use other anti-VEGF agents in that period. Descriptive statistics were used to analyse patient characteristics and injection intervals.Results: A total of 2089 patients with at least 12 months follow-up and one brolucizumab injection were analysed. Most were female (58.1%), aged 80? years (54.7%). A total of 539 (25.8%) were treatment-naive, 1550 (74.2%) treatment-experienced and, of those, 787 (50.8%) were persistent. Overall, the median (interquartile range, IQR) number of brolucizumab injections during the 12 months follow-up was 5.0 (3.0-8.0). In the treatment-naive and treatment-experienced sub-cohorts it was 5.0 (3.0-8.0) and 5.0 (3.0-9.0) injections, respectively. In the treatment-experienced persistent cohort the median (IQR) number of injections was 8.0 (5.0-10.0). In this same cohort, the median (IQR) treatment interval between anti-VEGF injections before switch to brolucizumab was 5.1 (4.0-8.0) weeks, whilst the brolucizumab interval at 12 months after switch was 8.0 (6.0-11.9) weeks. Of treatmentexperienced patients, 67% extended their treatment interval and those with pre-switch intervals less than 6 weeks (\ q6w), in

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First Year Real Life Experience With Intravitreal Brolucizumab for Treatment of Refractory Neovascular Age-Related Macular Degeneration

Cited by 22 publications

References 35 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

Brolucizumab for Wet Age-Related Macular Degeneration: One-Year Real-World Experience from a Tertiary Center

The Treatment Patterns with Brolucizumab in Germany (REALIZE) Study: A Retrospective Cohort Study Based on Longitudinal Prescription Data

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