Evidence mapPaperPMID 38520643Full record

ArticleOphthalmology and therapy2024

Real-World Safety Outcomes with Brolucizumab in Neovascular Age-Related Macular Degeneration: Findings from the IRIS® Registry.

Marco A Zarbin, Mathew W MacCumber, Helene Karcher, Eser Adiguzel, Andrew Mayhook, Andrew LaPrise, Ver L Bilano, Franklin Igwe, Michael S Ip, Charles C Wykoff

Open access · goldAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
9.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 18 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 8 institutions in 3 countries.

Marco A ZarbinDepartment of Ophthalmology and Visual Science, Rutgers New Jersey Medical School, Rutgers University, 90 Bergen Street, Room 6155, Newark, NJ, 07103, USA. zarbin@njms.rutgers.edu.
Mathew W MacCumberDepartment of Ophthalmology, Rush University Medical Center, Chicago, IL, USA.
Helene KarcherNovartis Pharma AG, Basel, Switzerland.
Eser AdiguzelNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Andrew MayhookOxford PharmaGenesis, Oxford, UK.
Andrew LaPriseVerana Health, Inc., San Francisco, CA, USA.
Ver L BilanoNovartis Pharmaceuticals UK Ltd, London, UK.
Franklin IgweNovartis Pharma AG, Basel, Switzerland.
Michael S IpDoheny Eye Institute, University of California, Los Angeles, CA, USA.
Charles C WykoffRetina Consultants of Texas, Houston, TX, USA.
Novartis (Switzerland) · CHIllinois Retina Associates · USMethodist Hospital · USNovartis (United Kingdom) · GBNovartis (United States) · USOxford Instruments (United Kingdom) · GBRutgers, The State University of New Jersey · USUniversity of California, Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTo assess real-world safety outcomes for adults with neovascular age-related macular degeneration (nAMD) treated with brolucizumab from the US-based IRIS® (Intelligent Research in Sight) Registry.

methodsIn this retrospective study, 18,312 eyes (15,998 patients) treated with ≥ 1 intravitreal brolucizumab injections between 8 October 2019 (US launch date for brolucizumab) and 7 October 2021 were followed up for ≤ 2 years after first injection (index date). The study assessed the predefined incident ocular adverse events of intraocular inflammation (IOI), retinal vasculitis (RV), and retinal vascular occlusion (RO).

resultsOverall, 614/18,312 eyes (3.4%) experienced any IOI, RV, and/or RO event. Median (interquartile range [IQR]) time to an event was 84 (42-167) days; 77.4% of events (475/614) occurred within 6 months after index date. Median (IQR) number of brolucizumab injections before an event was 2 (1-4). For eyes with an adverse event and visual acuity (VA) data (n = 406), median (IQR) change in Early Treatment of Diabetic Retinopathy Study (ETDRS) letters from pre-event VA was 0 (- 7 to + 5) at the 6-month follow-up; 50 eyes (12.3%) had a VA loss of 10 or more ETDRS letters. Risk of an event (hazard ratio [95% confidence interval]) was decreased in eyes from male patients (0.61 [0.53-0.71]), from older patients (0.83 [0.76-0.90]), from treatment-naive patients (0.51 [0.38-0.69]), and from patients who started brolucizumab in the second year after launch (0.68 [0.53-0.86] vs. first year).

conclusionIn this large real-world brolucizumab safety study, 3.4% of eyes experienced an IOI, RV, and/or RO event. Among eyes that experienced an adverse event for which VA data were available, median ETDRS vision change was 0 letters (IQR - 7 to + 5).

Indexed as

Anti-vascular endothelial growth factor therapyBrolucizumabIntraocular inflammationNeovascular age-related macular degenerationReal-world evidence

Identifiers

PMID38520643
PMCPMC11039576
OpenAlexW4393118862

What Socratic holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.