FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W3027184580> ?p ?o ?g. }

• W3027184580 endingPage "A8" @default.
• W3027184580 startingPage "A7" @default.
• W3027184580 abstract "The first reports of severe uveitis and occlusive retinal vasculitis associated with the use of brolucizumab (Beovu; Novartis, East Hanover, New Jersey, USA) appeared in early February of 2020, and more have appeared since then. Novartis sent information on the postapproval development to users on February 25 and updates have followed.1Novartis provides update on use and safety of Beovu® in patients with wet AMD.https://www.novartis.com/news/novartis-provides-update-use-and-safety-beovu-patients-wet-amdDate accessed: May 3, 2020Google Scholar Twenty-six cases associated with 70,000 injections and 37,000 treated patients were reported by March 27, 2020, in a report by the American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee.2American Society of Retina Specialists Research and Safety in Therapeutics Committee.https://www.asrs.org/about/committees/51Date: 2020Date accessed: May 3, 2020Google Scholar Although the ASRS ReST committee report was not publicly available, the American Academy of Ophthalmology (AAO) has provided an available audio report on these recent developments surrounding brolucizumab-induced inflammation.3American Academy of Ophthalmology Audio Episode 227: the ASRS ReST Report on Brolucizumab.https://www.aao.org/audio/episode-227-asrs-rest-report-on-brolucizumab-withDate: 2020Date accessed: May 3, 2020Google Scholar Neither the Novartis warning nor the latest ASRS ReST committee's report from April 7 recommended that brolucizumab injections be stopped, but they did recommend careful evaluation for inflammation and continued vigilance in monitoring brolucizumab treatment outcomes. However, for many of us, these recommendations did not go far enough, and we have stopped using brolucizumab because of the associated inflammation. Our patients have alternatives without incurring this risk. When brolucizumab became commercially available in late 2019, the retinal community was enthusiastic about this newest vascular endothelial growth factor (VEGF) inhibitor for the treatment of exudative age-related macular degeneration (eAMD). Brolucizumab offered the hope of fewer intravitreal injections for patients with eAMD.4Nguyen Q.D. Das A. Do D.V. et al.Brolucizumab: evolution through preclinical and clinical studies and the implications for the management of neovascular age-related macular degeneration.Ophthalmology. 2020; https://doi.org/10.1016/j.ophtha.2019.12.031Abstract Full Text Full Text PDF Scopus (113) Google Scholar The brolucizumab phase 3 studies suggested greater durability with similar visual acuity outcomes compared with aflibercept (Eylea; Regeneron, Tarrytown, New York, USA). Who wouldn't want fewer injections into their eye and comparable visual acuity results? With good reason, both patients and clinicians embraced this new drug. However, soon after the widespread community adoption of brolucizumab, sporadic reports began to surface that patients were experiencing severe sterile inflammation that could be difficult to distinguish from infectious endophthalmitis. Although cases of severe sterile noninfectious intraocular inflammation have been reported following the injection of other anti-VEGF drugs,5Ladas I.D. Karagiannis D.A. Rouvas A.A. Kotsolis A.I. Liotsou A. Vergados I. Safety of repeat intravitreal injections of bevacizumab versus ranibizumab: our experience after 2,000 injections.Retina. 2009; 29: 313-318Crossref PubMed Scopus (106) Google Scholar, 6Martin D.F. Maguire M.G. Ying G.S. et al.CATT Research GroupRanibizumab and bevacizumab for neovascular age-related macular degeneration.N Engl J Med. 2011; 364: 1897-1908Crossref PubMed Scopus (2228) Google Scholar, 7Martin D.F. Maguire M.G. Fine S.L. et al.Comparison of Age-related Macular Degeneration Treatments Trials Research GroupRanibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results.Ophthalmology. 2012; 119: 1388-1398Abstract Full Text Full Text PDF PubMed Scopus (1477) Google Scholar, 8Goldberg R.A. Shah C.P. Wiegand T.W. Heier J.S. Noninfectious inflammation after intravitreal injection of aflibercept: clinical characteristics and visual outcomes.Am J Ophthalmol. 2014; 158: 733-737.e1Abstract Full Text Full Text PDF PubMed Scopus (55) Google Scholar, 9Khanani A.M. Cohen G.L. Zawadzki R. A prospective masked clinical assessment of inflammation after intravitreal injection of ranibizumab or aflibercept.J Ocul Pharmacol Ther. 2016; 32: 216-218Crossref PubMed Scopus (20) Google Scholar, 10Kitchens J.W. Do D.V. Boyer D.S. et al.Comprehensive review of ocular and systemic safety events with intravitreal aflibercept injection in randomized controlled trials.Ophthalmology. 2016; 123: 1511-1520Abstract Full Text Full Text PDF PubMed Scopus (52) Google Scholar, 11Souied E.H. Dugel P.U. Ferreira A. Hashmonay R. Lu J. Kelly S.P. Severe ocular inflammation following ranibizumab or aflibercept injections for age-related macular degeneration: a retrospective claims database analysis.Ophthalmic Epidemiol. 2016; 23: 71-79Crossref PubMed Scopus (46) Google Scholar this brolucizumab-associated inflammation was unusual because it was associated with an occlusive vasculitis and irreversible severe vision loss, albeit rare.12Baumal C.R. Spaide R.F. Vajzovic L. et al.Retinal vasculitis and intraocular inflammation after intravitreal injection of brolucizumab.Ophthalmology. 2020; https://doi.org/10.1016/j.ophtha.2020.04.017Abstract Full Text Full Text PDF Scopus (163) Google Scholar, 13Haug S.J. Hien D.L. Uludag G. et al.Retinal arterial occlusive vasculitis following intravitreal brolucizumab administration.Am J Ophthalmol Case Rep. 2020; 18: 100680Crossref PubMed Scopus (93) Google Scholar, 14Jain A. Chea S. Matsumiya W. et al.Severe vision loss secondary to retinal arteriolar occlusions after multiple intravitreal brolucizumab administrations.Am J Ophthalmol Case Rep. 2020; 18: 100687Crossref PubMed Scopus (73) Google Scholar This unpredictable severe inflammation could develop weeks after the last brolucizumab injection even if previous injections of brolucizumab were well tolerated, so previous brolucizumab injections without inflammation were no guarantee that subsequent injections would be safe.12Baumal C.R. Spaide R.F. Vajzovic L. et al.Retinal vasculitis and intraocular inflammation after intravitreal injection of brolucizumab.Ophthalmology. 2020; https://doi.org/10.1016/j.ophtha.2020.04.017Abstract Full Text Full Text PDF Scopus (163) Google Scholar, 13Haug S.J. Hien D.L. Uludag G. et al.Retinal arterial occlusive vasculitis following intravitreal brolucizumab administration.Am J Ophthalmol Case Rep. 2020; 18: 100680Crossref PubMed Scopus (93) Google Scholar, 14Jain A. Chea S. Matsumiya W. et al.Severe vision loss secondary to retinal arteriolar occlusions after multiple intravitreal brolucizumab administrations.Am J Ophthalmol Case Rep. 2020; 18: 100687Crossref PubMed Scopus (73) Google Scholar The retinal community had not reported this type of vision-threatening occlusive retinal vasculitis after intravitreal injections of other commonly used anti-VEGF drugs, such as aflibercept, bevacizumab (Avastin; Genentech, South San Francisco, California, USA), and ranibizumab (Lucentis; Genentech). Retinal specialists started sharing this brolucizumab information with each other through social media, at meetings, and through published reports.12Baumal C.R. Spaide R.F. Vajzovic L. et al.Retinal vasculitis and intraocular inflammation after intravitreal injection of brolucizumab.Ophthalmology. 2020; https://doi.org/10.1016/j.ophtha.2020.04.017Abstract Full Text Full Text PDF Scopus (163) Google Scholar, 13Haug S.J. Hien D.L. Uludag G. et al.Retinal arterial occlusive vasculitis following intravitreal brolucizumab administration.Am J Ophthalmol Case Rep. 2020; 18: 100680Crossref PubMed Scopus (93) Google Scholar, 14Jain A. Chea S. Matsumiya W. et al.Severe vision loss secondary to retinal arteriolar occlusions after multiple intravitreal brolucizumab administrations.Am J Ophthalmol Case Rep. 2020; 18: 100687Crossref PubMed Scopus (73) Google Scholar Unlike our previous experience with inflammatory outbreaks when using other anti-VEGF drugs, there had been no previous history of safe routine clinical use of brolucizumab before these reports of inflammation surfaced, so one of our initial impressions of this drug was one of heightened concern. Retina specialists deserve credit for identifying this problem early and notifying the appropriate authorities. They alerted Novartis, their specialty societies, and the Food and Drug Administration (FDA). As a result, both the ASRS and Novartis established committees to investigate this brolucizumab-induced inflammation. Novartis has willingly refunded the cost of any previously purchased brolucizumab to retina practices. However, brolucizumab remains on the market and continues to be used with the cautious approval of both the ASRS and Novartis. Amid mounting speculation as to the underlying cause of this brolucizumab-associated inflammation, we all want the investigations to continue so we can learn the truth behind these adverse events. Whatever is learned from these ongoing investigations will provide invaluable information for anyone developing an agent for injection into the eye. But as this process plays out, it is our view that intravitreal injections of brolucizumab should stop. Brolucizumab is not the only drug that can be used for the treatment of eAMD. In the face of the known risk, its use is unwarranted. We praise the postmarketing surveillance of the vitreoretinal community in identifying these never-events, but now we need the ASRS, the Retina Society, the Macular Society, the AAO, and the FDA to make official what many retina specialists have already implemented—a moratorium on its use until the results of further investigations are concluded and remedies are implemented. Brolucizumab could fly again, but not until these safety concerns are addressed. Funding/Support: No funding or grant support. Financial Disclosures: Philip Rosenfeld receives research support from Carl Zeiss Meditec, Inc, and Stealth BioTherapeutics. He is also a consultant for Apellis, Biogen, Boehringer-Ingelheim, Carl Zeiss Meditec, Chengdu Kanghong Biotech, EyePoint, Ocunexus Therapeutics, Ocudyne, and Unity Biotechnology. Philip Rosenfeld has equity interest in Apellis, Valitor, Verana Health, and Ocudyne. David Browning receives research support from the DRCR Retina.net and Regeneron. He has an equity interest in Zeiss-Meditec. He receives royalties from Springer Inc. Prashanth Iyer, MD provided valuable background research support for this Editorial. All authors attest that they meet the current ICMJE criteria for authorship. Comment on: Is this a 737 Max Moment for BrolucizumabAmerican Journal of OphthalmologyVol. 223PreviewWe read with interest the editorial titled “Is this a 737 Max Moment for Brolucizumab.”1 At Novartis, providing safe and effective treatments for patients is our highest priority. Working closely with health authorities around the world, including FDA, we continuously monitor the benefit-risk profile of our medicines. Although other anti–vascular endothelial growth factor (anti-VEGF) agents are available, there are current unmet needs with neovascular AMD (nAMD) treatment that we believe brolucizumab addresses. Full-Text PDF" @default.
• W3027184580 created "2020-05-29" @default.
• W3027184580 creator A5021907714 @default.
• W3027184580 creator A5087700840 @default.
• W3027184580 date "2020-08-01" @default.
• W3027184580 modified "2023-10-14" @default.
• W3027184580 title "Is This a 737 Max Moment for Brolucizumab?" @default.
• W3027184580 cites W1481978003 @default.
• W3027184580 cites W1500728559 @default.
• W3027184580 cites W2040601983 @default.
• W3027184580 cites W2130626478 @default.
• W3027184580 cites W2274444581 @default.
• W3027184580 cites W2290597871 @default.
• W3027184580 cites W2341254978 @default.
• W3027184580 cites W2999438498 @default.
• W3027184580 cites W3014527467 @default.
• W3027184580 cites W3014659623 @default.
• W3027184580 cites W3017504588 @default.
• W3027184580 doi "https://doi.org/10.1016/j.ajo.2020.05.012" @default.
• W3027184580 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/7263271" @default.
• W3027184580 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/32505363" @default.
• W3027184580 hasPublicationYear "2020" @default.
• W3027184580 type Work @default.
• W3027184580 sameAs 3027184580 @default.
• W3027184580 citedByCount "11" @default.
• W3027184580 countsByYear W30271845802020 @default.
• W3027184580 countsByYear W30271845802021 @default.
• W3027184580 countsByYear W30271845802023 @default.
• W3027184580 crossrefType "journal-article" @default.
• W3027184580 hasAuthorship W3027184580A5021907714 @default.
• W3027184580 hasAuthorship W3027184580A5087700840 @default.
• W3027184580 hasBestOaLocation W30271845801 @default.
• W3027184580 hasConcept C121332964 @default.
• W3027184580 hasConcept C179254644 @default.
• W3027184580 hasConcept C41008148 @default.
• W3027184580 hasConcept C71924100 @default.
• W3027184580 hasConcept C74650414 @default.
• W3027184580 hasConceptScore W3027184580C121332964 @default.
• W3027184580 hasConceptScore W3027184580C179254644 @default.
• W3027184580 hasConceptScore W3027184580C41008148 @default.
• W3027184580 hasConceptScore W3027184580C71924100 @default.
• W3027184580 hasConceptScore W3027184580C74650414 @default.
• W3027184580 hasLocation W30271845801 @default.
• W3027184580 hasLocation W30271845802 @default.
• W3027184580 hasLocation W30271845803 @default.
• W3027184580 hasOpenAccess W3027184580 @default.
• W3027184580 hasPrimaryLocation W30271845801 @default.
• W3027184580 hasRelatedWork W1506200166 @default.
• W3027184580 hasRelatedWork W1995515455 @default.
• W3027184580 hasRelatedWork W2080531066 @default.
• W3027184580 hasRelatedWork W2748952813 @default.
• W3027184580 hasRelatedWork W2899084033 @default.
• W3027184580 hasRelatedWork W2935759653 @default.
• W3027184580 hasRelatedWork W3031052312 @default.
• W3027184580 hasRelatedWork W3032375762 @default.
• W3027184580 hasRelatedWork W3105167352 @default.
• W3027184580 hasRelatedWork W3108674512 @default.
• W3027184580 hasVolume "216" @default.
• W3027184580 isParatext "false" @default.
• W3027184580 isRetracted "false" @default.
• W3027184580 magId "3027184580" @default.
• W3027184580 workType "article" @default.