PMID- 37343623
OWN - NLM
STAT- MEDLINE
DCOM- 20231013
LR  - 20231013
IS  - 2468-6530 (Electronic)
IS  - 2468-6530 (Linking)
VI  - 7
IP  - 10
DP  - 2023 Oct
TI  - Detection and Management of Intraocular Inflammation after Brolucizumab Treatment 
      for Neovascular Age-Related Macular Degeneration.
PG  - 879-891
LID - S2468-6530(23)00260-9 [pii]
LID - 10.1016/j.oret.2023.06.009 [doi]
AB  - PURPOSE: To present interim descriptive insights from the OCTOPUS and SWIFT 
      studies on incidence, clinical features, management, and outcomes of intraocular 
      inflammation (IOI), vasculitis, and occlusive vasculitis with brolucizumab 
      treatment (Beovu, Novartis) in patients with neovascular age-related macular 
      degeneration (nAMD) who were anti-VEGF naive or pretreated with anti-VEGFs 
      (ranibizumab or aflibercept). DESIGN: OCTOPUS (NCT04239027) and SWIFT 
      (NCT04264819) studies are prospective phase IIIb single-arm, open-label, 
      multicenter studies assessing brolucizumab. SUBJECTS: Anti-VEGF naive (OCTOPUS) 
      and pretreated (SWIFT) patients with nAMD. METHODS: Interim prespecified analysis 
      on the efficacy end point provided an opportunity to analyze IOI-related safety. 
      Reports of IOI-related adverse events (AEs) were reviewed, and AE images and 
      clinical features and outcomes of each case were analyzed by a review committee. 
      RESULTS: Of 505 brolucizumab-treated eyes/patients with median brolucizumab 
      treatment of 8.8 months, 53 eyes demonstrated at least 1 IOI-related AE. The 
      incidence of overall IOI-related AEs was 10.5%; among these events, the incidence 
      was 7.1% for IOI only without retinal involvement and 3.4% for IOI with retinal 
      involvement (2.0% with vasculitis, 1.4% with vascular occlusion with or without 
      vasculitis). Incidence was similar in naive and pretreated patients. Before the 
      onset of the first IOI-related AE, eyes received a median of 2 brolucizumab 
      injections; 81.1% of IOI-related AEs occurred during the loading phase (median, 
      25.0 days from the last brolucizumab injection). At AE onset, most frequently 
      reported symptoms were floaters (52.8%) and blurred or decreased vision (37.8%). 
      Of the 86.8% of AEs that were treated, most were treated with topical 
      corticosteroids (75.5%), 28.3% by systemic corticosteroids, and 26.8% by 
      intraocular corticosteroids. No severe vision loss was reported for the 7 
      nontreated AEs. Overall, the median best-corrected visual acuity (BCVA) change at 
      IOI-related AEs resolution from baseline was 1 letter (range, -74 to +32 
      letters), and 2 patients with occlusive vasculitis had BCVA loss >/= 15 letters due 
      to IOI-related AEs. All eyes permanently discontinued brolucizumab after the 
      first IOI-related AE. CONCLUSIONS: This analysis highlights the need for 
      monitoring and education of patients to report any signs of IOI-related events 
      immediately when being treated with brolucizumab. IOI should be treated promptly 
      and intensely with corticosteroids. FINANCIAL DISCLOSURE(S): Proprietary or 
      commercial disclosure may be found in the Footnotes and Disclosures at the end of 
      this article.
CI  - Copyright (c) 2023 American Academy of Ophthalmology. Published by Elsevier Inc. 
      All rights reserved.
FAU - Bodaghi, Bahram
AU  - Bodaghi B
AD  - Department of Ophthalmology, IHU FOReSIGHT, Sorbonne University, APHP, Paris, 
      France.
FAU - Souied, Eric H
AU  - Souied EH
AD  - Department of Ophthalmology, Centre Hospitalier Intercommunal de Creteil, 
      Universite de Paris Est Creteil, Creteil, France.
FAU - Tadayoni, Ramin
AU  - Tadayoni R
AD  - Universite Paris Cite, AP-HP, Lariboisiere, St Louis and Fondation Adolphe de 
      Rothschild hospitals, Paris, France.
FAU - Weber, Michel
AU  - Weber M
AD  - Clinique Ophtalmologique, CHU de Nantes, 1, place Alexis Ricordeau, 44093 Nantes.
FAU - Ponthieux, Anne
AU  - Ponthieux A
AD  - Novartis Pharma SAS, Rueil-Malmaison, Malmaison, France. Electronic address: 
      anne.ponthieux@novartis.com.
FAU - Kodjikian, Laurent
AU  - Kodjikian L
AD  - Department of Ophthalmology, Croix-Rousse teaching Hospital, Hospices Civils de 
      Lyon, 69004 Lyon, France; UMR5510 MATEIS, CNRS, INSA Lyon, Universite Lyon 1, 
      69100 Villeurbanne, France.
LA  - eng
SI  - ClinicalTrials.gov/NCT04239027
SI  - ClinicalTrials.gov/NCT04264819
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
DEP - 20230619
PL  - United States
TA  - Ophthalmol Retina
JT  - Ophthalmology. Retina
JID - 101695048
RN  - 0 (Adrenal Cortex Hormones)
RN  - XSZ53G39H5 (brolucizumab)
SB  - IM
MH  - Humans
MH  - Adrenal Cortex Hormones
MH  - Inflammation
MH  - *Macular Degeneration/diagnosis/drug therapy
MH  - Prospective Studies
MH  - Retina
MH  - *Uveitis
MH  - *Vasculitis
OTO - NOTNLM
OT  - Brolucizumab
OT  - Intraocular inflammation
OT  - Neovascular age-related macular degeneration
OT  - OCTOPUS
OT  - SWIFT
OT  - Vasculitis
EDAT- 2023/06/22 01:07
MHDA- 2023/10/09 06:42
CRDT- 2023/06/21 19:12
PHST- 2023/03/21 00:00 [received]
PHST- 2023/06/05 00:00 [revised]
PHST- 2023/06/09 00:00 [accepted]
PHST- 2023/10/09 06:42 [medline]
PHST- 2023/06/22 01:07 [pubmed]
PHST- 2023/06/21 19:12 [entrez]
AID - S2468-6530(23)00260-9 [pii]
AID - 10.1016/j.oret.2023.06.009 [doi]
PST - ppublish
SO  - Ophthalmol Retina. 2023 Oct;7(10):879-891. doi: 10.1016/j.oret.2023.06.009. Epub 
      2023 Jun 19.