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Khanani AM, Zarbin MA, Barakat MR, et al. Safety Outcomes of Brolucizumab in Neovascular Age-Related Macular Degeneration: Results From the IRIS Registry and Komodo Healthcare Map. JAMA Ophthalmol. 2021;doi: 10.1001/jamaophthalmol.2021.4585.
Khanani, A. M., Zarbin, M. A., Barakat, M. R., Albini, T. A., Kaiser, P. K., B, G., Agashivala, N., Yu, J. S., Wykoff, C. C., & MacCumber, M. W. (2021). Safety Outcomes of Brolucizumab in Neovascular Age-Related Macular Degeneration: Results From the IRIS Registry and Komodo Healthcare Map. JAMA ophthalmology, . https://doi.org/10.1001/jamaophthalmol.2021.4585
Khanani, Arshad M, et al. "Safety Outcomes of Brolucizumab in Neovascular Age-Related Macular Degeneration: Results From the IRIS Registry and Komodo Healthcare Map." JAMA ophthalmology vol. (2021). doi: https://doi.org/10.1001/jamaophthalmol.2021.4585
Khanani AM, Zarbin MA, Barakat MR, Albini TA, Kaiser PK, B G, Agashivala N, Yu JS, Wykoff CC, MacCumber MW. Safety Outcomes of Brolucizumab in Neovascular Age-Related Macular Degeneration: Results From the IRIS Registry and Komodo Healthcare Map. JAMA Ophthalmol. 2021 Nov 24; doi: 10.1001/jamaophthalmol.2021.4585. Epub 2021 Nov 24. PMID: 34817566; PMCID: PMC8613703.
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JAMA Ophthalmol. 2021 Nov 24; doi: 10.1001/jamaophthalmol.2021.4585. Epub 2021 Nov 24.

Safety Outcomes of Brolucizumab in Neovascular Age-Related Macular Degeneration: Results From the IRIS Registry and Komodo Healthcare Map.

JAMA ophthalmology

Arshad M Khanani, Marco A Zarbin, Mark R Barakat, Thomas A Albini, Peter K Kaiser, Guruprasad B, Neetu Agashivala, Justin S Yu, Charles C Wykoff, Mathew W MacCumber

Affiliations

  1. Sierra Eye Associates, Reno, Nevada.
  2. Reno School of Medicine, University of Nevada, Reno.
  3. Institute of Ophthalmology and Visual Science, Rutgers-New Jersey Medical School, Rutgers University, Newark, New Jersey.
  4. Retinal Consultants of Arizona, Phoenix.
  5. Bascom Palmer Eye Institute, Miami, Florida.
  6. Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
  7. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
  8. Retina Consultants of Texas, Houston.
  9. Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas.
  10. Department of Ophthalmology at Rush University Medical Center, Chicago, Illinois.
  11. Illinois Retina Associates, SC, Chicago.

PMID: 34817566 PMCID: PMC8613703 DOI: 10.1001/jamaophthalmol.2021.4585

Abstract

IMPORTANCE: Limited data exist on the real-world safety outcomes of patients with neovascular age-related macular degeneration treated with brolucizumab (Beovu).

OBJECTIVE: To determine the real-world incidence of intraocular inflammation (IOI), including retinal vasculitis (RV) and/or retinal vascular occlusion (RO), for patients with neovascular age-related macular degeneration who underwent brolucizumab treatment. Additionally, potential risk factors associated with these adverse events were evaluated.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study included patients with neovascular age-related macular degeneration in the Intelligent Research in Sight (IRIS) Registry and Komodo Healthcare Map. Patients initiating and receiving 1 or more brolucizumab injections from October 8, 2019, to June 5, 2020, with up to 6 months of follow-up were included.

INTERVENTION: Brolucizumab injections.

MAIN OUTCOME AND MEASURES: Incidence of IOI (including RV) and/or RO and RV and/or RO and risk stratification for the identified risk factors.

RESULTS: Of 10 654 and 11 161 included eyes (from the IRIS Registry and Komodo Health database, respectively), the median follow-up times were 97 and 95 days. Most eyes switched from another anti-vascular endothelial growth factor agent (9686 of 10 654 [90.9%] and 10 487 of 11 161 [94.0%], respectively), most commonly aflibercept (7160 of 9686 [73.9%] and 7156 of 10 487 [68.2%]), and most were from women (6105 of 10 654 [57.3%] and 6452 of 11 161 [57.8%]). The overall incidence of IOI and/or RO was 2.4% (255 of 10 654 eyes) and 2.4% (268 of 11 161 eyes) for the IRIS and Komodo groups, respectively, and RV and/or RO, 0.6% (59 of 10 654 eyes and 63 of 11 161 eyes), respectively. Patients with a history of IOI and/or RO in the 12 months before brolucizumab initiation had an increased observed risk rate (8.7% [95% CI, 6.0%-11.4%] and 10.6% [95% CI, 7.5%-13.7%]) for an IOI and/or RO event in the 6 months following the first brolucizumab treatment compared with patients without prior IOI and/or RO (2.0% in both data sets). There was an increased estimated incidence rate in women (2.9% [95% CI, 2.5%-3.3%] and 3.0% [95% CI, 2.6%-3.4%]) compared with men (1.3% [95% CI, 1.0%-1.7%] and 1.4% [95% CI, 1.0%-1.7%]), but this risk was not as large as that of a prior IOI and/or RO. Similar findings were observed for patients with RV and/or RO events.

CONCLUSIONS AND RELEVANCE: The incidence rate of IOI and/or RO was approximately 2.4%. Patient eyes with IOI and/or RO in the 12 months prior to first brolucizumab injection had the highest observed risk rate for IOI and/or RO in the early months after the first brolucizumab treatment. However, given study limitations, the identified risk factors cannot be used as predictors of IOI and/or RO events, and causality with brolucizumab cannot be assessed.

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