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. 2023 Feb 1;9(1):8.
doi: 10.1186/s40942-023-00445-0.

Switching to brolucizumab: injection intervals and visual, anatomical and safety outcomes at 12 and 18 months in real-world eyes with neovascular age-related macular degeneration

Joseph M Coney  1 , Ryan Zubricky  2 , Samriddhi Buxy Sinha  3 , Nina Sonbolian  3 , Lujia Zhou  4 , Thomas P Hull  5 , Shawn A Lewis  5 , David G Miller  5 , Michael A Novak  5 , Scott D Pendergast  5 , Hang Pham  5 , Sean M Platt  5 , Llewelyn J Rao  5 , Jerome P Schartman  5 , Lawrence J Singerman  5 , Richard Donkor  5 , Margaret Fink  5 , Jasmyne McCoy  5 , Helene Karcher  3
Affiliations

Switching to brolucizumab: injection intervals and visual, anatomical and safety outcomes at 12 and 18 months in real-world eyes with neovascular age-related macular degeneration

Joseph M Coney et al. Int J Retina Vitreous. .

Abstract

Background: The anti-vascular endothelial growth factor (anti-VEGF) injection interval influences treatment burden and compliance in neovascular age-related macular degeneration (nAMD). This real-world study investigates visual acuity (VA), injection-interval extension, central macular thickness (CMT) and safety in nAMD eyes switched to the anti-VEGF agent brolucizumab and followed for up to 18 months.

Methods: This retrospective study included patients with nAMD who were switched from other anti-VEGF agents to brolucizumab only. Patient eyes were grouped into three nested cohorts with the overall cohort receiving ≥ 1 brolucizumab injection, the second receiving ≥ 3 brolucizumab injections with a follow-up period of ≥ 12 months and the third cohort receiving ≥ 3 brolucizumab injections with a follow-up period of ≥ 18 months. Study endpoints included changes from baseline at 12 or 18 months in VA, injection intervals, and CMT. Sub-group analyses were conducted using baseline injection interval length or baseline VA as qualifiers.

Results: Overall, 482 eyes received ≥ 1 brolucizumab injection; 174 eyes received ≥ 3 brolucizumab injections with ≥ 12 months of follow-up, and 95 eyes received ≥ 3 brolucizumab injections with ≥ 18 months of follow-up. VA (mean [95% confidence intervals]) remained stable relative to baseline after 12 months (- 1.1 [- 3.7, 1.6] letters; p = 0.42) and 18 months (0.0 [- 3.1, 3.1] letters; p = 0.98) of brolucizumab treatment, respectively, and pre-switch injection intervals or baseline VA had no notable effect. Following the switch to brolucizumab, injection intervals were extended from baseline to month 12 by 26.9 (19.7, 34.0) days (p < 0.0001), and eyes with pre-switch injection intervals < 8 weeks were able to have their injection intervals extended by 23.6 days longer than eyes with pre-switch injection intervals ≥ 8 weeks. At 18 months, injection intervals were extended by 36.3 (25.6, 46.9) days (p < 0.0001) compared to baseline. Following switch to brolucizumab, CMT was reduced at both 12 and 18 months (12 months: - 35.2 (- 51.7, - 18.8) µm, p < 0.0001; 18 months: - 38.9 (- 54.3, - 22.0) µm, p < 0.0001). Intraocular inflammation-related adverse events were reported in 4.6% of brolucizumab-treated eyes.

Conclusions: This real-world study demonstrates that injection intervals may be significantly extended with maintained vision and reduced CMT in nAMD eyes switching to brolucizumab therapy from other anti-VEGFs.

Keywords: Anti-VEGF; Beovu; Brolucizumab; Injection intervals; Neovascular age-related macular degeneration; Switch patients; Treatment burden; nAMD.

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Conflict of interest statement

NS and HK are Novartis employees and HK is a Novartis shareholder. SBS was a Novartis employee at the time of this study and is a current employee of the Novartis Sandoz division. LZ is an employee of KMK Consulting, which was paid by Novartis to conduct the statistical analysis of the study. JMC has received grants from Alimera Sciences, Allergan/Abbvie, Apellis, Genentech, MacTel, National Eye Institute, Novartis, Regeneron and RegenexBio, consulting fees from Alimera Sciences, Apellis and RegenexBio, honoraria from Alimera Sciences, Allergan/Abbvie, Apellis, Genentech, Novartis, Regeneron and RegenexBio. DM reports consultancy fees and Speakers’ Bureau honoraria from Regeneron Pharmaceuticals. LS has received grants from Alkeus, Apellis, Genentech, Ionis Pharm, NGM, Biopharmaceuticals, Graybug Vision and Kodiak Sciences.

Figures

Fig. 1
Fig. 1
Patient selection and definition of study cohorts and sub-groups
Fig. 2
Fig. 2
Effect of baseline injection interval length on injection interval length at Month 12. CI, confidence interval
Fig. 3
Fig. 3
Effect of baseline VA on injection interval length at Month 12. CI, confidence interval; Q, quartile; VA, visual acuity
Fig. 4
Fig. 4
Effect of baseline injection interval length on CMT at Month 12. CI, confidence interval; CMT, central macular thickness; VA, visual acuity
Fig. 5
Fig. 5
Effect of baseline VA on CMT at Month 12. CI, confidence interval; CMT, central macular thickness; Q, quarter; VA, visual acuity
See this image and copyright information in PMC

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