David R Lally1,2, Anat Loewenstein3, Jennifer J Arnold4, Yit C Yang5, Kinfemichael Gedif6, Catherine Best7, Hersh Patel8,9, Ramin Tadayoni10, Jeffrey S Heier11. 1. New England Retina Consultants, Springfield, MA, USA. david.lally@neretina.com. 2. Department of Surgery, University of Massachusetts Medical School-Baystate, Springfield, MA, USA. david.lally@neretina.com. 3. Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 4. Marsden Eye Specialists, Parramatta, NSW, Australia. 5. Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK. 6. Novartis Pharmaceuticals Corporation, Fort Worth, TX, USA. 7. Novartis Pharma AG, Basel, Switzerland. 8. Novartis Pharmaceuticals Corporation, East Hannover, NJ, USA. 9. IVERIC bio, Inc., New York, NY, USA. 10. Department of Ophthalmology, Université de Paris, AP-HP, Lariboisière, Saint Louis and Rothschild Foundation Hospitals, Paris, France. 11. Ophthalmic Consultants of Boston, Boston, MA, USA.
Abstract
OBJECTIVE: Post-hoc analysis to compare the outcomes of brolucizumab 6 mg vs. aflibercept 2 mg in neovascular age-related macular degeneration (nAMD) patients with early persistent retinal fluid in HAWK and HARRIER. METHODS: After 3 monthly loading doses, brolucizumab-treated eyes (N = 730) received injections every 12 weeks (q12w) or q8w if disease activity was detected. Aflibercept-treated eyes (N = 729) received fixed q8w dosing. Early persistent fluid was defined as the presence of subretinal fluid and/or intraretinal fluid up to Week 12. RESULTS: A lower proportion of brolucizumab patients had early persistent retinal fluid compared with aflibercept (11.2% (n = 82) vs. 19.2% (n = 140)). In these patients, 34.1% of the brolucizumab-treated group achieved a ≥ 15 ETDRS letter gain in best corrected visual acuity (BCVA) from baseline at Week 96 compared with 20.7% of the aflibercept-treated group. Brolucizumab achieved numerically better BCVA outcomes (Week 96: brolucizumab, +6.4 letters; aflibercept, +3.7 letters) and significantly greater central subfield thickness reductions versus aflibercept from baseline through Week 96 (Week 96: -202 µm vs. -145 µm; p = 0.0206). Brolucizumab demonstrated an overall favourable benefit/risk profile in this patient cohort. In their unmasked, post-hoc review, the Safety Review Committee identified two cases of retinal vasculitis and no cases of retinal vascular occlusion in the brolucizumab arm; no cases of retinal vasculitis or retinal vascular occlusion were identified in the aflibercept arm. CONCLUSION: In this analysis, anatomical and visual outcomes were better with brolucizumab compared with aflibercept. Brolucizumab may therefore achieve greater disease control than aflibercept in nAMD patients with early persistent retinal fluid.
OBJECTIVE: Post-hoc analysis to compare the outcomes of brolucizumab 6 mg vs. aflibercept 2 mg in neovascular age-related macular degeneration (nAMD) patients with early persistent retinal fluid in HAWK and HARRIER. METHODS: After 3 monthly loading doses, brolucizumab-treated eyes (N = 730) received injections every 12 weeks (q12w) or q8w if disease activity was detected. Aflibercept-treated eyes (N = 729) received fixed q8w dosing. Early persistent fluid was defined as the presence of subretinal fluid and/or intraretinal fluid up to Week 12. RESULTS: A lower proportion of brolucizumab patients had early persistent retinal fluid compared with aflibercept (11.2% (n = 82) vs. 19.2% (n = 140)). In these patients, 34.1% of the brolucizumab-treated group achieved a ≥ 15 ETDRS letter gain in best corrected visual acuity (BCVA) from baseline at Week 96 compared with 20.7% of the aflibercept-treated group. Brolucizumab achieved numerically better BCVA outcomes (Week 96: brolucizumab, +6.4 letters; aflibercept, +3.7 letters) and significantly greater central subfield thickness reductions versus aflibercept from baseline through Week 96 (Week 96: -202 µm vs. -145 µm; p = 0.0206). Brolucizumab demonstrated an overall favourable benefit/risk profile in this patient cohort. In their unmasked, post-hoc review, the Safety Review Committee identified two cases of retinal vasculitis and no cases of retinal vascular occlusion in the brolucizumab arm; no cases of retinal vasculitis or retinal vascular occlusion were identified in the aflibercept arm. CONCLUSION: In this analysis, anatomical and visual outcomes were better with brolucizumab compared with aflibercept. Brolucizumab may therefore achieve greater disease control than aflibercept in nAMD patients with early persistent retinal fluid.
Authors: Gregor S Reiter; Christoph Grechenig; Wolf-Dieter Vogl; Robyn H Guymer; Jennifer J Arnold; Hrvoje Bogunovic; Ursula Schmidt-Erfurth Journal: Retina Date: 2021-06-01 Impact factor: 4.256
Authors: Charles C Wykoff; W Lloyd Clark; Jared S Nielsen; Joel V Brill; Laurence S Greene; Cherilyn L Heggen Journal: J Manag Care Spec Pharm Date: 2018-02