Efficacy and safety of brolucizumab versus aflibercept in eyes with polypoidal choroidal vasculopathy in Japanese participants of HAWK.

Autor:	Ogura Y; Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan ogura@med.nagoya-cu.ac.jp., Jaffe GJ; Department of Ophthalmology, Duke University, Durham, North Carolina, USA., Cheung CMG; SingHealth Duke NUS Academic Medical Center, Singapore., Kokame GT; University of Hawaii School of Medicine, Honolulu, Hawaii, USA., Iida T; Department of Ophthalmology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan., Takahashi K; Department of Ophthalmology, Kansai Medical University, Moriguchi, Japan., Lee WK; Nune Eye Hospital, Seoul, Republic of Korea., Chang AA; Sydney Retina Clinic, Sydney Eye Hospital, Sydney University, Sydney, New South Wales, Australia., Monés J; Institut de la Màcula, Barcelona, Spain.; Barcelona Macula Foundation, Barcelona, Spain., D'Souza D; Novartis Pharma AG, Basel, Switzerland., Weissgerber G; Novartis Pharma AG, Basel, Switzerland., Gedif K; Novartis Pharma AG, Basel, Switzerland., Koh A; Eye and Retina Surgeons, Camden Medical Centre, Singapore.
Jazyk:	angličtina
Zdroj:	The British journal of ophthalmology [Br J Ophthalmol] 2022 Jul; Vol. 106 (7), pp. 994-999. Date of Electronic Publication: 2021 Jul 22.
DOI:	10.1136/bjophthalmol-2021-319090
Abstrakt:	Purpose: To compare the efficacy and safety of brolucizumab versus aflibercept in eyes with polypoidal choroidal vasculopathy (PCV) over 96 weeks in the HAWK study. Design: HAWK was a global, 2-year, randomised, double-masked, multicentre phase III trial in participants with neovascular age-related macular degeneration. Methods: Of the Japanese participants with PCV, 39 received brolucizumab 6 mg and 30 received aflibercept 2 mg. After 3 monthly loading doses, brolucizumab-treated eyes received an injection every 12 weeks (q12w) but were adjusted to q8w if disease activity was detected. Aflibercept-treated eyes received fixed q8w dosing. Mean change in best-corrected visual acuity (BCVA), the proportion of participants on q12w, retinal thickness, retinal fluid changes and safety were assessed to Week 96. Results: Mean change in BCVA (early treatment diabetic retinopathy study (ETDRS) letters) from baseline to week 48/week 96 was+10.4/+11.4 for brolucizumab and +11.6/+11.1 for aflibercept. For brolucizumab-treated eyes, the probability of only q12w dosing after loading through week 48 was 76%, and 68% through week 96. Fluid resolution was greater with brolucizumab than aflibercept: respective proportions of eyes with intraretinal fluid and/or subretinal fluid were 7.7% and 30% at week 48% and 12.8% and 16.7% at week 96. Brolucizumab exhibited an overall well-tolerated safety profile despite a higher rate of intraocular inflammation compared with aflibercept. Conclusion: In Japanese eyes with PCV, brolucizumab q12w/q8w monotherapy resulted in robust and consistent BCVA gains that were comparable to q8w aflibercept dosing. Anatomical outcomes favoured brolucizumab over aflibercept, with 76% of brolucizumab participants maintained on q12w dosing after loading to week 48. Competing Interests: Competing interests: Glenn Jaffe and Jordi Mones are members of the Brolucizumab Safety Review Committee. Y. Ogura: Consultant for Novartis, Bayer Holding, Alcon Japan, Wakamoto Pharmaceuticals, HOYA Corporation, Astellas Pharma, Senju Pharmaceutical, Boehringer Ingelheim, Chengdu Kanghong Biotechnology, Kyoto Drug Discovery & Development; Lecture fees—Santen Pharmaceuticals, KOWA, Novartis, Bayer Holding, TOPCON, NIKON Healthcare Japan, Sanwa KagakuG. J. Jaffe: Consultant for Novartis, Eyepoint, Iveric, Neurotech, RegeneronG. Cheung: Consultant for Novartis, Bayer, Roche, Boehringer-Ingelheim, Topcon, Samsung; Lecture fees - Topcon, Novartis, Bayer; Grant—ZeissG. T. Kokame: Consultant for Regeneron, Bayer, Genentech, Bausch and Lomb, Santen, Iveric, Allergan Zeiss; Speaker for Regeneron, Bayer, Second Sight, Bausch & Lomb, Salutaris Medical Devices, Zeiss; Research Support from Genentech, Regeneron, Salutaris Medical DevicesT. Iida: Consultant for Novartis, Bayer Healthcare Pharmaceuticals, Tyugai; Lecture fees and grant support—Nidek, Inc., Santen, Inc., Senju Pharmaceutical Co., Ltd, Alcon Laboratories, Inc, Novartis, Bayer Healthcare Pharmaceuticals; Grant support; Topcon Medical Systems Inc. K. Takahashi: Consultant for Novartis, Bayer, Kyowa Kirin, Santen, Allergan Japan, Lecture fees from Novartis, Bayer, Santen, SenjyuW. K. Lee: Consultant for Novartis, Bayer, Allergan, Santen, Boehringer-Ingelheim, Roche; Lecture fee from Novartis, Bayer, AllerganA. Chang: Consultant for Novartis, Bayer, Allergan, Roche, AlconJ. Monés: Consultant/Advisor for Novartis, Alcon, Bayer, Iveric Bio, Notal Vision, Roche, Cellcure, Lineage and Reneuron; Financial Interests: Iveric Bio, Notal Vision; Lecture Fees from Novartis, Roche and Ophthotech; Trial grants from Novartis, Bayer, Roche and IvericD. D’Souza, G. Weissgerber, K. Gedif: Employees of Novartis Pharma AGA. Koh: Consultant for Novartis, Bayer, Allergan, Carl Zeiss Meditec, and Heidelberg Engineering. (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu