Efficacy of Faricimab versus Aflibercept in Diabetic Macular Edema in the 20/50 or Worse Vision Subgroup in Phase III YOSEMITE and RHINE Trials.

Autor:	Zarbin M; Institute of Ophthalmology and Visual Science, Rutgers New Jersey Medical School, Newark, New Jersey., Tabano D; Genentech, Inc., South San Francisco, California. Electronic address: tabano.david@gene.com., Ahmed A; Genentech, Inc., South San Francisco, California., Amador M; Genentech, Inc., South San Francisco, California., Ding A; Genentech, Inc., South San Francisco, California., Holekamp N; Pepose Vision Institute, St. Louis, Missouri; Roche Pharma R&D, Basel, Switzerland., Lu XY; Genentech, Inc., South San Francisco, California., Stoilov I; Genentech, Inc., South San Francisco, California., Yang M; Genentech, Inc., South San Francisco, California.
Jazyk:	angličtina
Zdroj:	Ophthalmology [Ophthalmology] 2024 Nov; Vol. 131 (11), pp. 1258-1270. Date of Electronic Publication: 2024 Jun 08.
DOI:	10.1016/j.ophtha.2024.05.025
Abstrakt:	Purpose: Diabetic Retinopathy Clinical Research Network Protocol T suggests that the response to treatment among patients with diabetic macular edema (DME) may vary depending on baseline best-corrected visual acuity (BCVA). We evaluated the efficacy of faricimab 6 mg versus aflibercept 2 mg over 2 years in patients with DME and baseline BCVA of 20/50 or worse enrolled in faricimab phase III trials. Design: YOSEMITE and RHINE were identically designed, multicenter, randomized, double-masked, active comparator-controlled, noninferiority trials. Participants: Adults ≥18 years of age with center-involving macular edema secondary to type 1 or 2 diabetes. Methods: Patients were randomized to faricimab every 8 weeks (Q8W), faricimab personalized treat-and-extend (T&E) regimen, or aflibercept Q8W. Post hoc subgroup analyses were conducted using the intention-to-treat population with baseline BCVA of 20/50 or worse. Main Outcome Measures: Changes in ETDRS BCVA and central subfield thickness (CST) from baseline to years 1 and 2 were compared between treatment arms using mixed-model repeated measures analyses. Results: In YOSEMITE and RHINE, respectively, 220 and 217 patients in the faricimab Q8W arm, 220 and 219 patients in the faricimab T&E arm, and 219 and 214 patients in the aflibercept Q8W arm showed baseline BCVA of 20/50 or worse. In both trials, mean change in ETDRS BCVA was comparable between treatments across trials at years 1 and 2. In YOSEMITE, adjusted mean change from baseline in CST (μm) at year 1 was greater with faricimab Q8W (-232.8; P < 0.0001) and faricimab T&E (-217.4; P = 0.0004) ) versus aflibercept Q8W (-190.4). In RHINE, this was faricimab Q8W (-214.2; P = 0.0006) and faricimab T&E (-206.6; P = 0.0116) versus aflibercept Q8W (-186.6). In both trials, change from baseline in CST at year 2 was greater with faricimab Q8W versus aflibercept. The median time to first CST of <325 μm and first absence of intraretinal fluid was shorter in the faricimab arms versus the aflibercept arm, with fewer injections on average. Conclusions: In patients with DME and baseline ETDRS BCVA of 20/50 or worse, faricimab treatment resulted in comparable visual acuity, greater reduction in retinal thickness, and fewer injections compared with aflibercept. Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. (Copyright © 2024 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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