Scopus
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Faricimab Treat-and-Extend for Diabetic Macular Edema: Two-Year Results from the Randomized Phase 3 YOSEMITE and RHINE Trials
Ophthalmology · Haziran 2024
YÖKSİS Kayıtları
Faricimab Treat-and-Extend for Diabetic Macular Edema
Ophthalmology · 2024 SCI-Expanded
PROFESÖR BANU TURĞUT ÖZTÜRK →
Makale Bilgileri
DergiOphthalmology
Yayın TarihiHaziran 2024
Cilt / Sayfa131 · 708-723
Scopus ID2-s2.0-85187381197
Erişim🔓 Açık Erişim
Özet
Purpose: To evaluate the 2-year efficacy, durability, and safety of dual angiopoietin-2 and vascular endothelial growth factor (VEGF) A pathway inhibition with intravitreal faricimab according to a personalized treat-and-extend (T&E)-based regimen with up to every-16-week dosing in the YOSEMITE and RHINE (ClinicalTrials.gov identifiers, NCT03622580 and NCT03622593, respectively) phase 3 trials of diabetic macular edema (DME). Design: Randomized, double-masked, noninferiority phase 3 trials. Participants: Adults with visual acuity loss (best-corrected visual acuity [BCVA] of 25–73 letters) due to center-involving DME. Methods: Patients were randomized 1:1:1 to faricimab 6.0 mg every 8 weeks, faricimab 6.0 mg T&E (previously referred to as personalized treatment interval), or aflibercept 2.0 mg every 8 weeks. The T&E up to every-16-week dosing regimen was based on central subfield thickness (CST) and BCVA change. Main Outcome Measures: Included changes from baseline in BCVA and CST, number of injections, durability, absence of fluid, and safety through week 100. Results: In YOSEMITE and RHINE (n = 940 and 951, respectively), noninferior year 1 visual acuity gains were maintained through year 2; mean BCVA change from baseline at 2 years (weeks 92, 96, and 100 average) with faricimab every 8 weeks (YOSEMITE and RHINE, +10.7 letters and +10.9 letters, respectively) or T&E (+10.7 letters and +10.1 letters, respectively) were comparable with aflibercept every 8 weeks (+11.4 letters and +9.4 letters, respectively). The median number of study drug injections was lower with faricimab T&E (YOSEMITE and RHINE, 10 and 11 injections, respectively) versus faricimab every 8 weeks (15 injections) and aflibercept every 8 weeks (14 injections) across both trials during the entire study. In the faricimab T&E arms, durability was improved further during year 2, with > 60% of patients receiving every-16-week dosing and approximately 80% receiving every-12-week or longer dosing at week 96. Almost 80% of patients who achieved every-16-week dosing at week 52 maintained every-16-week dosing without an interval reduction through week 96. Mean CST reductions were greater (YOSEMITE/RHINE weeks 92/96/100 average: faricimab every 8 weeks –216.0/–202.6 µm, faricimab T&E –204.5/–197.1 µm, aflibercept every 8 weeks –196.3/–185.6 µm), and more patients achieved absence of DME (CST < 325 μm; YOSEMITE/RHINE weeks 92–100: faricimab every 8 weeks 87%–92%/88%–93%, faricimab T&E 78%–86%/85%–88%, aflibercept every 8 weeks 77%–81%/80%–84%) and absence of intraretinal fluid (YOSEMITE/RHINE weeks 92–100: faricimab every 8 weeks 59%–63%/56%–62%, faricimab T&E 43%–48%/45%–52%, aflibercept every 8 weeks 33%–38%/39%–45%) with faricimab every 8 weeks or T&E versus aflibercept every 8 weeks through year 2. Overall, faricimab was well tolerated, with a safety profile comparable with that of aflibercept. Conclusions: Clinically meaningful visual acuity gains from baseline, anatomic improvements, and extended durability with intravitreal faricimab up to every 16 weeks were maintained through year 2. Faricimab given as a personalized T&E-based dosing regimen supports the role of dual angiopoietin-2 and VEGF-A inhibition to promote vascular stability and to provide durable efficacy for patients with DME. Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Yazarlar (98)
1
Tien Y. Wong
ORCID: 0000-0002-8448-1264
2
Zdenka Haskova
3
Kemal Asik
4
Caroline R. Baumal
5
Karl G. Csaky
6
Nicole Eter
7
Jane A. Ives
8
Glenn J. Jaffe
9
Jean François Korobelnik
10
Hugh Lin
11
Toshinori Murata
12
Paisan Ruamviboonsuk
13
Patricio G. Schlottmann
14
András I. Seres
15
David Silverman
16
Xiaodong Sun
17
Yannan Tang
18
John A. Wells
19
Young Hee Yoon
20
Charles C. Wykoff
21
Thomas Aaberg
22
Ashkan Abbey
23
Elmira Abdulaeva
24
Santiago Abengoechea
25
Prema Abraham
26
Thomas Ach
27
Serrhel Adams
28
Alfredo Adan Civera
29
Sean Adrean
30
Hansjurgen Agostini
31
Suhail Alam
32
Arturo Alezzandrini
33
Virgil Alfaro
34
Daniel Aliseda
35
Arghavan Almony
36
Pedro Amat
37
Payam Amini
38
Andrew Antoszyk
39
Luis Arias
40
Riaz Asaria
41
Marcos Avila
42
Carl C. Awh
43
Joaquin Bafalluy
44
Carl Baker
45
Francesco Bandello
46
Mark Barakat
47
Karen Barraza
48
Gyorgy Bator
49
Rubens Belfort
50
Chris Bergstrom
51
George Bertolucci
52
Thomas Bochow
53
Matthias Bolz
54
Emilia Borcz
55
Arnaldo Bordon
56
David Boyer
57
Galina Bratko
58
Michael Brent
59
Jamin Brown
60
David M. Brown
61
Maria Budzinskaya
62
Sylvia Buffet
63
Stuart Burgess
64
Ben Burton
65
Miguel Busquets
66
Francisco Cabrera
67
Carlo Cagini
68
Jorge Calzada
69
Peter Campochiaro
70
John Carlson
71
Alessandro Castellarin
72
Carlos Cava
73
Voraporn Chaikitmongkol
74
Clement Chan
75
Emmanuel Chang
76
Jonathan Chang
77
Andrew Chang
78
Steve Charles
79
Nauman Chaudhry
80
Caroline Chee
81
Judy Chen
82
Fred Chen
83
Shih Jen Chen
84
Richard Cheong-Leen
85
Allen Chiang
86
Mark Chittum
87
David Chow
88
Brian Connolly
89
Pierre Loic Cornut
90
Carl Danzig
91
Arup Das
92
Vesselin Daskalov
93
Carmen Desco
94
Amr Dessouki
95
John Dickinson
96
Brian Do
97
Michael Dollin
98
Pravin Dugel
Anahtar Kelimeler
Angiopoietin-2
Diabetic macular edema
Faricimab
Vascular endothelial growth factor A
Vascular stability
Kurumlar
Asan Medical Center
Seoul South Korea
Budapest Retina Associates
Budapest Hungary
Centre Hospitalier Universitaire de Bordeaux
Talence France
Duke Eye Center
Durham United States
Genentech, Inc
San Francisco United States
Houston Methodist Hospital
Houston United States
New England Eye Center
Boston United States
Organizacion Medica de Investigacion
Buenos Aires Argentina
Palmetto Retina Center
Columbia United States
Rangsit University
Pathum Thani Thailand
Retina Foundation of the Southwest
Dallas United States
Roche Products Limited UK
Welwyn Garden City United Kingdom
Shanghai General Hospital
Shanghai China
Shinshu University
Matsumoto Japan
Tsinghua University
Beijing China
University of Münster
Munster Germany
Metrikler
18
Atıf
98
Yazar
5
Anahtar Kelime