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Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials
The Lancet · Şubat 2022
YÖKSİS Kayıtları
Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials
The Lancet · 2022 SCI-Expanded
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Makale Bilgileri
DergiThe Lancet
Yayın TarihiŞubat 2022
Cilt / Sayfa399 · 741-755
Scopus ID2-s2.0-85124662878
Özet
Background: To reduce treatment burden and optimise patient outcomes in diabetic macular oedema, we present 1-year results from two phase 3 trials of faricimab, a novel angiopoietin-2 and vascular endothelial growth factor-A bispecific antibody. Methods: YOSEMITE and RHINE were randomised, double-masked, non-inferiority trials across 353 sites worldwide. Adults with vision loss due to centre-involving diabetic macular oedema were randomly assigned (1:1:1) to intravitreal faricimab 6·0 mg every 8 weeks, faricimab 6·0 mg per personalised treatment interval (PTI), or aflibercept 2·0 mg every 8 weeks up to week 100. PTI dosing intervals were extended, maintained, or reduced (every 4 weeks up to every 16 weeks) based on disease activity at active dosing visits. The primary endpoint was mean change in best-corrected visual acuity at 1 year, averaged over weeks 48, 52, and 56. Efficacy analyses included the intention-to-treat population (non-inferiority margin 4 Early Treatment Diabetic Retinopathy Study [ETDRS] letters); safety analyses included patients with at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (YOSEMITE NCT03622580 and RHINE NCT03622593). Findings: 3247 patients were screened for eligibility in YOSEMITE (n=1532) and RHINE (n=1715). After exclusions, 940 patients were enrolled into YOSEMITE between Sept 5, 2018, and Sept 19, 2019, and 951 patients were enrolled into RHINE between Oct 9, 2018, and Sept 20, 2019. These 1891 patients were randomly assigned to faricimab every 8 weeks (YOSEMITE n=315, RHINE n=317), faricimab PTI (n=313, n=319), or aflibercept every 8 weeks (n=312, n=315). Non-inferiority for the primary endpoint was achieved with faricimab every 8 weeks (adjusted mean vs aflibercept every 8 weeks in YOSEMITE 10·7 ETDRS letters [97·52% CI 9·4 to 12·0] vs 10·9 ETDRS letters [9·6 to 12·2], difference −0·2 ETDRS letters [−2·0 to 1·6]; RHINE 11·8 ETDRS letters [10·6 to 13·0] vs 10·3 ETDRS letters [9·1 to 11·4] letters, difference 1·5 ETDRS letters [−0·1 to 3·2]) and faricimab PTI (YOSEMITE 11·6 ETDRS letters [10·3 to 12·9], difference 0·7 ETDRS letters [−1·1 to 2·5]; RHINE 10·8 ETDRS letters [9·6 to 11·9], difference 0·5 ETDRS letters [−1·1 to 2·1]). Incidence of ocular adverse events was comparable between faricimab every 8 weeks (YOSEMITE n=98 [31%], RHINE n=137 [43%]), faricimab PTI (n=106 [34%], n=119 [37%]), and aflibercept every 8 weeks (n=102 [33%], n=113 [36%]). Interpretation: Robust vision gains and anatomical improvements with faricimab were achieved with adjustable dosing up to every 16 weeks, demonstrating the potential for faricimab to extend the durability of treatment for patients with diabetic macular oedema. Funding: F Hoffmann-La Roche.
Yazarlar (99)
1
Charles C. Wykoff
2
Francis Abreu
3
Anthony P. Adamis
4
Karen Basu
5
David Eichenbaum
6
Zdenka Haskova
7
Hugh Lin
8
Anat Loewenstein
9
Shaun Mohan
10
Ian A. Pearce
11
Taiji Sakamoto
12
Patricio G. Schlottmann
13
David Silverman
14
Jennifer K. Sun
15
John A. Wells
16
Jeffrey R. Willis
17
Ramin Tadayoni
18
Thomas Aaberg
19
Ashkan Abbey
20
Elmira Abdulaeva
21
Santiago Abengoechea
22
Prema Abraham
23
Thomas Ach
24
Serrhel Adams
25
Alfredo Adan Civera
26
Sean Adrean
27
Hansjurgen Agostini
28
Suhail Alam
29
Arturo Alezzandrini
30
Virgil Alfaro
31
Daniel Aliseda
32
Arghavan Almony
33
Pedro Amat
34
Payam Amini
35
Andrew Antoszyk
36
Luis Arias
37
Riaz Asaria
38
Marcos Avila
39
Carl C. Awh
40
Joaquin Bafalluy
41
Carl Baker
42
Francesco Bandello
43
Mark Barakat
44
Karen Barraza
45
Gyorgy Bator
46
Caroline R. Baumal
47
Rubens Belfort
48
Chris Bergstrom
49
George Bertolucci
50
Thomas Bochow
51
Matthias Bolz
52
Emilia Borcz
53
Arnaldo Bordon
54
David Boyer
55
Galina Bratko
56
Michael Brent
57
Jamin Brown
58
David M. Brown
59
Maria Budzinskaya
60
Sylvia Buffet
61
Stuart Burgess
62
Ben Burton
63
Miguel Busquets
64
Francisco Cabrera
65
Carlo Cagini
66
Jorge Calzada
67
Peter Campochiaro
68
John Carlson
69
Alessandro Castellarin
70
Carlos Cava
71
Voraporn Chaikitmongkol
72
Clement Chan
73
Emmanuel Chang
74
Jonathan Chang
75
Andrew Chang
76
Steve Charles
77
Nauman Chaudhry
78
Caroline Chee
79
Judy Chen
80
Fred Chen
81
Shih Jen Chen
82
Richard Cheong-Leen
83
Allen Chiang
84
Mark Chittum
85
David Chow
86
Brian Connolly
87
Pierre Loic Cornut
88
Karl G. Csaky
89
Carl Danzig
90
Arup Das
91
Vesselin Daskalov
92
Carmen Desco
93
Amr Dessouki
94
John Dickinson
95
Brian Do
96
Michael Dollin
97
Pravin Dugel
98
Jaroslava Dusova
99
Bora Eldem
Kurumlar
Fondation Adolphe de Rothschild
Paris France
Genentech, Inc
San Francisco United States
Houston Methodist Hospital
Houston United States
Joslin Diabetes Center
Boston United States
Kagoshima University
Kagoshima Japan
Morsani College of Medicine
Tampa United States
Organizacion Medica de Investigacion
Buenos Aires Argentina
Palmetto Retina Center
Columbia United States
Retina Vitreous Associates of Florida
St Petersburg United States
Roche Products (Ireland)
Dublin Ireland
Roche Products Limited UK
Welwyn Garden City United Kingdom
Royal Liverpool University Hospital
Liverpool United Kingdom
Tel Aviv Sourasky Medical Center
Tel Aviv-Yafo Israel
Université Paris Cité
Paris France
Metrikler
216
Atıf
99
Yazar