SCI-Expanded
Özgün Makale
Scopus
Efficacy, durability, and safety of faricimab with extended dosing up to every 16 weeks in Japanese patients with diabetic macular edema: 1-year results from the Japan subgroup of the phase 3 YOSEMITE trial
Japanese Journal of Ophthalmology
2023
Cilt 67
Sayı 3
Scopus Eşleşmesi Bulundu
7
Atıf
67
Cilt
264-279
Sayfa
🔓
Açık Erişim
Scopus Yazarları: Nahoko Ogata, Yoshinori Mitamura, Hideyasu Oh, Haruka Ochi, Matthias Bolz, Vesselin Daskalov, Aneta Misheva, Iva Petkova, Petja Vassileva, Pierre Loic Cornut, Jean François Korobelnik, Olivier Lebreton, Ramin Tadayoni, Nicole Eter, Nicolas Feltgen, Carsten Framme, Katrin Lorenz, Attila Vajas, Balazs Varsanyi, Michaella Goldstein, Jaime Levy, Haia Morori-Katz, Irit Rosenblatt, Massimo Nicolo, Ken Hayashi, Takatoshi Maeno, Juan Ramirez Estudillo, Karen Barraza, Carlos Fernandez, Miguel Guzman, Silvio Lujan, Maciej Gawecki, Ewa Herba, Katarzyna Michalska-Malecka, Maria Muzyka-Wozniak, Kamila Nester-Ostrowska, Piotr Oleksy, Bogumil Wowra, Edward Wylęgała, Maria Budzinskaya, Alexey Kulikov, Tatiana Morugova, Maria Hurcikova, Marek Kacerík, Blandina Lipkova, Santiago Abengoechea, Alfredo Adan Civera, Pedro Amat, Francisco Cabrera, Carlos Cava, Alfredo Garcia-Layana, Francisco Gomez Ulla, Jose Maria Ruiz Moreno, Masahiko Shimura, Shigehiko Kitano, Shino Ohsawa, Akito Hirakata, Oliver Findl, Andreas Pollreisz, Martin Weger, Daniela Tosheva Guneva, Georg Spital, Gyorgy Bator, András I. Seres, Lajos Szalczer, Edit Toth-Molnar, Barak Yoreh, Francesco Bandello, Carlo Cagini, Leonardo Mastropasqua, Maria Cristina Parravano, Francesco Viola, Akira Fukutomi, Shigeru Honda, Yasuhiro Ikeda, Yasuki Ito, Tsutomu Kawasaki, Kazuhiro Kimura, Genichiro Kishino, Tomoaki Murakami, Kousuke Noda, Akira Obana, Osamu Sawada, Akito Shimouchi, Masahiko Sugimoto, Iichiro Sugita, Hitoshi Takagi, Kei Takayama, Teruyo Tanabe, Tsutomu Yasukawa, Shigeo Yoshida, Renata Garcia, David Lozano Rechy, Virgilio Morales Canton
Özet
Purpose: To evaluate efficacy, durability, and safety of faricimab in Japanese patients with diabetic macular edema (DME). Study design: Subgroup analysis of 2 global, multicenter, randomized, double-masked, active-comparator–controlled, phase 3 trials (YOSEMITE, NCT03622580; RHINE, NCT03622593). Methods: Patients with DME were randomized 1:1:1 to intravitreal faricimab 6.0 mg every 8 weeks (Q8W), faricimab 6.0 mg per personalized treatment interval (PTI), or aflibercept 2.0 mg Q8W through week 100. Primary endpoint was best-corrected visual acuity (BCVA) change from baseline at 1 year, averaged over weeks 48, 52, and 56. This is the first time 1-year outcomes between Japanese patients (only enrolled into YOSEMITE) and the pooled YOSEMITE/RHINE cohort (N = 1891) have been compared. Results: The YOSEMITE Japan subgroup included 60 patients randomized to faricimab Q8W (n = 21), faricimab PTI (n = 19), or aflibercept Q8W (n = 20). Consistent with global results, the adjusted mean (95.04% confidence interval) BCVA change at 1 year in the Japan subgroup was comparable with faricimab Q8W (+11.1 [7.6–14.6] letters), faricimab PTI (+8.1 [4.4–11.7] letters), and aflibercept Q8W (+6.9 [3.3–10.5] letters). At week 52, 13 (72%) patients in the faricimab PTI arm achieved ≥ Q12W dosing, including 7 (39%) patients receiving Q16W dosing. Anatomic improvements with faricimab were generally consistent between the Japan subgroup and pooled YOSEMITE/RHINE cohort. Faricimab was well tolerated; no new or unexpected safety signals were identified. Conclusion: Consistent with global results, faricimab up to Q16W offered durable vision gains and improved anatomic and disease-specific outcomes among Japanese patients with DME.
Anahtar Kelimeler (Scopus)
Angiopoietin-2
Anti-VEGF therapy
Diabetic macular edema
Faricimab
Vascular stability
Scimago Dergi Bilgisi
Otomatik ISSN Eşleştirmesi
2023 yılı verileri
Japanese Journal of Ophthalmology
Q1
SJR Quartile
0,907
SJR Skoru
70
H-Index
Kategoriler: Medicine (miscellaneous) (Q1) · Ophthalmology (Q1)
Alanlar: Medicine
Ülke: Japan
· Springer
Bu bilgiler makale yılına göre Scimago veritabanından ISSN eşleştirmesiyle otomatik getirilmektedir.
Dergi sıralama verileri Scimago'nun ilgili yılı baz alınmaktadır.
Anahtar Kelimeler
Angiopoietin-2
Anti-VEGF therapy
Diabetic macular edema
Faricimab
Vascular stability
Makale Bilgileri
Dergi
Japanese Journal of Ophthalmology
ISSN
0021-5155
Yıl
2023
/ 3. ay
Cilt / Sayı
67
/ 3
Sayfalar
264 – 279
Makale Türü
Özgün Makale
Hakemlik
Hakemli
Endeks
SCI-Expanded
Yayın Dili
Türkçe
Kapsam
Uluslararası
Toplam Yazar
361 kişi
Erişim Türü
Basılı+Elektronik
Erişim Linki
Makaleye Git
Alan
Sağlık Bilimleri Temel Alanı
Göz Hastalıkları
YÖKSİS Yazar Kaydı
Yazar Adı
ELDEM MEHMET BORA,MENTEŞ JALE,TURĞUT ÖZTÜRK BANU
YÖKSİS ID
8483458
Hızlı Erişim
Metrikler
Scopus Atıf
7
Yazar Sayısı
361