TY - JOUR
T1 - Efficacy, durability, and safety of faricimab with extended dosing up to every 16 weeks in Japanese patients with diabetic macular edema
T2 - 1-year results from the Japan subgroup of the phase 3 YOSEMITE trial
AU - on behalf of the YOSEMITE and RHINE Investigators
AU - Shimura, Masahiko
AU - Kitano, Shigehiko
AU - Ogata, Nahoko
AU - Mitamura, Yoshinori
AU - Oh, Hideyasu
AU - Ochi, Haruka
AU - Ohsawa, Shino
AU - Hirakata, Akito
AU - Bolz, Matthias
AU - Findl, Oliver
AU - Pollreisz, Andreas
AU - Weger, Martin
AU - Daskalov, Vesselin
AU - Misheva, Aneta
AU - Petkova, Iva
AU - Guneva, Daniela Tosheva
AU - Vassileva, Petja
AU - Cornut, Pierre Loic
AU - Korobelnik, Jean Francois
AU - Lebreton, Olivier
AU - Tadayoni, Ramin
AU - Eter, Nicole
AU - Feltgen, Nicolas
AU - Framme, Carsten
AU - Lorenz, Katrin
AU - Spital, Georg
AU - Bator, Gyorgy
AU - Seres, András
AU - Szalczer, Lajos
AU - Toth-Molnar, Edit
AU - Vajas, Attila
AU - Varsanyi, Balazs
AU - Goldstein, Michaella
AU - Levy, Jaime
AU - Morori-Katz, Haia
AU - Rosenblatt, Irit
AU - Yoreh, Barak
AU - Bandello, Francesco
AU - Cagini, Carlo
AU - Mastropasqua, Leonardo
AU - Nicolo, Massimo
AU - Parravano, Maria Cristina
AU - Viola, Francesco
AU - Fukutomi, Akira
AU - Hayashi, Ken
AU - Hirakata, Akito
AU - Honda, Shigeru
AU - Chang, Emmanuel
AU - Wykoff, Charles C.
AU - Brown, David M.
N1 - Publisher Copyright:
© 2023, Japanese Ophthalmological Society.
PY - 2023/5
Y1 - 2023/5
N2 - 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.
AB - 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.
KW - Angiopoietin-2
KW - Anti-VEGF therapy
KW - Diabetic macular edema
KW - Faricimab
KW - Vascular stability
KW - Receptors, Vascular Endothelial Growth Factor
KW - Diabetes Mellitus/chemically induced
KW - Japan/epidemiology
KW - Intravitreal Injections
KW - Humans
KW - Macular Edema/diagnosis
KW - Recombinant Fusion Proteins/adverse effects
KW - Treatment Outcome
KW - Visual Acuity
KW - Angiogenesis Inhibitors/therapeutic use
KW - Diabetic Retinopathy/complications
KW - East Asian People
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U2 - 10.1007/s10384-023-00979-8
DO - 10.1007/s10384-023-00979-8
M3 - Article
C2 - 36897413
AN - SCOPUS:85159762158
SN - 0021-5155
VL - 67
SP - 264
EP - 279
JO - Japanese Journal of Ophthalmology
JF - Japanese Journal of Ophthalmology
IS - 3
ER -