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

Shimura, M.; Kitano, S.; Ogata, N.; Mitamura, Y.; Oh, H.; Ochi, H.; Ohsawa, S.; Hirakata, A.; Bolz, M.; Findl, O.; Pollreisz, A.; Weger, M.; Daskalov, V.; Misheva, A.; Petkova, I.; Guneva, D. T.; Vassileva, P.; Cornut, P. L.; Korobelnik, J. F.; Lebreton, O.; Tadayoni, R.; Eter, N.; Feltgen, N.; Framme, C.; Lorenz, K.; Spital, G.; Bator, G.; Seres, A.; Szalczer, L.; Toth-Molnar, E.; Vajas, A.; Varsanyi, B.; Goldstein, M.; Levy, J.; Morori-Katz, H.; Rosenblatt, I.; Yoreh, B.; Bandello, F.; Cagini, C.; Mastropasqua, L.; Nicolo, M.; Parravano, Mariacristina; Viola, F.; Fukutomi, A.; Hayashi, K.; Hirakata, A.; Honda, S.; Ikeda, Y.; Ito, Y.; Kawasaki, T.; Kimura, K.; Kishino, G.; Kitano, S.; Maeno, T.; Mitamura, Y.; Murakami, T.; Noda, K.; Obana, A.; Ogata, N.; Oh, H.; Sawada, O.; Shimouchi, A.; Shimura, M.; Sugimoto, M.; Sugita, I.; Takagi, H.; Takayama, K.; Tanabe, T.; Yasukawa, T.; Yoshida, S.; Garcia, R.; Rechy, D. L.; Canton, V. M.; Estudillo, J. R.; Barraza, K.; Fernandez, C.; Guzman, M.; Lujan, S.; Gawecki, M.; Herba, E.; Michalska-Malecka, K.; Muzyka-Wozniak, M.; Nester-Ostrowska, K.; Oleksy, P.; Wowra, B.; Wylegala, E.; Budzinskaya, M.; Kulikov, A.; Morugova, T.; Hurcikova, M.; Kacerik, M.; Lipkova, B.; Abengoechea, S.; Civera, A. A.; Amat, P.; Cabrera, F.; Cava, C.; Garcia-Layana, A.; Ulla, F. G.; Moreno, J. M. R.; Vela, J. I.; Eldem, B.; Mentes, J.; Ozturk, B.; Aaberg Jr, T.; Abbey, A. C. K.; Abraham, P.; Alam, S.; Almony, A.; Amini, P.; Antoszyk, A.; Baker, C.; Bertolucci, G.; Bochow, T.; Brown, J.; Busquets, M. I. R.; Campochiaro, P.; Carlson, J.; Chan, C.; Chang, E.; Chang, J.; Charles, S. C. J.; Chen, J. F. A.; Danzig, C.; Das, A.; Dessouki, A.; B. J. M., Do; Feiner, L.; Ferrone, P.; Fine, H.; Fox, G. M.; Foxman, S.; Ghorayeb, G.; Gonzalez, V.; Greven, C.; Gupta, S.; Hau, V. H. V.; Heier, J.; Holekamp, N.; Hsu, J. R. C.; Hu, A.; Jacoby, R.; Javey, G.; Javid, C.; Kapoor, K.; Khanani, A.; Kim, B.; Kwun, R.; Laird, P.; Lee, S.; Liu, M.; London, N.; Makkouk, F. J. C.; Malik, K.; Maturi, R.; Mccabe, F.; Moore, J.; Newell, C.; Nielsen, J.; Oh, K.; Ohr, M.; Osher, J.; Parke, D. W.; Patel, S.; Patel, S.; Rathod, R.; Rofagha, S.; Rosberger, D.; Schadlu, R.; Shah, S.; Singer, M.; Singerman, L.; Stern, J.; Stoltz, R.; Stone, C.; Suan, E.; Sun, J.; Suner, I.; Tlucek, P.; Torti, R.; Weber, P.; Wee, R. K. G.; Weishaar, P.; Williams, T. R. W. T.; Wolfe, J.; Wykoff, C. C.; Yiu, G.; Alezzandrini, A.; Bafalluy, J.; Sola, F. F.; Schlottmann, P.; Zambrano, A.; Zeolite, C.; Chang, A.; Chen, F.; Fraser-Bell, S.; Mitchell, P.; Sandhu, S.; Wickremasinghe, S.; Wong, J.; Avila, M.; Belfort Jr, R.; Bordon, A.; Lavinsky, D.; Neto, J.; Penha, F.; Salomao, G.; Taleb, A.; Zacharias, L.; Brent, M.; Chow, D.; Dickinson, J.; Dollin, M.; Lalonde, L.; Ma, P.; Olivier, S.; Sheidow, T.; Williams, G.; Wong, D.; Sun, X.; Dusova, J.; Ernest, J.; Farkas, A.; Nemcansky, J.; Veith, M.; Larsen, M.; Laugesen, C.; Vorum, H.; Buffet, S.; Razavi, H.; Souied, E.; Agostini, H.; Kampik, D. A. T.; Lohmann, C. P.; Priglinger, S. W. A.; Sandner, D.; Schuart, C. W. T.; Seitz, B.; Fung, N. W. I.; Lai, T.; Kerenyi, A.; Papp, A.; Szecsko, T.; Vogt, G.; Lanzetta, P.; Nardi, M.; Pertile, G.; Ricci, F.; Virgili, G.; Kang, S. W.; Park, K. H.; Yoon, Y. H.; H. G., Yu; S. Y., Yu; Borcz, E.; Kaluzny, J.; Raczynska, D.; Romanczak, D.; Romanowska-Dixon, B.; Sikorski, B.; Zakrzewska, K. Z.; Zatorska, B.; Figueira, J.; Gomes, N.; Silva, R.; Vaz-Pereira, S.; Abdulaeva, E.; Bratko, G.; Pozdeyeva, N.; Yurieva, T.; Chee, C.; Rajagopalan, R.; Tan, G.; Aliseda, D.; Arias, L.; Desco, C.; Escobar, J. J.; Vega, A. F.; Figueroa, M.; Gallego-Pinazo, R.; Montero, J.; Sararols, L.; Hatz, K.; Chen, S. -J.; Lai, C. -C.; Yang, C. -H.; Chaikitmongkol, V.; Pongsachareonnont, P.; Ruamviboonsuk, P.; Karabas, L.; Ozcaliskan, S. P. I.; Sermet, F.; Yilmaz, G.; Asaria, R.; Burton, B.; Cheong-Leen, R. G. S.; Esposti, S.; Ghanchi, F.; Harris, M. M. H.; Jackson, T.; Jafree, A.; Lotery, A.; Mckibbin, M.; Menon, G.; Mohamed, Q.; Pearce, I.; Peto, T.; Ross, A.; Stone, A. M. S.; Talks, J.; Varma, D.; Adams, S.; Adrean, S.; Alfaro, V.; Awh, C. C.; Barakat, M. D. P.; Baumal, C.; Bergstrom, C.; Boyer, D.; Brown, D. M.; Burgess, S.; Castellarin, A.; Chaudhry, N.; Chiang, A. H. A.; Connolly, B.; Eichenbaum, D.; Engstrom, R.; Falk, N.; Fortun, J.; Goldberg, R.; Hershberger, V.; Higgins, P.; Khurana, R.; Kuriyan, A.; Kwong, H. K. -M. K.; Liu, J. T. A.; Marcus, D.; Margherio, A.; Modi, Y.; Oliver, S.; Pearlman, J.; Perkins, S.; Pieramici, D.; Qureshi, J.; Raskauskas, P.; Rosenblatt, B.; Shah, A.; Shah, R.; Sharma, S. S. R.; Sheth, V.; Spinak, D. J.; Steinle, N.; Stoller, G.; Tabassian, A.; Taylor, S. C. M.; Thompson, J.; Uchiyama, E.; Wells, J. A.; Wong, R.; Yates, P.; Zheutlin, J.

doi:10.1007/s10384-023-00979-8

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.

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

Shimura M.;Kitano S.;Ogata N.;Mitamura Y.;Oh H.;Ochi H.;Ohsawa S.;Hirakata A.;Bolz M.;Findl O.;Pollreisz A.;Weger M.;Daskalov V.;Misheva A.;Petkova I.;Guneva D. T.;Vassileva P.;Cornut P. L.;Korobelnik J. F.;Lebreton O.;Tadayoni R.;Eter N.;Feltgen N.;Framme C.;Lorenz K.;Spital G.;Bator G.;Seres A.;Szalczer L.;Toth-Molnar E.;Vajas A.;Varsanyi B.;Goldstein M.;Levy J.;Morori-Katz H.;Rosenblatt I.;Yoreh B.;Bandello F.;Cagini C.;Mastropasqua L.;Nicolo M.;Parravano, Mariacristina;Viola F.;Fukutomi A.;Hayashi K.;Hirakata A.;Honda S.;Ikeda Y.;Ito Y.;Kawasaki T.;Kimura K.;Kishino G.;Kitano S.;Maeno T.;Mitamura Y.;Murakami T.;Noda K.;Obana A.;Ogata N.;Oh H.;Sawada O.;Shimouchi A.;Shimura M.;Sugimoto M.;Sugita I.;Takagi H.;Takayama K.;Tanabe T.;Yasukawa T.;Yoshida S.;Garcia R.;Rechy D. L.;Canton V. M.;Estudillo J. R.;Barraza K.;Fernandez C.;Guzman M.;Lujan S.;Gawecki M.;Herba E.;Michalska-Malecka K.;Muzyka-Wozniak M.;Nester-Ostrowska K.;Oleksy P.;Wowra B.;Wylegala E.;Budzinskaya M.;Kulikov A.;Morugova T.;Hurcikova M.;Kacerik M.;Lipkova B.;Abengoechea S.;Civera A. A.;Amat P.;Cabrera F.;Cava C.;Garcia-Layana A.;Ulla F. G.;Moreno J. M. R.;Vela J. I.;Eldem B.;Mentes J.;Ozturk B.;Aaberg Jr T.;Abbey A. C. K.;Abraham P.;Alam S.;Almony A.;Amini P.;Antoszyk A.;Baker C.;Bertolucci G.;Bochow T.;Brown J.;Busquets M. I. R.;Campochiaro P.;Carlson J.;Chan C.;Chang E.;Chang J.;Charles S. C. J.;Chen J. F. A.;Danzig C.;Das A.;Dessouki A.;Do B. J. M.;Feiner L.;Ferrone P.;Fine H.;Fox G. M.;Foxman S.;Ghorayeb G.;Gonzalez V.;Greven C.;Gupta S.;Hau V. H. V.;Heier J.;Holekamp N.;Hsu J. R. C.;Hu A.;Jacoby R.;Javey G.;Javid C.;Kapoor K.;Khanani A.;Kim B.;Kwun R.;Laird P.;Lee S.;Liu M.;London N.;Makkouk F. J. C.;Malik K.;Maturi R.;McCabe F.;Moore J.;Newell C.;Nielsen J.;Oh K.;Ohr M.;Osher J.;Parke D. W.;Patel S.;Patel S.;Rathod R.;Rofagha S.;Rosberger D.;Schadlu R.;Shah S.;Singer M.;Singerman L.;Stern J.;Stoltz R.;Stone C.;Suan E.;Sun J.;Suner I.;Tlucek P.;Torti R.;Weber P.;Wee R. K. G.;Weishaar P.;Williams T. R. W. T.;Wolfe J.;Wykoff C. C.;Yiu G.;Alezzandrini A.;Bafalluy J.;Sola F. F.;Schlottmann P.;Zambrano A.;Zeolite C.;Chang A.;Chen F.;Fraser-Bell S.;Mitchell P.;Sandhu S.;Wickremasinghe S.;Wong J.;Avila M.;Belfort Jr R.;Bordon A.;Lavinsky D.;Neto J.;Penha F.;Salomao G.;Taleb A.;Zacharias L.;Brent M.;Chow D.;Dickinson J.;Dollin M.;Lalonde L.;Ma P.;Olivier S.;Sheidow T.;Williams G.;Wong D.;Sun X.;Dusova J.;Ernest J.;Farkas A.;Nemcansky J.;Veith M.;Larsen M.;Laugesen C.;Vorum H.;Buffet S.;Razavi H.;Souied E.;Agostini H.;Kampik D. A. T.;Lohmann C. P.;Priglinger S. W. A.;Sandner D.;Schuart C. W. T.;Seitz B.;Fung N. W. I.;Lai T.;Kerenyi A.;Papp A.;Szecsko T.;Vogt G.;Lanzetta P.;Nardi M.;Pertile G.;Ricci F.;Virgili G.;Kang S. W.;Park K. H.;Yoon Y. H.;Yu H. G.;Yu S. Y.;Borcz E.;Kaluzny J.;Raczynska D.;Romanczak D.;Romanowska-Dixon B.;Sikorski B.;Zakrzewska K. Z.;Zatorska B.;Figueira J.;Gomes N.;Silva R.;Vaz-Pereira S.;Abdulaeva E.;Bratko G.;Pozdeyeva N.;Yurieva T.;Chee C.;Rajagopalan R.;Tan G.;Aliseda D.;Arias L.;Desco C.;Escobar J. J.;Vega A. F.;Figueroa M.;Gallego-Pinazo R.;Montero J.;Sararols L.;Hatz K.;Chen S. -J.;Lai C. -C.;Yang C. -H.;Chaikitmongkol V.;Pongsachareonnont P.;Ruamviboonsuk P.;Karabas L.;Ozcaliskan S. P. I.;Sermet F.;Yilmaz G.;Asaria R.;Burton B.;Cheong-Leen R. G. S.;Esposti S.;Ghanchi F.;Harris M. M. H.;Jackson T.;Jafree A.;Lotery A.;McKibbin M.;Menon G.;Mohamed Q.;Pearce I.;Peto T.;Ross A.;Stone A. M. S.;Talks J.;Varma D.;Adams S.;Adrean S.;Alfaro V.;Awh C. C.;Barakat M. D. P.;Baumal C.;Bergstrom C.;Boyer D.;Brown D. M.;Burgess S.;Castellarin A.;Chaudhry N.;Chiang A. H. A.;Connolly B.;Eichenbaum D.;Engstrom R.;Falk N.;Fortun J.;Goldberg R.;Hershberger V.;Higgins P.;Khurana R.;Kuriyan A.;Kwong H. K. -M. K.;Liu J. T. A.;Marcus D.;Margherio A.;Modi Y.;Oliver S.;Pearlman J.;Perkins S.;Pieramici D.;Qureshi J.;Raskauskas P.;Rosenblatt B.;Shah A.;Shah R.;Sharma S. S. R.;Sheth V.;Spinak D. J.;Steinle N.;Stoller G.;Tabassian A.;Taylor S. C. M.;Thompson J.;Uchiyama E.;Wells J. A.;Wong R.;Yates P.;Zheutlin J.

2023-01-01

Abstract

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.

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	Anno
	
				2023
			
	Parole chiave
	
				Angiopoietin-2
Anti-VEGF therapy
Diabetic macular edema
Faricimab
Vascular stability
			
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/20.500.14245/9782

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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

2023-01-01

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