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. Japanese Ophthalmological Society..
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:67 |
|---|---|
| Enthalten in: |
Japanese journal of ophthalmology - 67(2023), 3 vom: 10. Mai, Seite 264-279 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Shimura, Masahiko [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 08.06.2023 Date Revised 08.06.2023 published: Print-Electronic ClinicalTrials.gov: NCT03622580, NCT03622593 Citation Status MEDLINE |
|---|
| doi: |
10.1007/s10384-023-00979-8 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM354030965 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM354030965 | ||
| 003 | DE-627 | ||
| 005 | 20231226061339.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1007/s10384-023-00979-8 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1180.xml |
| 035 | |a (DE-627)NLM354030965 | ||
| 035 | |a (NLM)36897413 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Shimura, Masahiko |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy, durability, and safety of faricimab with extended dosing up to every 16 weeks in Japanese patients with diabetic macular edema |b 1-year results from the Japan subgroup of the phase 3 YOSEMITE trial |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 08.06.2023 | ||
| 500 | |a Date Revised 08.06.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03622580, NCT03622593 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. Japanese Ophthalmological Society. | ||
| 520 | |a PURPOSE: To evaluate efficacy, durability, and safety of faricimab in Japanese patients with diabetic macular edema (DME) | ||
| 520 | |a STUDY DESIGN: Subgroup analysis of 2 global, multicenter, randomized, double-masked, active-comparator-controlled, phase 3 trials (YOSEMITE, NCT03622580; RHINE, NCT03622593) | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Angiopoietin-2 | |
| 650 | 4 | |a Anti-VEGF therapy | |
| 650 | 4 | |a Diabetic macular edema | |
| 650 | 4 | |a Faricimab | |
| 650 | 4 | |a Vascular stability | |
| 650 | 7 | |a Angiogenesis Inhibitors |2 NLM | |
| 650 | 7 | |a faricimab |2 NLM | |
| 650 | 7 | |a Receptors, Vascular Endothelial Growth Factor |2 NLM | |
| 650 | 7 | |a EC 2.7.10.1 |2 NLM | |
| 650 | 7 | |a Recombinant Fusion Proteins |2 NLM | |
| 700 | 1 | |a Kitano, Shigehiko |e verfasserin |4 aut | |
| 700 | 1 | |a Ogata, Nahoko |e verfasserin |4 aut | |
| 700 | 1 | |a Mitamura, Yoshinori |e verfasserin |4 aut | |
| 700 | 1 | |a Oh, Hideyasu |e verfasserin |4 aut | |
| 700 | 1 | |a Ochi, Haruka |e verfasserin |4 aut | |
| 700 | 1 | |a Ohsawa, Shino |e verfasserin |4 aut | |
| 700 | 1 | |a Hirakata, Akito |e verfasserin |4 aut | |
| 700 | 0 | |a YOSEMITE and RHINE Investigators |e verfasserin |4 aut | |
| 700 | 1 | |a Bolz, Matthias |e investigator |4 oth | |
| 700 | 1 | |a Findl, Oliver |e investigator |4 oth | |
| 700 | 1 | |a Pollreisz, Andreas |e investigator |4 oth | |
| 700 | 1 | |a Weger, Martin |e investigator |4 oth | |
| 700 | 1 | |a Daskalov, Vesselin |e investigator |4 oth | |
| 700 | 1 | |a Misheva, Aneta |e investigator |4 oth | |
| 700 | 1 | |a Petkova, Iva |e investigator |4 oth | |
| 700 | 1 | |a Guneva, Daniela Tosheva |e investigator |4 oth | |
| 700 | 1 | |a Vassileva, Petja |e investigator |4 oth | |
| 700 | 1 | |a Cornut, Pierre Loic |e investigator |4 oth | |
| 700 | 1 | |a Korobelnik, Jean Francois |e investigator |4 oth | |
| 700 | 1 | |a Lebreton, Olivier |e investigator |4 oth | |
| 700 | 1 | |a Tadayoni, Ramin |e investigator |4 oth | |
| 700 | 1 | |a Eter, Nicole |e investigator |4 oth | |
| 700 | 1 | |a Feltgen, Nicolas |e investigator |4 oth | |
| 700 | 1 | |a Framme, Carsten |e investigator |4 oth | |
| 700 | 1 | |a Lorenz, Katrin |e investigator |4 oth | |
| 700 | 1 | |a Spital, Georg |e investigator |4 oth | |
| 700 | 1 | |a Bator, Gyorgy |e investigator |4 oth | |
| 700 | 1 | |a Seres, András |e investigator |4 oth | |
| 700 | 1 | |a Szalczer, Lajos |e investigator |4 oth | |
| 700 | 1 | |a Toth-Molnar, Edit |e investigator |4 oth | |
| 700 | 1 | |a Vajas, Attila |e investigator |4 oth | |
| 700 | 1 | |a Varsanyi, Balazs |e investigator |4 oth | |
| 700 | 1 | |a Goldstein, Michaella |e investigator |4 oth | |
| 700 | 1 | |a Levy, Jaime |e investigator |4 oth | |
| 700 | 1 | |a Morori-Katz, Haia |e investigator |4 oth | |
| 700 | 1 | |a Rosenblatt, Irit |e investigator |4 oth | |
| 700 | 1 | |a Yoreh, Barak |e investigator |4 oth | |
| 700 | 1 | |a Bandello, Francesco |e investigator |4 oth | |
| 700 | 1 | |a Cagini, Carlo |e investigator |4 oth | |
| 700 | 1 | |a Mastropasqua, Leonardo |e investigator |4 oth | |
| 700 | 1 | |a Nicolo, Massimo |e investigator |4 oth | |
| 700 | 1 | |a Parravano, Maria Cristina |e investigator |4 oth | |
| 700 | 1 | |a Viola, Francesco |e investigator |4 oth | |
| 700 | 1 | |a Fukutomi, Akira |e investigator |4 oth | |
| 700 | 1 | |a Hayashi, Ken |e investigator |4 oth | |
| 700 | 1 | |a Hirakata, Akito |e investigator |4 oth | |
| 700 | 1 | |a Honda, Shigeru |e investigator |4 oth | |
| 700 | 1 | |a Ikeda, Yasuhiro |e investigator |4 oth | |
| 700 | 1 | |a Ito, Yasuki |e investigator |4 oth | |
| 700 | 1 | |a Kawasaki, Tsutomu |e investigator |4 oth | |
| 700 | 1 | |a Kimura, Kazuhiro |e investigator |4 oth | |
| 700 | 1 | |a Kishino, Genichiro |e investigator |4 oth | |
| 700 | 1 | |a Kitano, Shigehiko |e investigator |4 oth | |
| 700 | 1 | |a Maeno, Takatoshi |e investigator |4 oth | |
| 700 | 1 | |a Mitamura, Yoshinori |e investigator |4 oth | |
| 700 | 1 | |a Murakami, Tomoaki |e investigator |4 oth | |
| 700 | 1 | |a Noda, Kousuke |e investigator |4 oth | |
| 700 | 1 | |a Obana, Akira |e investigator |4 oth | |
| 700 | 1 | |a Ogata, Nahoko |e investigator |4 oth | |
| 700 | 1 | |a Oh, Hideyasu |e investigator |4 oth | |
| 700 | 1 | |a Sawada, Osamu |e investigator |4 oth | |
| 700 | 1 | |a Shimouchi, Akito |e investigator |4 oth | |
| 700 | 1 | |a Shimura, Masahiko |e investigator |4 oth | |
| 700 | 1 | |a Sugimoto, Masahiko |e investigator |4 oth | |
| 700 | 1 | |a Sugita, Iichiro |e investigator |4 oth | |
| 700 | 1 | |a Takagi, Hitoshi |e investigator |4 oth | |
| 700 | 1 | |a Takayama, Kei |e investigator |4 oth | |
| 700 | 1 | |a Tanabe, Teruyo |e investigator |4 oth | |
| 700 | 1 | |a Yasukawa, Tsutomu |e investigator |4 oth | |
| 700 | 1 | |a Yoshida, Shigeo |e investigator |4 oth | |
| 700 | 1 | |a Garcia, Renata |e investigator |4 oth | |
| 700 | 1 | |a Rechy, David Lozano |e investigator |4 oth | |
| 700 | 1 | |a Canton, Virgilio Morales |e investigator |4 oth | |
| 700 | 1 | |a Estudillo, Juan Ramirez |e investigator |4 oth | |
| 700 | 1 | |a Barraza, Karen |e investigator |4 oth | |
| 700 | 1 | |a Fernandez, Carlos |e investigator |4 oth | |
| 700 | 1 | |a Guzman, Miguel |e investigator |4 oth | |
| 700 | 1 | |a Lujan, Silvio |e investigator |4 oth | |
| 700 | 1 | |a Gawecki, Maciej |e investigator |4 oth | |
| 700 | 1 | |a Herba, Ewa |e investigator |4 oth | |
| 700 | 1 | |a Michalska-Malecka, Katarzyna |e investigator |4 oth | |
| 700 | 1 | |a Muzyka-Wozniak, Maria |e investigator |4 oth | |
| 700 | 1 | |a Nester-Ostrowska, Kamila |e investigator |4 oth | |
| 700 | 1 | |a Oleksy, Piotr |e investigator |4 oth | |
| 700 | 1 | |a Wowra, Bogumil |e investigator |4 oth | |
| 700 | 1 | |a Wylęgała, Edward |e investigator |4 oth | |
| 700 | 1 | |a Budzinskaya, Maria |e investigator |4 oth | |
| 700 | 1 | |a Kulikov, Alexey |e investigator |4 oth | |
| 700 | 1 | |a Morugova, Tatiana |e investigator |4 oth | |
| 700 | 1 | |a Hurcikova, Maria |e investigator |4 oth | |
| 700 | 1 | |a Kacerík, Marek |e investigator |4 oth | |
| 700 | 1 | |a Lipkova, Blandina |e investigator |4 oth | |
| 700 | 1 | |a Abengoechea, Santiago |e investigator |4 oth | |
| 700 | 1 | |a Civera, Alfredo Adan |e investigator |4 oth | |
| 700 | 1 | |a Amat, Pedro |e investigator |4 oth | |
| 700 | 1 | |a Cabrera, Francisco |e investigator |4 oth | |
| 700 | 1 | |a Cava, Carlos |e investigator |4 oth | |
| 700 | 1 | |a Garcia-Layana, Alfredo |e investigator |4 oth | |
| 700 | 1 | |a Ulla, Francisco Gomez |e investigator |4 oth | |
| 700 | 1 | |a Moreno, Jose Maria Ruiz |e investigator |4 oth | |
| 700 | 1 | |a Vela, Jose Ignacio |e investigator |4 oth | |
| 700 | 1 | |a Eldem, Bora |e investigator |4 oth | |
| 700 | 1 | |a Mentes, Jale |e investigator |4 oth | |
| 700 | 1 | |a Ozturk, Banu |e investigator |4 oth | |
| 700 | 1 | |a Aaberg, Thomas |c Jr |e investigator |4 oth | |
| 700 | 1 | |a Abbey, Ashkan Csaky Karl |e investigator |4 oth | |
| 700 | 1 | |a Abraham, Prema |e investigator |4 oth | |
| 700 | 1 | |a Alam, Suhail |e investigator |4 oth | |
| 773 | 0 | 8 | |i Enthalten in |t Japanese journal of ophthalmology |d 1979 |g 67(2023), 3 vom: 10. Mai, Seite 264-279 |w (DE-627)NLM01261789X |x 1613-2246 |7 nnns |
| 773 | 1 | 8 | |g volume:67 |g year:2023 |g number:3 |g day:10 |g month:05 |g pages:264-279 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1007/s10384-023-00979-8 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 67 |j 2023 |e 3 |b 10 |c 05 |h 264-279 | ||