Susumu Ishida, Shih-Jen Chen, Toshinori Murata, Yuichiro Ogura, Paisan Ruamviboonsuk, Taiji Sakamoto, Tachie Fujita, Mika Kawano, Shino Ohsawa, Francis Abreu, Zdenka Haskova, Jane Ives, David Silverman, Young Hee Yoon
{"title":"Faricimab治疗亚洲国家糖尿病黄斑水肿患者的疗效、持久性和安全性:YOSEMITE和RHINE III期试验的1年亚组分析。","authors":"Susumu Ishida, Shih-Jen Chen, Toshinori Murata, Yuichiro Ogura, Paisan Ruamviboonsuk, Taiji Sakamoto, Tachie Fujita, Mika Kawano, Shino Ohsawa, Francis Abreu, Zdenka Haskova, Jane Ives, David Silverman, Young Hee Yoon","doi":"10.1097/APO.0000000000000634","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To assess the 1-year efficacy, durability, and safety of faricimab in patients with diabetic macular edema from Asian and non-Asian countries.</p><p><strong>Design: </strong>Global, multicenter, randomized, double-masked, active comparator-controlled, phase III trials.</p><p><strong>Methods: </strong>Subgroup analysis of patients from Asian (N=144) and non-Asian (N=1747) countries randomized to faricimab 6.0 mg every 8 weeks (Q8W), faricimab per personalized treatment interval (PTI), or aflibercept 2.0 mg Q8W in the YOSEMITE/RHINE (NCT03622580/NCT03622593) trials. Primary endpoint: best-corrected visual acuity (BCVA) changes from baseline at 1 year, averaged over weeks 48, 52, and 56.</p><p><strong>Results: </strong>Mean BCVA change from baseline at 1 year in the Asian country subgroup was similar between arms: faricimab Q8W (n=50), +10.9 (95% CI: 8.6-13.2); faricimab PTI (n=48) +10.0 (7.7-12.4) letters; aflibercept Q8W (n=46) +9.0 (6.6-11.4) letters. BCVA gains in the non-Asian country subgroup (n=582, 584, 581) were +11.3 (10.5-12.1), +11.2 (10.5-12.0), and +10.7 (9.9-11.5) letters, respectively. At 1 year, 49% of Asian country patients in the faricimab PTI arm achieved Q16W dosing (vs. 52% non-Asian) and 78% achieved ≥Q12W dosing (vs. 72% non-Asian). Anatomic improvementswere generally greater with faricimab versus aflibercept and similar between the Asian and non-Asian country subgroups. Faricimab was well tolerated, with no new safety signals.</p><p><strong>Conclusions: </strong>Vision, durability, anatomic, and safety outcomes were generally similar between the Asian and non-Asian country subgroups, suggesting that global YOSEMITE/RHINE results may be generalized to the Asian population. These data support the benefit-risk profile of faricimab for treating Asian patients with diabetic macular edema.</p>","PeriodicalId":8594,"journal":{"name":"Asia-Pacific Journal of Ophthalmology","volume":null,"pages":null},"PeriodicalIF":3.7000,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy, Durability, and Safety of Faricimab in Patients From Asian Countries With Diabetic Macular Edema: 1-Year Subgroup Analysis of the Phase III YOSEMITE and RHINE Trials.\",\"authors\":\"Susumu Ishida, Shih-Jen Chen, Toshinori Murata, Yuichiro Ogura, Paisan Ruamviboonsuk, Taiji Sakamoto, Tachie Fujita, Mika Kawano, Shino Ohsawa, Francis Abreu, Zdenka Haskova, Jane Ives, David Silverman, Young Hee Yoon\",\"doi\":\"10.1097/APO.0000000000000634\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>To assess the 1-year efficacy, durability, and safety of faricimab in patients with diabetic macular edema from Asian and non-Asian countries.</p><p><strong>Design: </strong>Global, multicenter, randomized, double-masked, active comparator-controlled, phase III trials.</p><p><strong>Methods: </strong>Subgroup analysis of patients from Asian (N=144) and non-Asian (N=1747) countries randomized to faricimab 6.0 mg every 8 weeks (Q8W), faricimab per personalized treatment interval (PTI), or aflibercept 2.0 mg Q8W in the YOSEMITE/RHINE (NCT03622580/NCT03622593) trials. Primary endpoint: best-corrected visual acuity (BCVA) changes from baseline at 1 year, averaged over weeks 48, 52, and 56.</p><p><strong>Results: </strong>Mean BCVA change from baseline at 1 year in the Asian country subgroup was similar between arms: faricimab Q8W (n=50), +10.9 (95% CI: 8.6-13.2); faricimab PTI (n=48) +10.0 (7.7-12.4) letters; aflibercept Q8W (n=46) +9.0 (6.6-11.4) letters. BCVA gains in the non-Asian country subgroup (n=582, 584, 581) were +11.3 (10.5-12.1), +11.2 (10.5-12.0), and +10.7 (9.9-11.5) letters, respectively. At 1 year, 49% of Asian country patients in the faricimab PTI arm achieved Q16W dosing (vs. 52% non-Asian) and 78% achieved ≥Q12W dosing (vs. 72% non-Asian). Anatomic improvementswere generally greater with faricimab versus aflibercept and similar between the Asian and non-Asian country subgroups. Faricimab was well tolerated, with no new safety signals.</p><p><strong>Conclusions: </strong>Vision, durability, anatomic, and safety outcomes were generally similar between the Asian and non-Asian country subgroups, suggesting that global YOSEMITE/RHINE results may be generalized to the Asian population. These data support the benefit-risk profile of faricimab for treating Asian patients with diabetic macular edema.</p>\",\"PeriodicalId\":8594,\"journal\":{\"name\":\"Asia-Pacific Journal of Ophthalmology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2023-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Asia-Pacific Journal of Ophthalmology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/APO.0000000000000634\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/9/22 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"OPHTHALMOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Asia-Pacific Journal of Ophthalmology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/APO.0000000000000634","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/9/22 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
Efficacy, Durability, and Safety of Faricimab in Patients From Asian Countries With Diabetic Macular Edema: 1-Year Subgroup Analysis of the Phase III YOSEMITE and RHINE Trials.
Purpose: To assess the 1-year efficacy, durability, and safety of faricimab in patients with diabetic macular edema from Asian and non-Asian countries.
Design: Global, multicenter, randomized, double-masked, active comparator-controlled, phase III trials.
Methods: Subgroup analysis of patients from Asian (N=144) and non-Asian (N=1747) countries randomized to faricimab 6.0 mg every 8 weeks (Q8W), faricimab per personalized treatment interval (PTI), or aflibercept 2.0 mg Q8W in the YOSEMITE/RHINE (NCT03622580/NCT03622593) trials. Primary endpoint: best-corrected visual acuity (BCVA) changes from baseline at 1 year, averaged over weeks 48, 52, and 56.
Results: Mean BCVA change from baseline at 1 year in the Asian country subgroup was similar between arms: faricimab Q8W (n=50), +10.9 (95% CI: 8.6-13.2); faricimab PTI (n=48) +10.0 (7.7-12.4) letters; aflibercept Q8W (n=46) +9.0 (6.6-11.4) letters. BCVA gains in the non-Asian country subgroup (n=582, 584, 581) were +11.3 (10.5-12.1), +11.2 (10.5-12.0), and +10.7 (9.9-11.5) letters, respectively. At 1 year, 49% of Asian country patients in the faricimab PTI arm achieved Q16W dosing (vs. 52% non-Asian) and 78% achieved ≥Q12W dosing (vs. 72% non-Asian). Anatomic improvementswere generally greater with faricimab versus aflibercept and similar between the Asian and non-Asian country subgroups. Faricimab was well tolerated, with no new safety signals.
Conclusions: Vision, durability, anatomic, and safety outcomes were generally similar between the Asian and non-Asian country subgroups, suggesting that global YOSEMITE/RHINE results may be generalized to the Asian population. These data support the benefit-risk profile of faricimab for treating Asian patients with diabetic macular edema.
期刊介绍:
The Asia-Pacific Journal of Ophthalmology, a bimonthly, peer-reviewed online scientific publication, is an official publication of the Asia-Pacific Academy of Ophthalmology (APAO), a supranational organization which is committed to research, training, learning, publication and knowledge and skill transfers in ophthalmology and visual sciences. The Asia-Pacific Journal of Ophthalmology welcomes review articles on currently hot topics, original, previously unpublished manuscripts describing clinical investigations, clinical observations and clinically relevant laboratory investigations, as well as .perspectives containing personal viewpoints on topics with broad interests. Editorials are published by invitation only. Case reports are generally not considered. The Asia-Pacific Journal of Ophthalmology covers 16 subspecialties and is freely circulated among individual members of the APAO’s member societies, which amounts to a potential readership of over 50,000.