Efficacy, durability, and safety of faricimab with extended dosing up to every 16 weeks in diabetic macular edema: 2-year results from the Japan subgroup of the phase 3 YOSEMITE trial.

IF 2.1 3区 医学 Q2 OPHTHALMOLOGY
Japanese Journal of Ophthalmology Pub Date : 2024-09-01 Epub Date: 2024-07-31 DOI:10.1007/s10384-024-01078-y
Masahiko Shimura, Hideyasu Oh, Tetsuo Ueda, Shigehiko Kitano, Yoshinori Mitamura, Junko Sato, Keisuke Iwasaki, Akito Hirakata
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引用次数: 0

Abstract

Purpose: To evaluate the 2-year efficacy, durability, and safety of faricimab in patients with diabetic macular edema (DME) in the YOSEMITE Japan subgroup.

Study design: YOSEMITE/RHINE (NCT03622580/NCT03622593) subgroup analysis: global, multicenter, randomized, double-masked, active-comparator-controlled, phase 3 faricimab trials.

Methods: Patients were randomized 1:1:1 to intravitreal faricimab 6.0 mg every 8 weeks (Q8W) and per treat-and-extend (T&E) dosing, or aflibercept 2.0 mg Q8W. Outcomes were assessed through year 2 for the YOSEMITE Japan subgroup (N = 60) and the pooled YOSEMITE/RHINE global cohort (N = 1891).

Results: In the YOSEMITE Japan subgroup, 21, 19, and 20 patients were randomized to faricimab Q8W, faricimab T&E, and aflibercept Q8W, respectively (632, 632, and 627 patients in the pooled YOSEMITE/RHINE cohort). Vision gains and anatomic improvements with faricimab at year 1 were maintained over 2 years and were generally consistent between groups. Mean best-corrected visual acuity changes from baseline at year 2 (weeks 92-100 average) for the YOSEMITE Japan subgroup were +12.5, +9.0, and +5.0 letters in the faricimab Q8W, faricimab T&E and aflibercept Q8W arms, respectively (+10.8, +10.4, and +10.3 letters in the pooled YOSEMITE/RHINE cohort). At week 96, 61.1% of the YOSEMITE Japan subgroup and 78.1% of the pooled YOSEMITE/RHINE cohort were on ≥ Q12W dosing. Faricimab was well-tolerated with a safety profile comparable with aflibercept.

Conclusion: Faricimab up to Q16W offered durable vision gains and anatomic improvements up to 2 years in patients with DME in the YOSEMITE Japan subgroup. Outcomes were generally consistent with the pooled YOSEMITE/RHINE cohort.

Abstract Image

法尼单抗在糖尿病性黄斑水肿中延长用药至每 16 周一次的疗效、持久性和安全性:YOSEMITE 3 期试验日本亚组的 2 年结果。
目的:评估法尼单抗在YOSEMITE日本亚组糖尿病黄斑水肿(DME)患者中的2年疗效、持久性和安全性:YOSEMITE/RHINE(NCT03622580/NCT03622593)亚组分析:全球性、多中心、随机、双掩蔽、主动比较对照、法利西单抗三期试验:患者按1:1:1的比例随机分配到玻璃体内法利单抗6.0毫克,每8周一次(Q8W),按治疗和延长(T&E)给药,或aflibercept 2.0毫克,每8周一次(Q8W)。对YOSEMITE日本亚组(N = 60)和YOSEMITE/RHINE全球汇总队列(N = 1891)第2年的结果进行了评估:在 YOSEMITE 日本亚组中,分别有 21、19 和 20 名患者随机接受了法利西单抗 Q8W、法利西单抗 T&E 和阿弗利百普 Q8W 治疗(YOSEMITE/RHINE 合并队列中分别有 632、632 和 627 名患者)。第一年使用法尼单抗获得的视力提高和解剖学改善在两年内得以保持,且各组之间基本一致。第 2 年(第 92-100 周平均值),YOSEMITE 日本亚组的法尼单抗 Q8W、法尼单抗 T&E 和 aflibercept Q8W 三组的最佳矫正视力与基线相比的平均变化分别为 +12.5、+9.0 和 +5.0(YOSEMITE/RHINE 汇总队列中分别为 +10.8、+10.4 和 +10.3)。第96周时,61.1%的YOSEMITE日本亚组和78.1%的YOSEMITE/RHINE汇总队列≥Q12W剂量。法利单抗耐受性良好,安全性与阿弗利百普相当:结论:对于YOSEMITE日本亚组的DME患者来说,法利单抗的剂量最高可达Q16W,可在长达2年的时间内为患者带来持久的视力提高和解剖学改善。结果与YOSEMITE/RHINE队列的总体结果基本一致。
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来源期刊
CiteScore
4.80
自引率
8.30%
发文量
65
审稿时长
6-12 weeks
期刊介绍: The Japanese Journal of Ophthalmology (JJO) was inaugurated in 1957 as a quarterly journal published in English by the Ophthalmology Department of the University of Tokyo, with the aim of disseminating the achievements of Japanese ophthalmologists worldwide. JJO remains the only Japanese ophthalmology journal published in English. In 1997, the Japanese Ophthalmological Society assumed the responsibility for publishing the Japanese Journal of Ophthalmology as its official English-language publication. Currently the journal is published bimonthly and accepts papers from authors worldwide. JJO has become an international interdisciplinary forum for the publication of basic science and clinical research papers.
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