Ben Ghezala Inès, Gabrielle Pierre-Henry, Sibert Maxime, Steinberg Laure-Anne, Dautriche Anne, Arnould Louis, Creuzot-Garcher Catherine
From the Ophthalmology Department (I.B.G., P-H.G., M.S., L-A.S., L.A., C.C-G.), University Hospital, Dijon, France; Inserm, CIC 1432 (I.B.G.), Clinical Investigation Center, Clinical Epidemiology/Clinical Trials Unit, University Hospital, Dijon, France.
From the Ophthalmology Department (I.B.G., P-H.G., M.S., L-A.S., L.A., C.C-G.), University Hospital, Dijon, France; Eye and Nutrition Research Group (P-H.G., C.C-G.), CSGA, UMR1324 INRAE, 6265 CNRS, Dijon, France.
Am J Ophthalmol. 2025 Jan;269:11-19. doi: 10.1016/j.ajo.2024.08.008. Epub 2024 Aug 10.
To describe the patient characteristics and clinical course of severe intraocular inflammation (IOI) following intravitreal injection (IVT) of faricimab.
Retrospective case series.
Case series at a single French academic center (Dijon University Hospital) where 263 patients were treated with faricimab IVT between January 9, 2024 and May 7, 2024.
Over the 4-month period, a total of 1659 eyes (1338 patients) received anti-vascular endothelial growth factor (anti-VEGF) IVTs for a total of 3510 IVTs, of which 343 eyes (263 patients) received faricimab IVTs for a total of 971 IVTs. Overall, 6 pretreated eyes with neovascular age-related macular degeneration that were switched to faricimab developed severe unilateral IOI following faricimab IVT (1/162 injections [0.62%]), including 5 eyes presenting with a severe anterior and intermediate uveitis mimicking infectious endophthalmitis. All eyes were normotensive and presented with mild to moderate pain and predominantly moderate vitritis, associated with granulomatous keratic precipitates in 2 eyes and nonocclusive vasculitis in one eye. The clinical presentation, sterile vitreous sample culture, and rapid improvement with treatment made the diagnosis of infectious endophthalmitis unlikely. Four patients out of 6 did not recover their pre-IOI visual acuity, with an average visual loss of +0.2 logMAR. Two patients had positive antinuclear antibodies, including one with a history of cutaneous lupus.
In this case series, we reported 6 cases of severe IOI after intravitreal faricimab over 4 months in a single French center with an estimated incidence rate of 0.6% per injection. Future real-world data will contribute to a better evaluation of the epidemiology of this rare inflammatory adverse event related to intravitreal faricimab.
描述玻璃体内注射法西单抗后严重眼内炎症(IOI)的患者特征和临床病程。
回顾性病例系列。
在法国一个学术中心(第戎大学医院)进行的病例系列研究,2024年1月9日至2024年5月7日期间,263例患者接受了玻璃体内注射法西单抗治疗。
在这4个月期间,共有1659只眼(1338例患者)接受了抗血管内皮生长因子(抗VEGF)玻璃体内注射,总计3510次注射,其中343只眼(263例患者)接受了法西单抗玻璃体内注射,总计971次注射。总体而言,6只先前接受治疗的新生血管性年龄相关性黄斑变性眼改用了法西单抗,在玻璃体内注射法西单抗后发生了严重的单侧IOI(1/162次注射[0.62%]),其中5只眼表现为严重的前部和中间葡萄膜炎,类似于感染性眼内炎。所有眼眼压均正常,伴有轻至中度疼痛,主要为中度玻璃体炎,2只眼伴有肉芽肿性角膜后沉着物,1只眼伴有非闭塞性血管炎。临床表现、无菌玻璃体样本培养以及治疗后迅速改善,使得感染性眼内炎的诊断不太可能。6例患者中有4例未恢复到IOI前的视力,平均视力下降+0.2 logMAR。2例患者抗核抗体呈阳性,其中1例有皮肤狼疮病史。
在本病例系列中,我们报告了在法国一个单一中心4个月内玻璃体内注射法西单抗后发生6例严重IOI的病例,估计每次注射的发生率为0.6%。未来的真实世界数据将有助于更好地评估这种与玻璃体内注射法西单抗相关的罕见炎症不良事件的流行病学情况。