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阿柏西普治疗对贝伐单抗和雷珠单抗耐药的渗出性年龄相关性黄斑变性

Aflibercept therapy for exudative age-related macular degeneration resistant to bevacizumab and ranibizumab.

作者信息

Hamid Mohamed A, Abdelfattah Nizar S, Salamzadeh Jamshid, Abdelaziz Sahar T A, Sabry Ahmed M, Mourad Khaled M, Shehab Azza A, Kuppermann Baruch D

机构信息

Department of Ophthalmology, Gavin Herbert Eye Institute, University of California Irvine, Irvine, CA, USA.

Department of Ophthalmology, Minia University, Minia, 61111, Egypt.

出版信息

Int J Retina Vitreous. 2021 Apr 1;7(1):26. doi: 10.1186/s40942-021-00299-4.

Abstract

BACKGROUND

Despite the good outcomes achieved with intravitreal angiogenic therapy, a subset of neovascular age-related macular degeneration (AMD) patients experience resistance to therapy after repeated injections. Switching drugs could offer benefit to this group of patients.

PURPOSE

To determine visual and anatomical outcomes in a cohort of neovascular AMD patients resistant to repeated injections of bevacizumab/ranibizumab after switching to aflibercept therapy.

METHODS

This was a retrospective chart review of patients who had a diagnosis of neovascular AMD and persistent intraretinal (IRF) and/or subretinal fluid (SRF) on optical coherence tomography (OCT) for at least 3 months despite monthly bevacizumab and/or ranibizumab injections prior to transition to aflibercept. We reviewed patients' records and OCT images obtained at baseline, 1, 3, 6 and 12 months after transition to aflibercept. Data collected included demographics, best-corrected visual acuity (BCVA), number of injections received and the occurrence of any adverse events. Studied OCT parameters included central macular thickness (CMT) values and the presence or absence of SRF, IRF and/or pigment epithelial detachment (PED) at each visit.

RESULTS

We included 53 eyes of 48 patients. Mean change in BCVA from baseline was 0.05 ± 0.13 (P = 0.01) at M1, 0.04 ± 0.16 (P = 0.08) at M3, 0.01 ± 0.22 (P = 0.9) at M6, and 0.02 ± 0.28 (P = 1) at M12, while the mean change in CMT from baseline was 64 ± 75 μm (P < 0.0001) at M1, 42 ± 85 μm (P = 0.002) at M3, 47 ± 69 μm (P < 0.0001) at M6, and 46 ± 99 μm (P = 0.001) at M12. The percentage of eyes with SRF decreased from 77.4% at baseline to 39.6% at M1, then increased to 47.2% at M3, then decreased to 43.4% at M6, and to 41.5% at M12 (All p < 0.001, compared to baseline). Compared to baseline, there was a statistically significant decrease in the percentage of eyes having IRF from 47.2 to 20.8% at M1 (p < 0.001), 30.2% at M3, 24.5% at M6 and 26.4% at M12 (p < 0.01, each). The number of bevacizumab and/or ranibizumab injections (7.36 ± 1.85) was significantly higher than that of aflibercept (6.47 ± 2.45, p = 0.001). A significant direct relationship between CMT reduction and BCVA improvement was demonstrated at M1 (p = 0.01, r = 0.36), M3 (p = 0.03, r = 0.30) and M12 (p = 0.03, r = 0.30). Eyes with IRF had significantly poorer BCVA than eyes without IRF at baseline (p = 0.02) and M3 (p = 0.04).

CONCLUSION

Switching to intravitreal aflibercept therapy in a cohort of neovascular AMD patients resistant to chronic bevacizumab and/or ranibizumab injections can lead to significant visual improvement in the short term and sustained reduction of central macular thickness over 1 year of followup.

摘要

背景

尽管玻璃体内血管生成疗法取得了良好的治疗效果,但一部分新生血管性年龄相关性黄斑变性(AMD)患者在多次注射后对治疗产生耐药性。更换药物可能对这组患者有益。

目的

确定一组对贝伐单抗/雷珠单抗多次注射耐药的新生血管性AMD患者在改用阿柏西普治疗后的视力和解剖学结果。

方法

这是一项回顾性病历审查,研究对象为被诊断为新生血管性AMD且在光学相干断层扫描(OCT)上存在视网膜内(IRF)和/或视网膜下液(SRF)至少3个月的患者,这些患者在改用阿柏西普之前每月接受贝伐单抗和/或雷珠单抗注射。我们回顾了患者在改用阿柏西普之前的基线以及之后1、3、6和12个月时的病历和OCT图像。收集的数据包括人口统计学资料、最佳矫正视力(BCVA)、接受的注射次数以及任何不良事件的发生情况。研究的OCT参数包括每次就诊时的中心黄斑厚度(CMT)值以及SRF、IRF和/或色素上皮脱离(PED)的有无。

结果

我们纳入了48例患者的53只眼。BCVA自基线的平均变化在M1时为0.05±0.13(P = 0.01),M3时为0.04±0.16(P = 0.08),M6时为0.01±0.22(P = 0.9),M12时为0.02±0.28(P = 1);而CMT自基线的平均变化在M1时为64±75μm(P < 0.0001),M3时为42±85μm(P = 0.002),M6时为47±69μm(P < 0.0001),M12时为46±99μm(P = 0.001)。有SRF的眼的百分比从基线时的77.4%降至M1时的39.6%,然后在M3时升至47.2%,接着在M6时降至43.4%,在M12时降至41.5%(与基线相比,所有P < 0.001)。与基线相比,有IRF的眼的百分比在M1时从47.2%显著降至20.8%(P < 0.001),M3时为30.2%,M6时为24.5%,M12时为26.4%(每次P < 0.01)。贝伐单抗和/或雷珠单抗的注射次数(7.36±1.85)显著高于阿柏西普(6.47±2.45,P = 0.001)。在M1(P = 0.01,r = 0.36)、M3(P = 0.03,r = 0.30)和M12(P = 0.03,r = 0.30)时,CMT降低与BCVA改善之间存在显著的直接关系。在基线时(P = 0.02)和M3时(P = 0.04),有IRF的眼的BCVA显著低于无IRF的眼。

结论

对于一组对慢性贝伐单抗和/或雷珠单抗注射耐药的新生血管性AMD患者,改用玻璃体内阿柏西普治疗可在短期内显著改善视力,并在1年的随访中持续降低中心黄斑厚度。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec5f/8017745/9a5ebd575df8/40942_2021_299_Fig1_HTML.jpg

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