Johns Hopkins Medicine Wilmer Eye Institute, Baltimore, Maryland, USA.
Department of Ophthalmology, University Hospital Kralovske Vinohrady, Prague, Czech Republic.
Br J Ophthalmol. 2023 Mar;107(3):384-391. doi: 10.1136/bjophthalmol-2021-319637. Epub 2021 Oct 16.
BACKGROUND/AIMS: To provide longer-term data on efficacy, safety, immunogenicity and pharmacokinetics (PK) of ranibizumab biosimilar SB11 compared with the reference ranibizumab (RBZ) in patients with neovascular age-related macular degeneration (nAMD).
: Multicentre. : Randomised, double-masked, parallel-group, phase III equivalence study. : ≥50 years old participants with nAMD (n=705), one 'study eye'.
1:1 randomisation to monthly intravitreal injection of 0.5 mg SB11 or RBZ. : Visual efficacy endpoints, safety, immunogenicity and PK up to 52 weeks.
Baseline and disease characteristics were comparable between treatment groups. Of 705 randomised participants (SB11: n=351; RBZ: n=354), 634 participants (89.9%; SB11: n=307; RBZ: n=327) completed the study until week 52. Previously reported equivalence in primary efficacy remained stable up to week 52 and were comparable between SB11 and RBZ. The adjusted treatment difference between SB11 and RBZ in full analysis set at week 52 of change from baseline in best-corrected visual acuity was -0.6 letters (90% CI -2.1 to 0.9) and of change from baseline in central subfield thickness was -14.9 µm (95% CI -25.3 to -4.5). The incidence of ocular treatment-emergent adverse events (TEAEs) (SB11: 32.0% vs RBZ: 29.7%) and serious ocular TEAE (SB11: 2.9% vs RBZ: 2.3%) appeared comparable between treatment groups, and no new safety concerns were observed. The PK and immunogenicity profiles were comparable, with a 4.2% and 5.5% cumulative incidence of antidrug antibodies up to week 52 for SB11 and RBZ, respectively.
Longer-term results of this study further support the biosimilarity established between SB11 and RBZ.
背景/目的：提供雷珠单抗生物类似药 SB11 与参照药物雷珠单抗（RBZ）在治疗新生血管性年龄相关性黄斑变性（nAMD）患者中的疗效、安全性、免疫原性和药代动力学（PK）的长期数据。
多中心、随机、双盲、平行组、III 期等效性研究。纳入 nAMD（n=705）患者，单眼为“研究眼”，年龄≥50 岁。
每月进行玻璃体腔内注射 0.5mg SB11 或 RBZ，1:1 随机分组。
至 52 周的视觉疗效终点、安全性、免疫原性和 PK。
治疗组之间的基线和疾病特征具有可比性。705 名随机参与者（SB11：n=351；RBZ：n=354）中，634 名参与者（89.9%；SB11：n=307；RBZ：n=327）完成了 52 周的研究。主要疗效终点的先前报告等效性在 52 周时仍然稳定，SB11 和 RBZ 之间无差异。SB11 和 RBZ 治疗组在第 52 周时最佳矫正视力的基线变化的调整治疗差异为-0.6 个字母（90%CI-2.1 至 0.9），中央视网膜厚度的基线变化为-14.9μm（95%CI-25.3 至-4.5）。眼治疗相关不良事件（TEAE）的发生率（SB11：32.0% vs RBZ：29.7%）和严重眼 TEAE（SB11：2.9% vs RBZ：2.3%）在治疗组之间似乎相似，且未观察到新的安全性问题。PK 和免疫原性特征相似，SB11 和 RBZ 分别有 4.2%和 5.5%的累积抗药物抗体发生率至第 52 周。
本研究的长期结果进一步支持了 SB11 与 RBZ 之间的生物相似性。
