Abstract：
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).
Setting: Multicentre. Design: Randomised, double-masked, parallel-group, phase III equivalence study. Patient population: ≥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. Main outcome measures: 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.
Setting: Multicentre. Design: Randomised, double-masked, parallel-group, phase III equivalence study. Patient population: ≥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. Main outcome measures: 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.
摘要：
目的：为了提供更长期的疗效数据，安全,雷珠单抗生物仿制药SB11与参考雷珠单抗（RBZ）在新生血管性年龄相关性黄斑变性（nAMD）患者中的免疫原性和药代动力学（PK）。
方法：设置：多中心。设计：随机，双面蒙面,平行组，第三阶段等效性研究。患者人群：≥50岁的nAMD参与者（n=705），一只“研究眼睛”。
方法：1:1随机分组，每月玻璃体内注射0.5mgSB11或RBZ。主要结果指标：视觉功效终点，安全,免疫原性和PK长达52周。
结果：治疗组之间的基线和疾病特征相当。在705名随机参与者中（SB11：n=351；RBZ：n=354），634名参与者(89.9%;SB11:n=307;RBZ:n=327)完成研究直到第52周。先前报道的主要疗效的等效性在第52周保持稳定，并且在SB11和RBZ之间具有可比性。在第52周，最佳矫正视力从基线变化的完整分析集SB11和RBZ之间的调整治疗差异为-0.6个字母（90％CI-2.1至0.9），中央子场厚度从基线变化的差异为-14.9µm（95％CI-25.3至-4.5）。眼部治疗引起的不良事件（TEAE）（SB11：32.0％vsRBZ：29.7％）和严重眼部TEAE（SB11：2.9％vsRBZ：2.3％）的发生率在治疗组之间具有可比性，并且没有观察到新的安全问题。PK和免疫原性谱具有可比性，SB11和RBZ的抗药物抗体累积发生率为4.2%和5.5%，直至第52周，分别。
结论：本研究的长期结果进一步支持了SB11和RBZ之间建立的生物相似性。
方法：设置：多中心。
方法：1:1随机分组，每月玻璃体内注射0.5mgSB11或RBZ。
结果：治疗组之间的基线和疾病特征相当。
结论：本研究的长期结果进一步支持了SB11和RBZ之间建立的生物相似性。
