Department of Ophthalmology, Seoul National University Bundang Hospital, Republic of Korea.
Samsung Bioepis, Incheon, Republic of Korea.
Asia Pac J Ophthalmol (Phila). 2024 May-Jun;13(3):100069. doi: 10.1016/j.apjo.2024.100069. Epub 2024 May 15.
To identify baseline factors associated with 1-year outcomes when treating neovascular age-related macular degeneration (nAMD) with ranibizumab biosimilar SB11 or reference ranibizumab (rRBZ), and to compare efficacy of the two products within subgroups judged to be clinically relevant.
Post hoc analysis of a prospective, equivalence phase 3 randomized clinical trial (RCT) METHODS: 705 patients with nAMD were randomized 1:1 to receive SB11 or rRBZ for 48 weeks. Pooled and randomized groups were used to identify baseline factors associated with clinical outcomes at Week 52 using multiple linear regression models. Significant factors identified in regression analyses were confirmed in analyses of variance. Subgroup analyses comparing best-corrected visual acuity (BCVA) changes between SB11 and rRBZ were conducted.
634 (89.9%) participants completed the 52-week visit. Regression analyses showed that younger age, lower BCVA, and smaller total lesion area at baseline were associated with greater BCVA gain at Week 52, while older age, lower BCVA, and thicker central subfield thickness (CST) at baseline were predictors of greater CST reduction in the pooled group. Subgroup analyses demonstrated that BCVA outcomes appeared comparable for the SB11 and rRBZ groups.
Post hoc analyses of the SB11-rRBZ equivalence study showed that baseline age, BCVA, CST, and total lesion area were prognostic factors for visual or anatomical outcomes of nAMD, while subgroup analyses demonstrated comparable results for SB11 and rRBZ. Collectively, the results appear comparable to similar RCTs of anti-vascular endothelial growth factor reference products for nAMD and strengthen confidence in the biosimilarity of SB11.
确定使用雷珠单抗生物类似药 SB11 或参照雷珠单抗（rRBZ）治疗新生血管性年龄相关性黄斑变性（nAMD）时与 1 年结果相关的基线因素，并比较两种产品在被认为具有临床相关性的亚组内的疗效。
一项前瞻性、等效性 III 期随机临床试验（RCT）的事后分析。
705 例 nAMD 患者按 1:1 随机分为 SB11 或 rRBZ 组，接受治疗 48 周。使用多线性回归模型，对 SB11 和 rRBZ 治疗的第 52 周的临床结局相关的基线因素进行了合并和随机分组分析。回归分析中确定的显著因素在方差分析中得到了验证。比较了 SB11 和 rRBZ 之间最佳矫正视力（BCVA）变化的亚组分析。
634 例（89.9%）患者完成了 52 周的随访。回归分析显示，基线时年龄较小、BCVA 较低和总病变面积较小与第 52 周时 BCVA 增益较大相关，而基线时年龄较大、BCVA 较低和中央视网膜厚度（CST）较厚是合并组 CST 减少的预测因素。亚组分析表明，SB11 和 rRBZ 组的 BCVA 结果似乎相似。
SB11-rRBZ 等效性研究的事后分析表明，基线时的年龄、BCVA、CST 和总病变面积是 nAMD 视觉或解剖结果的预后因素，而亚组分析表明 SB11 和 rRBZ 的结果相似。总体而言，这些结果与其他 nAMD 抗血管内皮生长因子参照产品的类似 RCT 结果相似，增强了对 SB11 生物相似性的信心。
