Galeone Carlotta, Turati Federica, Nicolò Massimo, Parravano Mariacristina, Vujosevic Stela, Bianchino Laura, Sicari Emilia, Lanzetta Paolo
Bicocca Applied Statistics Center (BASC), Università degli Studi di Milano-Bicocca, Milan - Italy.
Biostatistics & Outcome Research, Statinfo, Milan - Italy.
Drug Target Insights. 2024 Dec 12;18:105-111. doi: 10.33393/dti.2024.3213. eCollection 2024 Jan-Dec.
To assess through an indirect treatment comparison (ITC) the potential benefit of faricimab over the anti-vascular endothelial growth factor (VEGF) real-life scenario, hereby defined standard of care (SoC), in Italy, that is, aflibercept, bevacizumab, and ranibizumab, in patients with neovascular age-related macular degeneration (nAMD) naïve to any anti-VEGF treatment.
Individual patient-level data from the phase III clinical trials TENAYA and LUCERNE (faricimab cohort) and the real-world study RADIANCE (RADIANCE cohort) were used. Efficacy was evaluated with changes in best corrected visual acuity (BCVA) and central subfield thickness (CST) from baseline to 1 year (week 52 in the RADIANCE and week 48 in the faricimab cohorts, respectively). Propensity score-based inverse probability of treatment weighting was utilized to balance cohorts and mitigate bias due to potential confounding. Sensitivity analyses were performed to evaluate treatment differences adjusted for the number of injections.
The ITC included 513 patients treated with faricimab and 263 patients treated with SoC. At 1 year, faricimab showed a greater mean BCVA gain (treatment difference +5.4 letters, p<0.001) and CST reduction (treatment difference -71.8 μm, p<0.001) compared to SoC. Sensitivity analyses confirmed the robustness of results, showing a BCVA improvement of +4.0 letters and a CST reduction of -71.5 μm in favor of faricimab.
Despite the limitations due to the use of ITC and the comparison between clinical trials and real-world cohorts, the present analysis suggests potential benefits in terms of vision gain and CST reduction in naïve nAMD patients treated with faricimab compared with SoC in a real-world setting.
通过间接治疗比较（ITC）评估在意大利新血管性年龄相关性黄斑变性（nAMD）患者中，法西单抗相对于抗血管内皮生长因子（VEGF）现实治疗方案（即定义为标准治疗（SoC）的阿柏西普、贝伐单抗和雷珠单抗）的潜在益处，这些患者未接受过任何抗VEGF治疗。
使用了III期临床试验TENAYA和LUCERNE（法西单抗队列）以及真实世界研究RADIANCE（RADIANCE队列）的个体患者水平数据。通过从基线到1年（RADIANCE中为第52周，法西单抗队列中为第48周）最佳矫正视力（BCVA）和中心子野厚度（CST）的变化来评估疗效。采用基于倾向评分的治疗加权逆概率来平衡队列并减轻潜在混杂因素导致的偏差。进行敏感性分析以评估根据注射次数调整后的治疗差异。
ITC纳入了513例接受法西单抗治疗的患者和263例接受SoC治疗的患者。在1年时，与SoC相比，法西单抗显示出更大的平均BCVA改善（治疗差异+5.4字母，p<0.001）和CST降低（治疗差异-71.8μm，p<0.001）。敏感性分析证实了结果的稳健性，显示有利于法西单抗的BCVA改善为+4.0字母，CST降低为-71.5μm。
尽管由于使用ITC以及临床试验与真实世界队列之间的比较存在局限性，但本分析表明，在现实环境中，与SoC相比，接受法西单抗治疗的初治nAMD患者在视力改善和CST降低方面具有潜在益处。
