Supplementary materials: Effectiveness of tisagenlecleucel versus real-world standard of care in relapsed/refractory follicular lymphoma

These are peer-reviewed supplementary materials for the article 'Effectiveness of tisagenlecleucel versus real-world standard of care in relapsed/refractory follicular lymphoma' published in the Journal of Comparative Effectiveness Research.Supplementary Figure 1: Flow chart of patient selection in real-world SoC cohortSupplementary Table 1: Baseline characteristics for ELARA cohort and real-world SoC cohort before and after weighting, subpopulation for evaluating CRR/ORR.Supplementary Table 2: Efficacy comparison between ELARA cohort and real-world SoC cohort from sensitivity analyses.Aim: To contextualize the effectiveness of tisagenlecleucel versus real-world standard of care (SoC) in relapsed/refractory follicular lymphoma. Materials & methods: A retrospective indirect matched comparison study using data from the phase II ELARA trial and the US Flatiron Health Research Database. Results: Complete response rate was 69.1 versus 17.7% and the overall response rate was 85.6 versus 58.1% in tisagenlecleucel versus SoC, post weighting by odds. For overall survival, an estimated reduction in the risk of death was observed in favor of tisagenlecleucel over SoC. The hazard ratio for progression free survival was 0.45 (95% CI: 0.26, 0.88), and for time-to-next treatment was 0.34 (95% CI: 0.15, 0.78) with tisagenlecleucel versus SoC. Conclusion: A consistent trend toward improved efficacy end points was observed in favor of tisagenlecleucel versus SoC.

本数据集为发表于《比较疗效研究杂志》的论文《替西吉单抗在复发性/难治性滤泡性淋巴瘤中相较于现实世界标准治疗方案的有效性》的同行评审补充材料。补充图1：现实世界标准治疗方案队列患者选择流程图；补充表1：ELARA队列和现实世界标准治疗方案队列在加权前后的基线特征，以及用于评估完全缓解率/客观缓解率的亚群；补充表2：基于敏感性分析的ELARA队列与现实世界标准治疗方案队列的疗效比较。研究目的：将替西吉单抗与现实世界标准治疗方案（SoC）在复发性/难治性滤泡性淋巴瘤中的有效性进行情境化分析。研究方法：采用回顾性间接匹配比较研究，使用来自II期ELARA试验和美国Flatiron Health研究数据库的数据。研究结果：在加权后，替西吉单抗组的完全缓解率为69.1%，而SoC组为17.7%；总体缓解率为85.6%与58.1%。对于总生存期，观察到替西吉单抗相较于SoC具有降低死亡风险的估计效应。无进展生存期的风险比（HR）为0.45（95%CI：0.26，0.88），与SoC相比，至下一次治疗的时间的HR为0.34（95%CI：0.15，0.78）。研究结论：在替西吉单抗与SoC之间，观察到疗效终点改善的一致趋势。