研究概要
cilta-cel 的 OP 给药相对于 IP 给药产生了相似的疗效和安全性结局,同时显著减少了 IP 资源使用。
中文摘要
背景
Ciltacabtagene autoleucel(cilta-cel)对复发/难治性多发性骨髓瘤(RRMM)显示出显著疗效。与住院给药相比,门诊给药日益用于提高治疗可及性并减少医疗资源利用(HCRU)。本研究比较了临床实践中既往接受≥4线治疗(LOT)的RRMM患者在住院(IP)与门诊(OP)接受cilta-cel后的全因HCRU和临床结局。
方法
研究使用Komodo Research Database索赔数据,识别2022年2月28日至2024年6月30日期间既往接受≥4线治疗并接受cilta-cel的成人,根据给药场景(IP/OP)分组。评估全因HCRU、无治疗间隔(TFI)、总生存期(OS)及临床事件(如细胞因子释放综合征[CRS]、免疫效应细胞相关神经毒性综合征[ICANS])。采用多变量回归比较结局,并以发生率比(IRR)和95%置信区间(CI)报告。
结果
242例患者中,148例(61.2%)住院接受cilta-cel,94例(38.8%)门诊接受。两组基线特征相近。门诊组中,31.9%的患者输注后3个月内无需住院。在这一期间,与住院组相比,门诊组每位患者每月住院天数显著较少(2.4比6.6天;IRR [95% CI]:0.37 [0.28–0.48],P<.001),门诊天数则较多(8.5比5.4天;IRR [95% CI]:1.43 [1.26–1.63],P<.001)。输注后第4个月起,HCRU未见显著差异。CRS和ICANS发生率,以及包括6个月和12个月TFI与OS在内的长期结局均相似。
结论
与住院给药相比,门诊给予cilta-cel的疗效和安全性结局相似,同时显著减少住院资源使用。这些发现支持门诊给药治疗RRMM具有可行性,并提示其可能减轻医疗系统负担。
展开英文摘要原文
BACKGROUND
Ciltacabtagene autoleucel (cilta-cel) has demonstrated remarkable efficacy in relapsed or refractory multiple myeloma (RRMM). Outpatient (OP) administration of cilta-cel is increasingly used to improve access and reduce healthcare resource utilization (HCRU) compared to inpatient (IP) administration. We compared all-cause HCRU and clinical outcomes of IP versus OP administration of cilta-cel in patients with RRMM after ≥4 prior lines of therapy (LOT) in clinical practice.
METHODS
We identified adults receiving cilta-cel between 02/28/2022 and 06/30/2024 after ≥4 prior LOT using Komodo Research Database claims data and classified patients into cohorts by setting of administration (IP/OP). All-cause HCRU, treatment-free interval (TFI), overall survival (OS), and clinical events (e.g. cytokine release syndrome [CRS], immune effector cell-associated neurotoxicity syndrome [ICANS]) were assessed. Outcomes were compared using multivariate regression and reported as incidence rate ratios (IRR) with 95% confidence intervals (CI).
RESULTS
Among 242 patients, 148 (61.2%) received cilta-cel in IP and 94 (38.8%) in OP. Baseline characteristics were comparable between cohorts. Of patients in the OP cohort, 31.9% did not require an IP admission within 3 months post-infusion. During this period, the OP cohort had significantly fewer IP days per-patient-per-month (2.4 vs. 6.6; IRR [95% CI]: 0.37 [0.28; 0.48], p < 0.001) and more OP days (8.5 vs 5.4; IRR [95% CI]: 1.43 [1.26; 1.63], p < 0.001) than the IP cohort. From the fourth month post-infusion, no significant differences in HCRU were observed. Rates of CRS and ICANS, and long-term outcomes including 6 and 12 month TFI and OS were similar.
CONCLUSION
OP administration of cilta-cel yielded similar effectiveness and safety outcomes relative to IP administration, while significantly reducing IP resource use. These findings support the feasibility of OP administration of cilta-cel in treating RRMM patients and its potential to reduce the burden on the healthcare system.
论文信息
- 作者
- Janakiram M、Fan L、Ghosh S、Alegria V、Perciavalle M、Emond B、Maitland J、Bixby T
- 第一作者单位
- Judy and Bernard Briskin Center for Multiple Myeloma Research, City of Hope, Duarte, CA, USA.Switzerland
- 通讯作者单位
- Clinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.United States
- 期刊
- Journal of medical economics2026 Dec