Groupe d'analyse, Ltée, Montréal, QC, Canada.
Merck & Co., Inc., Center for Observational and Real-world Evidence, Kenilworth, NJ, USA.
Target Oncol. 2021 Jan;16(1):85-94. doi: 10.1007/s11523-020-00778-y.
Patients with classical Hodgkin lymphoma (cHL) relapsed or refractory (R/R) disease who relapse after or are ineligible for autologous stem cell transplantation have a poor prognosis. Recently, the anti-PD1 monoclonal antibodies nivolumab and pembrolizumab were approved by the US Food and Drug Administration (FDA; May 2016 and March 2017, respectively) as treatment options for R/R cHL patients.
In the absence of comparative clinical trials between these agents, this observational study was conducted to evaluate the healthcare resource utilization (HRU) of patients with cHL initiated on pembrolizumab compared to nivolumab in the USA.
Healthcare insurance claims from Symphony Health's IDV® (Integrated Dataverse) (July 2014-June 2018) were used in this retrospective study. The study population included adult patients with cHL initiated on pembrolizumab or nivolumab (index date). Inverse probability of treatment weighting was used to adjust for differences in patient characteristics between cohorts. All-cause and cHL-related hospitalizations and outpatient visits were measured during the observation (post-index) period and reported per patient-year (PPY). Rates of HRU were compared between cohorts using rate ratios (RRs).
A total of 92 and 218 patients initiated on pembrolizumab and nivolumab, respectively, were included in the study population. After weighting, the mean age was similar at 55 years in both cohorts, while the proportion of females was lower in the pembrolizumab cohort (35.3%) compared to the nivolumab cohort (44.1%). Mean Quan-Charlson Comorbidity Index score was well balanced after weighting in the pembrolizumab and nivolumab cohorts (4.2 and 4.3, respectively). During the observation period, patients in the pembrolizumab cohort had significantly lower rates of all-cause hospitalizations (RR [95% CI] 0.33 [0.09-0.80]) and cHL-related hospitalizations (RR [95% CI] 0.14 [0.02-0.37]) than those in the nivolumab cohort. Rates of all-cause and cHL-related outpatient visits were not statistically different between patients in the pembrolizumab and nivolumab cohorts.
In this real-world study, adult cHL patients initiated on pembrolizumab had significantly lower rates of all-cause and cHL-related hospitalizations compared to patients initiated on nivolumab.
经典霍奇金淋巴瘤(cHL)患者在自体干细胞移植后复发或出现耐药(R/R),或不适合自体干细胞移植,预后较差。最近,抗 PD-1 单克隆抗体纳武单抗和派姆单抗被美国食品和药物管理局(FDA;分别于 2016 年 5 月和 2017 年 3 月)批准用于治疗 R/R cHL 患者。
由于这些药物之间没有进行比较临床试验,因此进行了这项观察性研究,以评估在美国开始使用派姆单抗治疗的 cHL 患者与开始使用纳武单抗治疗的患者相比,其医疗资源利用(HRU)情况。
该回顾性研究使用了 Symphony Health 的 IDV®(综合数据集)(2014 年 7 月至 2018 年 6 月)的医疗保险索赔数据。该研究人群包括在美国开始接受派姆单抗或纳武单抗(索引日期)治疗的 cHL 成年患者。采用逆概率治疗加权法来调整队列间患者特征的差异。在观察期(索引后)内测量所有原因和 cHL 相关的住院和门诊就诊次数,并按患者每年(PPY)报告。使用率比(RR)比较队列间的 HRU 率。
共纳入 92 名和 218 名分别开始接受派姆单抗和纳武单抗治疗的患者进入研究人群。经过加权后,两组的平均年龄相似,均为 55 岁,而派姆单抗组的女性比例(35.3%)低于纳武单抗组(44.1%)。加权后,派姆单抗组和纳武单抗组的平均 Quan-Charlson 合并症指数评分均保持平衡(分别为 4.2 和 4.3)。在观察期内,与纳武单抗组相比,派姆单抗组的所有原因住院率(RR[95%CI]0.33[0.09-0.80])和 cHL 相关住院率(RR[95%CI]0.14[0.02-0.37])显著降低。派姆单抗组和纳武单抗组的所有原因和 cHL 相关门诊就诊率无统计学差异。
在这项真实世界研究中,与开始使用纳武单抗治疗的患者相比,开始使用派姆单抗治疗的成年 cHL 患者的所有原因和 cHL 相关住院率显著降低。