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鲁索替尼治疗骨髓纤维化的持续治疗率和总生存率不受新冠疫情影响,尽管起始剂量有所降低:意大利药品管理局登记处分析

Treatment persistence and overall survival in myelofibrosis treated with ruxolitinib were not affected by the covid-19 pandemic, despite the reduced starting dose: Analysis of AIFA registries.

作者信息

Breccia Massimo, Celant Simone, Palandri Francesca, Passamonti Francesco, Olimpieri Pier Paolo, Summa Valentina, Guarcello Annalisa, Palumbo Giuseppe Alberto, Pane Fabrizio, Guglielmelli Paola, Zinzani Pierluigi, Corradini Paolo, Russo Pierluigi

机构信息

Department of Translational and Precision Medicine, Sapienza University, Rome, Italy.

AIFA Italian Medicines Agency, Rome, Italy.

出版信息

Ann Hematol. 2025 Sep 20. doi: 10.1007/s00277-025-06601-w.

Abstract

We analyzed the outcome of 2229 patients with myelofibrosis (MF) treated with ruxolitinib before and after the COVID-19 pandemic. Two populations of MF were defined from the AIFA web monitoring registries: the pre-COVID-19 (1703, 76.4%) and the post-COVID-19 (526, 23.6%) cohorts. The two populations were balanced using the Inversity Probability of Treatment Weighting. The median age was 69 years and 73 years in the pre- and post- COVID-19 era, respectively. There were no differences in spleen diameters at baseline prior to ruxolitinib in the two groups, but a difference in median spleen volume was noted (961 cm3 in the pre-era and 788.3 cm3 in the post-era). Overall, intermediate-2 IPSS risk were 67.2% in the pre- and 72% in the post-era, whereas the high-risk category was 32.7% and 27.9%, respectively. More patients started on a reduced dose in the post-COVID-19 era (73.5% versus 65% in the pre-era). After adjusting for the differences, an analysis of overall survival revealed no differences between the two groups (HR 0.875, p > 0.05). Patients who started ruxolitinib after COVID-19 had similar probability to stop treatment in the follow-up (HR 0.956, p > 0.05). The results indicate that COVID-19 did not affect the duration of treatment and the relative OS.

摘要

我们分析了2229例接受鲁索替尼治疗的骨髓纤维化(MF)患者在2019冠状病毒病大流行前后的治疗结果。从意大利药品管理局(AIFA)网络监测登记处确定了两组MF患者:2019冠状病毒病前队列(1703例,76.4%)和2019冠状病毒病后队列(526例,23.6%)。使用治疗权重的逆概率对两组进行平衡。2019冠状病毒病前和后的中位年龄分别为69岁和73岁。两组在开始使用鲁索替尼前的基线脾脏直径无差异,但中位脾脏体积存在差异(前时代为961 cm³,后时代为788.3 cm³)。总体而言,2019冠状病毒病前中等-2国际预后评分系统(IPSS)风险为67.2%,后时代为72%,而高风险类别分别为32.7%和27.9%。在2019冠状病毒病后时代,更多患者开始使用较低剂量(73.5%,而前时代为65%)。在调整差异后,总生存分析显示两组之间无差异(风险比[HR]为0.875,p>0.05)。在2019冠状病毒病后开始使用鲁索替尼的患者在随访中停药的概率相似(HR为0.956,p>0.05)。结果表明,2019冠状病毒病不影响治疗持续时间和相对总生存期。

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