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Abstract：
BACKGROUND: Ibrutinib is a Bruton\'s tyrosine kinase inhibitor indicated for the first-line treatment and relapse of chronic lymphocytic leukaemia (CLL), Waldenström\'s macroglobulinemia (WM) and mantle cell lymphoma (MCL). This study aimed to describe the characteristics of CLL patients treated with ibrutinib and its effectiveness, safety, and treatment pattern in real life.
METHODS: All patients covered by the general health scheme (approximately 80% of the French population) with a first ibrutinib dispensation from August 1, 2017 (date of reimbursement in France) to December 31, 2020, were identified in the French National Health Insurance database (SNDS). An algorithm was developed to identify the disease (CLL, MCL or WM) for which ibrutinib was prescribed. This article focused on CLL patients. The time to next treatment (TTNT) was plotted using Kaplan‒Meier curves.
RESULTS: During this period, 6,083 patients initiated ibrutinib, among whom 2,771 (45.6%) patients had CLL (mean age of 74 years; 61% of men). At ibrutinib initiation, 46.6% of patients had a cardiovascular comorbidity. Most patients (91.7%) were not hospitalized during the exposure period for one of the cardiovascular or bleeding events studied. Hospitalizations were more frequent in patients with a cardiovascular comorbidity (5.9% versus 11.0%, p-value < 0.0001) and aged over 70 (5.9% versus 9.4%, p-value < 0.0001). The median TTNT was not reached.
CONCLUSIONS: This is one of the largest cohorts of ibrutinib-treated patients in the world. The profile of CLL patients treated with ibrutinib was in accordance with the marketing authorization and reimbursement. This study confirmed effectiveness and safety data.
METHODS: All patients covered by the general health scheme (approximately 80% of the French population) with a first ibrutinib dispensation from August 1, 2017 (date of reimbursement in France) to December 31, 2020, were identified in the French National Health Insurance database (SNDS). An algorithm was developed to identify the disease (CLL, MCL or WM) for which ibrutinib was prescribed. This article focused on CLL patients. The time to next treatment (TTNT) was plotted using Kaplan‒Meier curves.
RESULTS: During this period, 6,083 patients initiated ibrutinib, among whom 2,771 (45.6%) patients had CLL (mean age of 74 years; 61% of men). At ibrutinib initiation, 46.6% of patients had a cardiovascular comorbidity. Most patients (91.7%) were not hospitalized during the exposure period for one of the cardiovascular or bleeding events studied. Hospitalizations were more frequent in patients with a cardiovascular comorbidity (5.9% versus 11.0%, p-value < 0.0001) and aged over 70 (5.9% versus 9.4%, p-value < 0.0001). The median TTNT was not reached.
CONCLUSIONS: This is one of the largest cohorts of ibrutinib-treated patients in the world. The profile of CLL patients treated with ibrutinib was in accordance with the marketing authorization and reimbursement. This study confirmed effectiveness and safety data.
摘要：
背景：Ibrutinib是一种布鲁顿酪氨酸激酶抑制剂，适用于慢性淋巴细胞白血病（CLL）的一线治疗和复发，Waldenström巨球蛋白血症（WM）和套细胞淋巴瘤（MCL）。本研究旨在描述依鲁替尼治疗CLL患者的特点及其有效性。安全,以及现实生活中的治疗模式。
方法：从2017年8月1日（法国报销日期）到2020年12月31日，所有接受一般健康计划（约占法国人口的80％）首次伊布替尼治疗的患者在法国国家健康保险数据库（SNDS）中进行了鉴定。开发了一种识别疾病的算法(CLL，MCL或WM），依鲁替尼被处方。本文主要针对CLL患者。使用Kaplan-Meier曲线绘制下一次治疗的时间(TTNT)。
结果：在此期间，6,083名患者开始伊布替尼，其中2,771例（45.6％）患者患有CLL（平均年龄74岁；男性占61％）。伊布替尼开始时，46.6%的患者有心血管合并症。大多数患者（91.7％）在暴露期间没有因心血管或出血事件而住院。心血管合并症患者住院频率更高(5.9%对11.0%，p值<0.0001)，年龄超过70岁(5.9%对9.4%，p值<0.0001)。未达到TTNT的中位数。
结论：这是世界上最大的依鲁替尼治疗患者队列之一。用依鲁替尼治疗的CLL患者的概况符合上市许可和报销。这项研究证实了有效性和安全性数据。
方法：从2017年8月1日（法国报销日期）到2020年12月31日，所有接受一般健康计划（约占法国人口的80％）首次伊布替尼治疗的患者在法国国家健康保险数据库（SNDS）中进行了鉴定。开发了一种识别疾病的算法(CLL，MCL或WM），依鲁替尼被处方。本文主要针对CLL患者。使用Kaplan-Meier曲线绘制下一次治疗的时间(TTNT)。
结果：在此期间，6,083名患者开始伊布替尼，其中2,771例（45.6％）患者患有CLL（平均年龄74岁；男性占61％）。伊布替尼开始时，46.6%的患者有心血管合并症。大多数患者（91.7％）在暴露期间没有因心血管或出血事件而住院。心血管合并症患者住院频率更高(5.9%对11.0%，p值<0.0001)，年龄超过70岁(5.9%对9.4%，p值<0.0001)。未达到TTNT的中位数。
结论：这是世界上最大的依鲁替尼治疗患者队列之一。用依鲁替尼治疗的CLL患者的概况符合上市许可和报销。这项研究证实了有效性和安全性数据。
