Long-term safety and effectiveness of ruxolitinib in patients with myelofibrosis in Japan: an observational study.

IF 2.6 4区医学 Q2 ONCOLOGY

Future oncology Pub Date : 2025-10-01 Epub Date: 2025-08-29 DOI:10.1080/14796694.2025.2550924

Yusuke Aruga, Wataru Hongo, Weizhe Lu

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引用次数: 0

Abstract

Aim: To evaluate the safety and effectiveness of ruxolitinib in patients with myelofibrosis (MF) in Japan.

Methods: A multicenter, observational study of patients who received ruxolitinib for MF from July 2014.

Results: Of 892 patients (mean age: 70 years, 45.9% primary MF, ruxolitinib treatment median duration, 541.0 days), 67.7% had adverse drug reactions (ADRs) and 31.5% had serious ADRs. The most frequent ADRs were anemia and decreased platelet count. Incidences of ADRs by time of onset were 57.7%, 20.3%, 14.4%, 11.1%, 11.3%, 9.0%, and 1.8% from the treatment initiation to Day 182, and every 6 months thereafter until Day 1,093 or later, respectively. ADRs of special interest included myelosuppression (46.8%), infections (17.6%), hepatic impairment (13.5%), hemorrhagic events (10.2%), cardiac failure (2.5%), interstitial lung disease (1.5%), malignancy (1.4%) and tuberculosis (0.5%). Incidences of common ADRs were similar between patients with hepatic or renal impairment and patients without hepatic or renal impairment. At 6 months, spleen responses and symptom improvement were observed in 26.2% and 52.0% of patients, respectively. Median overall survival was not reached.

Conclusion: In a real-world setting in Japan, ruxolitinib demonstrated a reasonable degree of effectiveness with no new safety concerns. Results were similar to those from clinical trials.

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鲁索利替尼在日本骨髓纤维化患者中的长期安全性和有效性：一项观察性研究。

目的：评价鲁索利替尼治疗日本骨髓纤维化（MF）患者的安全性和有效性。方法：对2014年7月开始接受鲁索利替尼治疗MF的患者进行多中心观察性研究。结果：892例患者（平均年龄70岁，45.9%原发MF，鲁索利替尼治疗中位持续时间541.0天）中，67.7%发生药物不良反应（adr）， 31.5%发生严重adr。最常见的不良反应是贫血和血小板计数减少。从治疗开始至第182天，以及此后每6个月至第1093天及以后，按发病时间划分的不良反应发生率分别为57.7%、20.3%、14.4%、11.1%、11.3%、9.0%和1.8%。特别关注的不良反应包括骨髓抑制（46.8%）、感染（17.6%）、肝功能损害（13.5%）、出血性事件（10.2%）、心力衰竭（2.5%）、间质性肺疾病（1.5%）、恶性肿瘤（1.4%）和结核病（0.5%）。常见不良反应的发生率在肝肾损害患者和无肝肾损害患者之间相似。6个月时，26.2%的患者脾脏得到缓解，52.0%的患者症状得到改善。中位总生存期未达到。结论：在日本的现实环境中，ruxolitinib显示出合理程度的有效性，没有新的安全性问题。结果与临床试验结果相似。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Future oncology ONCOLOGY-

CiteScore

5.40

自引率

3.00%

发文量

335

审稿时长

4-8 weeks

期刊介绍： Future Oncology (ISSN 1479-6694) provides a forum for a new era of cancer care. The journal focuses on the most important advances and highlights their relevance in the clinical setting. Furthermore, Future Oncology delivers essential information in concise, at-a-glance article formats - vital in delivering information to an increasingly time-constrained community. The journal takes a forward-looking stance toward the scientific and clinical issues, together with the economic and policy issues that confront us in this new era of cancer care. The journal includes literature awareness such as the latest developments in radiotherapy and immunotherapy, concise commentary and analysis, and full review articles all of which provide key findings, translational to the clinical setting.