Sasaki Ritsue, Shiino Chikako, Imawari Michio, Bentley Roy, Cai Bin, Yoshida Manami, Afdhal Nezam
Pharmacovigilance Department, Shionogi, Osaka, Japan.
Postmarketing Surveillance & Pharmacoepidemiology Department, Shionogi Pharmacovigilance Center, Osaka, Japan.
Hepatol Res. 2019 Oct;49(10):1169-1181. doi: 10.1111/hepr.13392. Epub 2019 Jul 22.
Lusutrombopag is approved for the treatment of thrombocytopenia in chronic liver disease patients undergoing invasive procedures. This real-world surveillance assesses the safety and effectiveness of lusutrombopag in Japan.
This ongoing, multicenter, prospective, real-world surveillance is collecting data from case report forms between October 2016 and May 2021. Interim data up to September 2018 were used to evaluate safety (adverse events and adverse drug reactions [ADRs]) and effectiveness (proportion of patients avoiding preoperative platelet transfusion and change in platelet count from baseline).
The safety analysis set included 331 patients. The mean baseline platelet count was 46.2 ± 13.7 × 10 /L. Of 377 invasive procedures, radiofrequency ablation (110 procedures, 29.2%) was the most frequent. The mean time from starting lusutrombopag treatment to invasive procedure was 12.3 days. Incidences of serious adverse events and ADRs were 8.76% and 3.32%, respectively. Six cases (1.81%) of portal vein thrombosis were considered serious adverse events; of these, four cases (1.21%) were classified as serious ADRs. Of 300 patients who underwent an invasive procedure (excluding those with platelet transfusion refractoriness), 282 (94.0%) avoided preoperative platelet transfusion. In patients with platelet measurements before and after lusutrombopag administration who did not undergo platelet transfusion, the mean maximum change in platelet count from baseline was 41.7 ± 31.4 × 10 /L (range, -6 to 276; n = 286). All patients receiving second (n = 20) and third (n = 1) treatments avoided preoperative platelet transfusion without developing any ADRs.
This real-world surveillance further supports the safety and effectiveness of lusutrombopag in patients with chronic liver disease undergoing invasive procedures.
卢索替尼已被批准用于治疗接受侵入性操作的慢性肝病患者的血小板减少症。本真实世界监测评估了卢索替尼在日本的安全性和有效性。
这项正在进行的多中心前瞻性真实世界监测从2016年10月至2021年5月期间的病例报告表中收集数据。截至2018年9月的中期数据用于评估安全性（不良事件和药物不良反应[ADR]）和有效性（避免术前血小板输注的患者比例以及血小板计数相对于基线的变化）。
安全性分析集包括331名患者。基线血小板计数的平均值为46.2±13.7×10⁹/L。在377例侵入性操作中，射频消融术（110例，29.2%）最为常见。从开始使用卢索替尼治疗到进行侵入性操作的平均时间为12.3天。严重不良事件和ADR的发生率分别为8.76%和3.32%。6例（1.81%）门静脉血栓形成被视为严重不良事件；其中，4例（1.21%）被归类为严重ADR。在300例接受侵入性操作的患者（不包括血小板输注无效的患者）中，282例（94.0%）避免了术前血小板输注。在未接受血小板输注的卢索替尼给药前后进行血小板测量的患者中，血小板计数相对于基线的平均最大变化为41.7±31.4×10⁹/L（范围，-6至276；n = 286）。所有接受第二次（n = 20）和第三次（n = 1）治疗的患者均避免了术前血小板输注，且未发生任何ADR。
这项真实世界监测进一步支持了卢索替尼在接受侵入性操作的慢性肝病患者中的安全性和有效性。
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