Mining and analysis of ADE signals of romiplostim and eltrombopag based on FAERS database

SHAO Xin; JIANG Xianhong; YOU Jun; LIU Yilong

doi:10.6039/j.issn.1001-0408.2023.19.15

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Mining and analysis of ADE signals of romiplostim and eltrombopag based on FAERS database

更新时间：2025-09-26

- Mining and analysis of ADE signals of romiplostim and eltrombopag based on FAERS database
- ZHONGGUO YAOFANG Vol. 34, Issue 19, Pages: 2391-2395(2023)
- 作者机构：
  
  1.乐山市人民医院药学部，四川乐山　614000
  2.乐山市人民医院胃肠外科，四川乐山　614000
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2023.19.15
  CLC： R969.3;R973
- Received：09 January 2023，
  
  Revised：2023-08-17，
  
  Accepted：18 August 2023，
  
  Published：15 October 2023
- 稿件说明：
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邵鑫,蒋先虹,尤俊,等.基于FAERS的罗米司亭和艾曲泊帕ADE信号挖掘与分析[J].中国药房,2023,34(19):2391-2395.

SHAO Xin,JIANG Xianhong,YOU Jun,et al.Mining and analysis of ADE signals of romiplostim and eltrombopag based on FAERS database[J].ZHONGGUO YAOFANG,2023,34(19):2391-2395.
邵鑫,蒋先虹,尤俊,等.基于FAERS的罗米司亭和艾曲泊帕ADE信号挖掘与分析[J].中国药房,2023,34(19):2391-2395. DOI： 10.6039/j.issn.1001-0408.2023.19.15.

SHAO Xin,JIANG Xianhong,YOU Jun,et al.Mining and analysis of ADE signals of romiplostim and eltrombopag based on FAERS database[J].ZHONGGUO YAOFANG,2023,34(19):2391-2395. DOI： 10.6039/j.issn.1001-0408.2023.19.15.

摘要

目的

为临床安全使用血小板生成素受体激动剂类药物罗米司亭和艾曲泊帕提供参考。

方法

利用美国FDA不良事件报告系统（FAERS）收集罗米司亭和艾曲泊帕从在美国上市至2022年9月30日的药物不良事件（ADE）报告，利用报告比值比（ROR）法与英国药品和健康产品管理局的综合标准法对2种药物的ADE信号进行分析。

结果

共收集到罗米司亭和艾曲泊帕的ADE报告分别为14 021、4 431份，性别构成均为女性多于男性。经信号筛选，得到罗米司亭563个ADE信号，累及25个系统器官分类（SOC）；艾曲泊帕433个ADE信号，累及26个SOC。2种药物发生频次最多的ADE信号均为血小板计数降低（分别为2 060、 1 585例），在其药品说明书中均有记载；按信号强度排序，罗米司亭的血小板生成素水平异常（ROR值为2 268.85）和艾曲泊帕的登革病毒检测阳性（ROR值为954.50）位列第一，且均未被其药品说明书记载。

结论

罗米司亭和艾曲泊帕的ADE主要累及血液及淋巴系统，且新的可疑高风险信号较多。

Abstract

OBJECTIVE

To provide a reference for the safe use of thrombopoietin receptor agonists romiplostim and eltrombopag in clinic.

METHODS

FDA adverse event reporting system （FAERS） in the United States was adopted to collect adverse drug event （ADE） reports of romiplostim and eltrombopag from their launch in the United States to September 30， 2022； the ADE signals of the two drugs were analyzed using the reporting odds ratio （ROR） method and the comprehensive standard method of the UK Medicines and Healthcare Products Regulatory Agency.

RESULTS

A total of 14 021 and 4 431 ADE reports were collected about romiplostim and eltrombopag， respectively， with a gender composition of more females than males. After signal screening， 563 ADE signals were obtained about romiplostim， involving 25 system organ classes （SOC）； eltrombopag had 433 ADE signals， involving 26 SOC. The most frequently reported ADE for both drugs was platelet count decreased （2 060， 1 585 cases）， which was mentioned in their drug instructions. In terms of signal intensity， romiplostim exhibited the highest signal for abnormal thrombopoietin levels （ROR of 2 268.85）， while eltrombopag had the highest signal for positive dengue virus test （ROR of 954.50）， with neither of these signals mentioned in their respective drug instructions.

CONCLUSIONS

The ADE of romiplostim and eltrombopag mainly affects the blood and lymphatic system， and there are many new suspicious high-risk signals.

关键词

Keywords

references

PALANDRI F ， ROSSI E ， BARTOLETTI D ， et al . Real-world use of thrombopoietin receptor agonists in older patients with primary immune thrombocytopenia [J ] . Blood ， 2021 ， 138 （ 7 ）： 571 - 583 .

BIDIKA E ， FAYYAZ H ， SALIB M ， et al . Romiplostim and eltrombopag in immune thrombocytopenia as a second-line treatment [J ] . Cureus ， 2020 ， 12 （ 8 ）： e9920 .

MENG F Q ， CHEN X Q ， YU S J ， et al . Safety and efficacy of eltrombopag and romiplostim in myelodysplastic syndromes：a systematic review and meta-analysis [J ] . Front Oncol ， 2020 ， 10 ： 582686 .

GHANIMA W ， COOPER N ， RODEGHIERO F ， et al . Thrombopoietin receptor agonists：ten years later [J ] . Haematologica ， 2019 ， 104 （ 6 ）： 1112 - 1123 .

LOZANO M L ， RODEGHIERO F . Thrombopoietin receptor agonist in chemotherapy-induced thrombocytopenia [J ] . Lancet Haematol ， 2022 ， 9 （ 3 ）： e168 - e169 .

李莉，杨卓，杨佳，等 . 基于FAERS的阿达木单抗相关不良事件风险信号挖掘 [J ] . 中国药房， 2022 ， 33 （ 16 ）： 2006 - 2011 .

LI L ， YANG Z ， YANG J ， et al . Risk signal mining of adverse events related to adalimumab based on FAERS [J ] . China Pharm ， 2022 ， 33 （ 16 ）： 2006 - 2011 .

曹珊珊，关月，张筱芳，等 . 血小板生成素受体激动剂致不良反应的文献分析 [J ] . 中国药物应用与监测， 2022 ， 19 （ 1 ）： 34 - 38 .

CAO S S ， GUAN Y ， ZHANG X F ， et al . Literature analysis of adverse drug reaction induced by thrombopoietin receptor agonists [J ] . China Drug Appl Monit ， 2022 ， 19 （ 1 ）： 34 - 38 .

侯明，胡豫 . 成人原发免疫性血小板减少症诊断与治疗中国指南：2020年版 [J ] . 中华血液学杂志， 2020 ， 41 （ 8 ）： 617 - 623 .

HOU M ， HU Y . Chinese guidelines for the diagnosis and treatment of primary immune thrombocytopenia in adults：2020 edition [J ] . Chin J Hematol ， 2020 ， 41 （ 8 ）： 617 - 623 .

LOZANO M L ， MINGOT-CASTELLANO M E ， PERERA M M ， et al . A decade of changes in management of immune thrombocytopenia，with special focus on elderly patients [J ] . Blood Cells Mol Dis ， 2021 ， 86 ： 102505 .

CASTELLI R ， GIDARO A ， DELILIERS G L . Risk of thrombosis in elderly immune primary trombocytopenic patients treated with thrombopoietin receptors agonists [J ] . J Thromb Thrombolysis ， 2020 ， 50 （ 4 ）： 903 - 907 .

KAWANO N ， HASUIKE S ， IWAKIRI H ， et al . Portal vein thrombosis during eltrombopag treatment for immune thrombocytopenic purpura in a patient with liver cirrhosis due to hepatitis C viral infection [J ] . J Clin Exp Hematop ， 2013 ， 53 （ 2 ）： 151 - 155 .

MULLA C M ， RASHIDI A ， LEVITOV A B . Extensive cerebral venous sinus thrombosis following a dose increase in eltrombopag in a patient with idiopathic thrombocytopenic purpura [J ] . Platelets ， 2014 ， 25 （ 2 ）： 144 - 146 .

ANDIC N ， GUNDUZ E ， AKAY O M ， et al . Cardiac and pulmonary thrombosis during multidrug treatment in an idiopathic thrombocytopenic purpura patient [J ] . Platelets ， 2014 ， 25 （ 1 ）： 69 - 70 .

OO Z ， MANVAR K ， WANG J C . Eltrombopag-induced thrombocytosis and thrombosis in patients with antiphospholipid syndrome and immune thrombocytopenic purpura [J ] . J Investig Med High Impact Case Rep ， 2022 ， 10 ： 23247096211060581 .

WU C ， ZHOU X M ， LIU X D . Eltrombopag-related renal vein thromboembolism in a patient with immune thrombocytopenia：a case report [J ] . World J Clin Cases ， 2021 ， 9 （ 11 ）： 2611 - 2618 .

GARABET L ， GHANIMA W ， HELLUM M ， et al . Increased microvesicle-associated thrombin generation in patients with immune thrombocytopenia after initiation of thrombopoietin receptor agonists [J ] . Platelets ， 2020 ， 31 （ 3 ）： 322 - 328 .

GHANIMA W ， GEYER J T ， LEE C S ， et al . Bone marrow fibrosis in 66 patients with immune thrombocytopenia treated with thrombopoietin-receptor agonists：a single-center，long-term follow-up [J ] . Haematologica ， 2014 ， 99 （ 5 ）： 937 - 944 .

QURESHI K ， PATEL S ， MEILLIER A . The use of thrombopoietin receptor agonists for correction of thrombocytopenia prior to elective procedures in chronic liver di- seases：review of current evidence [J ] . Int J Hepatol ， 2016 ， 2016 ： 1802932 .

GILREATH J ， LO M ， BUBALO J . Thrombopoietin receptor agonists （TPO-RAs）：drug class considerations for pharmacists [J ] . Drugs ， 2021 ， 81 （ 11 ）： 1285 - 1305 .

VLACHODIMITROPOULOU E ， CHEN Y L ， GARBOWSKI M ， et al . Eltrombopag：a powerful chelator of cellular or extracellular iron（Ⅲ） alone or combined with a second chelator [J ] . Blood ， 2017 ， 130 （ 17 ）： 1923 - 1933 .

ZHAO Z ， SUN Q ， SOKOLL L J ， et al . Eltrombopag mobilizes iron in patients with aplastic anemia [J ] . Blood ， 2018 ， 131 （ 21 ）： 2399 - 2402 .

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