目的:评价和分析维泊妥珠单抗上市后的药物不良反应(adverse drug reaction,ADR)信号,为临床安全性管理提供参考。方法:通过开放性OpenVigil数据平台,收集2019年6月10日(美国FDA批准上市时间)至2023年3月31日美国FDA不良事件报告系统(FA...目的:评价和分析维泊妥珠单抗上市后的药物不良反应(adverse drug reaction,ADR)信号,为临床安全性管理提供参考。方法:通过开放性OpenVigil数据平台,收集2019年6月10日(美国FDA批准上市时间)至2023年3月31日美国FDA不良事件报告系统(FAERS)数据库中维泊妥珠单抗的ADR报告。采用比例失衡法中的报告比值比(ROR)和比例报告比(PRR)进行信号挖掘。为提高阈值,得到信号较强、较常出现的ADR,将信号进行二次筛选。结果:共检索到维泊妥珠单抗相关ADR报告2408份,经过二次筛选得到83个ADR信号。其中,脊柱磁共振成像异常、骨吸收增加、骨质溶解、天门冬氨酸氨基转移酶降低、丙氨酸氨基转移酶降低、低纤维蛋白原血症、肺栓塞等26个ADR信号在药品说明书中未提及。信号数或累积例数较多的系统器官分类包含感染及侵染类疾病(24个信号、632例),各类检查(17个信号、675例),血液及淋巴系统疾病(11个信号、734例),各类神经系统疾病(7个信号、153例),免疫系统疾病(3个信号、95例),全身性疾病及给药部位各种反应(2个信号、145例),代谢及营养类疾病(2个信号、87例)等。结论:除说明书提示的常见ADR外,本研究发现了维泊妥珠单抗新的ADR风险信号。建议临床在关注感染、骨髓抑制、周围神经病、输液相关反应、肝功能异常等已知常见ADR的同时,予以脊柱磁共振成像异常、骨吸收增加等新的风险信号更多关注。展开更多
Objectives： The molecular targeting drugs for the treatment of B-cell lymphoma have been dramatically developed. Recently, novel drugs of monoclonal antibodies and small molecules are approved by US FDA （Food and Dr...Objectives： The molecular targeting drugs for the treatment of B-cell lymphoma have been dramatically developed. Recently, novel drugs of monoclonal antibodies and small molecules are approved by US FDA （Food and Drug Administration）. Key Findings： This review summarizes characteristics, mechanisms, and results of the trials in the novel molecular targeting drugs for B-cell lymphoma such as obinutuzumab, polatuzumab vedotin, ibrutinib, idelalisib, and venetoclax. Summary： As a novel anti-CD20 antibody, obinutuzumab has been clinically developed on going. ADC （antibody drug conjugate） against CD79b molecules is also developed for B-cell lymphoma. BCR pathway is one of the most crucial pathways, and ibrutinib is a BTK （Bruton＇s tyrosine kinase） inhibitor that is under development for the treatment of B-cell malignancies, including CLL （chronic lymphocytic leukemia）, MCL （mantle cell lymphoma）, and DLBCL （diffuse large B-cell lymphoma）, as well as FL （follicular lymphoma）. BCL-2 family dysfunction and impairment of apoptosis are common in most B-cell lymphoid malignancies. Venetoclax, which is a highly selective BCL-2 inhibitor, a mimic for its BCL2 homolog 3-domain to induce apoptosis, is also reported to be active against B-cell malignancies. Conclusions： Mechanism-based combination regimens including these drugs may be required in the future.展开更多
文摘目的:评价和分析维泊妥珠单抗上市后的药物不良反应(adverse drug reaction,ADR)信号,为临床安全性管理提供参考。方法:通过开放性OpenVigil数据平台,收集2019年6月10日(美国FDA批准上市时间)至2023年3月31日美国FDA不良事件报告系统(FAERS)数据库中维泊妥珠单抗的ADR报告。采用比例失衡法中的报告比值比(ROR)和比例报告比(PRR)进行信号挖掘。为提高阈值,得到信号较强、较常出现的ADR,将信号进行二次筛选。结果:共检索到维泊妥珠单抗相关ADR报告2408份,经过二次筛选得到83个ADR信号。其中,脊柱磁共振成像异常、骨吸收增加、骨质溶解、天门冬氨酸氨基转移酶降低、丙氨酸氨基转移酶降低、低纤维蛋白原血症、肺栓塞等26个ADR信号在药品说明书中未提及。信号数或累积例数较多的系统器官分类包含感染及侵染类疾病(24个信号、632例),各类检查(17个信号、675例),血液及淋巴系统疾病(11个信号、734例),各类神经系统疾病(7个信号、153例),免疫系统疾病(3个信号、95例),全身性疾病及给药部位各种反应(2个信号、145例),代谢及营养类疾病(2个信号、87例)等。结论:除说明书提示的常见ADR外,本研究发现了维泊妥珠单抗新的ADR风险信号。建议临床在关注感染、骨髓抑制、周围神经病、输液相关反应、肝功能异常等已知常见ADR的同时,予以脊柱磁共振成像异常、骨吸收增加等新的风险信号更多关注。
文摘Objectives： The molecular targeting drugs for the treatment of B-cell lymphoma have been dramatically developed. Recently, novel drugs of monoclonal antibodies and small molecules are approved by US FDA （Food and Drug Administration）. Key Findings： This review summarizes characteristics, mechanisms, and results of the trials in the novel molecular targeting drugs for B-cell lymphoma such as obinutuzumab, polatuzumab vedotin, ibrutinib, idelalisib, and venetoclax. Summary： As a novel anti-CD20 antibody, obinutuzumab has been clinically developed on going. ADC （antibody drug conjugate） against CD79b molecules is also developed for B-cell lymphoma. BCR pathway is one of the most crucial pathways, and ibrutinib is a BTK （Bruton＇s tyrosine kinase） inhibitor that is under development for the treatment of B-cell malignancies, including CLL （chronic lymphocytic leukemia）, MCL （mantle cell lymphoma）, and DLBCL （diffuse large B-cell lymphoma）, as well as FL （follicular lymphoma）. BCL-2 family dysfunction and impairment of apoptosis are common in most B-cell lymphoid malignancies. Venetoclax, which is a highly selective BCL-2 inhibitor, a mimic for its BCL2 homolog 3-domain to induce apoptosis, is also reported to be active against B-cell malignancies. Conclusions： Mechanism-based combination regimens including these drugs may be required in the future.
