英夫利西单抗及其生物仿制药在银屑病治疗中的长期安全性监测和疗效状况。

IF 1.1 Q4 PHARMACOLOGY & PHARMACY
Kiran Sharma, Roma Ghai, Neha Rana
{"title":"英夫利西单抗及其生物仿制药在银屑病治疗中的长期安全性监测和疗效状况。","authors":"Kiran Sharma, Roma Ghai, Neha Rana","doi":"10.2174/0115748863320685240830092746","DOIUrl":null,"url":null,"abstract":"<p><p>Infliximab (INF), a murine human monoclonal antibody, is a substantially more successful biologic than topical drugs for treating mild to severe psoriasis because it clears the skin rapidly due to its fast onset of action. Loss of responsiveness over time and some adverse effects, especially the experience of infusion reactions, are the major causes of non-compliance with INF medication. Therefore, evaluation of the long-term reliability of anti-tumor necrosis factor (TNF) medications is necessary for the assessment of the risks associated with long-term anti-TNF therapy. For psoriasis, there are registered safety statistics; however, these individuals might not receive the same level of care as those in a randomized study. Few assessments of the safety of anti- TNF medications across indications, including their biosimilars, are present, but it's still unknown how anti-infliximab antibodies arise and produce harmful effects. INF biosimilars, when subjected to human studies to reduce cost and improve access, provide therapeutic benefits with associated adverse events, showing variations in incidence depending upon varying patient populations and no new safety indications. During therapy, certain individuals develop antibodies against INF, which are believed to be linked to a loss of response (LOR). Additional research aimed at identifying individuals who are susceptible to treatment resistance is likely to assist doctors in accurately selecting the appropriate candidates for anti-TNF-α therapy and enhancing the long-term effectiveness of the treatment. From clinical studies, we expect to learn about how to utilize INF or its biosimilars more effectively in the management of psoriasis. Therefore, the paper focuses on the efficacy and safety monitoring of INF and developed biological therapies.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.1000,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Long-term Safety Monitoring and Efficacy Status of Infliximab and its Biosimilars in Psoriasis Management.\",\"authors\":\"Kiran Sharma, Roma Ghai, Neha Rana\",\"doi\":\"10.2174/0115748863320685240830092746\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Infliximab (INF), a murine human monoclonal antibody, is a substantially more successful biologic than topical drugs for treating mild to severe psoriasis because it clears the skin rapidly due to its fast onset of action. Loss of responsiveness over time and some adverse effects, especially the experience of infusion reactions, are the major causes of non-compliance with INF medication. Therefore, evaluation of the long-term reliability of anti-tumor necrosis factor (TNF) medications is necessary for the assessment of the risks associated with long-term anti-TNF therapy. For psoriasis, there are registered safety statistics; however, these individuals might not receive the same level of care as those in a randomized study. Few assessments of the safety of anti- TNF medications across indications, including their biosimilars, are present, but it's still unknown how anti-infliximab antibodies arise and produce harmful effects. INF biosimilars, when subjected to human studies to reduce cost and improve access, provide therapeutic benefits with associated adverse events, showing variations in incidence depending upon varying patient populations and no new safety indications. During therapy, certain individuals develop antibodies against INF, which are believed to be linked to a loss of response (LOR). Additional research aimed at identifying individuals who are susceptible to treatment resistance is likely to assist doctors in accurately selecting the appropriate candidates for anti-TNF-α therapy and enhancing the long-term effectiveness of the treatment. From clinical studies, we expect to learn about how to utilize INF or its biosimilars more effectively in the management of psoriasis. Therefore, the paper focuses on the efficacy and safety monitoring of INF and developed biological therapies.</p>\",\"PeriodicalId\":10777,\"journal\":{\"name\":\"Current drug safety\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.1000,\"publicationDate\":\"2024-09-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Current drug safety\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2174/0115748863320685240830092746\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current drug safety","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2174/0115748863320685240830092746","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0

摘要

英夫利昔单抗(INF)是一种鼠人单克隆抗体,在治疗轻度至重度银屑病方面,它是一种比外用药物更成功的生物制剂,因为它起效快,能迅速清除皮肤上的银屑病。随着时间的推移,反应性的丧失和一些不良反应,尤其是输液反应,是导致不遵从 INF 药物治疗的主要原因。因此,评估抗肿瘤坏死因子(TNF)药物的长期可靠性对于评估长期抗肿瘤坏死因子治疗的相关风险十分必要。对于银屑病,有登记在册的安全性统计数据;但是,这些人可能没有得到与随机研究中的人同等水平的护理。目前很少有对抗肿瘤坏死因子药物(包括其生物仿制药)的安全性进行评估,但抗英夫利昔单抗抗体是如何产生并产生有害影响的仍是未知数。INF生物仿制药在进行人体研究以降低成本和提高可及性时,在提供治疗益处的同时也会出现相关的不良反应,其发生率因患者人群的不同而有所差异,且没有新的安全适应症。在治疗过程中,某些人会产生 INF 抗体,这被认为与反应消失(LOR)有关。旨在识别易产生耐药性的个体的其他研究可能有助于医生准确选择抗肿瘤坏死因子-α疗法的合适人选,并提高治疗的长期有效性。我们期望从临床研究中了解如何更有效地利用 INF 或其生物仿制药治疗银屑病。因此,本文重点关注 INF 和开发的生物疗法的疗效和安全性监测。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Long-term Safety Monitoring and Efficacy Status of Infliximab and its Biosimilars in Psoriasis Management.

Infliximab (INF), a murine human monoclonal antibody, is a substantially more successful biologic than topical drugs for treating mild to severe psoriasis because it clears the skin rapidly due to its fast onset of action. Loss of responsiveness over time and some adverse effects, especially the experience of infusion reactions, are the major causes of non-compliance with INF medication. Therefore, evaluation of the long-term reliability of anti-tumor necrosis factor (TNF) medications is necessary for the assessment of the risks associated with long-term anti-TNF therapy. For psoriasis, there are registered safety statistics; however, these individuals might not receive the same level of care as those in a randomized study. Few assessments of the safety of anti- TNF medications across indications, including their biosimilars, are present, but it's still unknown how anti-infliximab antibodies arise and produce harmful effects. INF biosimilars, when subjected to human studies to reduce cost and improve access, provide therapeutic benefits with associated adverse events, showing variations in incidence depending upon varying patient populations and no new safety indications. During therapy, certain individuals develop antibodies against INF, which are believed to be linked to a loss of response (LOR). Additional research aimed at identifying individuals who are susceptible to treatment resistance is likely to assist doctors in accurately selecting the appropriate candidates for anti-TNF-α therapy and enhancing the long-term effectiveness of the treatment. From clinical studies, we expect to learn about how to utilize INF or its biosimilars more effectively in the management of psoriasis. Therefore, the paper focuses on the efficacy and safety monitoring of INF and developed biological therapies.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Current drug safety
Current drug safety PHARMACOLOGY & PHARMACY-
CiteScore
2.10
自引率
0.00%
发文量
112
期刊介绍: Current Drug Safety publishes frontier articles on all the latest advances on drug safety. The journal aims to publish the highest quality research articles, reviews and case reports in the field. Topics covered include: adverse effects of individual drugs and drug classes, management of adverse effects, pharmacovigilance and pharmacoepidemiology of new and existing drugs, post-marketing surveillance. The journal is essential reading for all researchers and clinicians involved in drug safety.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信