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英夫利昔单抗及其生物类似药治疗银屑病的长期安全性监测与疗效状况

Long-term Safety Monitoring and Efficacy Status of Infliximab and its Biosimilars in Psoriasis Management.

作者信息

Sharma Kiran, Ghai Roma, Rana Neha

机构信息

School of Dentistry and Medical Sciences, Charles Sturt University, 346, Leeds Parade, Orange, NSW 2800, Australia.

KIET School of Pharmacy, KIET Group of Institutions, Delhi-NCR, Ghaziabad-Meerut Road, Ghaziabad, Uttar Pradesh: 201206, India.

出版信息

Curr Drug Saf. 2025;20(3):271-286. doi: 10.2174/0115748863320685240830092746.

Abstract

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.

摘要

英夫利昔单抗(INF)是一种鼠源化人单克隆抗体,在治疗轻至重度银屑病方面比局部用药更为成功,因为其起效迅速,能快速清除皮肤症状。随着时间推移出现的反应性丧失以及一些不良反应,尤其是输液反应,是患者不依从INF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TNF治疗的相关风险是必要的。对于银屑病,有已登记的安全性统计数据;然而,这些个体可能无法获得与随机研究中的个体相同水平的护理。目前很少有针对包括生物类似药在内的不同适应症的抗TNF药物安全性的评估,但抗英夫利昔单抗抗体如何产生并产生有害影响仍不清楚。INF生物类似药在进行人体研究以降低成本并提高可及性时,会带来治疗益处,但也伴有不良事件,其发生率因患者群体不同而有所差异,且未显示新的安全指标。在治疗过程中,某些个体产生针对INF的抗体,这被认为与反应丧失(LOR)有关。旨在识别易出现治疗抵抗个体的进一步研究可能有助于医生准确选择抗TNF-α治疗的合适候选者,并提高治疗的长期有效性。从临床研究中,我们期望了解如何在银屑病管理中更有效地使用INF或其生物类似药。因此,本文重点关注INF及已开发的生物疗法的疗效和安全性监测。

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