抗tnf - α生物仿制药的药物生存期、长期安全性和有效性:一项单中心回顾性研究

IF 1.8 4区 医学 Q3 DERMATOLOGY
Giulia Nunziati, Antonella DI Cesare, Elia Rosi, Ilaria Scandagli, Gianmarco Silvi, Prisca Guerra, Francesca Prignano
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引用次数: 0

摘要

背景:在当前银屑病治疗管理领域,尽管最近市场上引入了高靶向分子,如抗白细胞介素,抗肿瘤坏死因子α (anti-TNF-α)生物制剂仍然发挥着关键作用,部分原因是具有成本效益的生物类似药的可用性。这些药物的保留率、长期安全性和有效性很少被研究。方法:我们进行了一项回顾性的单中心研究,包括接受阿达木单抗、依那西普和英夫利昔单抗生物类似药治疗的患者,以评估这些药物在较长时间内的药物生存期、安全性和有效性。结果:共纳入93例患者,中位治疗时间86个月。尽管存在一定的局限性,如回顾性设计和研究的单中心性质,我们的研究结果强调了抗tnf -α生物类似药在银屑病和PsA管理中的长期有效性和安全性,强调了在治疗决策中考虑疾病特征的重要性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Drug survival, long-term safety and efficacy of anti-TNF-alpha biosimilars: a monocentric retrospective study.

Background: In the current landscape of psoriasis therapeutic management, despite the more recent market introduction of highly targeted molecules such as anti-interleukins, anti-tumor necrosis factor alpha (anti-TNF-α) biologic agents still play a key role, partly due to the availability of cost-effective biosimilar alternatives. Retention rate, long-term safety and effectiveness of these drugs have rarely been investigated.

Methods: We carried out a retrospective monocentric study including patients treated with biosimilar adalimumab, biosimilar etanercept, and biosimilar infliximab to assess drug survival, safety and effectiveness of these drugs over an extended period.

Results: A total of 93 patients were included in this study, with a median treatment duration of 86 months. Drug survival at 12 months was 91.4%, declining to <50% at 86 months. Interestingly, no significant differences were observed among the three anti-TNF-α biosimilars in terms of drug survival. The presence of psoriatic arthritis (PsA) correlated with increased drug survival. Adverse drug reactions were reported in 61.3% of patients, with infections being the most common issue. Treatment discontinuation was predominantly due to loss of efficacy.

Conclusions: Despite certain limitations, such as the retrospective design and the monocentric nature of the study, our findings underscore the long-term effectiveness and safety of anti-TNF-α biosimilars in psoriasis and PsA management, emphasizing the importance of considering disease characteristics in treatment decisions.

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