治疗中重度慢性斑块型银屑病的生物仿制药

IF 5.2 Q1 DERMATOLOGY
Psoriasis (Auckland, N.Z.) Pub Date : 2025-08-18 eCollection Date: 2025-01-01 DOI:10.2147/PTT.S510156
Paolo Gisondi, Francesco Bellinato, Tea Curic, Giampiero Girolomoni
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引用次数: 0

摘要

牛皮癣是一种免疫介导的慢性炎症性皮肤病,影响全世界6000多万成人和儿童,可发生在从儿童期到成年期的任何年龄。如果患者有弥漫性牛皮癣,影响体表的10%以上,或涉及敏感区域,如面部、头皮、指甲和/或掌跖区,他或她是全身治疗的候选人。目前,在欧洲和美国,有几种药物被批准用于治疗中重度慢性斑块性银屑病。这些药物可分为常规制剂、生物制剂和小分子制剂。这些免疫调节剂有不同的给药方式,如口服、皮下注射和静脉注射。包括生物制剂和小分子在内的新型治疗方法可以提供可靠的疾病控制,即使从长远来看也具有良好的安全性,并且大大提高了许多患者的生活质量。然而,生物制剂价格昂贵,给国家卫生保健系统带来了沉重负担,并为需要这些改变生活的治疗方法的患者提供了障碍。生物仿制药是一种生物医学产品,与已经批准的参考生物药物(也称为原研药)高度相似。与参比产品相比,生物仿制药在安全性、纯度和有效性方面没有临床意义上的差异。生物仿制药已经上市好几年了,因此在临床实践中,帮助克服了这些挑战。生物仿制药有可能改善银屑病生物疗法的可及性,同时降低医疗成本。这篇叙述性综述的目的是描述生物仿制药及其使用可以提供的潜在成本节约效益。在这篇综述中,我们将讨论阿达木单抗、英夫利昔单抗、依那西普和乌斯特金单抗,以及它们相应的生物仿制药。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Biosimilars for the Treatment of Moderate to Severe Chronic Plaque Psoriasis.

Biosimilars for the Treatment of Moderate to Severe Chronic Plaque Psoriasis.

Psoriasis is an immune-mediated chronic inflammatory skin disease affecting over 60 million adults and children worldwide and can occur at any age, from childhood to adulthood. If the patient has a diffuse form of psoriasis, affecting more than ten percent of the body surface, or involving sensitive areas such as the face, scalp, nails, and/or palmoplantar region, he or she is a candidate for systemic therapy. Currently, several drugs are approved for the treatment of moderate to severe chronic plaque psoriasis in Europe and US. These are classified into conventional systemics, biologics, and small molecules. These immunomodulatory agents are available in different forms of administration, such as oral, subcutaneous, and intravenous. Novel treatments, including biologics and small molecules, can provide reliable disease control with a good safety profile even in the long term and have greatly improved the quality of life for many patients. Nevertheless, biologics can be expensive, placing a significant burden on national healthcare systems and creating a barrier to access for patients in need of these life-changing therapies. A biosimilar drug is a biologic medical product that is highly similar to an already approved reference biologic drug (also known as the originator). Biosimilars have no clinically meaningful differences in terms of safety, purity, and efficacy compared to the reference product. Biosimilar drugs have been on the market-and therefore in clinical practice-for several years now, helping to overcome these challenges. Biosimilars have the potential to improve access to biologic therapies for psoriasis while reducing healthcare costs. The aim of this narrative review is to describe biosimilars and the potential cost-saving benefits their use can offer. In this review, we will discuss adalimumab, infliximab, etanercept, and ustekinumab, as well as their corresponding biosimilars.

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