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英夫利昔单抗生物类似药治疗中重度斑块状银屑病。

The infliximab biosimilar in the treatment of moderate to severe plaque psoriasis.

机构信息

Department of Medical Sciences, Section of Dermatology, University of Turin, Turin, Italy.

Department of Dermatology, Rudolfstiftung Hospital, Academic Teaching Hospital, Medical University Vienna, Vienna, Austria; School of Medicine, Sigmund Freud University, Vienna, Austria.

出版信息

J Am Acad Dermatol. 2016 Oct;75(4):736-739. doi: 10.1016/j.jaad.2016.04.068. Epub 2016 Jul 26.

Abstract

BACKGROUND

The infliximab originator's patent recently expired, leading to the production of biosimilar versions of the drug. The biosimilars' efficacy was not tested on patients with psoriasis but most regulatory authorities approved their use in psoriasis because of an extrapolation of data from studies conducted in other diseases.

OBJECTIVE

We sought to describe the use of the infliximab biosimilar (Remsima; CT-P13) in patients with psoriasis.

METHODS

Objective (Psoriasis Area and Severity Index) and subjective (visual analog pain scale) measurements of disease activity were collected in 2 cohorts of patients with moderate to severe plaque psoriasis: cohort 1 patients switched from the infliximab originator to the infliximab biosimilar; and cohort 2 patients were infliximab-naïve and started on the infliximab biosimilar.

RESULTS

We observed no changes of Psoriasis Area and Severity Index and visual analog pain scale scores in 30 patients who switched from the infliximab originator to the biosimilar. Four of 5 infliximab-naïve patients who started infliximab biosimilar treatment achieved 75% improvement or better from baseline Psoriasis Area and Severity Index score at the end of the induction phase.

LIMITATIONS

Number of patients and length of follow-up was limited.

CONCLUSIONS

Patients with psoriasis taking infliximab originator treatment can switch to the infliximab biosimilar without experiencing a significant change in clinical response or additional adverse events. The use of the infliximab biosimilar could reduce the growing pressure on health care budgets.

摘要

背景

英夫利昔单抗原研药的专利最近已过期,导致该药物的生物类似药问世。生物类似药并未在银屑病患者中进行疗效测试,但大多数监管机构还是批准其在银屑病中的应用,因为其数据是从其他疾病的研究中推断出来的。

目的

我们旨在描述英夫利昔单抗生物类似药(Remsima;CT-P13)在银屑病患者中的应用。

方法

我们在 2 个中重度斑块状银屑病患者队列中收集了疾病活动的客观(银屑病面积和严重程度指数)和主观(视觉模拟疼痛量表)测量值:队列 1 患者从英夫利昔单抗原研药转换为英夫利昔单抗生物类似药;队列 2 患者为英夫利昔单抗初治患者,开始使用英夫利昔单抗生物类似药。

结果

我们观察到 30 名从英夫利昔单抗原研药转换为生物类似药的患者的银屑病面积和严重程度指数和视觉模拟疼痛量表评分没有变化。在开始英夫利昔单抗生物类似药治疗的 5 名初治患者中,有 4 名患者在诱导期结束时达到了从基线银屑病面积和严重程度指数评分改善 75%或以上的目标。

局限性

患者数量和随访时间有限。

结论

接受英夫利昔单抗原研药治疗的银屑病患者可以转换为英夫利昔单抗生物类似药,而不会导致临床反应出现显著变化或出现其他不良反应。英夫利昔单抗生物类似药的使用可以减轻医疗保健预算的不断增长压力。

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