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银屑病患者接受全身性生物制剂或非生物制剂治疗后的严重感染发生率:一项大型、单中心、回顾性、观察性队列研究。

Rate of serious infection in patients who are prescribed systemic biologic or nonbiologic agents for psoriasis: A large, single center, retrospective, observational cohort study.

机构信息

Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.

Department of Internal Medicine, Cleveland Clinic, Cleveland, Ohio.

出版信息

Dermatol Ther. 2017 Sep;30(5). doi: 10.1111/dth.12529. Epub 2017 Aug 10.

Abstract

BACKGROUND

Systemic biologic and nonbiologic agents used to treat psoriasis may or may not contribute to serious infection (SI) risk. Safety data, particularly for biologic agents, and associated risk for SI, are scarce. The study's aim was to explore the risk for SI in psoriasis patients exposed to systemic biologic or nonbiologic agents.

METHODS

A large, single-center electronic medical record repository was searched between January 2010 and December 2014. Records for patients prescribed a systemic agent for psoriasis (SAP) with psoriasis or psoriatic arthritis diagnoses were included (ICD-9 codes 696.1 and 696.0, respectively). SIs were those who required hospitalization, and/or injectable antibacterial, antiviral or antifungal therapy. SIs occurring within 120 days after exposure to a SAP, were included for study.

RESULTS

A total of 1,346 patients were exposed to a SAP between January 2010 and December 2014; 27 (2%) had a SI. Comparing biologic and nonbiologic agent exposure, no statistically significant difference for risk of SI was detectable (p = .83).

CONCLUSION

In this population, the SI rate for biologic and nonbiologic systemic agents was clinically indistinguishable, thereby supporting consideration of the entire spectrum of available systemic therapeutic agents, both biologic and nonbiologic agents, for management of moderate to severe psoriasis.

摘要

背景

用于治疗银屑病的全身性生物制剂和非生物制剂可能会或可能不会增加严重感染(SI)的风险。安全性数据,特别是生物制剂的数据,以及 SI 的相关风险,十分有限。本研究旨在探讨接受全身性生物制剂或非生物制剂治疗的银屑病患者发生 SI 的风险。

方法

在 2010 年 1 月至 2014 年 12 月期间,对一个大型的单中心电子病历数据库进行了检索。将诊断为银屑病或银屑病关节炎的患者处方全身性药物治疗银屑病(SAP)的记录纳入研究(ICD-9 编码分别为 696.1 和 696.0)。SI 是指需要住院治疗和/或接受注射用抗菌、抗病毒或抗真菌治疗的感染。将 SAP 暴露后 120 天内发生的 SI 纳入研究。

结果

2010 年 1 月至 2014 年 12 月期间,共有 1346 例患者接受了 SAP 治疗;其中 27 例(2%)发生了 SI。比较生物制剂和非生物制剂的暴露情况,未发现 SI 风险有统计学差异(p = 0.83)。

结论

在该人群中,生物制剂和非生物制剂治疗 SI 的发生率无显著差异,这支持考虑使用所有可获得的全身性治疗药物,包括生物制剂和非生物制剂,来治疗中重度银屑病。

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