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一项基于美国大型队列的疾病负担、合并症和治疗使用情况的特征分析:Corrona 银屑病登记处的研究结果。

Characterization of disease burden, comorbidities, and treatment use in a large, US-based cohort: Results from the Corrona Psoriasis Registry.

机构信息

University of Connecticut Health Center, Farmington, Connecticut; Probity Medical Research, Waterloo, Ontario, Canada.

Corrona LLC, Southborough, Massachusetts.

出版信息

J Am Acad Dermatol. 2018 Feb;78(2):323-332. doi: 10.1016/j.jaad.2017.10.012. Epub 2017 Oct 16.

Abstract

BACKGROUND

Psoriasis is an immunodysregulatory inflammatory disease associated with comorbidities affecting quality of life. With the advent of new treatments, there is growing need to assess the long-term safety and efficacy of treatments in a real-world setting.

OBJECTIVE

The objective of the Corrona Psoriasis Registry is to study the comparative safety and efficacy of Food and Drug Administration-approved biologic treatments.

METHODS

A cross-sectional study of patients enrolled in the registry, who initiated or switched to a systemic therapy at enrollment or previous 12 months. Descriptive characteristics (demographics, clinical and patient-reported outcomes, comorbidities, and treatment history) were examined at registry enrollment.

RESULTS

As of October 1, 2016, there were 1942 patients enrolled in the registry: 23% on apremilast, 4% on other nonbiologic systemic medications, 25% on interleukin (IL) 17A inhibitors, 22% on an IL-12/23 inhibitor, and 26% on tumor necrosis factor inhibitors. Overall, mean disease duration was 15.6 years, and 40% had a concurrent psoriatic arthritis diagnosis. About 66% had >3% body surface area involvement and 49% had a moderate or severe Investigator Global Assessment.

LIMITATIONS

Selection and channeling bias can result in potential confounding that needs to be addressed in modeled analyses.

CONCLUSION

This disease-based registry cohort represents a population exposed to multiple therapies, long disease duration, and multiple comorbidities and can be used to examine comparative safety and efficacy of various therapies.

摘要

背景

银屑病是一种免疫失调性炎症性疾病,与影响生活质量的合并症有关。随着新疗法的出现,越来越需要在真实环境中评估治疗的长期安全性和疗效。

目的

Corrona 银屑病登记处的目的是研究美国食品和药物管理局批准的生物治疗药物的比较安全性和疗效。

方法

这是一项对登记处中入组患者的横断面研究,这些患者在登记时或前 12 个月内开始或转为全身治疗。在登记时检查了描述性特征(人口统计学、临床和患者报告结果、合并症和治疗史)。

结果

截至 2016 年 10 月 1 日,登记处共入组了 1942 例患者:23%的患者接受阿普司特治疗,4%的患者接受其他非生物性全身药物治疗,25%的患者接受白细胞介素(IL)17A 抑制剂治疗,22%的患者接受 IL-12/23 抑制剂治疗,26%的患者接受肿瘤坏死因子抑制剂治疗。总体而言,平均疾病持续时间为 15.6 年,40%的患者同时诊断为银屑病关节炎。约 66%的患者有 >3%的体表面积受累,49%的患者有中度或重度研究者整体评估。

局限性

选择和渠道偏见可能导致潜在的混杂因素,需要在模型分析中加以解决。

结论

该基于疾病的登记处队列代表了一个暴露于多种治疗方法、疾病持续时间长和多种合并症的人群,可以用于比较各种治疗方法的安全性和疗效。

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