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抗白细胞介素-17抗体时代生物药物的生存率:一项时间周期调整后的登记分析。

Biologic drug survival rates in the era of anti-interleukin-17 antibodies: a time-period-adjusted registry analysis.

作者信息

Graier T, Salmhofer W, Jonak C, Weger W, Kölli C, Gruber B, Sator P G, Prillinger K, Mlynek A, Schütz-Bergmayr M, Richter L, Ratzinger G, Painsi C, Selhofer S, Häring N, Wippel-Slupetzky K, Skvara H, Trattner H, Tanew A, Inzinger M, Tatarski R, Bangert C, Ellersdorfer C, Lichem R, Gruber-Wackernagel A, Hofer A, Legat F, Schmiedberger E, Strohal R, Lange-Asschenfeldt B, Schmuth M, Vujic I, Hoetzenecker W, Trautinger F, Saxinger W, Müllegger R, Quehenberger F, Wolf P

机构信息

Department of Dermatology and Venereology, Medical University of Graz, Graz, Austria.

Department of Dermatology, Medical University of Vienna, Vienna, Austria.

出版信息

Br J Dermatol. 2021 Jun;184(6):1094-1105. doi: 10.1111/bjd.19701. Epub 2021 Feb 22.

Abstract

BACKGROUND

Drug survival rates reflect efficacy and safety and may be influenced by the availability of alternative treatment options. Little is known about time-dependent drug survival in psoriasis and the effect of increasing numbers of biologic treatment options.

OBJECTIVES

To determine whether drug survival is influenced by the availability of treatment options and by factors such as gender, psoriatic arthritis or previous biologic treatment.

METHODS

This observational, retrospective, multicentre cohort study analysed data from patients registered in the Austrian Psoriasis Registry (PsoRA) who were treated with biologics between 1 January 2015 and 30 November 2019.

RESULTS

A total of 1572 patients who received 1848 treatment cycles were included in this analysis. The highest long-term Psoriasis Area and Severity Index improvement was observed after treatment with ixekizumab, followed by ustekinumab and secukinumab, adalimumab and etanercept. Overall, ustekinumab surpassed all other biologics in drug survival up to 48 months. However, when adjusted for biologic naïvety, its superiority vanished and drug survival rates were similar for ixekizumab (91·6%), secukinumab (90·2%) and ustekinumab (92·8%), all of them superior to adalimumab (76·5%) and etanercept (71·9%) at 12 months and beyond. Besides biologic non-naïvety (2·10, P < 0·001), the introduction of a new drug such as secukinumab or ixekizumab (relative hazard ratio 1·6, P = 0·001) and female gender (1·50, P = 0·019) increased the risk of treatment discontinuation overall, whereas psoriatic arthritis did not (1·12, P = 0·21).

CONCLUSIONS

The time-dependent availability of drugs should be considered when analysing and comparing drug survival. Previous biologic exposure significantly influences drug survival. Women are more likely to stop treatment.

摘要

背景

药物生存率反映了疗效和安全性,可能会受到替代治疗方案可用性的影响。关于银屑病中时间依赖性药物生存率以及生物治疗方案数量增加的影响,人们了解甚少。

目的

确定药物生存率是否受治疗方案可用性以及性别、银屑病关节炎或既往生物治疗等因素的影响。

方法

这项观察性、回顾性、多中心队列研究分析了2015年1月1日至2019年11月30日期间在奥地利银屑病登记处(PsoRA)登记并接受生物制剂治疗的患者数据。

结果

本分析共纳入1572例接受1848个治疗周期的患者。使用依奇珠单抗治疗后观察到银屑病面积和严重程度指数的长期改善最高,其次是乌司奴单抗、司库奇尤单抗、阿达木单抗和依那西普。总体而言,乌司奴单抗在长达48个月的药物生存率方面超过了所有其他生物制剂。然而,在调整生物制剂初治情况后,其优势消失,依奇珠单抗(91.6%)、司库奇尤单抗(90.2%)和乌司奴单抗(92.8%)的药物生存率相似,在12个月及以后,它们均优于阿达木单抗(76.5%)和依那西普(71.9%)。除生物制剂非初治情况外(2.10,P<0.001),司库奇尤单抗或依奇珠单抗等新药的引入(相对风险比1.6,P=0.001)和女性性别(1.50,P=0.019)总体上增加了治疗中断的风险,而银屑病关节炎则没有(1.12,P=0.21)。

结论

在分析和比较药物生存率时应考虑药物的时间依赖性可用性。既往生物制剂暴露显著影响药物生存率。女性更有可能停止治疗。

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