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在美国真实世界环境中,司库奇尤单抗治疗对初治银屑病患者临床结局的应用趋势及影响

Utilization Trends and Impact of Secukinumab Treatment on Clinical Outcomes in Biologic-Naive Patients with Psoriasis in a US Real-World Setting.

作者信息

Strober Bruce, Patil Dhaval, McLean Robert R, Moore-Clingenpeel Melissa, Guo Ning, Levi Eugenia, Lebwohl Mark

机构信息

Yale University, New Haven, CT, USA.

Central Connecticut Dermatology Research, 1 Willowbrook Road, Suite 2, Cromwell, CT, 06416, USA.

出版信息

Dermatol Ther (Heidelb). 2022 Jun;12(6):1351-1365. doi: 10.1007/s13555-022-00740-y. Epub 2022 May 13.

Abstract

INTRODUCTION

Real-world evidence has demonstrated the effectiveness of secukinumab in the treatment of psoriasis; however, limited data are available on patient profiles of US secukinumab initiators over time and clinical outcomes in biologic-naive patients. This study describes clinical characteristics of secukinumab initiators by year, and the clinical outcomes in patients after 6- and/or 12-month follow-up visits, stratified by prior biologic use.

METHODS

This observational study included patients enrolled in the CorEvitas (formerly Corrona) Psoriasis Registry. Analyses were conducted in two patient cohorts: (1) all secukinumab initiators, stratified by year, and (2) those who initiated and maintained secukinumab through a 6- and/or 12-month follow-up visit. For all secukinumab initiators, patient characteristics at initiation were described per calendar year; in initiators with follow-up visits, mean (SD) differences in percentage affected body surface area (BSA), five-point Investigator's Global Assessment (IGA), and Psoriasis Area and Severity Index (PASI) scores between baseline and follow-up visits were calculated. Analyses were conducted separately for biologic-naive and biologic-experienced patients.

RESULTS

Between 2015 and 2020, the proportion of secukinumab initiators in the registry who were biologic-naive increased each year from 12.5% to 49.7%. Overall, 1518 patients initiated secukinumab at or after enrollment; 980 (64.6%) were biologic experienced, and 538 (35.4%) were biologic naive. At 6 months, biologic-experienced and biologic-naive patients reported mean (SD) decreases in BSA (-9.3 [14.5] versus -11.7 [16.6]), IGA (-1.4 [1.3] versus -1.7 [1.4]), and PASI (-5.2 [6.6] versus -6.7 [7.8]). The proportion of patients with an IGA score of clear/almost clear (0/1) increased over fivefold, irrespective of biologic experience. At 12 months, similar improvements were seen.

CONCLUSIONS

The proportion of biologic-naive secukinumab initiators increased over time. Biologic-naive patients demonstrated similar improvements in clinical outcomes compared with biologic-experienced patients, suggesting that secukinumab may be considered as a first-line therapy for psoriasis.

摘要

引言

真实世界证据已证明司库奇尤单抗治疗银屑病的有效性;然而,关于美国司库奇尤单抗初始使用者随时间变化的患者特征以及生物制剂初治患者的临床结局的数据有限。本研究按年份描述了司库奇尤单抗初始使用者的临床特征,以及在6个月和/或12个月随访后患者的临床结局,并根据既往生物制剂使用情况进行分层。

方法

这项观察性研究纳入了CorEvitas(原Corrona)银屑病登记处登记的患者。分析在两个患者队列中进行:(1)所有司库奇尤单抗初始使用者,按年份分层;(2)那些开始并维持司库奇尤单抗治疗达6个月和/或12个月随访的患者。对于所有司库奇尤单抗初始使用者,按日历年描述起始时的患者特征;对于有随访的初始使用者,计算基线和随访时受累体表面积(BSA)百分比、五分制研究者整体评估(IGA)以及银屑病面积和严重程度指数(PASI)评分的平均(标准差)差异。对生物制剂初治患者和有生物制剂使用经验的患者分别进行分析。

结果

2015年至2020年期间,登记处中生物制剂初治的司库奇尤单抗初始使用者比例逐年从12.5%增至49.7%。总体而言,1518例患者在入组时或之后开始使用司库奇尤单抗;980例(64.6%)有生物制剂使用经验,538例(35.4%)为生物制剂初治患者。在6个月时,有生物制剂使用经验和生物制剂初治的患者报告BSA平均(标准差)下降(-9.3 [14.5]对-11.7 [

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