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生物制剂治疗前病程对银屑病生物制剂治疗持续时间的影响:一项全国性队列研究。

Impact of the pre-biologic treatment journey on biologic drug survival in psoriasis: A nationwide cohort study.

作者信息

Thein David, Nielsen Mia-Louise, Maul Julia-Tatjana, Thomsen Simon Francis, Thyssen Jacob P, Egeberg Alexander

机构信息

Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.

Department of Dermatology, University of Zürich, Zürich, Switzerland.

出版信息

J Eur Acad Dermatol Venereol. 2025 Jul;39(7):1315-1323. doi: 10.1111/jdv.20259. Epub 2024 Jul 25.

Abstract

BACKGROUND

It is unknown whether the pre-biologic treatment journey affects subsequent biologic drug survival.

OBJECTIVE

To examine the potential impact of a complex treatment journey on subsequent biologic drug survival in patients with psoriasis.

METHODS

The study utilized longitudinal data from Danish national registries and included all patients who, for the first time, initiated a biological treatment for psoriasis. Maximum follow-up was 5 years and patients were included from 1 January 2010 to 30 June 2021. The study used three definitions of exposure to a complex treatment journey and the following conventional systemic treatments: acitretin, cyclosporine, dimethyl fumarate and methotrexate. The first definition was the cumulative number of treatment series. The second definition comprised the number of unique treatments. The third definition was time from the first conventional systemic treatment to biological therapy. Drug survival for the three definitions were illustrated using Kaplan-Meier curves and compared using log-rank test. The sensitivity analysis largely confirmed these findings by grouping patients according to pharmacotherapy.

RESULTS

A total of 2496 patients were included in the study, with 1380 (55.3%) receiving adalimumab, 608 (24.4%) receiving ustekinumab, 271 (10.9%) receiving secukinumab, 166 (6.7%) receiving etanercept and 71 (2.8%) receiving infliximab. The mean age at initiation of biologics was 43.6 years (standard deviation (SD) 15.2 years), and most patients were male (62.9%). During the follow-up of 5477 patient years, 1953 patients (78.2%) reached the main endpoint of discontinuation. Using a log-rank test, the probability of remaining on treatment was unaffected by the three definitions of complexity of the treatment journey.

CONCLUSION

None of the three exposures used to assess the complexity of the pre-biologic treatment journey appeared to impact drug survival. As long as patients experience adequate disease control, these results suggest that conventional systemic treatment do not negatively impact the drug survival of subsequent biologics.

摘要

背景

生物制剂治疗前的治疗历程是否会影响后续生物制剂的使用时长尚不清楚。

目的

探讨复杂治疗历程对银屑病患者后续生物制剂使用时长的潜在影响。

方法

本研究利用丹麦国家登记处的纵向数据,纳入所有首次开始接受银屑病生物治疗的患者。最长随访时间为5年,纳入患者的时间范围为2010年1月1日至2021年6月30日。本研究对复杂治疗历程暴露和以下传统全身治疗采用了三种定义:阿维A、环孢素、富马酸二甲酯和甲氨蝶呤。第一种定义是治疗系列的累积数量。第二种定义包括独特治疗的数量。第三种定义是从首次传统全身治疗到生物治疗的时间。使用Kaplan-Meier曲线展示三种定义下的药物使用时长,并使用对数秩检验进行比较。敏感性分析通过根据药物治疗对患者进行分组,在很大程度上证实了这些结果。

结果

本研究共纳入2496例患者,其中1380例(55.3%)接受阿达木单抗治疗,608例(24.4%)接受乌司奴单抗治疗,271例(10.9%)接受司库奇尤单抗治疗,166例(6.7%)接受依那西普治疗以及71例(2.8%)接受英夫利昔单抗治疗。开始使用生物制剂时的平均年龄为43.6岁(标准差[SD] 15.2岁),大多数患者为男性(62.9%)。在5477患者年的随访期间,1953例患者(78.2%)达到停药的主要终点。使用对数秩检验,继续治疗的概率不受治疗历程复杂性三种定义的影响。

结论

用于评估生物制剂治疗前治疗历程复杂性的三种暴露因素似乎均未影响药物使用时长。只要患者的疾病得到充分控制,这些结果表明传统全身治疗不会对后续生物制剂的药物使用时长产生负面影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/42af/12188509/e210791cb420/JDV-39-1315-g003.jpg

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