Post-Marketing Safety of Ustekinumab Based on 14-Year Follow-Up in Danish National Patient Data.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2024-12-01 DOI:10.1002/pds.70064

Sejun Kim, Andreas Jensen, Alexander Egeberg, Lone Graff Stensballe

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引用次数: 0

Abstract

Purpose: Psoriasis (PsO), a chronic inflammatory skin disorder affecting a substantial proportion of populations globally, often necessitates systemic treatment including biologics. This 14-year cohort study, based on Danish national register data, aimed to investigate the enduring safety profile of ustekinumab compared to other systemic psoriasis treatments.

Methods: Using comprehensive Danish national register data, this study scrutinized patients diagnosed with psoriasis or psoriatic arthritis (PsA) who received ustekinumab. The treatment group comparators were non-biological systemic treatment (non-biologic), tumor necrosis factor α inhibitor medicine groups (TNF-α), interleukin (IL)-17 inhibitors (IL-17), and IL-23 inhibitors (IL-23). The study periods for comparisons were 2009-2022 for non-biologic and TNF-α, 2015-2022 for IL-17, and 2018-2022 for IL-23. Outcomes were malignancies, cardiovascular events, serious infections, and serious hypersensitivity reactions. Cox proportional hazards regression models were employed to analyze two estimands: a standard intention-to-treat (ITT) estimand and a continuous-index-treatment (CIT) estimand, which considered switch and re-initiation of treatments within individuals.

Results: Users of ustekinumab were found to be younger on average, with an average age of 45.1 years compared to 51.6, 47.2, 49.0, and 48.4 years in the non-biologic, TNF-α, IL-17, and IL-23 groups, respectively. Also, 57.3% of the ustekinumab users were male, compared to 46.7%, 48.9%, 50.9%, and 58.3% for the non-biologic, TNF-α, IL-17, and IL-23 groups, respectively. Although the hazard ratio estimates varied across comparators, ustekinumab was found to be safe: regardless of PsA status, no discernible safety signals in terms of malignancy, MACE, severe infections, or severe hypersensitivity reactions were observed for ustekinumab when compared to the treatment comparators.

Conclusions: The present study corroborated the enduring safety of ustekinumab in the context of PsO treatment.

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基于丹麦全国患者 14 年随访数据的 Ustekinumab 上市后安全性。

目的：银屑病（PsO）是一种慢性炎症性皮肤病，影响着全球相当一部分人群，通常需要接受包括生物制剂在内的系统治疗。这项为期14年的队列研究以丹麦全国登记数据为基础，旨在调查乌司替尼与其他系统性银屑病治疗方法相比的持久安全性：本研究利用丹麦全国综合登记数据，对接受乌司替库单抗治疗的银屑病或银屑病关节炎（PsA）患者进行了仔细检查。治疗组比较对象为非生物系统治疗（非生物）、肿瘤坏死因子α抑制剂药物组（TNF-α）、白细胞介素（IL）-17抑制剂（IL-17）和IL-23抑制剂（IL-23）。进行比较的研究期间分别为：2009-2022年为非生物制剂组和TNF-α组，2015-2022年为IL-17组，2018-2022年为IL-23组。研究结果包括恶性肿瘤、心血管事件、严重感染和严重超敏反应。采用Cox比例危险回归模型分析了两种估计值：标准意向治疗（ITT）估计值和连续指数治疗（CIT）估计值，后者考虑了个体内治疗的转换和重新开始：乌司替尼使用者的平均年龄为45.1岁，而非生物制剂组、TNF-α组、IL-17组和IL-23组的平均年龄分别为51.6岁、47.2岁、49.0岁和48.4岁。此外，57.3%的乌司替尼使用者为男性，而非生物制剂组、TNF-α组、IL-17组和IL-23组的男性比例分别为46.7%、48.9%、50.9%和58.3%。尽管不同对比组的危险比估计值不同，但乌司替库单抗被认为是安全的：无论PsA状态如何，与治疗对比组相比，乌司替库单抗在恶性肿瘤、MACE、严重感染或严重超敏反应方面均未观察到明显的安全性信号：本研究证实了乌司替库单抗在PsO治疗中的持久安全性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.