Long-Term Safety of Ixekizumab Treatment in Patients with Psoriasis, Psoriatic Arthritis, or Axial Spondyloarthritis: a Post Hoc Analysis of Cerebro-Cardiovascular Events.

IF 4.2 3区医学 Q1 DERMATOLOGY Dermatology and Therapy Pub Date : 2025-01-01 Epub Date: 2025-01-22 DOI:10.1007/s13555-024-01323-9

Mark Lebwohl, Atul Deodhar, Sergio Schwartzman, Carlo Salvarani, Meghan Feely McDonald, Natalia Bello, Elsie L Grace, Elsa Inman, Andris Kronbergs, Marcus Ngantcha, Proton Rahman, Kim A Papp, Joseph F Merola, Alice B Gottlieb, Andrew Blauvelt

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Abstract

Introduction: Psoriasis (PsO), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) may confer an increased risk for cardiovascular (CV) disease, including major adverse cerebro-cardiovascular events (MACE), deep vein thrombosis (DVT), and pulmonary embolism (PE). Patients with these conditions are often exposed for extended time periods to biologics, such as ixekizumab (IXE). Therefore, understanding the risk of CV events, especially MACE, in patients with PsO, PsA, and axSpA exposed to IXE is important.

Methods: The incidence of MACE (i.e., adjudicated cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke), DVT, and PE was assessed in adults who received ≥ 1 dose of IXE across 25 randomized clinical trials (17 PsO, 4 PsA, 4 axSpA). Rates of CV events were analyzed for pooled studies by indication and analyzed from treatment initiation up to the end of the study program. Exposure-adjusted incidence rates per 100 patient-years (IR/100 PY) are reported.

Results: This integrated safety analysis included 6892 patients with PsO, 1401 with PsA, and 932 with axSpA. The median duration of IXE exposure was 478.5 days (1.3 years) for patients with PsO, 504.5 days (1.4 years) for patients with PsA, and 981.0 days (2.7 years) for patients with axSpA. The incidence of adjudicated MACE was low (IR/100 PY: PsO = 0.5; PsA = 0.5; axSpA = 0.3) and stable over the treatment periods. The most common types of MACE reported were non-fatal myocardial infarction (IR/100 PY: PsO = 0.3; PsA = 0.3; axSpA = 0.3), followed by non-fatal stroke (IR/100 PY: PsO = 0.1; PsA = 0.2; axSpA = 0.0), and cardiovascular death (IR/100 PY: PsO = 0.1; PsA = 0.1; axSpA = 0.0). The incidences of DVT (IR/100 PY: PsO = 0.1; PsA = 0.1; axSpA = 0.1) and PE (IR/100 PY: PsO = 0.1; PsA = 0.0; axSpA = 0.0) were low.

Conclusion: This integrated safety analysis of 25 randomized clinical trials showed that the incidence of adjudicated MACE was low among adult patients with PsO, PsA, and axSpA and that the rates did not increase with increasing IXE exposure.

Trial registration: The supplementary Table S1 provides a comprehensive list of clinical trials and their registration numbers.

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Ixekizumab治疗银屑病、银屑病关节炎或轴性脊柱炎患者的长期安全性：对脑血管事件的事后分析

银屑病（PsO）、银屑病关节炎（PsA）和轴性脊柱炎（axSpA）可能会增加心血管（CV）疾病的风险，包括主要不良脑血管事件（MACE）、深静脉血栓形成（DVT）和肺栓塞（PE）。患有这些疾病的患者通常长时间暴露于生物制剂，如ixekizumab （IXE）。因此，了解暴露于IXE的PsO、PsA和axSpA患者的心血管事件风险，特别是MACE，是很重要的。方法：在25个随机临床试验（17个PsO， 4个PsA， 4个axSpA）中，评估接受≥1剂量IXE的成人MACE（即判定的心血管死亡、非致死性心肌梗死和非致死性卒中）、DVT和PE的发生率。根据适应症对合并研究的CV事件发生率进行分析，并分析从治疗开始到研究项目结束的时间。报告了每100患者年的暴露调整发病率（IR/100 PY）。结果：这项综合安全性分析包括6892例PsO患者，1401例PsA患者和932例axSpA患者。IXE暴露的中位持续时间为：PsO患者478.5天（1.3年），PsA患者504.5天（1.4年），axSpA患者981.0天（2.7年）。判定MACE的发生率较低(IR/100 PY: PsO = 0.5；PsA = 0.5；axSpA = 0.3)，并在治疗期间保持稳定。最常见的MACE类型为非致死性心肌梗死(IR/100 PY: PsO = 0.3；PsA = 0.3；axSpA = 0.3)，其次是非致死性卒中(IR/100 PY: PsO = 0.1；PsA = 0.2；axSpA = 0.0)，心血管死亡(IR/100 PY: PsO = 0.1；PsA = 0.1；axSpA = 0.0)。DVT发生率(IR/100 PY: PsO = 0.1；PsA = 0.1；axSpA = 0.1)和PE (IR/100 PY: PsO = 0.1；PsA = 0.0；axSpA = 0.0)较低。结论：这项对25项随机临床试验的综合安全性分析显示，PsO、PsA和axSpA成年患者中确定的MACE发生率较低，并且发生率不随IXE暴露的增加而增加。试验注册：补充表S1提供了临床试验的综合列表及其注册编号。

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来源期刊

Dermatology and Therapy Medicine-Dermatology

CiteScore

6.00

自引率

8.80%

发文量

187

审稿时长

6 weeks

期刊介绍： Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.