Abstract Objectives The aim of this integrated analysis is to evaluate the long-term safety and tolerability of ixekizumab in adults with psoriasis, PsA and axial SpA. Methods Integrated safety data from 21 clinical trials are presented by indication in patients who received at least one dose of ixekizumab. Adverse events (AEs) and treatment-emergent adverse events (TEAEs) adjusted incidence rates (IRs) per 100 patient-years (PY) up to 5 years’ exposure are reported. Results A total of 8228 patients with an ixekizumab exposure of 20 895.9 PY were included in this analysis. The most common TEAEs were nasopharyngitis, upper respiratory tract infection and injection-site reactions. Across populations, IRs were low for AEs leading to discontinuation (IRs ≤5.1 per 100 PY), serious AEs (IRs ≤6.0 per 100 PY) and death (IRs ≤0.3 per 100 PY). The most reported TEAEs of special interest were infections (IRs ≤35.8 per 100 PY). Patients rarely reported malignancies (IR ≤0.8), IBD including ulcerative colitis and Crohn’s disease (IR ≤0.8) and major adverse cardiovascular events (IR ≤0.5). TEAEs were most commonly reported the first 2 years of exposure with ixekizumab and IR decreased over the years (infections, injection-site reactions and depression) or remained constant over the entire treatment period (serious infections, major adverse cardiovascular events, malignancies and IBD). Conclusion This long-term analysis on the safety of ixekizumab was consistent with previously published reports and did not show any new safety signals. The safety profile and tolerability reported in this integrated analysis remained consistent with the known safety profile for ixekizumab.

中文翻译：

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ixekizumab 在斑块状银屑病、银屑病关节炎和中轴性脊柱关节炎成人患者中的安全性：来自 21 项临床试验的数据

摘要 目的 本综合分析的目的是评估 ixekizumab 在成人银屑病、PsA 和中轴型 SpA 中的长期安全性和耐受性。方法 21 项临床试验的综合安全性数据按接受至少一剂 ixekizumab 的患者的适应症提供。报告了每 100 患者年 (PY) 最多 5 年暴露的不良事件 (AE) 和治疗中出现的不良事件 (TEAE) 调整后的发生率 (IR)。结果 共有 8228 名患者的 ixekizumab 暴露量为 20 895.9 PY 被纳入该分析。最常见的 TEAE 是鼻咽炎、上呼吸道感染和注射部位反应。在整个人群中，导致停药（IRs ≤5.1/100 PY）、严重 AE（IRs ≤6.0/100 PY）和死亡（IRs ≤0.3/100 PY）的 IRs 较低。报告最多的特别关注的 TEAE 是感染（IR ≤ 35.8/100 PY）。患者很少报告恶性肿瘤（IR ≤0.8）、IBD 包括溃疡性结肠炎和克罗恩病（IR ≤0.8）和主要不良心血管事件（IR ≤0.5）。TEAE 最常报告为暴露于 ixekizumab 的前 2 年，IR 多年来下降（感染、注射部位反应和抑郁）或在整个治疗期间保持不变（严重感染、主要不良心血管事件、恶性肿瘤和 IBD） . 结论 这项关于 ixekizumab 安全性的长期分析与之前发表的报告一致，没有显示任何新的安全性信号。该综合分析中报告的安全性和耐受性与 ixekizumab 的已知安全性保持一致。