治疗溃疡性结肠炎的依曲莫德:ELEVATE UC 临床项目的感染事件分析

Miguel Regueiro, Britta Siegmund, Andres J Yarur, Flavio Steinwurz, Krisztina B Gecse, Martina Goetsch, Abhishek Bhattacharjee, Joseph Wu, Jesse Green, Aoibhinn McDonnell, Catherine Crosby, Krisztina Lazin, Diogo Branquinho, Irene Modesto, Maria T Abreu
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引用次数: 0

摘要

背景和目的 感染是溃疡性结肠炎(UC)患者的一个安全问题。Etrasimod是一种口服、每日一次(QD)的选择性1磷酸鞘磷脂(S1P)1,4,5受体调节剂,用于治疗中度至重度活动性溃疡性结肠炎。它可导致选择性和可逆性淋巴细胞螯合以及部分外周淋巴细胞计数下降。我们报告了 ELEVATE 3 期项目中的感染事件。方法 报告了 Pivotal UC 队列(ELEVATE UC 52 和 ELEVATE UC 12)中所有感染、严重感染、重症感染、带状疱疹感染和机会性感染的比例、发病率(IRs;每 100 患者年)和描述性分析。Cox 回归模型评估了潜在的基线风险因素。结果 在这项分析(n=787)中,接受依曲莫德 2 毫克 QD(18.8% [41.1])或安慰剂(17.7% [49.0])治疗的患者发生所有感染事件的比例(IRs)相似。接受依曲莫德和安慰剂治疗的患者中分别有 3 例(0.6%)和 5 例(1.9%)发生严重感染。每组均报告了两例带状疱疹事件(依拉西莫德:0.4%;安慰剂:0.8%),均为局部感染且不严重。每组均报告了一起机会性感染事件。绝对淋巴细胞计数(ALC)为<0.2×109/L的患者均未报告严重/重度感染或机会性感染;未发现此类事件的基线风险因素。无死亡病例发生。结论 接受依曲莫德治疗的患者感染风险没有增加。各组严重感染和带状疱疹的发生率相似。在接受依拉西莫德治疗的患者中,未观察到ALC <0.5 × 109/L与感染事件之间存在关联。长期随访将进一步确定依拉莫德的安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Etrasimod for the Treatment of Ulcerative Colitis: Analysis of Infection Events From the ELEVATE UC Clinical Program
Background and Aims Infections are a safety concern in patients with ulcerative colitis (UC). Etrasimod is an oral, once-daily (QD), selective sphingosine 1phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to severely active UC. It leads to selective and reversible lymphocyte sequestration, and partial peripheral lymphocyte count decrease. We report infection events from the phase 3 ELEVATE program. Methods Proportions, incidence rates (IRs; per 100 patient-years) and descriptive analyses of all, serious, severe, herpes zoster, and opportunistic infections are reported in the Pivotal UC cohort (ELEVATE UC 52 and ELEVATE UC 12). Cox regression models evaluated potential baseline risk factors. Results In this analysis (n=787), proportions (IRs) of all infection events were similar for patients receiving etrasimod 2 mg QD (18.8% [41.1]) or placebo (17.7% [49.0]). Serious infections occurred in three (0.6%) and five (1.9%) patients receiving etrasimod and placebo, respectively. Two herpes zoster events were reported in each group (etrasimod: 0.4%; placebo: 0.8%); all localized and non-serious. One opportunistic infection event was reported in each group. No patient with an absolute lymphocyte count (ALC) <0.2 × 109/L reported serious/severe or opportunistic infections; no baseline risk factors were identified for such events. No deaths occurred. Conclusions Patients receiving etrasimod demonstrated no increased risk of infection. The incidence of serious infections and herpes zoster was similar in each group. Among patients receiving etrasimod, no association between ALC <0.5 × 109/L and infection events was observed. Longer-term follow-up will further characterize the etrasimod safety profile.
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