BACKGROUND The long-term safety was assessed in patients with psoriatic arthritis who were treated with ixekizumab in three clinical trials (SPIRIT-P1/-P2/-P3). METHODS Integrated safety data from three trials (controlled and uncontrolled), including two pivotal phase 3, randomized, double-blind clinical trials: SPIRIT-P1 and SPIRIT-P2, were assessed. Safety data were integrated from the all ixekizumab exposure safety population (defined as all patients receiving ≥ 1 dose of ixekizumab). We report exposure-adjusted incidence rates (IRs) per 100 patient-years (PY) at 1-year intervals up to 3 years for adverse events. RESULTS Total exposure to IXE reached 1822.2 PY (1118 patients). The IRs/100 PY for the following treatment discontinuations were as follows: adverse events (5.3); serious infections (1.3); injection-site reactions (12.7); infections (34.2); and deaths (0.3). The IRs for treatment-emergent adverse events decreased or remained stable over time, the most common being upper respiratory tract infection, nasopharyngitis, and injection-site reactions. The IRs for serious adverse events and serious infections remained stable over time, whereas for injection-site reactions and general infections, IRs decreased with longer ixekizumab exposure. Opportunistic infections were limited to oral and esophageal candida and localized herpes zoster. No suicide or self-injury-related behaviors were reported. The IRs/100 PY for safety topics of special interest included inflammatory bowel disease (adjudicated; 0.1), depression (1.6), malignancies (0.7), and major adverse cardiovascular events (0.6). CONCLUSIONS The findings of this integrated safety analysis in patients with psoriatic arthritis are consistent with the known safety profile of ixekizumab. No unexpected safety signals were observed with ixekizumab treatment in patients with psoriatic arthritis. TRIAL REGISTRATION SPIRIT-P1 (NCT01695239; Registered August 08, 2012), SPIRIT-P2 (NCT02349295; September 23, 2014), and SPIRIT-P3 (NCT02584855; August 04, 2015).

中文翻译：

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伊克珠单抗与1822.2病人-年的安全性结果：对成人银屑病关节炎患者的3项临床试验的综合分析。

背景技术在三项临床试验（SPIRIT-P1 / -P2 / -P3）中，对接受伊克珠单抗治疗的银屑病关节炎患者的长期安全性进行了评估。方法评估了来自三个试验（对照和非对照）的综合安全性数据，包括两个关键的第3期，随机，双盲临床试验：SPIRIT-P1和SPIRIT-P2。从所有ixekizumab暴露安全人群（定义为接受≥1剂量ixekizumab的所有患者）中整合安全性数据。我们报告不良事件的间隔为每100个病人年（PY）的暴露调整后的发生率（IR），间隔为1年，最长为3年。结果IXE的总暴露达到1822.2 PY（1118例患者）。以下中断治疗的IRs / 100 PY如下：不良事件（5.3）；严重感染（1.3）；注射部位反应（12.7）；感染（34.2）; 和死亡（0.3）。随着时间的推移，用于治疗的不良事件的IR下降或保持稳定，最常见的是上呼吸道感染，鼻咽炎和注射部位反应。随着时间的推移，严重不良事件和严重感染的IR保持稳定，而对于注射部位反应和一般感染，随着伊克珠单抗暴露时间的延长，IR降低。机会性感染仅限于口腔和食道念珠菌和局部带状疱疹。没有自杀或自伤相关行为的报道。与安全相关的IRs / 100 PY特别引起关注，包括炎症性肠病（已裁决； 0.1），抑郁症（1.6），恶性肿瘤（0.7）和主要的不良心血管事件（0.6）。结论对银屑病关节炎患者进行的这种综合安全性分析的结果与已知的依克珠单抗的安全性一致。牛皮癣关节炎患者用依克珠单抗治疗未观察到意外的安全信号。试用注册SPIRIT-P1（NCT01695239; 2012年8月8日注册），SPIRIT-P2（NCT02349295; 2014年9月23日）和SPIRIT-P3（NCT02584855; 2015年8月4日）。