Background and Aims Previously published long-term safety data reported a favorable ustekinumab safety treatment profile for treatment of inflammatory bowel disease (IBD). We present the final cumulative safety data from pooled ustekinumab IBD phase 2/3 clinical studies through 5 years in Crohn’s disease (CD) and 4 years in ulcerative colitis (UC). Methods In phase 3 studies, patients received a single IV placebo or ustekinumab (130mg or ~6mg/kg) induction dose followed by subcutaneous maintenance doses of placebo or ustekinumab (90mg q8w or q12w). Analyses included all patients who received one dose of study treatment and included patients who were biologic-naïve and patients with a history of biologic failure. Safety outcomes are summarized and presented using number of events per 100 patient-years of follow-up and corresponding 95% confidence interval. Results In this final pooled safety analysis, 2575 patients were treated with ustekinumab with 4826 patient-years of follow-up. Rates of key safety events, including MACE and malignancies, were similar between placebo and ustekinumab or not higher for ustekinumab. Opportunistic infections, including tuberculosis, and malignancies were reported infrequently. Rates of key safety events in the IBD group were no higher in the ustekinumab group than in the placebo group for both patients who were biologic naïve or who had previously failed a biologic. No lymphomas or cases of posterior reversible encephalopathy syndrome (PRES; formerly known as reversible posterior leukoencephalopathy syndrome [RPLS] were reported. Conclusion The final cumulative ustekinumab safety data through 5 years in CD and 4 years in UC demonstrated favorable safety compared to placebo and continues to support the well-established safety profile across all approved indications.

中文翻译：

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乌司奴单抗治疗炎症性肠病的安全性：克罗恩病 5 年和溃疡性结肠炎 4 年的汇总安全性分析

背景和目标 先前发表的长期安全性数据报告了优特克单抗治疗炎症性肠病 (IBD) 的安全性。我们提供了 5 年克罗恩病 (CD) 和 4 年溃疡性结肠炎 (UC) 合并乌特克单抗 IBD 2/3 期临床研究的最终累积安全性数据。方法 在 3 期研究中，患者接受单次 IV 安慰剂或优特克单抗（130mg 或 ~6mg/kg）诱导剂量，随后皮下注射安慰剂或优特克单抗维持剂量（90mg 每 8 周或每 12 周）。分析包括接受一剂研究治疗的所有患者，包括未接受过生物治疗的患者和有生物治疗失败史的患者。使用每 100 个患者年的随访事件数和相应的 95% 置信区间来总结和呈现安全性结果。结果 在最终的汇总安全性分析中，2575 名患者接受了乌特克单抗治疗，并进行了 4826 患者年的随访。安慰剂和乌特克单抗之间的关键安全事件（包括 MACE 和恶性肿瘤）发生率相似，或者乌特克单抗并不更高。机会性感染，包括结核病和恶性肿瘤的报道很少。对于未使用过生物制剂或之前生物制剂失败的患者，优特克单抗组的 IBD 组关键安全事件发生率并不高于安慰剂组。未报告淋巴瘤或可逆性后部白质脑病综合征 (PRES；以前称为可逆性后部白质脑病综合征 [RPLS]) 病例。结论 5 年 CD 治疗和 4 年 UC 治疗的最终累积乌特克单抗安全性数据表明，与安慰剂相比，乌特克单抗具有良好的安全性，并且继续支持所有批准适应症的既定安全概况。