BACKGROUND Vedolizumab is a gut-selective antibody to α4 β7 integrin approved to treat moderate-to-severe Crohn's disease and ulcerative colitis in adults. Inflammatory bowel disease (IBD) and immunosuppressant use are associated with increased risk of malignancy. AIM To analyse the incidence of malignancy with vedolizumab treatment in the GEMINI long-term safety (LTS) study and post-marketing (PM) setting. METHODS Malignancy data from the LTS study (May 2009 to May 2018), and data from the vedolizumab Global Safety Database (20 May 2014 to 19 May 2018), were identified using Medical Dictionary for Regulatory Activities coding. The number of patients experiencing malignancies in the LTS study (excluding malignancies within 1 year following vedolizumab initiation) was indirectly standardised against the number expected, using age- and sex-specific rates in patients with IBD from Optum's Clinformatics™ Data Mart (CDM) database. RESULTS Among 1785 patients with ≥1 year of follow-up post-vedolizumab initiation in the LTS study (total 5670 patient-years), observed numbers of malignancies were similar to those expected compared with CDM data (31 vs 29; ratio of observed to expected events = 1.08; P = 0.71; 95% confidence intervals [CI] 0.73, 1.53). The most common malignancies were renal and bladder (6). PM, 293 patients reported 299 malignancies (including malignancies within 1 year following vedolizumab initiation), in approximately 208 050 patient-years of vedolizumab exposure. Lower gastrointestinal malignancies were most common (59). CONCLUSIONS The number of malignancies in the LTS study was similar to that expected from an IBD population with no statistically significant differences, although few confounders could be corrected for. Limitations of PM safety reporting require consideration; however, the number of malignancies with vedolizumab appeared low.

中文翻译：

---

使用维多珠单抗与恶性肿瘤发生率增加无关：GEMINI LTS研究结果和上市后数据。

背景技术维多珠单抗是针对α4β7整合素的肠道选择性抗体，已被批准用于治疗成人的中度至重度克罗恩氏病和溃疡性结肠炎。炎症性肠病（IBD）和免疫抑制剂的使用与恶性肿瘤风险增加相关。目的在GEMINI长期安全性（LTS）研究和上市后（PM）设置中分析使用vedolizumab治疗的恶性肿瘤发生率。方法使用《医疗活动监管词典》对LTS研究（2009年5月至2018年5月）的恶性数据以及vedolizumab全球安全性数据库（2014年5月20日至2018年5月19日）进行识别。LTS研究中发生恶性肿瘤的患者数量（不包括维多珠单抗启动后1年内的恶性肿瘤）与预期的数量间接标准化，使用来自Optum的Clinformatics™数据集市（CDM）数据库的IBD患者的年龄和性别特异性比率。结果在LTS研究中，对1785例接受维多珠单抗治疗后随访≥1年的患者（总计5670患者-年）中，与CDM数据相比，观察到的恶性肿瘤数量与预期的相似（31比29；预期事件= 1.08； P = 0.71； 95％置信区间[CI] 0.73，1.53）。最常见的恶性肿瘤是肾和膀胱（6）。下午，在vedolizumab暴露的约208050患者年中，有293名患者报告了299例恶性肿瘤（包括维多珠单抗启动后1年内的恶性肿瘤）。下消化道恶性肿瘤最常见（59）。结论LTS研究中的恶性肿瘤数量与IBD人群的预期恶性肿瘤数量相似，无统计学显着差异，尽管可以纠正的混杂因素很少。PM安全报告的局限性需要考虑；但是，维多珠单抗的恶性肿瘤数量很少。