Background and Aims

Vedolizumab is a gut-selective antibody to α ₄ β ₇ integrin, approved to treat moderate-to-severe ulcerative colitis and Crohn’s disease in adults. Clinical trial data on patients meeting protocol-specified criteria may not reflect real-world clinical practice. This is a descriptive analysis of 4 years of post-marketing safety data on vedolizumab.

Methods

The Vedolizumab Global Safety Database contains all adverse event reports collated by Takeda Pharmaceutical Company Ltd since vedolizumab approval [May 20, 2014]. Adverse event reports received between approval and May 19, 2018 were identified using Medical Dictionary for Regulatory Activities version 21.0 Preferred Terms. Adverse event frequencies were calculated and categorised.

Results

In approximately 208 050 patient-years of vedolizumab exposure, 32 752 patients reported 80 218 events. In patients with Crohn’s disease or ulcerative colitis, 37 662 and 34 259 events occurred in 14 191 and 14 042 patients, respectively, and 8297 events occurred in 4519 individuals with other [off-label] or unreported indications. Overall, 5230 [14%; Crohn’s disease] and 3580 [10%; ulcerative colitis] events were serious. Most frequently reported were gastrointestinal events (Crohn’s disease, 6156 [16%]; ulcerative colitis, 5701 [17%]). Patients with Crohn’s disease or ulcerative colitis reported 251 malignancies [<1%], 402 hepatobiliary events [<1%], and 5876 infections (1137 serious [19%], 301 opportunistic [5%]). Patients aged ≥70 years [2326 patients] reported <10% of events.

Conclusions

Adverse event patterns were consistent with clinical trials, with no new safety concerns. Most reported events were non-serious and event frequency was low, considering patient-years of exposure. Although limitations of post-marketing safety reports require acknowledgement, these real-world data support a favourable safety profile of vedolizumab.

中文翻译：

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维多珠单抗在溃疡性结肠炎和克罗恩病中的安全性：四年全球上市后数据

背景和目标

维多珠单抗是一种肠道选择性抗体α  ₄ β  ₇整合，批准用于治疗中度至重度溃疡性结肠炎和克罗恩成人病。符合协议指定标准的患者的临床试验数据可能无法反映实际的临床实践。这是对维多珠单抗上市后4年安全性数据的描述性分析。

方法

Vedolizumab全球安全性数据库包含自vedolizumab批准以来[2014年5月20日]武田制药有限公司整理的所有不良事件报告。批准至2018年5月19日之间收到的不良事件报告使用《管制活动医学词典》第21.0版``首选条款''进行了识别。计算不良事件发生频率并进行分类。

结果

在约208050患者年的维多珠单抗暴露中，32 752位患者报告了80 218次事件。在克罗恩病或溃疡性结肠炎患者中，分别有14 191和14 042患者发生了37 662和34 259事件，在4519患有其他[标签外]或未报告适应症的患者中发生了8297事件。总计5230 [14％；克罗恩病]和3580 [10％；溃疡性结肠炎]事件严重。最常报告的是胃肠道事件（克罗恩氏病，6156 [16％]；溃疡性结肠炎，5701 [17％]）。克罗恩病或溃疡性结肠炎患者报告251例恶性肿瘤[<1％]，402例肝胆事件[<1％]和5876例感染（严重1137例[19％]，301例机会[5％]）。≥70岁的患者[2326名患者]报告的事件少于10％。

结论

不良事件模式与临床试验一致，没有新的安全隐患。考虑到患者的暴露年限，大多数报告的事件为非严重事件，事件发生频率较低。尽管需要确认上市后安全报告的局限性，但这些实际数据支持vedolizumab的良好安全性。