INTRODUCTION The benefit of adding an immunomodulator to vedolizumab and ustekinumab remains unclear and may compromise the safety of these biologics. We evaluated the prevalence and predictors of immunomodulator use with vedolizumab or ustekinumab in patients with inflammatory bowel disease in a large longitudinal cohort. METHODS Clinical information was ascertained from electronic medical records of patients enrolled in TARGET-IBD, a prospective longitudinal observational cohort of patients with inflammatory bowel disease (IBD) at 34 sites. The prevalence of immunomodulator use with vedolizumab, ustekinumab, and antitumor necrosis factor therapies and predictors of immunomodulator use with vedolizumab and ustekinumab were estimated. Rates of combination therapy were additionally stratified by time from drug approval. RESULTS Four thousand thirty-nine adults with IBD were identified, of whom 18.8% were treated with vedolizumab and 13.0% were treated with ustekinumab. Combination therapy with vedolizumab and ustekinumab exceeded 30% (30.7% and 36.2%, respectively) and was more likely in those with perianal disease or previous biologic exposure. Age and presence of extraintestinal manifestations did not consistently predict the use of an immunomodulator. Combination therapy decreased in the years after drug approval. DISCUSSION Combination therapy with vedolizumab or ustekinumab was common and was associated with perianal disease and greater exposure to other biologics, although the practice is decreasing with time. Further data are needed to determine the efficacy and safety of combination therapy in patients initiating vedolizumab or ustekinumab for IBD.

中文翻译：

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免疫调节剂与维多珠单抗或乌司奴单抗联合治疗炎症性肠病的流行情况。

简介 在维多珠单抗和乌特克单抗中添加免疫调节剂的益处仍不清楚，并且可能会损害这些生物制剂的安全性。我们在大型纵向队列中评估了炎症性肠病患者使用维多珠单抗或乌特克单抗免疫调节剂的患病率和预测因素。方法 通过 TARGET-IBD 患者的电子病历确定临床信息，TARGET-IBD 是一个前瞻性纵向观察队列，涵盖 34 个地点的炎症性肠病 (IBD) 患者。估计了维多珠单抗、乌特克单抗和抗肿瘤坏死因子疗法中免疫调节剂使用的流行率以及维多珠单抗和乌特克单抗联合免疫调节剂使用的预测因子。联合治疗的比例还根据药物批准后的时间进行分层。结果 确定了 4,39 名 IBD 成人，其中 18.8% 接受维多珠单抗治疗，13.0% 接受乌特克单抗治疗。维多珠单抗和乌特克单抗联合治疗超过 30%（分别为 30.7% 和 36.2%），并且在患有肛周疾病或既往生物制剂暴露的患者中更有可能。年龄和肠外表现的存在并不能一致地预测免疫调节剂的使用。药物批准后的几年里，联合治疗的数量有所减少。讨论 维多珠单抗或乌特克单抗的联合治疗很常见，并且与肛周疾病和更多地接触其他生物制剂有关，尽管这种做法随着时间的推移而减少。需要进一步的数据来确定联合治疗对于开始使用维多珠单抗或乌特克单抗治疗 IBD 的患者的疗效和安全性。