Vieujean Sophie, Louis Edouard, Danese Silvio, Peyrin-Biroulet Laurent
Hepato-Gastroenterology and Digestive Oncology, University Hospital CHU of Liège, Liège, Belgium.
Department of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy.
Expert Rev Gastroenterol Hepatol. 2023 May;17(5):413-430. doi: 10.1080/17474124.2023.2194632. Epub 2023 Mar 26.
Ustekinumab is a humanized monoclonal antibody, targeting the p40 subunit common to both human interleukin 12 and 23, approved by the European Medicines Agency and US Food and Drug Administration for the treatment of moderate-to-severe ulcerative colitis.
In this review, the results of the phase 3 UNIFI and the real-world studies assessing the efficacy and safety of ustekinumab in moderate-to-severe ulcerative colitis are discussed, as well as limitations of these studies. Predictive factors of response, the interest of therapeutic drug monitoring and the positioning of ustekinumab in specific situations are also addressed. Finally, in the light of data presented, the positioning of ustekinumab in the therapeutic algorithm of ulcerative colitis will also be considered.
Ustekinumab has been shown to be effective to induce and maintain clinical, endoscopic and histologic remission in moderate-to-severe ulcerative colitis both in phase 3 and real-world studies, with a favorable safety profile. Overall, its favorable risk-benefit ratio, its efficacy on extra-intestinal manifestations and in biologics failure patients make ustekinumab an ideal candidate as first, second, or third-line therapy in ulcerative colitis.
优特克单抗是一种人源化单克隆抗体，靶向人白细胞介素12和23共有的p40亚基，已获欧洲药品管理局和美国食品药品监督管理局批准用于治疗中重度溃疡性结肠炎。
在本综述中，讨论了3期UNIFI研究以及评估优特克单抗治疗中重度溃疡性结肠炎疗效和安全性的真实世界研究结果，以及这些研究的局限性。还探讨了反应的预测因素、治疗药物监测的意义以及优特克单抗在特定情况下的定位。最后，根据所呈现的数据，也将考虑优特克单抗在溃疡性结肠炎治疗方案中的定位。
在3期研究和真实世界研究中，优特克单抗已被证明能有效诱导和维持中重度溃疡性结肠炎的临床、内镜和组织学缓解，且安全性良好。总体而言，其良好的风险效益比、对肠外表现的疗效以及在生物制剂治疗失败患者中的疗效，使优特克单抗成为溃疡性结肠炎一线、二线或三线治疗的理想选择。
