Shawn Gurwara, Hou Jason K
Department of Medicine, Baylor College of Medicine, Houston, Texas.
Section of Gastroenterology, Michael E. DeBakey VA Medical Center, Houston, Texas.
Gastroenterol Hepatol (N Y). 2022 May;18(5):243-247.
Crohn's disease (CD) and ulcerative colitis, collectively termed inflammatory bowel disease, are progressive autoimmune conditions of the gastrointestinal tract. Mucosal healing has been associated with fewer major abdominal surgeries and hospitalizations in patients with CD compared with patients with CD but without mucosal healing. Therefore, a treat-to-target (T2T) management approach to escalate treatment by targeting objective markers of inflammation rather than clinical symptoms alone has been introduced in recent years. The STARDUST trial is the first T2T randomized trial of adult patients with CD using endoscopy and biomarkers for dose adjustment of ustekinumab. Patients with active CD were randomized to 2 arms: T2T and standard of care (SoC). In the T2T arm, changes in dosing interval were based on endoscopic severity, clinical symptoms, and biomarkers, whereas in the SoC arm, dosing adjustments were made based on clinical symptoms alone. The primary endpoint was 50% or greater improvement in Simple Endoscopic Score for Crohn's Disease at week 48. The results of the primary endpoint found increased endoscopic response in the T2T arm compared with the SoC arm. However, the endpoint was not statistically significant using nonresponder imputation analyses. This article discusses the details and limitations of the STARDUST trial and addresses further questions regarding T2T approaches for CD.
克罗恩病（CD）和溃疡性结肠炎统称为炎症性肠病，是胃肠道的进行性自身免疫性疾病。与未实现黏膜愈合的克罗恩病患者相比，黏膜愈合与克罗恩病患者较少的大型腹部手术和住院次数相关。因此，近年来引入了一种以达到治疗目标（T2T）为导向的管理方法，即通过针对炎症的客观指标而非仅临床症状来强化治疗。STARDUST试验是第一项针对成年克罗恩病患者的T2T随机试验，该试验使用内镜检查和生物标志物来调整优特克单抗的剂量。活动性克罗恩病患者被随机分为两组：T2T组和标准治疗（SoC）组。在T2T组中，给药间隔的调整基于内镜严重程度、临床症状和生物标志物，而在SoC组中，仅根据临床症状进行剂量调整。主要终点是在第48周时克罗恩病简易内镜评分改善50%或更高。主要终点结果显示，与SoC组相比，T2T组的内镜反应有所增加。然而，使用无反应者插补分析时，该终点无统计学意义。本文讨论了STARDUST试验的细节和局限性，并探讨了有关克罗恩病T2T方法的进一步问题。
