Shooting for the Stars: Review of the STARDUST Trial and the Treat-to-Target Approach for Crohn's Disease.

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.