105 Clinical and Endoscopic Response to Treat-to-Target Versus Standard of Care in Crohn's Disease Patients Treated With Ustekinumab: Week 48 Results of the Stardust Trial

Ustekinumab improves health‐related quality of life in patients with moderate‐to‐severe Crohn's disease: Results up to Week 104 of the STARDUST trial

“…The baseline demographic and disease characteristics at the induction baseline for the RAS population were similar in the two treatment arms and have been reported previously 12 . For the mRAS population, baseline disease characteristics are presented in Supplementary Table .…”

“…The STARDUST study design and primary outcomes, including the safety data, have been reported previously 12 . In brief, the STARDUST trial (NCT03107793) is an open‐label, multicentre, randomized phase 3b trial conducted in 12 European countries.…”

“…We believe that treating to target may result in better long‐term outcomes, including HRQoL. STARDUST was the first randomized controlled trial comparing a treat‐to‐target (T2T) approach using early endoscopic assessment, regular biomarker and clinical symptom monitoring, and dose intensification for persistent inflammatory activity with a clinically driven standard of care (SoC) maintenance strategy in patients with moderate‐to‐severe active CD receiving ustekinumab 12 . We previously reported that the primary endpoint of this trial, endoscopic response, and other endpoints were not significantly different between the two treatment strategies 12 .…”

“…STARDUST was the first randomized controlled trial comparing a treat‐to‐target (T2T) approach using early endoscopic assessment, regular biomarker and clinical symptom monitoring, and dose intensification for persistent inflammatory activity with a clinically driven standard of care (SoC) maintenance strategy in patients with moderate‐to‐severe active CD receiving ustekinumab 12 . We previously reported that the primary endpoint of this trial, endoscopic response, and other endpoints were not significantly different between the two treatment strategies 12 . After the completion of the first year of treatment, patients entering the long‐term extension (LTE) period were evaluated until Week 104, with algorithm‐driven dose escalation/de‐escalation available for all patients regardless of whether patients were in the T2T or SoC treatment arms.…”

Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Crohn’s Disease

“…Only one other trial has used an endoscopic determination (25% improvement in SES-CD) to assign maintenance dosing, but the results describing the effect of this determination on endoscopic and clinical outcomes after maintenance therapy are not yet available. 21 In this trial, patients who had failed to demonstrate even a 1-point improvement in SES-CD by Week 12 were continued on mirikizumab at the highest dose through Week 52, and although this group had lower rates of endoscopic response and remission at 1 year compared with those who had endoscopic improvement at Week 12, 1 of 5 of these patients achieved endoscopic response and more than a third achieved PRO remission by Week 52. The significance of these observations is similar to other reports of early outcomes predicting later responses and should be further evaluated.…”