Ustekinumab T2T strategy offers long-term alternative for standard of care in Crohn’s disease

A treat-to-target strategy of ustekinumab in CD patients could maintain a proportion of patients in endoscopic response in a long-term extension of a phase 3 trial.

Dose adjustment in the T2T strategy was based on an algorithm

The phase 3 STARDUST trial (NCT03107793) compared a T2T strategy with ustekinumab in combination with early endoscopic assessment to an SoC regimen with ustekinumab in an adult population of CD patients. Efficacy and safety data of this trial have been presented last year1. In total, 323 patients entered the LTE of the trial2. The participants followed either the T2T or the SoC regimen.

Dose adjustment in the T2T strategy was based on an algorithm evaluating clinical symptoms, endoscopies, and biomarkers. Within the SoC regimen, dose adjustment was solely based on disease flare as confirmed by a physician. Visitations were scheduled every 8 weeks. Primary clinical endpoint was an endoscopic response of ≥50% reduction in the simple endoscopic subscore (SES)-CD in comparison with baseline at week 104.

No apparent differences in discontinuation figures

Prof. Laurent Peyrin-Biroulet (University Hospital of Nancy, France) presented the results. Of the patients who completed the LTE until week 104, 57.2% achieved the primary endpoint (as observed). There was no apparent difference between patients in the SoC group (57.0%) and the T2T group (57.4%). In addition, the proportion of patients that reached the primary endpoint was maintained throughout the LTE (week 48, 43.7% vs week 104, 39.3%).

Similarly, the proportion of patients in endoscopic remission was mostly sustained over the course of the LTE (week 48, 17.0% vs week 104, 14.6%). In total, 20.6% of the participants who were enrolled in the LTE discontinued the study. Approximately one-third discontinued due to non-efficacy reasons. There were no apparent differences in discontinuation figures between the 2 arms of the study. No new safety issues emerged during this LTE.

References
  1. Danese S, et al. United European Gastroenterol J. 2020;8:1264-1265 (Abstract LB11)
  2. Peyrin-Biroulet L, et al. Clinical and Endoscopic Outcomes with Ustekinumab in Patients with Crohn’s Disease: Results from the Long-Term Extension Period of the STARDUST Trial. LB14, UEG Week 2021 Virtual Congress, 3-5 October.