STARDUST is the first randomized treat-to-target (T2T) trial using endoscopy at week 16 to guide dose escalation in patients with Crohn’s disease . After 48 weeks of maintenance therapy with ustekinumab, a numerically higher proportion of patients achieved an endoscopic response in the T2T versus standard-of-care arm. Hence, T2T could be an additional tool for physicians to guide ustekinumab dosing decisions in Crohn’s disease.
T2T has been proposed as an effective strategy to optimize the management of Crohn’s disease. The phase 3b STARDUST trial compared a T2T maintenance strategy and standard-of-care in 500 patients with active, moderate-to-severe Crohn’s disease who failed conventional therapy and/or 1 biologic. They received intravenous, weight-based ustekinumab at week 0 (baseline) and thereafter subcutaneous ustekinumab at week 8.
The current analysis evaluated endoscopic and clinical results after 48 weeks. A numerically higher proportion of patients in the T2T achieved the primary endpoint, namely ≥50% reduction in Simple Endoscopic Score in Crohn’s disease (SES-CD) versus baseline, at week 48 compared with the standard-of-care arm: 37.7% versus 29.9% (P=0.0933; non-responder imputation [NRI]). A statistically significant difference was reached in a sensitivity analysis: 40.0% T2T versus 30.8% standard-of-care (P=0.0494; last observation carried forward [LOCF]).
At week 48, high clinical response rates were achieved in both arms:
Furthermore, high biomarker responses were achieved in T2T versus standard-of-care regarding improvement of ≥50% in faecal calprotectin (39.4% versus 46.5% (P>0.05; NRI); and 63.1% versus 60.6% (P>0.05; LOCF)) and C-reactive protein (41.7% versus 53.3% (P=0.032; NRI); and 53.2% versus 57.2% (P>0.05; LOCF)). No new safety signals were reported.
The current results suggest that T2T could be an additional tool for physicians to guide ustekinumab dosing decisions in Crohn’s disease.
1. Danese S. 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. UEG Week Virtual 2020, abstract LB11.