Ustekinumab in CD: a T2T trial

Clinical and endoscopic results of the STARDUST trial of ustekinumab in patients with moderate-to-severe Crohn's disease (CD) showed two-thirds of patients achieved clinical remission after 16 weeks of ustekinumab induction. Of responders then randomised to the treat-to-target (T2T) arm, 37% showed endoscopic response after another 16 weeks [1].

STARDUST is an ongoing phase 3b randomised strategy trial of ustekinumab in CD. “This is the first T2T trial in CD patients using endoscopy at week 16 as a decision point for dose adjustment”, explained Prof. Laurent Peyrin-Biroulet (CHRU de Nancy, France). Eligible for enrolment were CD patients who failed conventional therapy and at most 1 biologic. At baseline, patients received intravenous ustekinumab of ~6 mg/kg induction and, at week 8, subcutaneous ustekinumab 90 mg. After 16 weeks, patients with a Clinical Disease Activity Index (CDAI) reduction of ≥70 points were randomised to T2T or standard of care.

The intention-to-treat (ITT) full set included 500 patients. After 16 weeks, 79.4% of patients had a clinical response; 66.6% were in clinical remission. About half of the patients showed ≥50% improvement in faecal calprotectin (FCP) and C-reactive protein (CRP) levels, which normalised in about one third of patients. Of patients with a response after 16 weeks, 84% were in clinical remission. There were statistically significant changes from baseline in CDAI, FCP, and CRP at week 8, and in Inflammatory Bowel Disease Questionnaire (IBDQ) scores at week 16. Of patients in the T2T group (n=220), 36.8% achieved endoscopic response after 16 weeks, while 11.4% achieved remission. Endoscopic response was numerically better for colonic versus ileal disease. Prof. Peyrin-Biroulet added that no new safety signals were reported.

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   1. Danese S, et al. ECCO-IBD 2020, DOP13.

 



Posted on 14 April, 20208 April, 2024