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Treat to target vs standard of care for patients with Crohn's disease treated with ustekinumab (STARDUST): An open-label, multicenter, randomized phase 3b trial

The Lancet: Gastroenterology & Hepatology Feb 04, 2022

Among patients suffering from Crohn disease, no significantly better endoscopic outcomes were obtained at week 48 in those who underwent timely escalation of ustekinumab therapy, based on early endoscopic response, clinical symptoms, and biomarkers, when compared with symptom-driven decisions alone. There is a need for future studies to corroborate if some subgroups of patients might benefit from a treat-to-target strategy with ustekinumab.

  • In this open-label, multicenter, randomized phase 3b trial, adults with active, moderate-to-severe Crohn disease for whom conventional therapy or one biologic therapy, or both, had failed were administered ustekinumab at baseline and at week 8; patients with a Crohn's Disease Activity Index improvement of 70 or more points at week 16 from baseline were randomized (1:1) to receive standard-of-care or treat-to-target maintenance treatment through week 48.

  • A total of 498 patients underwent standard induction therapy, of whom 440 were randomized to the treat-to-target group (n=219) or the standard-of-care group (n=221).

  • The two groups did not differ significantly at week 48 for endoscopic response (38% vs 30%), endoscopic remission (11% vs 15%), mucosal healing (14% vs 17%), and clinical remission (62% vs 70%); the treat-to-target group showed significantly lower clinical response than the standard-of-care group (68% vs 78%).

  • No significant differences in other endoscopic, clinical, and biomarker outcomes were found between groups.

  • Nasopharyngitis (13% in the treat-to-target group vs 13% in the standard-of-care group), abdominal pain (11% vs 9%), arthralgia (11% vs 9%), and headache (11% vs 10%) comprised the most commonly reported treatment-emergent adverse events.

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