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Treat to target versus standard of care for patients with Crohn's disease treated with ustekinumab (STARDUST)

The Lancet: Gastroenterology & Hepatology Apr 30, 2022

Why this study matters

Although TNF antagonists are considered first-line biologic therapy in CD patients who have failed conventional immunosuppressant therapy, nearly two-thirds of CD patients do not respond to TNF antagonists and/or have intolerable side effects.  

Ustekinumab is a good treatment option for such patients.  Although the optimal dosing strategy is still in question, it appears that dosing based on patient-reported symptoms is effective.

Study design

A total of 440 CD patients with moderate-to-severe CD who had failed conventional or biologic therapy were enrolled in this phase 3b multi-center trial.  The participants received usekinumab (6 mg/kg iv at baseline and 90 mg sc at week 8). 

Patients with an improvement in the Crohn’s Disease Activity Index (CDAI) > 70 points from baseline were randomized to receive treat-to-target or standard care through week 48.  The treat-to-target group received ustekinumab q12 weeks or q8 weeks according to the Simple Endoscopic Score in Crohn’s Disease (SES-CD).  This group was eligible for q4 week escalation as indicated.  The standard care group also received ustekinumab q8 or q12 weeks, with escalation q12 weeks. 

The primary outcome measure was the endoscopic response at 48 weeks.

Results and conclusion

After 48 weeks of treatment with ustekinumab, no differences were detected in the treat-to-target and standard care groups with respect to endoscopic response, endoscopic remission, mucosal healing, and clinical remission between the treat-to-target and standard care groups; however, the clinical response was better in the latter group (78%) than the former group (68%). 

The side effects were similar between the two groups of CD patients and included nasopharyngitis, abdominal pain, arthralgias, and headaches.

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