Treat to target with ustekinumab for Crohn's disease

The clinical care strategy in Crohn's disease has evolved over time to emphasise a treat-to-target approach in which treatment effectiveness is determined using specific objective treatment goals, in particular healing of the intestinal mucosa on endoscopy. 1 Colombel J-F Narula N Peyrin-Biroulet L Management strategies to improve outcomes of patients with inflammatory bowel diseases. Gastroenterology. 2017; 152: 351-361 Google Scholar The STRIDE-II initiative of the International Organisation∼ for the Study of Inflammatory Bowel Disease defined clinical and endoscopic remission as ultimate targets for Crohn's disease and recommended regular assessment of short-term and intermediate-term targets to adjust therapy for tight control of inflammation. 2 Turner D Ricciuto A Lewis A et al. STRIDE-II: an update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) initiative of the International Organization for the Study of IBD (IOIBD): determining therapeutic goals for treat-to-target strategies in IBD. Gastroenterology. 2021; 160: 1570-1583 Google Scholar In The Lancet Gastroenterology & Hepatology, Silvio Danese and colleagues report the findings of the STARDUST trial, the first prospective study analysing a treat-to-target strategy in Crohn's disease with ustekinumab. 3 Danese S Vermeire S D'Haens G et al. Treat to target versus standard of care for patients with Crohn's disease treated with ustekinumab (STARDUST): an open-label, multicentre, randomised phase 3b trial. Lancet Gastroenterol Hepatol. 2022; (published online Feb 1.)https://doi.org/10.1016/S2468-1253(21)00474-X Google Scholar Patients in the treat-to-target arm received ustekinumab as standard induction therapy and then escalated based on endoscopic response at week 16, with further dose optimisation based on clinical symptoms combined with biomarkers (C-reactive protein [CRP] or faecal calprotectin). This was compared with a standard-of-care approach where escalation was based on clinical judgement. At week 48, there was no significant difference between groups in terms of the primary endpoint of endoscopic response, nor for most of the secondary endpoints. Treat to target versus standard of care for patients with Crohn's disease treated with ustekinumab (STARDUST): an open-label, multicentre, randomised phase 3b trialTimely escalation of ustekinumab therapy for patients with Crohn's disease, based on early endoscopic response, clinical symptoms, and biomarkers, did not result in significantly better endoscopic outcomes at week 48 than symptom-driven decisions alone. Future studies need to confirm if some subgroups of patient might benefit from a treat-to-target strategy with ustekinumab. Full-Text PDF