Ustekinumab escalation using a treat-to-target strategy did not improve endoscopic outcomes among all patients with Crohn disease (CD) but may have some efficacy among certain subgroups. These findings, from an open-label, multicenter, randomized, phase 3b trial, were published in The Lancet Gastroenterology and Hepatology.

Patients (N=498) with moderate to severe CD were recruited at centers in 12 European countries for the STARDUST trial ( Identifier: NCT03107793). During an induction phase, patients received 6 mg/kg intravenous ustekinumab at baseline and 90 mg subcutaneous ustekinumab at week 8. Responders (n=440) were randomly assigned at week 16 to receive a treat-to-target (n=219) or standard-of-care (n=221) dosing strategy.

The primary endpoint was endoscopic response at week 48. For the treat-to-target strategy, patients who had <25% improvement were treated every 8 weeks starting at week 16 and those with ³25% improvement received treatment every 12 weeks starting at week 20.

Continue Reading

The intervention and control cohorts were 52% and 50% women, aged median 36.0 (IQR, 27.0-48.0) and 34.0 (IQR, 25.0-47.0) years, body mass index was 23.05 (IQR, 20.28-26.85) and 23.36 (IQR, 20.70-26.01) kg/m2, 98% and 96% were taking ³1 concomitant medication, and 84% and 77% had uncomplicated CD, respectively.

Among the intervention cohort, 59% initially received ustekinumab every 12 weeks and 60% remained on that therapy through week 48. The remaining patients received therapy every 8 weeks and 40% remained on that schedule.

Endoscopic response was achieved by 38% of the treat-to-target and 30% of the standard-of-care recipients (P =.087). Using a last observation carried forward approach, more patients in the treat-to-target cohort achieved endoscopic response at week 48 (40% vs 31%; P =.046). Similarly, treat-to-target was favored for endoscopic response in the modified nonresponder imputation analysis (43% vs 32%; P =.036).

Fewer treat-to-target recipients exhibited a Crohn Disease Activity Index (CDAI-70) improvement response (adjusted treatment difference, -8.5; 95% CI, -16.7 to -0.4; P =.042).

In a subgroup analysis, treat-to-target was favored for patients with longer duration (greater median) disease (odds ratio [OR], 2.15; 95% CI, 1.17-3.94; P =.013) and among those who were older (greater median age; OR, 1.82; 95% CI, 1.00-3.31; P =.050).

Adverse events were reported by 86% of the treat-to-target and 81% of the standard care cohorts. Discontinuation due to adverse events occurred among 5% and 9% of patients, respectively.

This study was limited by its open-label design and by the fact that more patients in the intervention group (4%) refused the 16-week endoscopy.

This study found that a treat-to-target approach had similar outcomes as a standard-of-care approach for the treatment of moderate to severe CD using ustekinumab. However, among some patient groups, this treatment strategy may be more effective and warrants further analysis.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.


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. Published online February 1, 2022. doi:10.1016/S2468-1253(21)00474-X