Ustekinumab treat-to-target strategy offers long-term alternative for standard-of-care in CD

A treat-to-target (T2T) strategy of ustekinumab in a population of Crohn’s disease (CD) patients was able to maintain the proportion of patients in endoscopic response in a long-term extension (LTE) of the phase 3 STARDUST trial. Moreover, the majority of patients who completed the LTE achieved the primary clinical endpoint of endoscopic response. However, the T2T strategy did not outperform the standard-of-care (SoC) therapy.

The phase 3 STARDUST trial (NCT03107793) compared a T2T strategy with ustekinumab in combination with early endoscopic assessment to a SoC regimen with ustekinumab in an adult population of CD patients. Efficacy and safety data of this trial were presented last year [1]. In total, 323 patients entered the LTE of the trial [2]. The participants followed either the T2T or the SoC regimen. Dose adjustment in the T2T strategy was based on an algorithm evaluating clinical symptoms, endoscopies, and biomarkers. Within the SoC regimen, dose adjustment was solely based on disease flare as confirmed by a physician. Hospital visits were scheduled every 8 weeks. The primary clinical endpoint was an endoscopic response of ≥50% reduction in the simple endoscopic subscore (SES)-CD in comparison with baseline at week 104. Prof. Laurent Peyrin-Biroulet (University Hospital of Nancy, France) presented the results.

Of the patients who completed the LTE until week 104, 57.2% achieved the primary endpoint (as observed). There was no apparent difference between patients in the SoC group (57.0%) and the T2T group (57.4%). In addition, the proportion of patients that reached the primary endpoint was maintained throughout the LTE (week 48, 43.7% vs week 104, 39.3%). Similarly, the proportion of patients in endoscopic remission was mostly sustained over the course of the LTE (week 48, 17.0% vs week 104, 14.6%).

In total, 20.6% of the participants who were enrolled in the LTE discontinued the study. Approximately one-third discontinued because of inadequate benefit-risk ratio treatment. There were no apparent differences in discontinuation figures between the 2 arms of the study. No new safety issues emerged during this LTE.

1. Danese S, et al. United European Gastroenterol J. 2020;8:1264-1265 (Abstract LB11)
2. Peyrin-Biroulet L, et al. Clinical and endoscopic outcomes with ustekinumab in patients with Crohn’s disease: results from the long-term extension period of the STARDUST trial. LB14, UEG Week 2021 Virtual Congress, 03–05 October.

 

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Posted on 27 October 20218 April 2024