U-ENDURE long-term extension: sustained efficacy of upadacitinib in Crohn’s disease

The efficacy of upadacitinib was maintained over 2 years of treatment in patients with moderately to severely active Crohn’s disease (CD), results of the U-ENDURE long-term extension study showed. According to the authors, no new safety issues were identified.

In the U-ENDURE trial, upadacitinib maintenance therapy, at either a 15 mg or 30 mg dose, outperformed placebo across clinical and endoscopic endpoints over 52 weeks [1]. Participants who completed the 52-week maintenance period could continue in the long-term extension study of U-ENDURE. In total, 173 participants on upadacitinib 30 mg, 107 participants on upadacitinib 15 mg, and 89 participants on placebo entered the long-term extension study. Dr Geert D’Haens (Amsterdam University Medical Centers, the Netherlands) presented the findings [2].

After 48 weeks, stool frequency/abdominal pain score (SF/APS) clinical remission rates were sustained in the 30 mg arm (80.3% at week 0 vs 76.7% at week 48), the 15 mg arm (78.3% vs 82.1%), and in the placebo arm (73.0% vs 70.2%). Similar outcomes were observed for Crohn’s Disease Activity Index (CDAI) clinical remission rates and clinical response rates. Looking at endoscopic response, rates were sustained in the 30 mg arm (66.5% vs 66.7%) and the 15 mg arm (59.6% vs 65.8%), but appeared to have dropped somewhat in the placebo arm (32.9% vs 25.0%).

Overall, clinical and endoscopic outcomes were maintained with prolonged treatment with upadacitinib in patients with CD, without revealing new safety issues.

1. Loftus EV, et al. N Engl J Med 2023;388:1966-1980.
2. D’Haens G, et al. Efficacy and safety of Upadacitinib in patients with moderately to severely active Crohn’s disease: results from the U-ENDURE long-term extension. OP10, 19^th Congress of ECCO, 21–24 February 2024, Stockholm, Sweden.

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Posted on 18 April 2024