The effect of dose-intensification after secondary loss of response to ustekinumab in Crohn's disease: Results of the REScUE study.
(2026) Gastroenterology — (2026)
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- Secondary loss of response to ustekinumab is observed in patients with Crohn's disease (CD). Multiple dose-intensification regimens have been proposed. We aimed to test prospectively two different dose-intensification regimens with ustekinumab in patients with CD experiencing secondary loss of response. This was an investigator-initiated, multicenter, randomized, placebo-controlled trial conducted at 15 hospitals in Belgium. Eligible patients were adults with CD treated with ustekinumab on maintenance dosing of 90 mg subcutaneous q8 weeks and experiencing a secondary loss of response (PRO-2: abdominal pain (AP) score >1 and liquid or very soft stool frequency (SF) >3 and an objective documentation of disease). Patients were randomized 1:1 to receiving a single intravenous re-induction with ustekinumab ≈ 6mg/kg followed by either subcutaneous ustekinumab 90 mg q4 weeks or q8 weeks till week 48. The primary endpoint was the proportion of patients with steroid-free clinical remission at week 48, defined as PRO-2 remission: (AP ≤ 1 AND SF ≤3) and fecal calprotectin <250μg/g and no steroids in the 90 days prior to week 48. Between March 2020 and October 2023, 108 patients were randomized. Steroid free clinical remission at week 48 was reached in 15% versus 19% of patients in the Q4W versus the Q8W group (difference 4%; p=0.5). Serious adverse events occurred in 17% vs 13% of patients. In patients with CD and secondary loss of response to ustekinumab, dose-intensification with a single intravenous administration and followed by 4 weekly subcutaneous dosing of ustekinumab was not more effective than one intravenous administration followed by 8 weekly SC dosing of ustekinumab. gov number: NCT04245215.
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Bossuyt, P., Rahier, J.-F., Baert, F., Cruysmans, E., Macken, E., Lobaton, T., Busschaert, J., Peeters, H., Dewint, P., Franchimont, D., Willandt, B., Claessens, C., Vansteenkiste, L., Dewit, O., Ferrante, M., & Vermeire, S. (2026). The effect of dose-intensification after secondary loss of response to ustekinumab in Crohn’s disease: Results of the REScUE study. Gastroenterology. Accepted/in-press. https://doi.org/10.1053/j.gastro.2026.01.042 (Original work published 2026)