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The effect of dose-intensification after secondary loss of response to ustekinumab in Crohn's disease: Results of the REScUE study - PubMed

3 hours ago
  • #ustekinumab
  • #Crohn's disease
  • #dose-intensification
  • Study evaluates dose-intensification of ustekinumab in Crohn's disease patients with secondary loss of response.
  • Multicenter, randomized, placebo-controlled trial conducted in Belgium with 108 patients.
  • Patients received either q4 weeks or q8 weeks subcutaneous ustekinumab after a single IV re-induction.
  • Primary endpoint: steroid-free clinical remission at week 48 (PRO-2 remission, fecal calprotectin <250μg/g, no steroids).
  • No significant difference in remission rates between q4W (15%) and q8W (19%) groups (p=0.5).
  • Serious adverse events occurred in 17% (q4W) vs. 13% (q8W) of patients.
  • Conclusion: q4W dosing post-IV re-induction was not more effective than q8W dosing.