Impact of immediate drug optimization of ustekinumab on medium term targets in Crohn's disease: results from the multicentre retrospective real-life study MUST

Abstract

Background and aim: Whether immediate drug dose intensification is a valuable option to optimize ustekinumab efficacy in Crohn's disease (CD) remains unknown. We compared the one-year efficacy of immediate optimisation of ustekinumab 90 mg to 4-weekly with standard 8-weekly dosing in bio-exposed CD patients.

Methods: All consecutive CD patients starting ustekinumab between 2019 and 2020 were included in this multicentre retrospective study, either with immediate drug intensification (MUST group), or standard dosing (STD group). Primary endpoint was combined clinical and biomarkers remission at 52 weeks. A multivariate analysis was led to adjust for main prognostic factors, and a sensitivity analysis was added using a propensity score adjustment.

Results: 203 adult patients were included, 59 in the MUST group and 144 in the STD group. No significant difference in baseline characteristics was found between groups. At week 52, 21 (35.6 %) patients were in combined remission in the MUST group, as compared to 26 (19.7 %) in the STD group (p = 0.028). This remained significant in multivariate analysis (OR = 2.84 [1.30-6.31]) and after propensity score adjustment (OR = 1.32 [1.10-1.57]).

Conclusion: This study found that immediate escalation of ustekinumab therapy to 4-weekly dosing could achieve higher remission rates at one year than 8-weekly dosing in refractory CD.

Keywords: Crohn’s disease; Inflammatory bowel disease; Optimisation; Ustekinumab.