Intravenous ustekinumab maintenance in Crohn's disease: a single-center retrospective cohort study.

BACKGROUND

Despite the established efficacy of ustekinumab (UST) in Crohn's disease (CD), real-world studies reveal suboptimal treatment persistence and limited endoscopic healing. Current optimization paradigms remain constrained by suboptimal durability and escalating therapeutic demands.

OBJECTIVES

To evaluate the clinical utility and safety of intravenous (IV) ustekinumab maintenance therapy in CD.

DESIGN

This was a single-center retrospective cohort study.

METHODS

This study included CD patients receiving ⩾2 IV-UST maintenance infusions between June 2020 and October 2023 (N = 234). The protocol featured weight-based induction-equivalent dosing (260-520 mg) at response-guided intervals. The primary endpoint was the corticosteroid-free clinical remission rate at Week 24.

RESULTS

At 24 weeks, 88.1% (185/210) achieved steroid-free remission with C-reactive protein (CRP) normalization in 90.0% (44/88). Median Harvey-Bradshaw Index decreased from 4 (interquartile range (IQR) 2-5) to 2 (IQR 1-3; p < 0.001). 52-week endoscopic remission (simplified endoscopic score for Crohn's disease ⩽3) reached 48.7% (56/115), with fecal calprotectin normalization in 33.6% (35/104). Multivariate analysis identified baseline CRP >5 mg/L (adjusted odds ratio (aOR) 3.62, 1.16-11.25), intensive dosing (⩾6 cycles/year; aOR 12.06, 1.99-73.05), and disease duration ⩾1 year (aOR 3.53, 1.08-11.54) as predictors of endoscopic non-remission. Safety analysis demonstrated 44.4% adverse event incidence (104/234) and 3.0% serious adverse events (7/234).

CONCLUSION

IV-UST maintenance demonstrates high rates of corticosteroid-free clinical remission and endoscopic healing with manageable safety in CD.