Ustekinumab in Crohn's disease: Real-world outcomes from the Sicilian network for inflammatory bowel diseases

Abstract

Background and aim: Ustekinumab is approved in Europe for the treatment of moderate to severe Crohn's disease (CD). Italian real-life data are scarce, so the aim of this study was to assess the effectiveness and safety of ustekinumab in an Italian cohort of CD patients.

Methods: Data of patients with CD who started using ustekinumab were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease. Primary end-points were steroid-free clinical remission at 8, 24, and 52 weeks of therapy and reduction of C-reactive protein. Secondary end-points were treatment response, treatment persistence at 12 months, and safety.

Results: A total of 131 patients (males 56%; mean age 46 years ±15) were included. All patients were biologics experienced except for one. At 24 and 52 weeks, 40% and 43% of patients achieved steroid-free clinical remission, and 64% and 62% had clinical response, respectively. At the end of follow-up, there was a significant reduction of steroid use (P = 0.012) and of the Harvey-Bradshaw Index (P = 0.001). The probability of persistence in therapy with ustekinumab after 12 months of treatment was 89%. The only factor associated with discontinuation was older age.

Conclusions: Data from our real-life cohort of treatment-refractory CD patients suggest the satisfactory effectiveness and safety profile of ustekinumab.

Keywords: anti‐interleukin‐12/23; efficacy; persistence; safety.

Figure 1

Flowchart of the present study. FU, follow‐up. *patients included in final analysis.

Figure 2

Reduction of Harvey‐Bradshaw Index (HBI) (Wilcoxon‐test) (a) and of steroid use (b) during follow‐up (McNemar test).

Figure 3

Kaplan–Meier survival analysis showed persistence at 12 months of treatment.