One-year effectiveness and safety of ustekinumab in ulcerative colitis: a multicenter real-world study from Italy

Expert Opin Biol Ther. 2021 Nov;21(11):1483-1489. doi: 10.1080/14712598.2021.1981855. Epub 2021 Sep 27.

Abstract

Background: Efficacy and safety of ustekinumab for the treatment of ulcerative colitis (UC) has been demonstrated in clinical trials, but few real-world data are available so far. The aim of this study was to assess effectiveness and safety of ustekinumab in a cohort of refractory UC patients.

Methods: Data of patients with moderate to severe UC treated with ustekinumab were retrospectively collected. Primary endpoint was steroid-free clinical remission at weeks 24 and 52 of therapy. Secondary endpoints were treatment response, endoscopic remission, treatment persistence at 12 months and safety.

Results: A total of 68 patients [males 63%; median (range) age 42 (16-72) years] were included. Almost all patients (97%) were biologics experienced. At weeks 24 and 52, 31% and 50% of patients achieved steroid-free clinical remission, 84% and 82% had clinical response, respectively. At the end of follow-up, there was a significant reduction of pMS from baseline (p < 0.001) and of steroid use (p < 0.001). At week 52, 22% of the available endoscopies (18/38) showed mucosal healing. The probability to persist in therapy at week 52 was 87%. Only one adverse event occurred.

Conclusions: Data from our real-life cohort of refractory UC patients suggest satisfactory effectiveness and a good safety of ustekinumab.

Keywords: Ulcerative colitis; anti-interleukin (IL)-12/23; efficacy; mucosal healing; persistence; safety.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Colitis, Ulcerative* / diagnosis
  • Colitis, Ulcerative* / drug therapy
  • Humans
  • Male
  • Remission Induction
  • Retrospective Studies
  • Treatment Outcome
  • Ustekinumab* / adverse effects

Substances

  • Ustekinumab