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

Michele Francesco Chiappetta, Anna Viola, Mauro Mastronardi, Laura Turchini, Sonia Carparelli, Adele Orlando, Antonio Orlando, Giuseppe Biscaglia, Agnese Miranda, Laura Guida, Giuseppe Costantino, Angela Giusy Costantino, Franco Scaldaferri, Fabrizio Bossa, Sara Renna, Maria Cappello, Angela Alibrandi, Ambrogio Orlando, Antonio Orlando, Alessandro ArmuzziWalter Fries

Research output: Contribution to journalArticle


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.
Original languageEnglish
Pages (from-to)1483-1489
Number of pages7
JournalExpert Opinion on Biological Therapy
Publication statusPublished - 2021


  • Ulcerative colitis
  • anti-interleukin (IL)-12/23
  • efficacy
  • mucosal healing
  • persistence
  • safety


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