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One-year effectiveness and safety of ustekinumab in ulcerative colitis: a multicenter real-world study from Italy
Michele Francesco Chiappetta1,2, Anna Viola1, Mauro Mastronardi3
1IBD-unit, Dept. Of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
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.