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Background: Real-world data on the effectiveness and safety of ustekinumab (UST) in ulcerative colitis (UC) are lacking in Latin America. In this study, we aimed to describe the effectiveness and safety of UST in a real-world multicenter cohort of Brazilian patients with UC., Methods: We conducted a multicenter retrospective observational cohort study, including patients with moderate-to-severe UC (total Mayo score 6-12, with an endoscopic subscore of 2 or 3) who received UST. The co-primary endpoints were clinical remission, defined as a total Mayo score ≤2 at 1 year, with a combined rectal bleeding and stool frequency subscore of ≤1, and endoscopic remission (endoscopic Mayo subscore of 0) within 1 year from baseline. Secondary endpoints included clinical response between weeks 12 and 16, endoscopic response within 1 year of starting UST, steroid-free clinical remission at week 52, and biochemical remission at week 52. We also evaluated UST treatment persistence and safety., Results: A total of 50 patients were included (female, n  = 36, 72.0%), with a median disease duration of 9.2 years (1-27). Most patients had extensive colitis ( n  = 38, 76.0%), and 43 (86.0%) were steroid dependent at baseline. Forty patients (80.0%) were previously exposed to biologics (anti-TNF drugs, n  = 31; vedolizumab [VDZ], n  = 27). The co-primary endpoints of clinical remission at 1 year and endoscopic remission within 1 year were achieved by 50.0% and 36.0% of patients, respectively. Clinical response at weeks 12-16 was 56.0%, and endoscopic response, steroid-free clinical remission, and biochemical remission at week 52 were 68.0%, 46.5%, and 50.0%, respectively. The UST treatment persistence rate at 24 months was 73.7%. During the follow-up, 10 patients (20.0%) were hospitalized, mostly due to disease progression, and 3 patients required colectomy. Nine patients (18.0%) discontinued the drug mainly due to a lack of effectiveness. Twenty-seven adverse events (AEs) were reported, 16 of which were considered as serious AEs., Conclusions: In this real-world cohort of difficult-to-treat UC patients, UST was associated with improvements in clinical, biochemical, and endoscopic outcomes. The safety profile was favorable, consistent with the known profile of UST., Competing Interests: R.S.P. has received fees for serving as a speaker and/or an advisory board member for Takeda, Janssen, Abbvie, and Pfizer. J.M.F.C. has received fees for serving as a speaker and/or an advisory board member for Takeda, Janssen, AbbVie, Abbott, and Sandoz. M.F.C.A. has received fees for serving as a speaker and/or an advisory board member for Takeda, Abbvie, Pfizer, and Janssen. L.A.C. has received fees for serving as a speaker and/or an advisory board member for Takeda and Janssen. G.P.Z. has received fees for serving as a speaker and/or an advisory board member for Janssen, Abbvie, and Takeda. O.S.C. has received fees for serving as a speaker and/or an advisory board member for Nestle, Abbvie, Janssen, Takeda, and Buhlmann. R.S.B.F. is a speaker for Janssen, Abbvie, Takeda, Ferring, Pfizer, and CSL Vifor. G.O.S. is a speaker for Abbvie, Celtrion, Janssen, and Takeda; conducts clinical research for Janssen, Lilly, Takeda, Polpharma, and Roche; and serves as an advisory board member for Janssen and Pfizer. M.I. has received fees for serving as a speaker and/or an advisory board member for Abbvie, Janssen, Pfizer, and Takeda. A.C.S.M. has received fees for serving as a speaker and/or an advisory board member for Janssen, Abbvie, and Takeda. F.V.T. is a speaker and an advisory board member of Takeda. A.J.T.A.J. has received fees for serving as a speaker and/or an advisory board member for Janssen, Takeda, UCB, and Abbvie. N.L.T.G.J. is a speaker and an advisory board member of Janssen and Takeda. S.C.F. has received fees for serving as a speaker and/or an advisory board member for Janssen, Takeda, and Pfizer. S.F.Q.N. has received fees for serving as a speaker and/or an advisory board member for Takeda, Janssen, Abbvie, and Pfizer. P.G.K. has received fees for serving as a speaker and/or an advisory board member for Janssen, Abbvie, Pfizer, and Takeda. He also has received scientific grants from Pfizer and Takeda. M.L., D.O.M., and F.O. report no conflicts of interest. P.G.K. holds the position of Associate Editor for Crohn’s & Colitis 360 and has been recused from reviewing or making decisions for the manuscript. N.S.F.Q. is a Deputy Editor for Crohn’s & Colitis 360 and has been recused from reviewing or making decisions for the manuscript., (© The Author(s) 2024. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)