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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.)

Background: In real-world experience, the number of patients using vedolizumab as first-line biological therapy was low. We aimed to evaluate the effectiveness and safety of vedolizumab in mild-to-moderate Crohn's disease (CD) biologic-naïve patients., Methods: We performed a retrospective multicentric cohort study with patients who had clinical activity scores (Harvey-Bradshaw Index [HBI]) measured at baseline and weeks 12, 26, 52, as well as at the last follow-up. Clinical response was defined as a reduction ≥3 in HBI, whereas clinical remission as HBI ≤4. Mucosal healing was defined as the complete absence of ulcers in control colonoscopies. Kaplan-Meier survival analysis was used to assess the persistence with vedolizumab., Results: From a total of 66 patients, 53% (35/66) reached clinical remission at week 12. This percentage increased to 69.7% (46/66) at week 26, and 78.8% (52/66) at week 52. Mucosal healing was achieved in 62.3% (33/53) of patients. Vedolizumab was well tolerated, and most adverse events were minor. During vedolizumab treatment, 3/66 patients underwent surgery., Conclusions: This study demonstrates the effectiveness and safety of vedolizumab as a first-line biological agent in patients with mild-to-moderate CD., Competing Interests: P.G.K. and N.S.F.Q. hold the position of Associate Editor for Crohn’s & Colitis 360 and has been recused from reviewing or making decisions for the manuscript. A.Z.D. received a funding to a Master’s Degree scholarship for 2 years. D.O.M., E.G.V., M.M.L., R.L.P., R.L.K.J., and M.A.G.F. have nothing to declare. J.M.F.C. served as speaker for Abbott, Abbvie, Janssen and Takeda. LAC e ARA served as speaker for Janssen, Takeda, Abbvie. F.S. served as Advisory board member of Eurofarma, Janssen, Pfizer, Takeda, and speaker for AbbVie, Amgen, Ferring, Janssen, Pfizer, Sandoz, and Takeda. M.A. served as speaker from Janssen, Takeda, Abbvie, and Pfizer. NSC served as speaker from Janssen, Abbvie, and Sandoz. J.M.L.P. and J.C.L. served as speaker for Takeda. R.S.P. received lecture fee[s] from AbbVie, Janssen, Takeda, Pfizer; is an advisory committee member for Janssen and AbbVie; and he also does clinical research for Janssen and Abbvie. C.F. served as speaker from Takeda, Abbvie, Janssen, Sandoz, Pfizer. E.M.M. served as speaker from Takeda, Janssen, and Ferring. S.C.F. and G.M.N. served as speaker for Takeda and Janssen. N.S.F.Q. served a speaker and advisory board member for Janssen, Takeda, and Abbvie. P.G.K. served as speaker and consultancy for Janssen, Takeda, Abbvie, and Pfizer., (© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)

The conversion of azathioprine (AZA) to active 6-thioguanine nucleotides (6-TGN) is essential for its clinical efficacy; however, another metabolite formed, 6-methylmercaptopurine (6-MMP), is related to hepatotoxicity. Blood samples were collected from 37 patients under AZA's treatment, and a new HPLC-UV method was validated and applied for simultaneous quantification of 6-TGN and 6-MMP in erythrocytes of Crohn's disease (CD) patients. The concentration of 6-TGN and 6-MMP found ranged from 4.5 to 2,456 ρmol/8 × 108 red blood cells (RBCs) for 6-TGN and from 170 to 53,951 ρmol/8 × 108 RBCs for 6-MMP. Reduced levels of 6-MMP in patients into combo therapy with AZA and allopurinol (2,031 ρmol/8 × 108 RBCs) have been observed when compared to patients undergoing monotherapy with AZA (9,098 ρmol/8 × 108 RBCs). Additionally, there was a negative correlation (r = -83.7%, P < 0.05) between lymphocyte count and 6-TGN levels. The method developed is reliable, accurate and reproducible and can be used as an important tool in the monitoring routine of patients with CD under AZA treatment, allowing the individualization of the dose, monitoring adherence to the treatment and the evaluation of the clinical outcome of these patients., (© The Author(s) 2021. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Background and Aims: Studies on inflammatory bowel disease [IBD] have shown that religiousness and spirituality [R/S] were associated with better mental health and quality of life [QOL]. However, longitudinal studies assessing the impact of R/S on long-term clinical outcomes of Crohn's disease [CD] are scarce. The aim of this study was to assess the influence of R/S on the course of CD after a 2-year follow-up and to determine whether these R/S beliefs were associated with mental health and QOL., Methods: A longitudinal 2-year follow-up study was conducted at a referral centre for IBD, including patients with moderately to severely active CD. Clinical data, disease activity [Harvey-Bradshaw Index], QOL [Inflammatory Bowel Disease Questionnaire-IBDQ], depression and anxiety [Hospital Anxiety and Depression Scale-HADS], and R/S [Duke Religion Index-DUREL, Spirituality Self-Rating Scale-SSRS, and Spiritual/Religious Coping-SRCOPE scale] were assessed at baseline and at the end of the 2-year follow-up. Linear and logistic regression models were employed., Results: A total of 90 patients [88.2%] were followed up for 2 years. On logistic regression, baseline levels of spirituality (odds ratio [OR] = 1.309; 95% confidence interval [CI]= 1.104-1.552, p = 0.002) and intrinsic religiousness [OR = 1.682; 95% CI = 1.221-2.317, p = 0.001] were predictors of remission at 2 years. On linear regression, the different dimensions of R/S did not significantly predict IBDQ or anxiety and depression scores after 2 years., Conclusions: R/S predicted remission of CD patients after a 2-year follow-up. However, these beliefs failed to predict mental health or QOL. Health professionals who treat CD should be aware of the religious and spiritual beliefs of their patients, given these beliefs may impact on the disease course., (© The Author(s) 2020. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)