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Background and Aims: The development programm UNIFI has shown promising results of ustekinumab in ulcerative colitis [UC] treatment which should be confirmed in clinical practice. We aimed to evaluate the durability, effectiveness, and safety of ustekinumab in UC in real life., Methods: Patients included in the prospectively maintained ENEIDA registry, who received at least one intravenous dose of ustekinumab due to active UC [Partial Mayo Score [PMS]>2], were included. Clinical activity and effectiveness were defined based on PMS. Short-term response was assessed at Week 16., Results: A total of 95 patients were included. At Week 16, 53% of patients had response [including 35% of patients in remission]. In the multivariate analysis, elevated serum C-reactive protein was the only variable significantly associated with lower likelihood of achieving remission. Remission was achieved in 39% and 33% of patients at Weeks 24 and 52, respectively; 36% of patients discontinued the treatment with ustekinumab during a median follow-up of 31 weeks. The probability of maintaining ustekinumab treatment was 87% at Week 16, 63% at Week 56, and 59% at Week 72; primary failure was the main reason for ustekinumab discontinuation. No variable was associated with risk of discontinuation. Three patients reported adverse events; one of them had a fatal severe SARS-CoV-2 infection., Conclusions: Ustekinumab is effective in both the short and the long term in real life, even in a highly refractory cohort. Higher inflammatory burden at baseline correlated with lower probability of achieving remission. Safety was consistent with the known profile of ustekinumab., (© The Author(s) 2021. 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.)

Aims: The objective of the current study was to compare two patient assessment strategies using colonoscopy and MRI alternatively as first- and second-line examinations., Methods: Clinical data, endoscopy and magnetic resonance imaging (MRI) examinations of 100 patients diagnosed with ileocolonic Crohn's disease (CD) performed within 1 week were blindly reviewed by 4 clinical investigators. Two investigators evaluated MRI followed by colonoscopy for 50 cases and the same examinations in reverse order for another 50 cases; the other 2 investigators evaluated the same cases switching the order of examinations. The assessments included the likelihood of the presence of inflammation, stenosis, fistula and abscess, and therapeutic recommendations., Results: Information from the first examination was considered sufficient for management in 80% of cases for MRI and only 34% of cases for colonoscopy (p < 0.001). Adding MRI to the information from colonoscopy changed the clinicians' confidence grade in a higher proportion of patients than adding colonoscopy to information from MRI for the diagnosis of disease activity (10 vs 4%, p = 0.03), stenosis (25 vs 9%, p < 0.001), fistula (31 vs 0%, p < 0.001) and internal abscess (27 vs 0%, p < 0.001). Indications for anti-tumour necrosis factor (TNF) therapy (51 vs 37%, F = 0.006), and surgery (12 vs 5%, F = 0.019) were more frequent after MRI than after colonoscopy as first examination. As a second examination, MRI led to change in therapy in a higher proportion of patients than colonoscopy (28 vs 8%, p < 0.001)., Conclusions: In CD, information provided by MRI has a higher impact on patient management than colonoscopy and may be considered as a first-line examination for CD assessment., (Copyright © 2016 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Information on efficacy and predictors of response to adalimumab in ulcerative colitis (UC) clinical practice is limited., Aim: Assessment of response to adalimumab and its predictors in an observational cohort study., Methods: Retrospective cohort study based on data obtained from ENEIDA registry. All patients diagnosed with UC treated with adalimumab were included. Response to adalimumab was evaluated at weeks 12, 28, and 54 according to the partial Mayo score, and requirement of colectomy until end of follow-up., Results: 48 patients with UC treated with adalimumab were included; 39 (81.3%) had previously received infliximab. Response rates at weeks 12, 28 and 54 were 70.8%, 43.2% and 35% respectively. Response to prior treatment with infliximab was the only predictive factor of response to adalimumab at week 12, which was obtained in 90% of infliximab remitters, 53.8% of responders and 33.3% of primary non-responders (p=0.01). Colectomy was required in 11 patients (22.9%), after a mean time of 205 days. The only clinical independent predictor of colectomy was non-response to adalimumab at week 12: colectomy rates were 5/34 (14.7%) in responders and 6/14 (42.9%) in non-responders (p=0.035), time free of colectomy was significantly reduced in non-responders (p=0.01). Adalimumab withdrawal due to adverse events occurred in 4.2% of patients., Conclusion: This study shows that adalimumab is an effective treatment in patients with UC. If used as a second anti-TNF, previous achievement of remission with the first anti-TNF predicts response, and failure to achieve response at week 12 predicts colectomy., (Copyright © 2012 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.)

Background: Few data are available on the efficacy of methotrexate (MTX) in ulcerative colitis (UC)., Aim: To evaluate the efficacy and safety of MTX in UC patients., Patients and Methods: UC patients who had been treated with MTX were identified from the databases of 8 Spanish IBD referral hospitals. Patients were included in the study if they received MTX for steroid dependency or steroid refractoriness. Therapeutic success was defined as the absence of UC-related symptoms, complete steroid withdrawal and no requirement of rescue therapies within the first 6 months after starting MTX., Results: Forty patients were included, 70% treated for steroid dependency and 27% for steroid refractoriness. Thiopurines had been previously attempted in 87.5% of patients. The median dose of MTX used for induction was 25mg (IIQ 17.5-25) weekly given parenterally in 82.5% of cases. Eighty-five percent of patients were on steroids when MTX was started. Forty-five percent of patients met criteria for therapeutic success. Initial treatment failures were mainly due to inefficacy (50%) or intolerance (36%). After a median follow-up of 28 months (IQR 22-47), 38% of patients with initial therapeutic success required new steroid courses, 22% started biological therapy, and only 1 patient required colectomy. The cumulative probability of maintaining steroid-free clinical remission was 60%, 48%, and 35% at 6, 12, and 24 months after starting MTX, respectively. Eleven patients (27.5%) experienced adverse events, leading to MTX discontinuation in only 8 of them., Conclusions: MTX appears to be effective to maintain clinical remission in UC, at least in the short-term, with an acceptable safety profile., (Copyright © 2011 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.)