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Background: Ustekinumab is approved for ulcerative colitis (UC)., Aims: To assess the durability of ustekinumab in patients with UC and its short-term effectiveness, durability and tolerability in clinical practice., Methods: Retrospective, multicentre study of patients who had received their first ustekinumab dose at least 16 weeks before inclusion. Patients were followed until treatment discontinuation or last visit. Only patients with active disease at the start of ustekinumab treatment were considered in the effectiveness analysis. Patients who stopped ustekinumab before their last visit were considered not to be in subsequent remission., Results: We included 620 patients; 155 (25%) discontinued ustekinumab during follow-up (median 12 months). Rate of discontinuation was 20% per patient-year of follow-up. Anaemia at baseline (hazard ratio, HR 1.5; 95% confidence interval [CI] 1.1-2.1), steroids at baseline (HR 1.5; 95% CI 1.06-2.08) and more severe clinical activity at baseline (HR 1.5; 95% CI 1.09-2.06) were associated with higher risk of discontinuation. At the end of induction, 226 (40%) patients were in steroid-free clinical remission. Moderate-severe vs mild disease activity at baseline (odds ratio [OR] 0.3; 95% CI 0.2-0.5), male sex (OR 0.5; 95% CI 0.4-0.8), and increased number of previous biologics (OR 0.6; 95% CI 0.6-0.8) were associated with lower likelihood of steroid-free clinical remission at week 16. One hundred and seventy-six patients (28%) had at least one adverse event. We observed no negative impact of ustekinumab on extraintestinal manifestations and/or immune-mediated diseases., Conclusions: Ustekinumab durability in UC was relatively high, and treatment was effective in highly refractory patients. The safety profile was consistent with previous studies., (© 2024 The Author(s). Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.)

Background: We aimed to (1) analyze the applicability of the updated Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE-II) recommendations in real-world clinical practice, (2) identify barriers to their implementation, and (3) propose practical measures to overcome these obstacles., Methods: This qualitative study was based on a survey, a literature review, and expert opinions. Nine inflammatory bowel disease (IBD) experts identified 7 areas likely to be controversial or potential implementation barriers in daily clinical practice: endoscopy, histology, ultrasound, quality of life, biomarkers, symptom control, and patient-reported outcomes (PROs). Based on this, a survey was carried out among educational course participants. The experts discussed the literature review and survey results and proposed several statements and practical actions., Results: A total of 55 gastroenterologists answered the survey. The reported difficulty level in reaching STRIDE-II treatment goals in clinical practice was high. Only 22% of participants performed clinical remission assessments using clinical indexes and PROs. Seventy percent of responders did not use fecal calprotectin cutoffs and considered changes from the previous levels instead. Mucosal healing as a long-term therapeutic goal was considered necessary to be individualized in specific patient subgroups (eg, elderly/fragile patients, multiple treatment failures, and last-line therapies). Other barriers, like the lack of access to imaging techniques or insufficient knowledge and skills among healthcare professionals, were detected. The experts suggested adding less stringent treatment goals and measurements, patient stratification, local adaptations, educational activities, and research., Conclusions: STRIDE-II recommendations face various implementation barriers needing careful evaluation in order to enhance their adoption in clinical practice, and ultimately improve outcomes in IBD patients., Competing Interests: ER has received support for congress and conference attendance, speaker fees, research support, or consulting fees from MSD, Abbvie, Ferring, Janssen, Otsuka, Pfizer, Takeda, Faes Farma, Galapagos, Kern Pharma, Lilly, and Fresenius-Kabi. DG has received support for congress and conference attendance, speaker fees, or consulting fees from MSD, Abbvie, Ferring, Janssen, Adacyte, Pfizer, Takeda, Faes Farma, Galapagos, Kern Pharma, Lilly, and Fresenius-Kabi. I M-J has been a speaker, consultant, and advisory member for or has received research funding from Abbvie, Amgen, Chiesi, Dr. Falk Pharma, Faes Farma, Ferring, Fresenius, Galapagos, Gebro Pharma, Janssen, Kern Pharma, Lilly, MSD, Otsuka Pharmaceutical, Pfizer, Sandoz, Shire Pharmaceuticals, Takeda, Tillotts Pharma, and Vifor Pharma. LM has been a speaker, consultant, or advisory member for or has received unrestricted grants from MSD, Abbvie, Takeda, Janssen, Pfizer, Biogen, Galapagos, Kern Pharma, Lilly Otsuka Pharmaceuticals, Tillotts, Dr. Falk Pharma, Ferring, Medtronic, and General Electric. DC has been a speaker, consultant, or advisory member for or has received unrestricted grants from Abbvie, Dr Falk Pharma, Faes, Ferring, Galapagos, Johnson & Johnson, Kern Pharma, Lilly, MSD, Pfizer, Takeda, and Tillots. The rest of the authors declare no conflicts of interest., (© The Author(s) 2024. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)

It is widely acknowledged that inflammatory bowel disease (IBD) is associated with a high prevalence of sexual dysfunction (SD). However, there is a notable paucity of specific literature in this field. This lack of information impacts various aspects, including the understanding and comprehensive care of SD in the context of IBD. Furthermore, patients themselves express a lack of necessary attention in this area within the treatment of their disease, thus creating an unmet need in terms of their well-being. The aim of this position statement by the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) is to provide a review on the most relevant aspects and potential areas of improvement in the detection, assessment, and management of SD in patients with IBD and to integrate the approach to sexual health into our clinical practice. Recommendations are established based on available scientific evidence and expert opinion. The development of these recommendations by GETECCU has been carried out through a collaborative multidisciplinary approach involving gastroenterologists, gynecologists, urologists, surgeons, nurses, psychologists, sexologists, and, of course, patients with IBD., (Copyright © 2024 The Author(s). Publicado por Elsevier España, S.L.U. All rights reserved.)

Background: Despite research, there are still controversial areas in the management of Crohn's disease (CD)., Objective: To establish practical recommendations on using anti-tumour necrosis factor (TNF) drugs in patients with moderate-to-severe CD., Methods: Clinical controversies in the management of CD using anti-TNF therapies were identified. A comprehensive literature review was performed, and a national survey was launched to examine current clinical practices when using anti-TNF therapies. Their results were discussed by expert gastroenterologists within a nominal group meeting, and a set of statements was proposed and tested in a Delphi process., Results: Qualitative study. The survey and Delphi process were sent to 244 CD-treating physicians (response rate: 58%). A total of 14 statements were generated. All but two achieved agreement. These statements cover: (1) use of first-line non-anti-TNF biological therapy; (2) role of HLA-DQA1*05 in daily practice; (3) attitudes in primary non-response and loss of response to anti-TNF therapy due to immunogenicity; (4) use of ustekinumab or vedolizumab if a change in action mechanism is warranted; (5) anti-TNF drug level monitoring; (6) combined therapy with an immunomodulator., Conclusion: This document sought to pull together the best evidence, experts' opinions, and treating physicians' attitudes when using anti-TNF therapies in patients with CD., Competing Interests: Competing interests: IM-J has served as a speaker, consultant, or advisory member for or has received unrestricted grants from Dr Falk Pharma, Galapagos, Tillotts, Otsuka, Sandoz, MSD, AbbVie, Takeda, Janssen, Pfizer, Amgen, Kern Pharma, and Ferring. GB has served as a speaker, consultant, or advisory member for or has received unrestricted grants from AbbVie, Takeda, Janssen, Pfizer, Galapagos, Kern Pharma, Tillotts, and Ferring. ER has served as a speaker, consultant, or advisory member for or has received research funding from MSD, AbbVie, Takeda, Janssen, Galapagos, Fresenius Kabi, Pfizer, Amgen, Kern Pharma, and Ferring. YG-L has served as a speaker, consultant, or advisory member for or has received unrestricted grants from MSD, AbbVie, Takeda, Janssen, Pfizer, Amgen, Kern Pharma, and Ferring. LM has served as a speaker, consultant or advisory member for or has received unrestricted grants from MSD, AbbVie, Takeda, Janssen, Pfizer, Biogen, Galapagos, Kern Pharma, Tillotts, Dr Falk Pharma, Ferring, Medtronic, and General Electric. DG has served as a speaker, consultant, or advisory member for or has received unrestricted grants from AbbVie, Takeda, Janssen, Pfizer, Biogen, Adacyte, Sandoz, and Ferring. DC has served as a speaker, consultant, or advisory member for or has received unrestricted grants from AbbVie, Takeda, Janssen, Pfizer, Adacyte, Galapagos, Fresenius-Kabi, and Ferring. FM has served as a speaker, consultant, or advisory member for or has received unrestricted grants from AbbVie, Takeda, Janssen, Pfizer, and Ferring. DC has served as a speaker, consultant or advisory member for or has received unrestricted grants from AbbVie, Fresenius-Kabi, Ferring, Galapagos, Gilead, Janssen, Kern, MSD, Pfizer, and Takeda., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Identifying novel treatment strategies for patients with ulcerative colitis (UC) and at risk of relapse is critical. The objective of this study was to assess the efficacy of beclomethasone dipropionate (BDP) in lowering fecal calprotectin (FC) levels in UC patients in clinical remission and at risk of relapse., Methods: This multicenter study comprised a double-blind, randomized, placebo-controlled phase (part I) and an open-label, non-randomized phase (part II). Eligible participants with UC in clinical remission treated with 5-aminosalicylic acid and with FC levels ≥250 μg/g were randomized to receive 5 mg/day of BDP or placebo for 4 weeks (part I). At week 5, patients with FC ≥100 μg/g were treated with 5 mg/day of BDP for 4 weeks (part II), and FC levels were tested at week 9., Results: Forty-three patients were randomized: 22 received BDP (group A) and 21 placebo (group B). At week 4, 13 patients (59.1%) in group A and 3 (17.6%) in group B had FC levels <100 μg/g (p value = 0.010). In the double-blind phase of the study, no patient relapsed in group A and 4 in group B (p value = 0.049). Both treatment groups showed a favorable safety profile, with the most common adverse events being gastrointestinal disorders., Conclusion: In this multicenter, randomized clinical trial including patients with UC in clinical remission but with elevated FC, BDP was efficacious in reducing FC and well-tolerated., (© 2024 The Author(s). Published by S. Karger AG, Basel.)