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Background: Ustekinumab (UST) is an interleukin-12/interleukin-23 receptor antagonist approved for the treatment of Crohn's disease (CD). Only limited real-life data on the long-term outcomes of CD patients treated with UST are available. This study assessed UST's long-term effectiveness and safety in a large population-based cohort of moderate to severe CD patients. Methods: This was a multicenter, retrospective, observational cohort study that included both naïve and biologic-experienced patients treated with UST who achieved clinical remission or clinical response after at least one year of treatment. Clinical activity was scored according to the Harvey-Bradshaw Index (HBI). The primary endpoints were the maintenance or achievement of clinical remission after a further 12-month period of treatment, defined as an HBI of ≤5, and safety. Other endpoints included steroid-free remission, mucosal healing (MH), steroid discontinuation, and the need for treatment optimization during the follow-up. Results: Out of 562 CD patients, after an overall 24-month follow-up, clinical remission was present in 450 (80.0%) patients, and at 12 months, clinical remission was observed in 417/437 (95.4%) patients; 33/125 (26.4%) showed clinical response at 12 months ( p = 0.000). A total of 38/103 (36.9%) patients achieved MH. Only 2.1% (12/562), 3% (17/562), and 1.1% (6/562) of patients required surgery, optimization, and re-induction, respectively. Adverse events occurred in eight patients (1.42%). According to a multivariate analysis, the only predictor of long-term remission was the presence of remission at the 12-month follow-up ( p = 0.000). Conclusions : Long-term treatment with UST presents good efficacy and safety profiles in CD patients, especially for patients who achieve remission after one year.

Background: Inflammatory Bowel Diseases (IBD), Crohn's Disease (CD), and Ulcerative Colitis (UC) may have extraintestinal manifestations, including disorders of the urinary tract. The prevalence of lower urinary tract symptoms (LUTS) in IBD patients remains unclear., Aims: Assess the prevalence of LUTS in patients with CD or UC, evaluate the variables implicated in any difference in LUTS prevalence between CD or UC, and assess any relationship between disease activity and LUTS METHODS: LUTS were evaluated in 301 IBD patients through standardised questionnaires: Bristol Female Lower Urinary Tract Symptoms (BFLUTS), NIH-Chronic Prostatitis Symptom Index (NIH-CPSI), and International Prostate Symptom Score (IPSS). IBD activity was determined through the Crohn's Disease Activity Index (CDAI), Partial Mayo Score (PMS), and Total Mayo Score (TMS)., Results: BFLUTS total score for females was 6 (3-11). Patients with a higher age at diagnosis had worse filling symptoms (p = 0.049) and a worse quality of life (p = 0.005). In males, 67.1% had mild, 28.5% moderate, and 4.4% severe IPSS symptom grades. The overall NIHCPSI prevalence of chronic prostatitis-like symptoms was 26.8%. The questionnaires revealed some significant differences in the subgroups analysed., Conclusion: LUTS should be evaluated in IBD patients by urologic-validated questionnaires for prompt diagnosis and early treatment., Competing Interests: Conflict of interest The authors declare that they have no conflicts of interest to disclose., (Copyright © 2023 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Introduction: Sexual function is often impaired in patients with chronic illnesses. Several patients with chronic gastrointestinal and liver disorders have been shown to suffer from sexual dysfunction, and celiac disease is a highly prevalent gastroenterological disorder., Aim: The aim of this study was to investigate the sexual function incidence and the risk factors for sexual dysfunction in both male and female celiac disease patients., Methods: Two hundred and eighty-four patients (170 females, 114 males) participated in this cross-sectional observational study in an anonymous manner. Female sexual function was assessed through the Female Sexual Function Index questionnaire. Male sexual function was assessed through the International Index of Erectile Function-5 questionnaire. Clinical-demographic variables were recorded. We investigated differences in the patient-reported outcomes among the different subgroups and whether there were clinical-demographic predictors of sexual dysfunction in our setting., Main Outcome Measures: Prevalence and assessment of sexual dysfunction in celiac disease patients., Results: In the female group, 85 subjects (50%) had a total score compatible with sexual dysfunction: 43 (61.42%) showed low desire, 79 (46.47%) showed arousal disorder, 66 (38.82%) lubrication disorder, and 84 (49.41%) inability of obtaining an orgasm. Also, a large proportion of our female patients, 161 (94.70%), showed sexual discomfort during intercourse. In the male group, 79 patients (62.2%) showed scores compatible with normal erectile function, eight (7.01%) had mild erectile dysfunction, 24 (21.05%) mild to moderate erectile dysfunction, and three (2.63%) presented severe erectile dysfunction. Altered body mass index was significantly associated with sexual dysfunction both in male and female patients. Early age at diagnosis was a significant predictor of sexual dysfunction in male celiac disease patients., Conclusions: A significant proportion of celiac disease patients present sexual dysfunction. Early age at diagnosis and high body mass index seem to predict sexual dysfunction in this clinical setting. Assessment of sexual function should be part of the initial evaluation of celiac disease patients in order to establish a prompt diagnosis and early treatment., (© 2022 The Authors. Andrology published by Wiley Periodicals LLC on behalf of American Society of Andrology and European Academy of Andrology.)

Ustekinumab (UST), a human anti-IL12/23p40 monoclonal antibody, was approved by FDA and EMA for the treatment of moderate to severe Crohn's disease (CD). Whether UST is effective in inducing deep remission, including mucosal healing and transmural healing, in patients with CD in a real life setting is not completely clear. This study was performed on 92 subjects with confirmed diagnosis of moderate to severe Crohn's disease and no neoplasia. Before inclusion, all patients had been exposed and had failed to respond to conventional and/or at least one biological therapy. All patients underwent endoscopic examination and bowel MRI and ultrasonography at baseline (T0). At week 52 (T52), patients underwent colonoscopy for assessment of mucosal healing and MRI or ultrasonography for assessment of transmural healing. CDAI was used for the assessment of clinical response and clinical remission. SES-CD was used to assess endoscopic response and remission. Incidence of treatment-related adverse events (TRAEs) was recorded during the study period. Clinical response at week 52 was achieved in 38 (50.5%) patients and clinical remission in 29 (39%). Twenty-six (34%) patients showed mucosal healing, 34 (45%) showed partial endoscopic response. We observed a reduction in SES-CD of at least 50% in 34 (45%) patients as well as an SES-CD ≤ 2 in 26 (35%) patients. All patients with mucosal healing also showed transmural healing. No major TRAEs were observed during treatment. In this multicenter, real life study, we show that UST was well tolerated and effective in inducing clinical response and clinical remission in patients with moderate to severe CD who had previously failed to respond to conventional or biologic therapy. UST showed limited efficacy in inducing deep remission (i.e. mucosal+transmural healing).

Background: Bismuth quadruple (BQT) and non-bismuth quadruple (N-BQT) therapies are the recommended first-line treatments for Helicobacter (H.) pylori infection., Objective: To compare the efficacy of BQT and N-BQT in clinical practice in an area with high clarithromycin resistance, choosing the regimen on the basis of previous exposure to clarithromycin., Methods: A total of 404 consecutive H pylori-positive, naïve patients were enrolled. A total of 203 patients without previous exposure to clarithromycin received N-BQT, 100 patients for 10 days and 103 for 14 days, whereas 201 with previous exposure to clarithromycin received 10-day BQT. Efficacy and treatment-related adverse events were assessed., Results and Conclusions: Eradication rates by intention-to-treat analysis were 88.2% for N-BQT and 91.5% for BQT (P = .26); per-protocol analysis eradication rates were 91.2% and 95.8% for N-BQT and BQT, respectively (P = .07). Eradication rates were significantly higher with 14-day than 10-day CT (P < .003). Almost all patients had a good compliance with both N-BQT (95.6%) and BQT (95%). Adverse events occurred in 24.1% and 26.9% (P = .53) of patients in the N-BQT and BQT group, respectively. In conclusion, clarithromycin-containing non-bismuth or bismuth quadruple therapy, based on the knowledge of previous clarithromycin exposure, is effective and safe even in an area of high prevalence of clarithromycin-resistant H pylori strains., (© 2020 John Wiley & Sons Ltd.)

Purpose: Pathophysiology of pouchitis after ileal pouch-anal anastomosis is controversial because of the potential for development of carcinoma. Cyclooxygenase-2-derived prostaglandins may be involved in the inflammatory process and play a role in the pathogenesis of colon cancer. Vascular endothelial growth factor plays a major role in neoangiogenesis and is overexpressed in a number of gastrointestinal malignancies. The goal of this study was to evaluate the expression of cyclooxygenase-2 and vascular endothelial growth factor and to assess neoangiogenesis and epithelial cell proliferation in patients with ileal pouch-anal anastomosis., Methods: Endoscopic biopsies were obtained from 15 patients with ileal pouch-anal anastomosis without pouchitis (10 biopsies from the ileal pouch and 10 from ileal nonpouch mucosa) and from 15 subjects with irritable bowel syndrome (10 biopsies from normal-appearing ileum and rectum). Cyclooxygenase-1, cyclooxygenase-2, and vascular endothelial growth factor messenger ribonucleic acid expression was determined by reverse transcriptase polymerase chain reaction. Cyclooxygenase-2 and vascular endothelial growth factor protein expression was evaluated by Western blot. Cyclooxygenase-2, vascular endothelial growth factor, CD34 (neoangiogenesis marker), and Ki67 (proliferation marker) mucosal localizations were evaluated by immunohistochemistry., Results: Expression of cyclooxygenase-2 and vascular endothelial growth factor was increased in ileal pouch mucosa compared with ileal nonpouch mucosa, normal ileum, and rectum. Cyclooxygenase-2 and vascular endothelial growth factor immunostaining in ileal pouch mucosa was more intense in the crypt area than in the surface epithelium compared with ileal nonpouch mucosa. CD34 (neoangiogenesis marker) and Ki67 (proliferation marker) expression was increased in ileal pouch mucosa., Conclusions: Cyclooxygenase-2 and vascular endothelial growth factor are overexpressed in the ileal pouch mucosa. This is associated with increased proliferative activity and neoangiogenesis. Cyclooxygenase-2 and vascular endothelial growth factor overexpression might play a role in the pathogenesis of pouchitis.