BACKGROUND:Mirikizumab (MIRI), an IgG4 monoclonal antibody targeting IL-23 p19, was recently licensed for ulcerative colitis (UC). Most available data come from the pivotal trials, but real-life data are scant. We aimed to evaluate the effectiveness and safety of MIRI in a real-world setting. METHODS:UC patients from 12 centres of the SN-IBD were prospectively enrolled. The primary endpoints were clinical response, steroid-free remission (SFR), and reduction of urgency at week 12 and at week 24. As secondary endpoint, the need for prolonged induction was considered. All patients received 3 infusions at monthly intervals of 300 mg MIRI; in case of inadequate response, the induction period was prolonged. Urgency was determined by means of the Urgency Numerical Rating Scale (UNRS). RESULTS:One hundred and five patients were included. Previous failures to 2 or more lines of advanced therapies were present in 74% of patients. At week 12, 24% of patients achieved a clinical response and 53% achieved SFR. At week 24 (n = 71), the rates were 20% and 68%, respectively. The median urgency score decreased from 6 at baseline to 2 at week 12 and to 1 at week 24 (p < 0.001, both). Prolonged induction was necessary to half of patients. Adverse events were reported in 5% of patients. Treatment failures occurred in 14 patients (13%). CONCLUSIONS:Our real-life study confirmed the short-term effectiveness and safety of MIRI in patients with UC especially in relieving bowel urgency. The flexible induction schedule allows an additional gain in response and remission.

Long-term real-world data on vedolizumab outcomes remain limited: the LONG-LIVE study evaluates 5-year effectiveness and safety in a large Italian cohort. This is a long-term extension of the multicenter LIVE study involving patients with Crohn’s disease (CD) and ulcerative colitis (UC). The primary outcome was the cumulative probability of major adverse clinical outcomes (the composite of IBD-related surgeries, non-surgical hospitalizations, and serious adverse events). Secondary outcomes included cumulative incidences of IBD-related surgery and non-surgical hospitalization, vedolizumab persistence, rates of death, cancer and adverse events of special interest (AESIs), and longitudinal response group transitions; outcomes in elderly patients (≥ 65 years) were compared to non-elderly using inverse probability weighting (IPW). Overall, 782 patients were included (50.4 Vedolizumab is a gut-selective biologic therapy approved for Crohn's disease (CD) and ulcerative colitis (UC). While its short-term effectiveness is well established, data on what happens to patients beyond 2 years of treatment remain limited. In this study, we followed 782 patients for up to 7 years across 47 Italian centers to track hard clinical outcomes: surgery, hospitalization, serious adverse events, and death. About one in three patients experienced a major adverse clinical outcome over 5 years—a composite endpoint that includes IBD-related surgeries, non-surgical hospitalizations, and serious adverse events—with no meaningful difference between CD and UC. Surgery occurred in approximately one in five patients, and non-surgical hospitalizations were more frequent in CD. Serious adverse events, including deaths, cancers, and infections, remained uncommon throughout follow-up. Patients who responded early to treatment were more likely to achieve deep remission within 2 years, which was in turn associated with deep remission at last follow-up. Elderly patients faced higher risks of hospitalization and major adverse clinical outcomes, but not of cancer or serious adverse events, suggesting that vedolizumab can be used across different age groups without a disproportionate increase in safety risk.

Malnutrition and sarcopenia are increasingly recognized as frequent and clinically relevant complications in inflammatory bowel disease (IBD). Recent studies have reported malnutrition rates up to 65–75% and sarcopenia prevalence as high as 70%, both conditions being associated with higher hospitalization rates, surgery risk, and poorer quality of life. To evaluate the prevalence of malnutrition and sarcopenia in a cohort of hospitalized IBD patients, exploring correlations according to disease type and pharmacological treatment. A cross-sectional study including 65 adult IBD patients (43.1% ulcerative colitis [UC], 56.9% Crohn’s disease [CD]; mean age 47.6 ± 19.4 years). Nutritional assessment included screening tools (NRS-2002, MNA, GLIM criteria), body composition analysis via bioelectrical impedance analysis (BIA), and muscle strength evaluation through handgrip test. A high prevalence of malnutrition was observed: 47.7% of patients were at nutritional risk (NRS-2002), 72.3% met GLIM criteria, and 18.5% presented severe malnutrition. Sarcopenia affected 20% of the cohort, with muscle mass reductions ranging from 15.4% to 27.7%. UC patients showed higher overweight prevalence (50% vs 24.3%, p = 0.03) and muscle strength impairment (32.1% vs 8.1%, p = 0.01). Patients receiving biological therapy had a lower prevalence of phase angle < 5 (15.3% vs 41.0%, p = 0.02) and a trend toward reduced severe malnutrition (7.7% vs 25.6%, p = 0.05). Malnutrition and sarcopenia are common in hospitalized IBD patients and vary according to disease type and therapy. Routine, multimodal nutritional assessment including body composition and muscle function analysis should be implemented by trained dietitians. Conflict of interest: Dr. Bracciamà, Emanuele: No conflict of interest Cimminisi, Stefania: No conflict of interest Zimbardo, Sergio: No conflict of interest Amari, Carola: No conflict of interest Filangeri, Laura: No conflict of interest Giambò, Orazio: No conflict of interest Sferruzza, Giuseppe: No conflict of interest Di Maria, Gabriele: No conflict of interest Milano, Alessia: No conflict of interest Di Giorgio, Francesca Maria: No conflict of interest Petta, Salvatore: No conflict of interest Cappello, Maria: No conflict of interest Cammà, Calogero: No conflict of interest

While colonoscopy remains the gold standard for colorectal neoplasia screening and therapeutic resection, its clinical efficacy is often compromised by significant interoperator variability in adenoma detection rates (ADR) and characterization precision. To address these disparities, Artificial intelligence (AI) systems – specifically deep learning-based computer-aided detection (CADe) and computer-aided diagnosis (CADx) – have been integrated into clinical practice to augment endoscopic performance through enhanced lesion recognition and real-time optical biopsy. This review synthesizes evidence from randomized controlled trials, meta-analyses, and clinical guidelines up to 2025 to evaluate the interplay between endoscopist expertise and AI assistance. Current data indicate that AI-augmented colonoscopy significantly optimizes ADR and the detection of diminutive or nonpolypoid lesions. Furthermore, CADx frameworks demonstrate robust accuracy in predicting real-time histology, potentially facilitating “resect-and-discard” strategies. However, widespread implementation is currently hindered by algorithmic biases, variable external validity, false-positive rates, and unresolved medicolegal implications. Ultimately, AI serves as a potent diagnostic adjunct that reduces operator dependency. Optimal clinical outcomes depend on a synergistic integration of seasoned endoscopic judgment and validated AI algorithms, supported by standardized training and transparent regulatory frameworks.

The VIVID-1 study is a phase 3 randomized controlled trial assessing the efficacy and safety of mirikizumab in moderate-to-severe active Crohn's disease.1 The study confirms the advantage of selective IL-23 inhibition, while the treat-through design and the choice of composite coprimary endpoints represent an innovative strategy in conducting clinical trials in Crohn's disease.

Introduction: Inflammatory bowel diseases (IBDs) require immunosuppressive drugs like biologics. All IBD patients, including those on biological therapy, should be vaccinated against COVID-19, according to the ECCO recommendations. IBD patients on anti-TNF treatment exhibited lower COVID-19 vaccine responses; however, SARS-CoV-2 variant neutralizing antibody titers have been seldom studied. Methods: IBD patients and healthcare professionals (control group) were tested for COVID-19 vaccine immunogenicity by neutralizing antibody titers against Wild-Type SARS-CoV-2 and its variants. IBD patients were assigned to no treatment/mesalamine, anti-TNF biologic therapy, or non-anti-TNF biologic therapy. The study was performed in a tertiary hospital in Palermo, Sicily, from May to July 2021. Results: In total, 107 IBD patients and 41 healthcare workers were enrolled. A total of 46 patients received mesalamine or no medication, 28 received anti-TNF biologics, and 33 received non-anti-TNF biologics. No significant differences were found in age, gender, or timing of blood sampling post vaccination. Omicron neutralizing activity was markedly reduced in all groups (p < 0.001). The group of patients on anti-TNF biologics showed lower neutralizing antibody titers against Alpha, Delta, and Gamma strains than every other group analyzed. Conclusions: IBD patients on anti-TNF drugs have a reduced serological response to the SARS-CoV-2 vaccine, with the Omicron variant not being neutralized. This highlights the necessity for tailored vaccine strategies for these patients.

BACKGROUND & AIMS:The optimal management of inflammatory bowel disease (IBD) patients with a partial response after intravenous (IV) vedolizumab (VDZ) induction remains unclear. METHODS:PRIVEDO was an observational, non-randomized, open-label, prospective cohort study conducted within the Sicilian Network for IBD. It compared subcutaneous (SC) VDZ (108 mg every 2 weeks) versus intensified IV VDZ (300 mg every 4 weeks) in Crohn's disease (CD) or ulcerative colitis (UC) patients with a partial response at Week 14 post-induction. Partial response was defined as: (1) clinical remission with fecal calprotectin >250 µg/g and/or steroid use, or (2) a reduction in the Harvey-Bradshaw Index by ≥3 points (for CD) or in the Partial Mayo Score by ≥2 points (for UC) from baseline, without fulfilling clinical remission criteria. The primary endpoint was steroid-free clinical remission with fecal calprotectin <250 µg/g at Weeks 26 and 52. The secondary endpoints were clinical benefit (remission or partial response), regardless of calprotectin values, and treatment persistence. RESULTS:107 patients were enrolled (CD: 58/107, 54.2%; UC: 49/107, 45.8%), allocated to SC (n = 52) or IV (n = 55) groups. The primary endpoint was met more often with SC VDZ at Week 26 (30/52, 57.7% vs. 14/55, 25.5%; P < 0.001; odds ratio [OR]: 3.57, P = 0.004 at multivariable analysis) and at Week 52 (25/52, 48.1% vs. 14/55, 25.5%; P = 0.016; OR: 3.05, P = .029 at multivariable analysis). Clinical benefit was also higher in the SC group at both timepoints, though not statistically significant. Treatment persistence was comparable between the 2 groups (log-rank test, P = .225). CONCLUSIONS:In IBD patients with partial response to IV VDZ induction, switching to SC VDZ may lead to more profound remission than continuing IV optimization.

BACKGROUND:Janus kinase inhibitors (JAKi), including tofacitinib (TOFA, pan-JAK) and filgotinib (FILGO, selective JAK1), are oral agents approved for moderate-to-severe ulcerative colitis (UC). Head-to-head comparative data in real-world settings are limited. AIM:To compare effectiveness and safety of TOFA and FILGO in patients with UC. METHODS:We conducted a multicenter cohort study using data from the Sicilian Network for Inflammatory Bowel Diseases. Consecutive adult UC patients treated with TOFA or FILGO and ≥16 weeks of follow-up were included. Propensity score weighting (IPTW) was used to balance baseline characteristics. RESULTS:263 patients were included (TOFA: n = 171; FILGO: n = 92). At week 24, steroid-free clinical remission was observed in 58.8 % with TOFA and 44.9 % with FILGO (IPTW-adjusted OR: 1.37; 95 % CI: 0.76-2.49; P = 0.30). Clinical response rates at 24 weeks were 63.6 % for TOFA and 59.0 % for FILGO (IPTW-adjusted OR: 1.13; 95 % CI: 0.62-2.08; P = 0.69). Treatment persistence at 24 weeks was 83.5 % for TOFA vs. 76.4 % for FILGO (HR: 0.78; P = 0.30). Adverse event rates were higher with TOFA (12.7 vs. 5.4 per 100 person-years), though not statistically significant (P = 0.152). CONCLUSION:TOFA and FILGO demonstrated similarly high effectiveness and persistence in real-world UC patients. Both had acceptable safety profiles.

Objective Quality of care in inflammatory bowel disease (IBD) patients is a major priority as it is associated with better outcomes. We assessed the adherence of Italian gastroenterologists to current international recommendations regarding quality performance measures for clinical and endoscopic IBD activities. Methods From March to July 2023, 179 Italian specialists participated in an online questionnaire-based survey concerning their demographic details, affiliations, clinical, and endoscopic practice. Data on the characteristics of the specialists’ centres were also collected. Recommendations from European Crohn's and Colitis Organisation, Building Resources and Research in IBD Globally group, and European Society of Gastrointestinal Endoscopy for clinical and endoscopic standards were used as reference standards. Results Deviations from guidelines’ recommendations included suboptimal availability of all specialties required for multidisciplinary teams, underuse of maintenance treatment with oral mesalamine in ulcerative colitis but still frequent use in Crohn’s disease, suboptimal dosages of topical therapy, low attention to performing ileal biopsies in suspected IBD and to Paris and mucosal pattern classifications for lesion characterisation. No significant regional differences were observed, while significantly lower performances were reported for many responses coming from small centres or doctors less dedicated to IBD care. Conclusion In Italy, adherence to current standards of care for IBD is generally good, with some practices to be improved. There is a need to support small centres and doctors less engaged in IBD within integrated clinical care networks.

Background:The efficacy of tofacitinib (TOFA) in various rheumatic diseases has generated interest in its potential benefits for treating spondyloarthritis (SpA) associated with ulcerative colitis (UC). Objectives:RETUCAS (Real-world Effectiveness of Tofacitinib on Ulcerative Colitis-Associated Spondyloarthropathy) is the first study designed to evaluate the effectiveness of TOFA in UC-associated SpA. Design:This was a prospective, multicentre, single-arm, observational study promoted by the Italian Group for the Study of Inflammatory Bowel Disease. Effectiveness was assessed using standardized rheumatologic scores. Methods:Patients with UC and a confirmed diagnosis of active axial or peripheral SpA at baseline were enrolled. The primary endpoint was steroid-free joint response (SFJR) at weeks 8 and 52, defined as a decrease of ⩾1.1 units in Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (CRP) for axial SpA, or a decrease of >0.6 units in Disease Activity Score 28-CRP for peripheral SpA, without the use of corticosteroids. Results:A total of 44 patients were enrolled: axial SpA: 9.1%; peripheral SpA: 70.4%; mixed axial and peripheral SpA: 20.5% All but two patients had previous exposure to biologic therapies, with more than half having failed two or more biologics. At week 8, SFJR was achieved in 52.3% of patients, with a significant difference between those with peripheral SpA and those with axial or mixed forms (67.7% vs 15.4%; p = 0.001). At week 52, SFJR was maintained in 59.1% of patients overall, again with better outcomes in peripheral SpA compared to axial/mixed SpA (71.0% vs 30.8%; p = 0.01). Conclusion:This is the first prospective study specifically designed to assess Inflammatory Bowel Diseases-associated SpA. In patients with UC and refractory SpA-many of whom had previously failed multiple biologic therapies-TOFA demonstrated effectiveness, particularly in those with peripheral SpA.

This multicentre cohort study showed that Risankizumab is an effective induction therapy in patients with Crohn's disease, and that the best results are obtained when Risankizumab is used as second-line therapy following a previous failure with a TNF inhibitor.

BACKGROUND AND AIMS:Real-world studies on vedolizumab in inflammatory bowel disease (IBD) are often limited by small sample size and short follow-up. In this study, we investigated the 2-year effectiveness and safety of vedolizumab in patients with IBD, and applied eXplainable Artificial Intelligence (XAI) to identify predictors of both. METHODS:The Long-term Italian Vedolizumab Effectiveness (LIVE) study is multicentric, ambispective, observational study enrolling 1111 IBD patients (563 Crohn's disease, CD, 542 ulcerative colitis, UC). Steroid-free clinical remission (SFCR) at 24 months was the primary endpoint. A XAI model (eXtreme Gradient Boosting, XGB) was applied to identify the main clinical predictors of SFCR and development of adverse events (AEs). RESULTS:Rates of SFCR at 24 months were 31.6 % and 39.7 % in CD and UC patients, and 0.14 AEs per patient-year was recorded. On XGB analysis, previous exposure to anti-TNFα and older age were the most important drivers for the prediction of SFCR; lower baseline CRP levels and fewer comorbidities were the most important features associated with no development of AEs. CONCLUSIONS:Vedolizumab is effective and safe in IBD patients. XAI yielded promising results in identifying the most important predictors of SFCR and development of AEs.

Background/Objectives: Ulcerative colitis (UC) is a part of inflammatory bowel disease (IBD) and it is characterized by colonic-mucosal chronic inflammation with intermittent clinical activity. Personalized medicine is becoming more and more a relevant method of approach in this field, and the identification of potential concerns in a single patient may contribute to the improvement of the clinical approach. Mesalamine represents the cornerstone of therapy for mild–moderate disease forms, but non-adherence to medical therapy represents a critical health problem, although it is underestimated by many physicians, with evident consequences in terms of disease-related complications. The aim of the present study is to evaluate the magnitude of non-adherence to oral mesalamine in UC patients performing a systematic review and meta-analysis of literature. Methods: A literature search in PubMed and Cochrane databases was performed for studies reporting the non-adherence rate to oral mesalamine in adult UC patients, and eligible studies have been selected for evaluation. The type of study (trial vs. observational), geographic area, sample size, method of adherence assessment, and non-adherence rate were considered. Results: From a total of 464 articles, 34 studies were included in the meta-analysis after selection. Sixteen studies (47%) are observational, and eighteen (53%) are clinical trials. A total of 12/34 (35%) studies are from North America, 14/34 (41%) from Europe, 4/34 (12%) from Asia, with 4/34 (12%) from mixed areas of the world. The mean non-adherence rate was 32%, but with a consistent variability among the studies. In particular, the non-adherence rate was significantly higher in observational studies vs. clinical trials (47 vs. 20%, p < 0.001), and in North American vs. European and Asian studies (54 vs. 23 vs. 4%, respectively, p < 0.001). Conclusions: The non-adherence rate to oral mesalamine is variably reported in the literature due to the inhomogeneity of available studies, but it represents a consistent problem, often neglected, that deserves future research. A personalized approach by a physician to a single patient can improve the effectiveness of medical therapy and the management of UC patients.

Abstract Background Biologics and small molecules are increasingly used in inflammatory bowel diseases (IBD). However, real-world data on sequence choices are still limited as well as the impact of treatment sequence on outcomes. The aim of this study was to evaluate the treatment persistence for different lines of biological drugs in two samples of patients, one suffering from Crohn’s disease (CD) and the other from ulcerative colitis (UC), refractory to conventional therapy. Methods This retrospective-prospective real world study included consecutive IBD patients followed in our IBD tertiary referral center. Sankey diagrams were used to describe sequencies. Treatment persistence was assessed using Kaplan-Meier curves and Hazard Ratios (HR) were calculated to compare persistence across treatment lines. Patients discontinued for non-efficacy/safety reasons or treated with non-IBD doses or indications were excluded. Results 228 IBD patients; 122 CD (Mean age 51,5, range 21-84) and 106 UC (Mean age 54,9, range 18-86) were enrolled. In CD (Picture 1) the third and fourth lines of treatment compared to the first line have the highest level of persistence, 96 (HR 2,6759; IC 95% 1,7803-4,0221) and 64 (HR 4,0229;IC 95% 2,0228-8,0006) months respectively. Vedolizumab had the highest persistence in the first and third line, 40 (IC 95% 15,750-61,000) and 39 (IC 95% 14,000-90,750) months respectively. In UC (Picture 2) the lines with a higher median of persistence are the second and third lines. The medians of persistence are greater for vedolizumab in all lines. Data on ustekinumab and tofacitinib need further observation. Conclusion Our study suggests that second-line biologics may offer benefits in terms of therapeutic continuity, likely due to improved efficacy and tolerability. These results encourage the use of second-line drugs earlier, to ensure sustained remission and potentially change the disease course.