Publications by authors named "Javier P Gisbert"

Advanced combination treatment (ACT)-the combination of two advanced agents such as biologics or small molecules-has emerged as a promising strategy in the management of inflammatory bowel disease refractory to conventional treatment, with severe extraintestinal manifestations, or with coexisting immune-mediated inflammatory diseases. ACT including complementary mechanisms of action aims to overcome the therapeutic ceiling observed with monotherapy. Its rationale is supported by preclinical and mechanistic data demonstrating synergistic immunological effects when distinct inflammatory pathways are targeted simultaneously.

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Objective: The introduction of biologic therapies has transformed the management of Crohn's disease (CD), yet few studies have evaluated their impact on real-world outcomes over time. We aimed to compare two population-based cohorts of CD patients in Navarra, Spain, diagnosed in 2001-2003 (cohort A) and in 2017 (cohort B), to assess whether early use of advanced therapies has altered disease trajectory.

Patients And Methods: This prospective, multicentre cohort study included adult patients with confirmed CD from two periods.

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Background And Study Aims: Current general-purpose artificial intelligence (AI) large language models (LLMs) demonstrate limited efficacy in clinical medicine, often constrained to question-answering, documentation, and literature summarization roles. We developed GastroGPT, a proof-of-concept specialty-specific, multi-task, clinical LLM, and evaluated its performance against leading general-purpose LLMs across key gastroenterology tasks and diverse case scenarios.

Methods: In this structured analysis, GastroGPT was compared with three state-of-the-art general-purpose LLMs (LLM-A: GPT-4, LLM-B: Bard, LLM-C: Claude).

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Thiopurines (azathioprine and mercaptopurine) are immunosuppressant drugs widely used for the treatment of acute lymphocytic leukemia, organ transplantation and autoimmune diseases, including inflammatory bowel diseases. Thiopurine-induced myelotoxicity (TIM) remains a significant concern in thiopurine therapy, with around 50 % of cases lacking explanation through known genetic variants in thiopurine methyltransferase (TPMT) or nudix (nucleoside diphosphate linked moiety X)-type motif 15 (NUDT15). For these patients, genetic influence remains unknown.

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Background:  Helicobacter pylori infection remains prevalent globally. Despite the relatively low reported prevalence in Switzerland, the actual burden is thought to be higher, primarily due to migration. To date, limited evidence is available regarding the effectiveness of Helicobacter pylori eradication therapy in Switzerland.

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Background: Real-world data on dose escalation/de-escalation in inflammatory bowel disease (IBD) are scarce.

Aims: To assess the frequency, effectiveness and durability of escalation/de-escalation of infliximab, adalimumab, golimumab, vedolizumab and ustekinumab in IBD, and to identify factors influencing relapse and drug discontinuation and re-escalation efficacy.

Methods: We included patients from the ENEIDA registry of GETECCU who were exposed to biologics and analysed escalations/de-escalations.

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Local audits of () prescriptions and outcomes are necessary to assess guideline awareness among clinicians and treatment effectiveness. The aims were to investigate first-line prescriptions and effectiveness over a 10-year period in Ireland and evaluate the influence of the 2017 Irish consensus guidelines on these trends. Data were collected at e-CRF AEG-REDCap from the European Registry on management (Hp-EuReg) and quality reviewed from 2013 to 2022.

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Purpose: Golimumab (GLM), an anti-tumour necrosis factor alpha (anti-TNFα) agent, is indicated for moderate to severe ulcerative colitis (UC). This post-authorisation safety study evaluated the risk of colectomy due to intractable disease and advanced colonic neoplasia (high-grade dysplasia and/or colorectal cancer) under real-world conditions of GLM use.

Methods: This bidirectional cohort study using Spanish ENEIDA registry data (2013-2022) included adults with UC who initiated GLM, other anti-TNFα agents, or thiopurines (TPs).

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Introduction: Dysbiosis is a key mechanism in inflammatory bowel disease (IBD) pathophysiology. Previous microbiota studies in IBD generally have involved patients treated with immunosuppressive agents, which can affect the results. We aimed to elucidate the fecal microbiota composition in newly diagnosed treatment-naïve IBD patients.

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Helicobacter pylori (H. pylori) is the most common carcinogenic pathogen globally and the leading cause of gastric cancer. Here, we develop a reinforcement learning-based AI Clinician system to personalise treatment selection and evaluate its ability to improve eradication success compared to clinician-prescribed therapies.

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Objective: Real-world evidence (RWE) on vedolizumab (VDZ), an anti-lymphocyte trafficking treatment that selectively targets the α4β7/MAdCAM-1 interaction on the gut, is mostly limited to patients who are repeatedly refractory to anti-tumor necrosis factor-alpha (anti-TNF-α), and other treatments. The EVOLVE-IBERIA study assessed VDZ or anti-TNF-α as first- or second-line biologic treatment, in patients with Crohn's disease or ulcerative colitis (UC); here, we present the outcomes in patients with UC.

Patients And Methods: Medical records were retrospectively reviewed from 25 hospitals in Spain and Portugal.

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Background: resistance to antibiotics commonly used in eradication regimens is increasing dramatically in many locations; new strategies are needed to manage this infectious disease.

Objective: This study's aim was to collect and update information on antibiotic resistance (AR) rates in as well as current strategies for management, including public health issues, from a global perspective.

Design: An international survey was conducted in 31 countries on 6 continents to address key issues concerning the management of -related AR.

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Background: The V Spanish Consensus Conference on Helicobacter pylori recommended either a 14-day non-bismuth quadruple concomitant therapy (CT: proton pump inhibitor [PPI], clarithromycin, amoxicillin, and metronidazole) or a 10-day bismuth-containing quadruple therapy (Sc-BQT: PPI, bismuth, tetracycline, and metronidazole in a single capsule). The relative advantages of each remain uncertain.

Aim: To compare the effectiveness and safety of first-line empirical CT versus Sc-BQT in Spain.

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Background & Aims: The impact of biologic treatment for inflammatory bowel disease (IBD) during pregnancy and lactation on infant psychomotor development is barely studied. We investigated the effect of exposure to biologics in utero or during breastfeeding on the psychomotor development of offspring during their first year.

Methods: The study included patients and infants from DUMBO, an ongoing prospective, observational registry of GETECCU enrolling pregnant women (aged ≥18 years) with IBD from 60 centers across Spain.

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Background: Fatigue is a debilitating multifactorial symptom experienced by patients with Crohn's disease (CD). Mirikizumab, an anti-interleukin-23p19 antibody, demonstrated significant efficacy and safety in the patients with moderately to severely active CD. This analysis investigated the impact of mirikizumab on fatigue and the association between changes in clinical, endoscopic, and patient-reported outcomes with improvement in fatigue from baseline in the Phase 3 VIVID-1 study.

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Pediatric-onset familial inflammatory bowel disease (IBD) may differ from sporadic pediatric-onset IBD in its genetic and environmental background and may have distinct clinical and therapeutic implications. To evaluate the influence of a positive family history of IBD on the use of medical therapies and surgical interventions in adult patients with pediatric-onset IBD. Retrospective case-control study using the Spanish ENEIDA registry, including adults diagnosed with pediatric-onset IBD since 2006.

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The infection caused by Helicobacter pylori is the most common on the planet, affecting half of the global population. It is usually transmitted during childhood and persists for life if untreated. It is the primary cause of chronic gastritis, peptic ulcer, and gastric cancer.

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Background: The period prior to the diagnosis of inflammatory bowel disease (IBD), defined as the preclinical phase, has emerged as a potential target for disease modification strategies. Despite the relevance of an early diagnosis to the prognosis of the disease, only a limited number of patients are diagnosed during this window of opportunity.

Objectives: To determine the risk of developing symptoms after an incidental diagnosis of IBD and to describe the clinical, genetic, and immunological characteristics of IBD during its preclinical phase.

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Background: The EXIT trial found no difference in sustained remission at 12 months between inflammatory bowel disease (IBD) patients in remission who withdrew anti-TNF therapy [withdrawal arm (WA)] and those who maintained treatment [maintenance arm (MA)].

Aims: To compare the long-term risk of relapse between these groups and assess the response to anti-TNF resumption.

Methods: This was a follow-up extension of the EXIT trial.

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Tofacitinib is effective for refractory ulcerative colitis (UC), a chronic inflammatory disease of the colonic mucosa. However, its use has been associated with an increased risk of thromboembolic events, prompting regulatory restrictions. Understanding the pathophysiological mechanisms contributing to these potential risks is critical for patient safety.

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Background And Aims: Inflammatory bowel disease (IBD) patients with Clostridioides difficile infection (CDI) are at increased risk of adverse outcomes. Data on fidaxomicin use in IBD remain scarce. We assessed the effectiveness and safety of fidaxomicin for CDI and its impact on IBD outcomes in a large international cohort.

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