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2 results on '"Hépatologie Gastro-Entérologie"'

1. Safety, pharmacokinetic, and pharmacodynamic study of sibofimloc, a novel FimH blocker in patients with active Crohn's disease

Author

Walter Reinisch, Xavier Hébuterne, Anthony Buisson, Stefan Schreiber, Pierre Desreumaux, Christian Primas, Jean‐Michel Paillarse, Grégoire Chevalier, Christophe Bonny, Medizinische Universität Wien = Medical University of Vienna, Centre Hospitalier Universitaire de Nice (CHU Nice), Service d'Hépatologie Gastro-entérologie [CHU Clermont-Ferrand], CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Infection Inflammation et Interaction Hôtes Pathogènes [CHU Clermont-Ferrand] (3IHP ), Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte (M2iSH), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), University Medical Center of Schleswig–Holstein = Universitätsklinikum Schleswig-Holstein (UKSH), Kiel University, CHU Lille, and Enterome

Subjects
Adult, clinical trials, Adhesins, Escherichia coli, Hepatology, FimH receptor, microbiology, Gastroenterology, microbiome, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, basic science, adherent-invasive E. coli, Anti-Bacterial Agents, Crohn's disease, Crohn Disease, FimH blocker, experimental models and pathophysiology, Escherichia coli, sibofimloc, Humans, Fimbriae Proteins, Biomarkers
Abstract

Essai clinique - Phase I; International audience; Background and aim: Expression of FimH adhesin by invasive Escherichia coli in the gastrointestinal tract of patients with Crohn's disease (CD) facilitates binding to epithelial glycoproteins and release of pro-inflammatory cytokines. Sibofimloc is a first-in-class FimH blocker that showed little systemic absorption in healthy volunteers. The current study evaluated systemic absorption, safety, and effect on inflammatory biomarkers of sibofimloc in patients with CD.Methods: This was an open-label, multicenter phase 1b study in adults with active CD. In part 1, two patients received a single oral dose of 3000-mg sibofimloc followed by 1500 mg b.i.d. for 13 days. In part 2, six patients received 1500-mg sibofimloc b.i.d. for 13 days. Blood was drawn for pharmacokinetic and biomarker analysis, and stool was collected for biomarker and microbiome analysis.Results: Eight patients with active ileal or ileocolonic CD were enrolled into the study. Systemic sibofimloc exposure was low. Sibofimloc was well tolerated with only grade 1-2 events observed. Several pro-inflammatory biomarkers, including IL-1β, IL-6, IL-8, TNF-α, IFN-γ, and calprotectin, were decreased in stool by end of study.Conclusions: This first study of the novel FimH blocker, sibofimloc, in patients with active CD demonstrated minimal systemic exposure with good tolerance, while decreasing several inflammatory biomarkers. EudraCT number: 2017-003279-70.

Published
2022
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2. Ustekinumab is more effective than azathioprine to prevent endoscopic postoperative recurrence in Crohn's disease

Author

Buisson, Anthony, Nancey, Stéphane, Manlay, Luc, Rubin, David, Hebuterne, Xavier, Pariente, Benjamin, Fumery, Mathurin, Laharie, David, Roblin, Xavier, Bommelaer, Gilles, Pereira, Bruno, Peyrin‐biroulet, Laurent, Vuitton, Lucine, Post-Op Study Grp, Ustek, Service d'Hépatologie Gastro-entérologie [CHU Clermont-Ferrand], CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte (M2iSH), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), Service d'Hépatogastroentérologie [CHU Lyon-Sud], Hospices Civils de Lyon (HCL), The University of Chicago Medicine [Chicago], Servcie Hépato-gastroentérolgie et Nutrition clinique [CHU Nice], Centre Hospitalier Universitaire de Nice (CHU Nice), Service Gastro-entérologie adulte – Maladies de l’appareil digestif [CHU Lille], CHU Lille, Service d'Hépato Gastroenterologie [CHU Amiens-Picardie], CHU Amiens-Picardie, Périnatalité et Risques Toxiques - UMR INERIS_I 1 (PERITOX), Institut National de l'Environnement Industriel et des Risques (INERIS)-Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie, Service Gastroentérologie [CHU Bordeaux], Centre Hospitalier Universitaire de Bordeaux (CHU Bordeaux), Service de Gastro-entérologie et Hépatologie [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), Service d'Hépato-gastro-entérologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Service de Gastro-Entérologie [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), 'Francois Aupetit' Association (AFA CrohnRCH), CHU Clermont-Ferrand (DRCI), Centre Hospitalier Universitaire de Lille (CHU Lille), Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie-Institut National de l'Environnement Industriel et des Risques, Service de gastroentérologie [CHU Saint-Etienne], and Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne)

Subjects
Adult, Male, medicine.medical_specialty, medicine.medical_treatment, Azathioprine, Antibodies, Monoclonal, Humanized, Gastroenterology, ustekinumab, law.invention, 03 medical and health sciences, 0302 clinical medicine, Crohn Disease, Gastrointestinal Agents, Randomized controlled trial, Recurrence, law, Internal medicine, Ustekinumab, Secondary Prevention, medicine, Clinical endpoint, Humans, postoperative recurrence, Propensity Score, Retrospective Studies, Crohn's disease, azathioprine, business.industry, Inflammatory Bowel Disease, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Bowel resection, medicine.disease, Control Groups, 3. Good health, Oncology, 030220 oncology & carcinogenesis, Cohort, Propensity score matching, Original Article, Female, 030211 gastroenterology & hepatology, business, Immunosuppressive Agents, medicine.drug
Abstract

International audience; Background: Preventing postoperative recurrence (POR) is a major concern in Crohn's disease (CD). While azathioprine is an option, no data is available on ustekinumab efficacy in this situation.Aims: We compared the effectiveness of ustekinumab versus azathioprine in preventing endoscopic POR in CD.Methods: We retrospectively collected data from all consecutive CD patients treated with ustekinumab after intestinal resection in 9 centers. The control group (azathioprine alone) was composed of patients who participated in a randomized controlled trial conducted in the same centers comparing azathioprine alone or in combination with curcumin. Propensity score analyses (inversed probability of treatment weighting = IPTW) were applied to compare the two groups. The primary endpoint was endoscopic POR (Rutgeerts' index ≥ i2) at 6 months.Results: Overall, 32 patients were included in the ustekinumab group and 31 in the azathioprine group. The propensity score analysis was adjusted on the main risk factors (smoking, fistulizing phenotype, prior bowel resection, resection length >30 cm and ≥2 biologics before surgery) and thiopurines or ustekinumab exposure prior to surgery making the two arms comparable (∣d∣ < 0.2). After IPTW, the rate of endoscopic POR at 6 months was lower in patients treated with ustekinumab compared to azathioprine (28.0% vs. 54.5%, p = 0.029). After IPTW, the rates of i2b-endoscopic POR (Rutgeerts' index ≥ i2b) and severe endoscopic POR (Rutgeerts' index ≥ i3) were 20.8% versus 42.5% (p = 0.066) and 16.9% versus 27.9% (p = 0.24), in the ustekinumab and azathioprine groups, respectively.Conclusion: Ustekinumab seemed to be more effective than azathioprine in preventing POR in this cohort of CD patients.

Published
2021
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