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1. Hepatitis E Virus Infection in Patients with Chronic Inflammatory Bowel Disease Treated with Immunosuppressive Therapy

Author

Ilias Kounis, Christophe Renou, Stephane Nahon, Frederic Heluwaert, Gilles Macaigne, Morgane Amil, Stephane Talom, Benedicte Lambare, Claire Charpignon, Thierry Paupard, Monica Stetiu, Marie Pierre Ripault, Armand Yamaga, Florent Ehrhard, Franck Audemar, Maria Carmen Ortiz Correro, David Zanditenas, Florence Skinazi, Helene Agostini, Audrey Coilly, and Anne Marie Roque-Afonso

Subjects
hepatitis E, intestinal bowel disease, immunomodulators, Medicine
Abstract

Background: Medical treatment of inflammatory bowel disease (IBD) has evolved significantly, and treatment with immunomodulators is recommended. These medications may alter the patient’s immune response and increase the risk of opportunistic infections. Our aim was to evaluate the prevalence and the incidence of acute or chronic HEV infection in IBD patients under immunomodulatory treatment. Patients and Methods: We conducted a retrospective, multicenter, observational study between 2017 and 2018. IBD outpatients hospitalized for the infusion of immunomodulators were included in 16 French centers. During their daily hospitalization, blood samples were drawn for HEV serology (IgM and IgG) and HEV RNA detection. Results: A total of 488 patients were included, of which 327 (67%) patients had Crohn’s disease and 161 (33%) ulcerative colitis. HEV IgM was detected in 3 patients, but HEV RNA was undetectable in all patients. The HEV IgG seroprevalence rate was 14.2%. IgG-positive patients were older at sampling (p = 0.01) and IBD diagnosis (p = 0.03), had higher seafood consumption (p = 0.01) and higher doses of azathioprine (p = 0.03). Ileal and upper digestive tract involvement was more frequent in IgG-positive patients (p = 0.009), and ileocolic involvement was more frequent in IgG-negative patients (p = 0.01). Under multivariate analysis, age > 50 years [OR: 2.21 (1.26, to 3.85), p = 0.004] was associated with previous HEV infection. Conclusion: Systematic screening for HEV infection is not needed among IBD patients on immunomodulatory medications. However, in the event of abnormal liver test findings, HEV should be part of the classic diagnostic assessment.

Published
2023
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2. Effectiveness and Safety of Vedolizumab Induction Therapy for Patients With Inflammatory Bowel Disease

Author

Aurelien Amiot, Jean-Charles Grimaud, Laurent Peyrin-Biroulet, Jerome Filippi, Benjamin Pariente, Xavier Roblin, Anthony Buisson, Carmen Stefanescu, Caroline Trang-Poisson, Romain Altwegg, Philippe Marteau, Thibaud Vaysse, Anne Bourrier, Stephane Nancey, David Laharie, Matthieu Allez, Guillaume Savoye, Jacques Moreau, Charlotte Gagniere, Lucine Vuitton, Stephanie Viennot, Alexandre Aubourg, Anne-Laure Pelletier, Guillaume Bouguen, Vered Abitbol, Yoram Bouhnik, Camille Zallot, Marc-Andre Bigard, Xavier Hebuterne, Maria Nachury, Pierre Desreumaux, Emilie Del Tedesco, Gilles Bommelaer, Arnaud Boureille, Xavier Dray, Franck Carbonnel, Philippe Seksik, Laurent Beaugerie, Jacques Cosnes, Harry Sokol, Cecilia Landman, Gilles Boschetti, Florian Poullenot, Jean-Marc Gornet, Clautilde Baudry, Stephane Koch, Laurence Picon, Gaelle Sickersen, Stanislas Chaussade, Stephane Nahon, Betsy Winkfield, Hedia Brixi-Benmansour, Rodica Gincul, Jean-Christophe Barberis, Bruno Bonaz, Christophe Michiels, Franck Zerbib, Marie Bourrier de Beauregard, Christophe Locher, Sophie Davin-Couve, Armelle Poirette, Laurence Guillem, Monica Stetiu-Mocanu, Sylvain Beorchia, Jawad Al Qaddi, EA 4393 EC2M3 Laboratoire d'Investigation Clinique, Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Aix-Marseille Université - Faculté de médecine (AMU MED), Aix Marseille Université (AMU), Nutrition-Génétique et Exposition aux Risques Environnementaux (NGERE), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Hépato-Gastroentérologie, Centre Hospitalier Universitaire de Nice (CHU Nice), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), CHU Clermont-Ferrand, Pole des maladies de l'appareil digestif, gastroentérologie et assistance nutritive, AP-HP Hôpital Beaujon, Institut des Maladies de l'Appareil Digestif, Université de Nantes (UN), Hépato-gastro-entérologie, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Service de neurologie [Le Kremlin Bicêtre], Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Bicêtre, Service de Gastroentérologie et nutrition [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Saint-Antoine [APHP], Service de rhumatologie, inflammation-immunopathologie- biothérapie [CHU Saint-Antoine] (DHU i2B ), CHU Saint-Antoine [APHP]-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Service d'hépato-gastroentérologie, Hospices Civils de Lyon (HCL), Service d'Hépato-Gastro-Entérologie, CHU Bordeaux [Bordeaux]-Hôpital Saint-André, Hôpital Saint-Louis, Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Département des maladies de l'appareil digestif, CHU Rouen, Normandie Université (NU)-Normandie Université (NU), Nutrition, inflammation et dysfonctionnement de l'axe intestin-cerveau (ADEN), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Normandie Université (NU), Institute for Research and Innovation in Biomedicine (IRIB), CHU Toulouse [Toulouse], EA 4393 Laboratoire d'Investigation Clinique, Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon), Service d'Hépato-Gastro-Enterologie et Nutrition [CHU Caen], CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Université de Caen Normandie (UNICAEN), Génétique, immunothérapie, chimie et cancer (GICC), UMR 7292 CNRS [2012-2017] (GICC UMR 7292 CNRS), Université de Tours-Centre National de la Recherche Scientifique (CNRS), Hôpital Bichat - Claude Bernard, Foie, métabolismes et cancer, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Département de gastroentérologie, CHU Cochin [AP-HP], Centre Hospitalier Universitaire de Nice (CHU de Nice), Université Nice Sophia Antipolis (... - 2019) (UNS), Université Côte d'Azur (UCA), Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Lille, Droit et Santé, Neuropathies du système nerveux entérique et pathologies digestives, implication des cellules gliales entériques, Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM), ASTRE [Cergy-Pontoise], Equipes Traitement de l'Information et Systèmes (ETIS - UMR 8051), Ecole Nationale Supérieure de l'Electronique et de ses Applications (ENSEA)-Centre National de la Recherche Scientifique (CNRS)-Université de Cergy Pontoise (UCP), Université Paris-Seine-Université Paris-Seine-Ecole Nationale Supérieure de l'Electronique et de ses Applications (ENSEA)-Centre National de la Recherche Scientifique (CNRS)-Université de Cergy Pontoise (UCP), Université Paris-Seine-Université Paris-Seine, Hépatogastroentérologie, CHU de Bicêtre, CHU Saint-Antoine [APHP], French group of faecal microbotia transplantation (FGFT), WHO Collaborating Center on Prevention and Treatment of Human Echinococcosis, Université de Franche-Comté (UFC), Gastroenterology, AP-HP - Hôpital Cochin Broca Hôtel Dieu [Paris], Service de Gastro-entérologie, Centre hospitalier Universitaire, Hôpital Edouard Herriot [CHU - HCL], INSERM U836, équipe 8, Stress et interactions neurodigestives, Grenoble Institut des Neurosciences (GIN), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Grenoble-Université Joseph Fourier - Grenoble 1 (UJF)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Grenoble-Université Joseph Fourier - Grenoble 1 (UJF), Maladies de l'Appareil Digestif, Centre Hospitalier de Meaux, Laboratoire d'Investigation Clinique (LIC), Early detection of Colon Cancer using Molecular Markers and Microbiota (EA 7375) (EC2M3), Service de Gastroentérologie [Hôpital Beaujon], Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Diderot - Paris 7 (UPD7), Département d'Hépato-Gastroentérologie et de Transplantation Hépatique [CHU Saint-Eloi], Université de Montpellier (UM)-CHU Saint-Eloi, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Service de rhumatologie [CHU Saint-Antoine], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Hopital Saint-Louis [AP-HP] (AP-HP), Normandie Université (NU)-Normandie Université (NU)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Université de Tours (UT)-Centre National de la Recherche Scientifique (CNRS), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Hôpital Pontchaillou, Université de Rennes (UNIV-RENNES), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA), Hôpital Claude Huriez [Lille], CHU Lille, Service d'Hépato-gastroentérologie [CHU Saint-Etienne], Ecole Nationale Supérieure de l'Electronique et de ses Applications (ENSEA)-Centre National de la Recherche Scientifique (CNRS)-CY Cergy Paris Université (CY)-Ecole Nationale Supérieure de l'Electronique et de ses Applications (ENSEA)-Centre National de la Recherche Scientifique (CNRS)-CY Cergy Paris Université (CY), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service d'Hépatologie et de Gastroentérologie [Lyon], Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Service d'Endocrinologie, Diabétologie, Maladies Métaboliques, Hôpital Avicenne, Wallenberg Centre for Molecular Medicine (WCMM), Hépato-Gastro-Onco-Entérologie [CHRU de Tours], Service d'hépato-gastro-entérologie [Hôpital Saint-Louis, APHP], Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Service de Gastro-entérologie et hépatologie [AP-HP Hôpital Cochin], Sorbonne Paris Cité-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Descartes - Paris 5 (UPD5), Service d’hépato-gastro-entérologie [CH Le Raincy-Montfermeil], Groupe Hospitalier Intercommunal Le Raincy-Montfermeil, Observatory on Efficacy and of Vedolizumab in Patients With Inflammatory Bowel Disease Study Group, Groupe d’Étude Thérapeutique des Affections Inflammatoires du Tube Digestif (GETAID), Stress et Interactions neuro-digestives, [GIN] Grenoble Institut des Neurosciences (GIN), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Hôpital Saint Eloi (CHRU Montpellier), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Université de Montpellier (UM), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Université de Rennes (UR), Université Nice Sophia Antipolis (1965 - 2019) (UNS), Centre de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), and Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS)

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Drug-Related Side Effects and Adverse Reactions, [SDV]Life Sciences [q-bio], IBD, Antibodies, Monoclonal, Humanized, Inflammatory bowel disease, Gastroenterology, Vedolizumab, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Gastrointestinal Agents, Internal medicine, medicine, Humans, Prospective Studies, Adverse effect, Aged, Crohn's disease, Gastrointestinal agent, Hepatology, business.industry, drug, cell adhesion, Middle Aged, medicine.disease, Inflammatory Bowel Diseases, Ulcerative colitis, 3. Good health, Surgery, Discontinuation, inhibitor, Treatment Outcome, 030220 oncology & carcinogenesis, Concomitant, 030211 gastroenterology & hepatology, Administration, Intravenous, Female, business, medicine.drug
Abstract

International audience; Background & aims - Phase 3 trials have shown the efficacy of vedolizumab, which binds to integrin α4β7, in patients with Crohn's disease (CD) or ulcerative colitis (UC). We investigated the effectiveness and safety of vedolizumab in patients who failed anti-tumor necrosis factor therapy. Methods - From June through December 2014, there were 173 patients with CD and 121 patients with UC who were included in a multicenter nominative compassionate early access program granted by French regulatory agencies. This program provided patients with access to vedolizumab before it was authorized for marketing. Vedolizumab (300 mg) was administered intravenously at weeks 0, 2, and 6, and then every 8 weeks. Disease activity was assessed using the Harvey-Bradshaw Index for CD and the partial Mayo Clinic score for UC. We report results obtained after the 14-week induction phase. Results - Among the 294 patients treated with vedolizumab (mean age, 39.5 ± 14.0 y; mean disease duration, 10.8 ± 7.6 y; concomitant steroids, 44% of cases), 276 completed the induction period, however, 18 discontinued vedolizumab because of a lack of response (n = 14), infusion-related reaction (n = 2), or infections (n = 2). At week 14, 31% of patients with CD were in steroid-free clinical remission and 51% had a response; among patients with UC, 36% were in steroid-free clinical remission and 50% had a response. No deaths were reported. Severe adverse events occurred in 24 patients (8.2%), including 15 (5.1%) that led to vedolizumab discontinuation (1 case of pulmonary tuberculosis and 1 rectal adenocarcinoma). Conclusions - In a cohort of patients with CD or UC who failed previous anti-tumor necrosis factor therapy, approximately one third of patients achieved steroid-free clinical remission after 14 weeks of induction therapy with vedolizumab. This agent had an acceptable safety profile in these patients.

Published
2015

3. Usefulness of the Serum Carcinoembryonic Antigen Kinetic for Chemotherapy Monitoring in Patients With Unresectable Metastasis of Colorectal Cancer

Author

Bernard Paillot, Aude Duclos, Emilie Astruc, Monica Stetiu, I. Iwanicki-Caron, Jacques Benichou, David Tougeron, Sébastien Thureau, Pierre Michel, Jean Pierre Basuyau, Sandrine Saillard, Isabelle Roque, and Frédéric Di Fiore

Subjects
Adult, Male, Cancer Research, medicine.medical_specialty, Pathology, Lung Neoplasms, Colorectal cancer, Antineoplastic Agents, Kaplan-Meier Estimate, Sensitivity and Specificity, Gastroenterology, Disease-Free Survival, Metastasis, Carcinoembryonic antigen, Predictive Value of Tests, Internal medicine, Odds Ratio, Humans, Medicine, Prospective Studies, Prospective cohort study, Aged, Proportional Hazards Models, Aged, 80 and over, Receiver operating characteristic, biology, business.industry, Liver Neoplasms, Cancer, Middle Aged, medicine.disease, Carcinoembryonic Antigen, Kinetics, Treatment Outcome, ROC Curve, Oncology, Predictive value of tests, Disease Progression, biology.protein, Female, Drug Monitoring, Colorectal Neoplasms, business, Oncofetal antigen
Abstract

Purpose The aim of the study was to evaluate the relationship between serum carcinoembryonic antigen (CEA) kinetic and response to chemotherapy in patients with unresectable metastasis of colorectal cancer. Patients and Methods The kinetic was calculated using the slope of an exponential-regressive curve connecting the semi-logarithmic values of CEA. Receiver operating characteristic (ROC) curves were drawn to select the CEA slope thresholds to define patients with progressive or responsive disease with the highest sensitivity, specificity, and diagnosis accuracy odds ratio (DOR). The correlation between the CEA slopes and progression-free survival (PFS) was evaluated by the Cox model and Kaplan-Meier methods. Results A total of 122 patients were included. Progression defined by CEA slope greater than +0.05 resulted in sensitivity of 85.7%, specificity of 85.1%, and DOR of 34. The area under the ROC (AUROC) curve was 0.885 (95% CI, 0.815 to 0.936; P = .0001). Response defined by CEA slope less than −0.2 resulted in sensitivity of 74.7%, specificity of 82.5%, and DOR of 16. The AUROC curve was 0.847 (95% CI, 0.770 to 0.906; P = .0001). The difference between AUROC curves calculated with six or four CEA values was not significant. PFS was correlated with CEA slopes (hazard ratio, 4.6; 95% CI, 2.48 to 8.57). The median PFS was 10 months for patients with CEA slope values less than −0.2 months versus 6 months for patients with CEA slope values greater than −0.2 (P < .0001). Conclusion These results suggest that the CEA kinetic is an accurate, simple, and noninvasive method to identify the disease progression in patients with unresectable metastasis of colorectal cancer.

Published
2008

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