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1. Randomised clinical trial: once- vs. twice-daily prolonged-release mesalazine for active ulcerative colitis

Author

Xavier Hébuterne, D Maetz, T G Tan, Hervé Hagège, J P Kuyvenhoven, Gilbert Tucat, Marieke Pierik, Bernard Flourié, Chris Probert, Ad A.M. Masclee, D. Aoucheta, O. Dewit, Interne Geneeskunde, and RS: NUTRIM - R2 - Gut-liver homeostasis

Subjects
Male, Time Factors, medicine.medical_treatment, Severity of Illness Index, Gastroenterology, THERAPY, law.invention, chemistry.chemical_compound, DOUBLE-BLIND, Randomized controlled trial, law, Pharmacology (medical), Mesalamine, Aged, 80 and over, MMX MESALAMINE, ISSUES, INDUCTION, Anti-Inflammatory Agents, Non-Steroidal, Enema, Middle Aged, Ulcerative colitis, Treatment Outcome, Female, Adult, medicine.medical_specialty, Adolescent, 5-AMINOSALICYLIC ACID, Drug Administration Schedule, Young Adult, Mesalazine, Prolonged release, Internal medicine, Severity of illness, medicine, MANAGEMENT, Humans, Colitis, Aged, Hepatology, business.industry, REMISSION, medicine.disease, digestive system diseases, Clinical trial, MAINTENANCE, chemistry, Delayed-Action Preparations, Colitis, Ulcerative, business, INFLAMMATORY-BOWEL-DISEASE
Abstract

BACKGROUND: Aminosalicylates are first-choice treatment for mild-to-moderately active ulcerative colitis (UC); however, multi-dosing regimens are inconvenient. AIM: To compare the efficacy and safety of once- (OD) vs. twice- (BD) daily prolonged-release mesalazine (Pentasa, Ferring, Saint-Prex, Switzerland) for active mild-to-moderate UC in a non-inferiority study. METHODS: Eligible patients (n = 206) were randomised to 8 weeks of mesalazine (4 g/day), either OD with two sachets of 2 g mesalazine granules in the morning (n = 102) or BD with one 2 g sachet in the morning and one in the evening (n = 104). Patients also received 4 weeks of mesalazine enema 1 g/day. Disease activity was assessed at randomisation, weeks 4, 8 and 12 using the UC Disease Activity Index (UC-DAI). Clinical and endoscopic remission (primary endpoint) was assessed after 8 weeks. Patients recorded stool frequency and rectal bleeding in a daily diary. RESULTS: The primary endpoint, non-inferiority in clinical and endoscopic remission with OD vs. BD mesalazine at 8 weeks, was met (intent-to-treat population: 52.1% vs. 41.8%, respectively, 95% confidence interval -3.4, 24.1; P = 0.14). Improvement of UC-DAI score (92% vs. 79%; P = 0.01) and mucosal healing (87.5% vs. 71.1%; P = 0.007) were significantly better, time to remission significantly shorter (26 vs. 28 days; P = 0.04) and safety similar with OD vs. BD dosing. CONCLUSIONS: When combined with mesalazine enema, prolonged-release mesalazine once-daily 4 g is as effective and well tolerated as 2 g twice-daily for inducing remission in patients with mild-to-moderately active ulcerative colitis (Clinicaltrials.gov: NCT00737789).

Published
2013
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2. High Risk of Anal and Rectal Cancer in Patients With Anal and/or Perianal Crohn’s Disease

Author

Laurent Beaugerie, Fabrice Carrat, Stéphane Nahon, Jean-David Zeitoun, Jean-Marc Sabaté, Laurent Peyrin-Biroulet, Jean-Frédéric Colombel, Matthieu Allez, Jean-François Fléjou, Julien Kirchgesner, Magali Svrcek, Jacques Cosnes, Jean-Pierre Gendre, Marc Lémann, Xavier Hébuterne, Antoine Cortot, Yoram Bouhnik, David Laharie, Jean Louis Dupas, Bernard Flourié, Eric Lerebours, Bernard Messing, Guillaume Cadiot, Philippe Marteau, Jean-Claude Soulé, Jean-Marc Gornet, Michel Veyrac, Bernard Duclos, Philippe Beau, Arnaud Bourreille, Philippe Baumer, Franck Carbonnel, Denis Heresbach, Etienne-Henry Metman, Christian Florent, Antoine Blain, Jean-Luc Faucheron, Bruno Bonaz, Xavier Roblin, Pascal Potier, Christian Boehm, Thierry Kurtz, Hervé Lamouliatte, Isabelle Nion-Larmurier, Jean-Charles Delchier, Stanislas Chaussade, Anne Marie Weiss, Jean Pierre Cézard, Laurent Siproudhis, Daniel Sondag, Raymond Jian, Jean-Christophe Souquet, Pierre Bord, Benoit Coffin, Hélène D’almagne, Patrick Delasalle, Régis Fournier, Maryan Cavicchi, Marc-Henry Souffran, Luc Vandromme, Claire Guedon, Philippe Seksik, Christophe Michiels, Pascal Renard, Patrice Rogier, Sylvie Gouilloud, André Rotenberg, Guillaume Savoye, Alain Thevenin, Laurent Mallet, Franck Brazier, Francois Jean, Anne-Marie Justum, Jean-Paul Latrive, Jean-Luc Gerbal, Robert Pierrugues, Gérard Chardonnal, Laurence Picon, Nicole Reix, Nicolas Drouët D’aubigny, Hervé Uettwiller, Anne Courillon Mallet, Alain Palacci, Raoul-Jacques Bensaude, Pierre Bonniaud, Olivier Empinet, Andrée Nisard, Alain Rudelli, Bernard Tubiana, Philippe Capelle, Alain Dabadie, Daniel Evard, Pierre-Emile Julien, Magali Picon-Coste, Stéphane Schneider, Denis Goldfain, Jérôme Bellanger, Jean-Pierre Blondelot, Philippe Lamy, Sébastien Lemière, Jean Francois Mockly, Benoit Pellat, Gilles Gatineau-Sailliant, Bernard Nalet, Stéphane Nancey, Daniel Kusielewicz, Patrick Loison, Jean-Michel Popot, François Merite, Jean-Pol Roux, Pauline Afchain, Alain Blanquart, Laurent Heyries, Marc Reville, Dominique Viron, Frank Zerbib, Christophe Claviere, Didier Léostic, Philippe Pouderoux, Alain Moitry, Hervé Hagège, Jean-Pierre Hugot, Benoit Humeau, Jean-Marc Sabate, Emmanuel Lederman, Dominique Lescut, Fabrice Luneau, Bruno Mesnard, Lionel Smadja, Michel Steinberg, Marc Brun, Gilles Macaigne, Jean Luc Marchal, Stéphane Ollivier, Dominique Ouvry, Jean Paul Perche, Serge Rambaud, Robert Benamouzig, Jean Louis Cazenave, Jean-Charles Coffin, Martine Blazquez, Marion Lagneau, Bruno Person, Christian Wittersheim, Bertrand Napoleon, Israël Cemachovic, Franck Iglicki, Mehran Howaizi, Eric Leprince, Bruno Leurent, Thierry Morin, Riad Darsouni, Alain Attar, Philippe Baron, Anne Breton, Jean Marie Gillion, Jean-Marc Guemene, Claude Jouffre, Xavier Moreau, Pierre Claude, André Quinton, Vered Abitbol, Jean Michel Brichard, Benoit Desaint, Martin Bouygues, Philippe Chatrenet, Marcelo Salmeron, Jean Silvie, Bruno Waldner, Yves Emery, Armand Moraillon, Daniel Kunkel, Philippe Dubois, Patrick Faure, Christian L'Hirondel, Jean-Eric Labérenne, Pierre Moreau, Adelino Pereira, Genevieve Plihon, Thierry Wolff, Yann Ngo, Arnaud Boruchowicz, Béatrice Jost, Jean Pierre Gotlib, Odile Danne, Philippe Raoux, Marie-José Ramond-Bouhali, Andre Baetz, Bruno Veyres, Christian Chapoutot, Gérard Le Dréau, Jérôme Filippi, Jean Mudry, Philippe Kalt, Sophie Minault, Pierre-André Bounin, Tony Andréani, Jacky Charneau, Didier Reijasse, Jean-Louis Bolze, Jean Luc Thaunat, Christian Le Couteulx, Chantal Maurage, Robert Bader, Philippe Codjovi, Jean-Luc Migairou, Alain Morali, Philippe Rey, Bruno Richard Molard, Richard Petit, Stéphane Koch, Philippe Cassan, Jean-Paul Deschamps, Christine Meicler Caby, Jean-Jacques Meurisse, Philippe Prades, James Boulant, Michel Diacono, Jean-Marie Monsch, J-François Dupuy, Guy Bellaiche, Martine Guegan, Jean-Marc Comte, Jean-Michel Cayla, Francois Le Tallec, Franck Meurisse, Philippe Desurmont, Laurent Roget, Philippe Bouyssou, Bruno Le Gall, Francis Bloch, Loic Larvol, Monique Jullien, Jacques Moreau, Laurent Rebouissoux, Bruno Decroix, Nina Dib, Paul Dieterling, Frédéric Lenormand, Emmanuel Lagier, Philippe Fallourd, Serge Charpin, Hugues Bertrand, Gilles Bommelaer, Daniel Battistelli, Bernard Delon, Lionel Dentant, Etienne Dorval, Jérôme Dumortier, Eric Gaye-Bareyt, Yves Gerosa, Chantal Guez, Martine Mornet, Paul Benfredj, René Piperaud, Noel Stremsdoerfer, Eric Verdier, Alain Grinholtz, Georges Barjonet, Antoine See, Ramuntxo Arotçarena, Anne Baudet, Joel Broyer, Antoine Charachon, Hugues Blondon, Pascal Mouton, Hubert Claudez, Jacques Labat-Labourdette, Jacques Haëm, Patrick Estable, Patrick Levy, Alain Rosenbaum, Yvon Balavoine, Alain Blanchi, Pierre Coutarel, Nadege Delaperriere, Michel Dervichian, Francis Marois, Jacques Seroka, Laurent Michaud, Olivier Leroy, Emmanuel Meyran, Bernard Poilroux, Abdallah Tensaouti, Thierry Paupard, Dominique Agard, Sandrine Beaulieu, Kader Benfiguig, Patrice Capony, Jean Cottereau, Pierre Desreumaux, Jean-Michel Dramard, Mathieu Duché, Patrick Mamou, Isabelle Etienney, Gilles D'Abrigeon, Béatrice Godeberge, Gilbert Tucat, Jean Puech, Jean Roger, Marie-George Lapalus, Paul Bauret, Philippe Houcke, Béatrice Pornin, Bruno Champigneulle, Laurent Cuissard, Xavier-Richard David, Frédéric Lombard, Antoine Granveau, Jean-François Hamon, Olivier Ink, Fabienne Blondel, Alain Namias, Didier Pillon, Antoine Reignier, Gilles Tordjman, Christos Christidis, Simon Zirabe, Michel Audebert, Eric Bion, Claude Bourgeaux, Cécile Poupardin, Philippe Deplaix, Gérard Fratini, Thierry Garnier, Gerard Desseaux, Hervé Magois, Sylvain Lochum, Jean-Francois Vergier, Patrick Texereau, Christel Rat, Francoise Uzzan, Alain Vidal, Nadia Vinante, Bernard Watrin, Cécile Wurtz-Huckert, Bruno Barre, Dominique Chaslin Ferbus, Jean-François Contou, Dominique Coupier, Benoit David, Dany Gargot, Denis Huc, Remy Barraya, Roger Faroux, Jean-Luc Fourgeaud, Hubert Grimprel, Jean Auroux, Jean-François Rey, Jean Pierre Arnoux, Franck Lentini, Ludovic Tardy, Olivier Mouterde, Claire Spyckerelle, Bruno Vacherot, Alain Weissman, Michel Alpérine, Anne Le Sidaner, Pierre-Olivier Bonnet-Eymard, Jean Louis Colson, Daniel Pellet, Bernard Deltombe, André Edouard, Henri Maechel, Jean-Claude Jaillet, Julien Genes, Anne-Marie Leveque, Damien Lucidarme, Philippe Maignan, Nathalie Mallier Gehrke, Jérôme Sanchez, Frank Tusseau, Alban Casteur, Jacques Bottlaender, Denis Constantini, Thierry Coton, Philippe Even, Francois Druart, François Riot, Jean-Michel Gauchet, Geneviève Hecquet, Gerard Henry, Patrick Hochain, Jean Pierre Arpurt, Abdelkrim Medini, Michele Dartois-Hoguin, Henri Moindrot, Philippe Emery, Pierre Periac, Annie Prunier, Pascal Renkes, Christine Tawil-Longreen, Edmond Vincent, René-Louis Vitte, Christian Loeb, Alain Carwana, Didier Barbereau, Philippe Bohon, Céline Corrieri-Baizeau, Daniel Sahy, Philippe Derreveaux, Dominique David, François Desbazeille, Patrick Fontenelle, Jean Luc Slama, Yvon Le Mercier, Michel Certin, Jean Jacques Reig, Isabelle Rosa, Thierry Helbert, Patrick Tounian, Luc Turner, Valéry Perot, Luc Aillet, Arnaud Pauwels, Philippe Barré, Bernard Nury, Claude Cazalbou, Franck Devulder, Alain Durget, Jeanne Dubroca, Daniele Gaudy, Michel Greff, Christian Jacques, Jocelyne Lafarge, Gilles Kezachian, Ronan Le Gall, Alex Pariente, Tiphaine Pinault, Michaël Bismuth, Nathalie Boyer-Darrigrand, Philippe Bretagnolle, Stephane Carpentier, Franck Cholet, Christian Theodore, Rémi Combes, Francois Combet, Christophe Delanoe, Stéphanie De Montigny, Denis Soudan, Olivier Fourdan, Gilles Minier, Jeanne Languepin, Jean Roche, Jean-Louis Ginies, Olivier Nouel, Philippe Petitgars, Edith Robin, Romain Hamm, Jean François Roques, Sylvie Roussin-Bretagne, Agnès Sénéjoux, Sophie Muron, Nicolas Bardoux, Philippe Berthelemy, Patrick Madonia, Bertrand Carles, Catherine Reynier, Emmanuel Cuillerier, Innocenti Dadamessi, Jacques Danis, Bernard Debenes, Nathalie Dubuc-Rey, Gilles Lesur, Pauline Jouet, Catherine Lenaerts, Marc Garret, Alexandra Mineur, Bernard Chabry, Francois Pigot, Valérie Rossi, Ruth Tennenbaum, Julien Salloum, Maurice Hakim Slaoui, Stéphane Mathieu, Valérie Papapietro, Sheila Viola, Alexis Bezet, Claude Altman, Alain Audan, Jean Calabet, Claude Masliah, Laurent Fayemendy, Marc Duruy, Benoit Gauffeny, Ludovic Helie, Kamran Imani, Raoul Janin-Manificat, Jean-Paul Galmiche, Anne Kerlirzin, Laurent Bedenne, Christophe Locher, Gilles Michaudel, Gilles Missonnier, Michel Rinaldi-Dovio, Jean-Michel Rouillon, Stéphane Ecuer, Arnaud Patenotte, Jean Ariel Bronstein, Vincent Baty, Michel Bougnol, Pierre Bourbon, Philippe Cerbelaud, Annick Chavaillon, Franck Boiffin, Béatrice Dubern, Isabelle Duval De Laguierce, Fernand Greco, Florence Bouhot, Philippe Godeberge, Brigitte Grandmaison, Pascal Gros, Guy Targues, Jacques Corallo, Jean Boutin, Jacques Guillan, Jean Pierre Barbieux, Isabelle Loury Lariviere, Henri Le Genissel, Henri Leroi, Marc Bellaiche, Marie-Claire Elie-Legrand, Michel Dapoigny, Philippe Denoyel, Patrice Pienkowski, Philippe Pouche, Marc Michel Saurfelt, Jean Marie Thorel, Thierry Piche, Bruno Travers, Patrick Tuvignon, Marc Zalcberg, Guy Boulay, Christophe Zamora, Joelle Samama, Etienne Ricotie, Patrice De Fleury, Francois Maille, Jean Louis Mougenel, Olivier Gonot, Jean Philippe Menat, Mehdi Kaassis, Francoise Lang, Laurent Abramowitz, Nathalie Ganne, Olivier Pecriaux, Jacques-Arnaud Seyrig, Iradj Sobhani, Thierry Parmentier, Antoine Van Nieuwenhuyse, Francois-Xavier Weber, André Glibert, Catherine Bineau, Bernard Canet, Catherine Collin, Frederic Cordet, David David Parlier, Dominique Carre, Annie Peytier, Francine Fein, Jerome Barouk, Jacques Dewannieux, Johannes Hartwig, Jean-Louis Jouve, Bertrand Laplane, Gilles Lascar, Christophe Legrand, Pierre Le Marchand, Marie Pierre Liebaert, Michele Terdiman-Pire, Naceur Abdelli, Dominique Neveu, Philippe De La Lande, Patrick De Saint Louvent, Cécile Pelatan, Agnès Petit, Martial Richecoeur, Frederic Texier, Jean Brice Cazals, Bertrand Tissot, Christian Mourrut, Marie Doubremelle, Marc Foltz, Florence Gautier-Jubé, Jacques Martin, Elie Khouri, Thierry Lons, Martine Carlier-Bandu, Jean-Luc Monnin, Hervé Roche, Bernard Willemin, Xavier Houard, Abdelaziz Fatisse, Michèle Algard, Kamel Arab, Isabelle Borel, Cécile Lagarrigue, Ariane Chryssostalis, Dominique Boutroux, Jean-Pierre Dupuychaffray, Saïd Khaddari, François Mion, Thierry Puy-Montbrun, Jean-Philippe Girardet, Bruno Gury, Alain Landau, Monique Le Bihan, Sandrine Nieuviarts, Jean Ollivry, Philippe Le Bourgeois, Marie-Astrid Piquet, Michel -Pierre Escartin, Remi Systchenko, Franck Venezia, Michel Wantiez, Xavier Lesage, Elie Zrihen, Philippe Aygalenq, Barbara Dieumegard, Bernard Savarieau, Philippe Bulois, Stéphane Cattan, Jean-Lucien Diez, Olivier Fauchot, Eric Durous, Valérie Gazut, Christian Guilleminet, Jean-Marc Bories, Isabelle Joly Le Floch, Jean-Paul Vove, Stéphane Lelouch, Philippe Lévy, François Lhopital, Norma Marcato, Marianne Mozer-Bernardeau, Jean-Baptiste Nousbaum, Philippe Cattan, Alain Plane, Jean-Michel Raymond, Gilles Roseau, Gerald Rozental, Christian Boustière, Corinne Bonny, Mariepierre Cordier-Collet, Laurent Courat, Bernard Croguennec, Karine Delaunay- Tardy, Damien Labarriere, Edmond Geagea, Frédéric Gottrand, Eve Gelsi, Gerard Thiefin, Eric Wohlschies, Mathieu Miguet, Philippe Ponsot, Jean Suzanne, Yves Teste, Anne-Claire Dupont Gossart, Jean-Luc Baroni, Benabdallah Benchaa, Georges Blanc, Bernard Maroy, Philippe Bonjean, Catherine Brézault, Laure Bridoux-Henno, Claude Chayette, Dominique Auby, Robert Fiorucci, Georges Galindo, Gilles Hubert, Gilles Bonneau, Evelyne Marinier, Michele Pouteau, Afchine Alamdari, Bruno Delbende, Patrick Chamouard, Pascale D'Abravanel, Hélène Dall'Osto, Sophie Hervé, Jean Lefebvre, Damien Levoir, Philippe Lillo, Michel Rouch, Muriel Mathonnet, Mercédes De Lustrac, François-Jean Ramond, Bernard Roupret, and Alain Soupison

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Colorectal cancer, Population, Risk Assessment, Gastroenterology, Inflammatory bowel disease, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Crohn Disease, Risk Factors, Internal medicine, medicine, Humans, Anal cancer, education, Aged, education.field_of_study, Crohn's disease, Hepatology, Rectal Neoplasms, business.industry, Incidence, Cancer, Odds ratio, Middle Aged, Anus Neoplasms, medicine.disease, Ulcerative colitis, Case-Control Studies, 030220 oncology & carcinogenesis, Female, 030211 gastroenterology & hepatology, France, business, Follow-Up Studies
Abstract

Background & Aims Little is known about the magnitude of the risk of anal and rectal cancer in patients with anal and/or perineal Crohn's disease. We aimed to assess the risk of anal and rectal cancer in patients with Crohn's perianal disease followed up in the Cancers Et Surrisque Associe aux Maladies Inflammatoires Intestinales En France (CESAME) cohort. Methods We collected data from 19,486 patients with inflammatory bowel disease (IBD) enrolled in the observational CESAME study in France, from May 2004 through June 2005; 14.9% of participants had past or current anal and/or perianal Crohn's disease. Subjects were followed up for a median time of 35 months (interquartile range, 29–40 mo). To identify risk factors for anal cancer in the total CESAME population, we performed a case-control study in which participants were matched for age and sex. Results Among the total IBD population, 8 patients developed anal cancer and 14 patients developed rectal cancer. In the subgroup of 2911 patients with past or current anal and/or perianal Crohn's lesions at cohort entry, 2 developed anal squamous-cell carcinoma, 3 developed perianal fistula–related adenocarcinoma, and 6 developed rectal cancer. The corresponding incidence rates were 0.26 per 1000 patient-years for anal squamous-cell carcinoma, 0.38 per 1000 patient-years for perianal fistula–related adenocarcinoma, and 0.77 per 1000 patient-years for rectal cancer. Among the 16,575 patients with ulcerative colitis or Crohn's disease without anal or perianal lesions, the incidence rate of anal cancer was 0.08 per 1000 patient-years and of rectal cancer was 0.21 per 1000 patient-years. Among factors tested by univariate conditional regression (IBD subtype, disease duration, exposure to immune-suppressive therapy, presence of past or current anal and/or perianal lesions), the presence of past or current anal and/or perianal lesions at cohort entry was the only factor significantly associated with development of anal cancer (odds ratio, 11.2; 95% CI, 1.18-551.51; P = .03). Conclusions In an analysis of data from the CESAME cohort in France, patients with anal and/or perianal Crohn's disease have a high risk of anal cancer, including perianal fistula–related cancer, and a high risk of rectal cancer.

Published
2018
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3. Assessing patients' satisfaction with anti-TNFα treatment in Crohn's disease: qualitative steps of the development of a new questionnaire

Author

Claire, Marant, Benoit, Arnould, Alexia, Marrel, Céderic, Spizak, Jean-Frédéric, Colombel, Patrick, Faure, Hervé, Hagege, Marc, Lemann, Stéphane, Nahon, Gilbert, Tucat, Luc, Vandromme, Emmanuel, Thibout, and Gérard, Goldfarb

Subjects
Crohn’s disease, anti-TNF treatment, patient satisfaction, questionnaire, patient-reported outcome, Original Research
Abstract

Purpose: To develop a self-administered questionnaire assessing patients’ satisfaction with treatments in Crohn’s disease for use in clinical research and epidemiological studies. Patients and methods: Semi-directive interviews (16) were conducted with patients with severe Crohn’s disease treated with anti-tumor necrosis factor alpha (anti-TNFα). Transcripts were analyzed and concepts related to satisfaction with treatment were extracted and organized into a model. Items were generated using patients’ words. The resulting test version was tested for relevance and comprehension with 7 patients and revised accordingly; the new version was tested with 5 other patients and revised to provide the pilot version. A clinician advisory board was involved at each milestone of the development. Results: The test questionnaire assessed treatment satisfaction through 67 items, organized into 5 sections: treatment efficacy, side-effects, convenience and constraints, overall impact, and satisfaction. Conceptual content of the questionnaire includes comparison with prior state and with expectations, satisfaction, acceptability, and intentions. The questionnaire was generally well accepted and understood by patients; few modifications were made in the structure and item formulation. After the second round of comprehension tests, the pilot version contained 62 items; the questionnaire was named Satisfaction of PAtients in Crohn’s diseasE (SPACE©). Conclusion: The questionnaire is a unique tool to assess treatment satisfaction in patients with Crohn’s disease. A scoring and validation study is currently being performed to finalize and establish its scoring, as well as its psychometric properties.

Published
2011

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