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2. Safety and tolerability of spesolimab in patients with ulcerative colitis

Author

Marc Ferrante, Peter M Irving, Christian P Selinger, Geert D’Haens, Tanja Kuehbacher, Ursula Seidler, Savion Gropper, Thomas Haeufel, Sebastiano Forgia, Silvio Danese, Jochen Klaus, and Brian G. Feagan

Subjects
INTERLEUKIN-36, EXPRESSION, MAINTENANCE THERAPY, Science & Technology, INDUCTION, General Medicine, spesolimab, DIAGNOSIS, TRIALS, Pharmacology (medical), Pharmacology & Pharmacy, Safety, tolerability, CONSENSUS, Life Sciences & Biomedicine, ulcerative colitis, INFLAMMATORY-BOWEL-DISEASE
Abstract

BACKGROUND: Interleukin (IL)-36 signaling has been shown to be increased in ulcerative colitis (UC). Spesolimab, a novel humanized monoclonal antibody, targets the IL-36 pathway. RESEARCH DESIGN AND METHODS: We report safety, immunogenicity, and efficacy data of intravenous (IV) spesolimab in UC. Study 1: phase II, randomized, placebo-controlled trial (300 mg single dose; 450 mg every 4 weeks [q4w]; or 1,200 mg q4w, three doses). Study 2: phase IIa, randomized, placebo-controlled trial (1,200 mg q4w). Study 3: phase IIa, open-label, single-arm trial (1,200 mg q4w). Studies lasted 12 weeks, with a 12-, 24-, and 16-week safety follow-up, respectively. RESULTS: Adver+se event (AE) rates were similar for spesolimab and placebo in Studies 1 (N = 98; 64.9%; 65.2%) and 2 (N = 22; 86.7%; 71.4%); all patients in Study 3 (N = 8) experienced AEs. The most frequent investigator-assessed drug-related (spesolimab; placebo) AEs were skin rash (5.4%; 0%) and nasopharyngitis (4.1%; 0%) in Study 1; acne (13.3%; 0%) in Study 2; one patient reported skin rash, nasopharyngitis, headache, and acne in Study 3. Efficacy endpoints were not met. CONCLUSIONS: Spesolimab was generally well tolerated, with no unexpected safety concerns. The safety data are consistent with studies in other inflammatory diseases. ispartof: EXPERT OPINION ON DRUG SAFETY vol:22 issue:2 pages:141-152 ispartof: location:England status: published

Published
2022

3. I-CARE, a European Prospective Cohort Study Assessing Safety and Effectiveness of Biologics in Inflammatory Bowel Disease

Author

Laurent Peyrin-Biroulet, Jean-François Rahier, Julien Kirchgesner, Vered Abitbol, Sebastian Shaji, Alessandro Armuzzi, Konstantinos Karmiris, Javier P. Gisbert, Peter Bossuyt, Ulf Helwig, Johan Burisch, Henit Yanai, Glen A. Doherty, Fernando Magro, Tamás Molnar, Mark Löwenberg, Jonas Halfvarson, Edyta Zagorowicz, Hélène Rousseau, Cédric Baumann, Filip Baert, Laurent Beaugerie, Jean-Marc Gornet, Jean-Marie Reimund, Xavier Hebuterne, Aurélien Amiot, Franco Armelao, Pierre Blanc, Claudio Papi, Guillaume Pineton De Chambrun, Xavier Roblin, null Chu, Sohail Shariq, Nikolaos Viazis, Jimmy Limdi, Piotr Eder H, Georgios Michalopoulos, Andrew Bell, Livia Biancone, Marie Dewitte, Zia Mazhar, Denis Franchimont, Stephane Nancey, Gilles Macaigne, Maria Beatrice Principi, Mathurin Fumery, Gareth Parkes, Jean-Christophe Valats, Glen Doherty, Guillaume Bouguen, Hersin Tsai, Mohsin Gangi, Natalia Pedersen, Frédéric Heluwaert, Richard Shenderey, Sebastian Zeissig, Jeffrey Butterworth, Fabiana Castiglione, Lynsey Corless, Camille Zallot, Salil Singh, Sunil Sonwalkar, Elizabeth Clayton, Deven Vani, Guy Bellaiche, Martine De Vos, Uri Kopylov, Triana Lobaton, Christophe Locher, Gerassimos Mantzaris, George Abouda, Katie Smith, Michael Sprakes, Angeliki Theodoropoulou, Emma Wesley, Joëlle Bonnet, David Elphick, Cyrielle Gilletta, John Gordon, David Laharie, Antoine Nakad, Ambrogio Orlando, Patrick Dubois, Peter Hasselblatt, Christophe Michiels, Cathryn Preston, Anca Staicu, Lucine Vuitton, Mehdi Kaassis, Ally Speight, Deb Ghosh, Nicolas Mathieu, Anne-Laure Pelletier, Anne Phillips, Romain Altwegg, Irit Avni, null biron, Jonathon Landy, Maria Nachury, Achuth Shenoy, Caroline Trang, Georgios Bamias, Klaudia Farkas, Christian Maaser, Ariella Shitrit, Britta Siegmund, Jérôme Filippi, Colm O'morain, Laurent Costes, David Hobday, Zoltán Szepes, Emma Calabrese, Helen Dallal, Michael Fung, Arvind Ramadas, Bijay Baburajan, Konrad Koss, Christophe Barberis, Anthony Buisson, Morgane Amil, Paola Balestrieri, Matthew Johnson, Maria Tzouvala, Stéphanie Viennot, Ferenc Nagy, Nick Thompson, Laurent Alric, Sunil Samuel, Anne Bourrier, Elise Chanteloup, Emilie Del Tedesco, Marcus Harbord, Alan Lobo, Sally Myers, Richard Pollok, Tariq Ahmad, Rakesh Chaudhary, Christos Karakoidas, Ashraf Soliman, Carmen Stefanescu, Georgios Theocharis, Stijn Vanden Branden, Belén Beltran, Yoram Bouhnik, Arnaud Bourreille, Joana Branco, Ben Colleypriest, Rami Eliakim, Paul Knight, Aoibhlinn O'toole, Virgina Robles, Konstantinos Triantafyllou, Marta Maia Bosca, Guy Lambrecht, Lucia Marquez Mosquera, Simon Panter, Aikaterini Pappa, Marion Simon, Ganesh Sivaji, Christophe Bellanger, Arthur Belle, Natalia Borruel, Laurence Egan, Harald Peeters, Daniel Sharpstone, Ramesh Arasaradnam, José Manuel Benitez, Jens Frederik Dahlerup, Olga Giouleme, Miguel Minguez, Eftychia Tsironi, Angela Variola, Patrick Allen, Lucille Boivineau, Andy Cole, Nina Dib, Fernando Gomollon, Richard Johnston, Konstantinos Katsanos, Nick Kennedy, Marianne Kiszka-Kanowitz, Ignacio Marin-Jimenez, Pál Miheller, Pilar Nos, Othman Saraj, Lars Vinter-Jensen, Eran Zittan, Clotilde Baudry, Xavier Calvet, Marie-Christine Cazelles-Boudier, Jean-Louis Coenegrachts, Garret Cullen, Marco Daperno, Anjan Dhar, Romain Gerard, Nanna Jensen, Nitsan Maharshak, Mark Mcalindon, Simon Mcloughlin, Miles Parkes, Kamal Patel, Armando Peixoto, Dimitrios Polymeros, Francisco Portela, Rodolfo Rocca, Philippe Seksik, Sreedhar Subramanian, Ruth Tennenbaum, Raja Atreya, Oliver Bachmann, Arthur Berger, Renáta Bor, Maire Buckley, Daniel Carpio, María Chaparro, Francesco Costa, Eugeni Domenech, Maria Esteve, Stephen Foley, Jordi Guardiola, Ioannis Koutroubakis, Tanja Kuehbacher, Cécilia Landman, Alessandro Lavagna, Noemí Manceñido, Míriam Mañosa, Maria Dolores Martín-Arranz, Laurianne Plastaras, Maria Lia Scribano, Subhasish Sengupta, Nils Teich, My-Linh Tran-Minh, Evanthia Zampeli, Leila Amininejad, Teresa Arroyo, Alain Attar, Ann-Sofie Backman, Anita Bálint, John Beckly, Shomron Ben Horin, Sónia Bernardo, Ludovic Caillo, Bénédicte Caron, María Shanika de Silva, Anna FábiáN, Gionata Fiorino, Ana Gutierrez, Adi Lahat, Mohamed Masmoudi, Marco Mendolaro, Vinciane Muls, Florian Poullenot, Christopher Probert, Catherine Reenaers, Mariann Rutka, Zaman Sarwari, Joanne Sayer, Beatriz Sicilia, Helena Sousa, Catherine van Kemseke, Yamile Zabana, Marco Astegiano, Paul Banim, Dominik Bettenworth, Médina Boualit, Jacob Broder Brodersen, Angeliki Christidou, Rachel Cooney, João Cortez Pinto, Portugal Marília Cravo, Anneline Cremer, Silvio Danese, Antonio di Sabatino, Jan Fallingborg, Antonio Ferronato, Esther Garcia Planella, Sanjay Gupta, Eran Israeli, Samantha Kestenbaum, Lone Larsen, Elisabeth Macken, Nicoletta Mathou, Ágnes Milassin, Joanna Pofelski, Chiara Ricci, Francisco Rodriguez-Moranta, Martin Schmidt-Lauber, Ian Shaw, Marta Soares, Heithem Soliman, Christos Triantos, Konstantinos Zografos, Anurag Agrawal, Alexandre Aubourg, Manuel Barreiro-de Acosta, Jesús Barrio, Daniel Bergemalm, Fernando Bermejo, Giorgia Bodini, Johan Bohr, Dimitrios Christodoulou, Christophe Claessens, Paul Collins, Ruth de Francisco, Santiago Garcia, Sotirios Georgopoulos, Felix Goutorbe, Chrisostomos Kalantzis, Anastasia Kourikou, Vincent Mace, Georgia Malamut, Paula Ministro, Isabelle Nion Larmurier, Elena Ricart, Mélanie Serrero, Juliette Sheridan, Petra Weimers, Vibeke Andersen, Bruno Arroja, Bernd Bokemeyer, Luis Bujanda, Thibault Degand, Carl Eriksson, Cécile Garceau, Henning Glerup, Idan Goren, Lucina Jackson, Stéphane Koch, Francisco Mesonero, Ingrid Ordas, Pauline Riviere, Simone Saibeni, João Soares, Noémie Tavernier, Klaus Theede, Bella Ungar, Elke Bästlein, Antonio Gasbarrini, Andreas Protopapas, Wolfgang Reindl, Fabrizio Bossa, Ailsa Hart, Franz-Josef Heil, Anthony O'Connor, Bas Oldenburg, Luca Pastorelli, null Stephen patchett, Subramaniam Ramakrishnan, John de Caestecker, Ana Echarri, David Kevans, Jürgen Büning, Rosa Coelho, Jeroen Jansen, Benjamin Koslowski, Christopher Wells, Daniel Ceballos, Ingrid König, Hari Padmanabhan, Timi Patani, Raheel Qureshi, Matthieu Allez, Emmanouil Archavlis, Delphine Bonnet, Luisa Guidi, Deirdre Mcnamara, Piero Vernia, Michael Weidenhiller, Lang Alon, Trine Boysen, Charlotte Delattre, Richard Farrell, Rolf-Achim Krüger, Thierry Paupard, Ida Vind, Flavio Caprioli, Vladimir Gancho, Vincent Quentin, Benjamin Avidan, Geert D’Haens, Jane Mccarthy, Jonathon Snook, Konstantinos Soufleris, Frank Zerbib, Dan Carter, Annekatrien Depla, Thomas Eisenbach, Walter Fries, Nikolaos Grammatikos, Saskia Ilegems, Antonio Lopez-Sanroman, Jacques Moreau, Gabriele Riegler, Svend Rietdijk, Marta Rocha, Isabelle Rosa, Barbara Ryan, Yelena Yeremenko, Arnaud Boruchowicz, Filipe Damião, Foteini Laoudi, Andreas Lügering, Giampiero Macarri, Konstantinos Thomopoulos, Luísa Barros, Thomas Blixt, Aurélien Garros, Sam Khorrami, Harry Sokol, Andreas Sturm, Dan Livovsky, Jochen Maul, Heinrich Miks, Vasileios Papadopoulos, Carsten Schmidt, Yifat Snir, Lise Svenningsen, Wafaa Ahmed, Yelena Broitman, Emmanuel Cuillerier, Prashant Kant, Jan Leyden, Lev Lichtenstein, Susana Lopes, Chloé Martineau, Hugh Mulcahy, Axel Schweitzer, Fiona Van Schaik, Hagar Banai, Pauline Danion, Charlotte Dulery, Herma Fidder, Claire Gay, Hervé Hagege, Florence Harnois, Søren Peter Jørgensen, Jens Müller-Ziehm, Michail Oikonomou, Carolina Palmela, Jörg Schulze/Röske, Mark Smith, Tamar Thurm, Francesca Bresso, Hedia Brixi, John Jones, Padraig Macmathuna, Claire Painchart, Yulia Ron, Marianne Vester-Andersen, Gonçalo Alexandrino, Norbert Börner, Mariana Cardoso, Cristina Chagas, Axel Dignaß, Iris Dotan, Charlotte Hedin, Pantelis Karatzas, Panagiotis Kasapidis, Károly Palatka, Georgios Sakizlis, Ana Wilson, Nick Bosanko, Paulo Caldeira, Charlotte Gagniere, Louise Libier, Camille Meunier, Gero Moog, Audrey Pasquion, Roberta Pica, Ayesha Akbar, Nadia Arab, Guillaume Cadiot, João Carvalho, Claire Charpignon, Laus Fellermann, Sigal Fishman, Gerald Fraser, Nathan Gluck, Mark Hoesl, Jarosław Kierkus, Maria Klopocka, Eduardo Martin Arranz, Luis Menchen, Susanna Nikolaus, Anca Petrache, Cyriel Ponsioen, Sabino Riestra, Pilar Robledo, Cristina Rodriguez, Misheal Samer, Matthias Tischer, Joanna Wypych, Julien Baudon, Cristina Bezzio, Gilles Boschetti, Tom Creed, Maria Giulia Demarzo, Stefano Festa, Andrés Figueroa, Mette Julsgaard, Pablo Navarro, Pablo Perez-Galindo, Cléa Rouillon, Emanuele Sablich, Joan Tosca, Mathias Vidon, Marine Vidon, René-Louis Vitte, Anne Wampach, Isabelle Clerc Urmes, Marc Borie, Mathieu Uzzan, Kelly Chatten, Rimmer Peter, Iqbal Tariq, Marta Cossignani, Fiorella Cañete, Tom Holvoet, Susanne Krasz, Sandra Dias, Hadas Abalia, Aziza Abaza, Gal Abramovich, Ingrid Ackzell, Carol Adams, Catherine Addleton, Erika Alfambra, Alicia Algaba, Clare Allcock, Joanna Allison, Karine Amouriaux, Julie Anderson, Emma Anderson, Saskia Appelmans, Lisa Armstrong, Stacey Atkins, Masoumeh Attaran-Bandarabadi, Yvonne Bailey, Stephanie Bardot, Natasha Beck, Lillie Bennett, Jonathan Phil Bergfeld, Ramdane Berkane, Hanne Boey, Louise Bowlas, Joanne Bradley-Potts, Tracy Brear, Nicole Bretlander-Peters, Ellen Brown, Johanna Brown, Elizabeth Buckingham, Katrien Buellens, Rhian Bull, Maura Burke, Leighanne Burns, Julie Burton, Agness Bwalya, Karine Cabanas, Muriel Callaghan, Océane Camou, Debbie Campbell, Elvira Capoferro, Mandy Carnahan, Cornelia Carnio, Anne Carter, Concetta Casali Clack, Leïla Chedouba, Bessie Cipriano, Sophie Claeys, Manon Closset, Dilek Coban, Sara Cococcia, Carolann Coe, Helen Cole, Emilie Collet, Kayleigh Collins, Isabelle Combes, Emma Connor, Kathryn Constantin, Susan Cooke, Nathanaëlle Cornet, Estelle Corrihons, Pilar Corsino, Rosie Cortaville, Donna Cotterill, Amanda Cowton, Harriet Cox, Viktoria Cripps, Amanda Crowder, Tzufit Cukier, Amelia Daniel, Chris Dawe, Jose de Haan, Rosanna de la Croix, Evva Dejonckheere, Juan Delare Villanegro, Guillaume Delaval, Mariangela Delliponti, Aude Delommez, Emilie Detry, Melanie Dhanaratne, Laura Diez Galan, Marie Dodel, Emma Dooks, Joseph Du Cheyron, Linda Duane, Jennifer Dulling Vulgo Cochran, Simona Dyer, Harvey Dymond, Charlotte Ekblad, Kerry Elliott, Ingrid Emmerson, Irène Eugene-Jolchine, Lorna Fleming, Eve Fletcher, Sarah Ford, Greg Forshaw, Angela Foulds, Caroline Francois, Nicole Fuge, Gal Gafni, Miri Ganon, Olga Garcia Nuñez, Laura Garcia Ramirez, Sophie Gelder, Raimonda Gettkowski, Daniela Gilardi, Paolo Giuffrida, Vincent Gobert, Jo Godden, Nuala Godwin, Kay Goulden, Sharon Graham, Charlotte Green, Marie Green, Aboubakar Gueye, Tuba Guler, Ida Gustavsson, Helena Hadjisavvas, Fiona Hammonds, Christina Hantzi, Marion Hauke, Julie Haydock, Orla Hayes, Lizette Helbo Nislev, Jessica Hochstodter, Ashleigh Hogg, Manuela Hölbing, Maureen Holland, Maartje Holsbergen, Linda Howard, Aviya Hoyda, Robert Hull, Jane Irish, Wendy Jackson, Wendy Janssen, Lesley Jeffrey, Sofia Jourdan, Izabela Jutrowska, Chava Kaniel, Theofilos Karezos, Niamh Kelly, Jessica Kelly, Mary Kennedy, Una Kennedy, Joyce Kibaru, Gemma Kirkman, Janine Klaproth, Corinna Kneese, Andrea Koch, Kathleen Kokke, Martha Koppelow, Sabine Krause, Sabine Krauspe, Petra Kwakkenbos, Nunzia Labarile, Hannah Lang, Marianne Lassailly, Martine Leconte, Linda Lepczynski, Emma Levell, Nina Levhar, Kerstin Lindhort, Jessica Lisle, Beatriz Lopez Cauce, Gabriele Lorenz, Ambra Lovati, Tracey Lowry, Margareta Lund, Anne Lutz Vorderbrügge, Suzanne Maansson, Videsheka Madapathage, Maelys Cheviakoff, Alison Magness, Orla Manley, Catherine Manyoni, Ingke Marg, Antonella Marra, Carole Martins, Arianna Massella, Aurore Mathias, Danielle Mervyn, Charlotte Minsart, Sally Mitchell, Kathleen Monks, Mélanie Montero, Alson Moore, Maren Moser, Alison Moss, Angela Mullen, M. Francisca Murciano, Deanna Naylor, Ansgar Nehus, Anne Nicholson, Sarah Nöding, Sinead Nolan, Janet Nörenberg, Clare Northcott, Jim O'Connell, Alison O’Kelly, Noam Orbach-Zingboim, Judit Orobitg, Charlene Otieno, Charlotte Owen, Sarah Patch, Maor Pauker, Renate Pauli, Harriet Pearson, Falgon Peggy, Séverine Petit, Christine Petrissans, Simona Piergallini, Lucy Pippard, Laura Pitt, Gabriella Pócsik, Yoann Poher, Chloé Pomes, Lucy Pritchard, Laura Puchades, Sheena Quaid, Aleem Rana, Dana Raynard, Mykla Reilly, Sonja Reinert, Manuela Reinknecht, Baerbel Renner, Rob Reynolds, Giulia Rizzuto, Matthew Robinson, Joke Robrechts, Eva M. Rodriguez, Efrat Rosenblum, Tamlyn Russel, Ibiyemi Sadare, Noa Salama, Toos Schakel, Anja Schauer, Elisa Schiavoni, Caroline Shaw, Sarah Shelton, Virginie Sicart, Elodie Siouville, Orla Smith, Théo Soude, Sophie Stephenson, Elaine Stephenson, Marjan Steppe, An Sterkx, Jo Stickley, Kathleen Sugrue, Natalia Swietec, Charlotte Tasiaux, Bhavneet Thamu, Susane Thomas, Ogwa Tobi, Kahina Touabi, Shifra Tovi, Julie Tregonning, Laura Turchini, Julia Unkhoff, Olesya Unruh, Nurcan Uzun, Frauke Van Aert, Sandrine Vanden Bergh, Louise Vandenbroucke, Laura Vansteenkiste, Shay Vardit, Valentin Vergriete, Elaine Walker, Eleanor Warner, Olivia Watchorn, Ekaterina Watson, Marie-Claire Wauthier, Belgium Maria Weetman, Margaret Weston, Wiebke West-Petroschka, Susann Wienecke, Kerstin Wierling, Miriam Wiestler, Rebecca Wilcox, Elva Wilhelmsen, Angharad Williams, Georgina Williamson, Deborah Wilson, Kate Wistance, Nicolas Wortmann, Subie Wurie, Karin Yadgar, Gail Young, Megan Young, Julien Aucouturier, Marie- Jo Bertin, Hasnae Bougrine, Marie Coisnon, Antoine Defrance, Kati Gutierrez, Amel Harouz, Laure Jerber, Aida Khlifi, Amina Kirati, Nasaladjine Liworo, Maude Logoltat, Charlotte Mailhat, Chancely M'Bayi, Yasmina Medane, Dalal Merkhoufa, Saouda Mohamed Elhad, Bertille Monthe, Fanny Moyon, Pascaline Rabiega, Jennifer Sekela, Charlotte Thilloy, Naima Hamamouche, Frederic Partisotti, Patrick Blandin, Hocine Mokhtari, Laure Coutard, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service de gastro-entérologie, Gastroenterology and hepatology, Gastroenterology and Hepatology, and AGEM - Amsterdam Gastroenterology Endocrinology Metabolism

Subjects
Biological Products, Hepatology, Efficacy, Lymphoma, Tumor Necrosis Factor-alpha, Inflammatory Bowel Disease, Gastroenterology, Biologics, Crohn Disease/diagnosis, Inflammatory Bowel Diseases/chemically induced, Colitis, Ulcerative/diagnosis, Cohort Studies, Necrosis, Immunologic Factors/adverse effects, Humans, Female, 03.02. Klinikai orvostan, Prospective Studies, Safety, I-CARE, Cancer, Immunosuppressive Agents
Abstract

BACKGROUND AND AIMS: There is a need to evaluate the benefit-risk ratio of current therapies in inflammatory bowel disease (IBD) patients to provide the best quality of care. The primary objective of I-CARE (IBD Cancer and serious infections in Europe) was to assess prospectively safety concerns in IBD, with specific focus on the risk of cancer/lymphoma and serious infections in patients treated with anti-tumor necrosis factor and other biologic monotherapy as well as in combination with immunomodulators.METHODS: I-CARE was designed as a European prospective longitudinal observational multicenter cohort study to include patients with a diagnosis of Crohn's disease, ulcerative colitis, or IBD unclassified established at least 3 months prior to enrollment.RESULTS: A total of 10,206 patients were enrolled between March 2016 and April 2019, including 6169 (60.4%) patients with Crohn's disease, 3853 (37.8%) with ulcerative colitis, and 184 (1.8%) with a diagnosis of IBD unclassified. Thirty-two percent of patients were receiving azathioprine/thiopurines, 4.6% 6-mercaptopurine, and 3.2% methotrexate at study entry. At inclusion, 47.3% of patients were treated with an anti-tumor necrosis factor agent, 8.8% with vedolizumab, and 3.4% with ustekinumab. Roughly one-quarter of patients (26.8%) underwent prior IBD-related surgery. Sixty-six percent of patients had been previously treated with systemic steroids. Three percent of patients had a medical history of cancer prior to inclusion and 1.1% had a history of colonic, esophageal, or uterine cervix high-grade dysplasia.CONCLUSIONS: I-CARE is an ongoing investigator-initiated observational European prospective cohort study that will provide unique information on the long-term benefits and risks of biological therapies in IBD patients. (EudraCT, Number: 2014-004728-23; ClinicalTrials.gov, Number: NCT02377258).

Published
2022
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4. 775d Ustekinumab Versus Adalimumab for Induction and Maintenance Therapy in Moderate-to-Severe Crohn’s Disease: The SEAVUE Study

Author

Stephen B. Hanauer, Oksana Shchukina, Matthieu Allez, Edward V. Loftus, Long-Long Gao, Andrew Greenspan, Remo Panaccione, Christopher Gasink, James D. Lewis, Silvio Danese, Bruce E. Sands, Emese Mihály, Timothy Hoops, J Izanec, Vipul Jairath, Peter M. Irving, Tanja Kuehbacher, William J. Sandborn, and Ellen Scherl

Subjects
Moderate to severe, medicine.medical_specialty, Crohn's disease, Hepatology, business.industry, Gastroenterology, medicine.disease, Maintenance therapy, Internal medicine, Ustekinumab, medicine, Adalimumab, business, medicine.drug
Published
2021
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5. OP02 Ustekinumab versus adalimumab for induction and maintenance therapy in Moderate-to-Severe Crohn’s Disease: The SEAVUE study

Author

A Greenspan, W J Sandborn, Mathieu Allez, O Shchukina, Remo Panaccione, Stephen B. Hanauer, Long-Long Gao, Tanja Kuehbacher, Ellen Scherl, Peter M. Irving, J Izanec, Bruce E. Sands, Christopher Gasink, Silvio Danese, Edward V. Loftus, Vipul Jairath, James D. Lewis, T Hoops, and Emese Mihály

Subjects
medicine.medical_specialty, Abdominal pain, Crohn's disease, Surrogate endpoint, business.industry, Gastroenterology, General Medicine, medicine.disease, Crohn's Disease Activity Index, Maintenance therapy, Internal medicine, Ustekinumab, medicine, Adalimumab, medicine.symptom, Adverse effect, business, medicine.drug
Abstract

Background We studied the efficacy and safety of ustekinumab (UST) vs adalimumab (ADA) through 1 year in biologic-naïve patients (pts) with moderate-to-severe Crohn’s disease. Methods SEAVUE was a multicenter, randomized, blinded, parallel-group, active-controlled study in adults with CD Activity Index (CDAI) scores ≥220/≤450. Biologic-naïve pts failing/intolerant to conventional therapy with any size ulcer on baseline (BL) ileocolonoscopy were eligible. Pts were randomized 1:1 to UST (⁓6mg/kg IV at BL then 90mg SC every 8 weeks [Ws]) or ADA (160/80mg SC at BL/W2, then 40mg SC every 2 Ws) per US-approved regimens (no dose modifications). Primary endpoint was clinical remission at W52 (CDAI Results 386 pts were randomized to UST or ADA. BL demographics and disease characteristics were balanced between groups and indicative of pts with early, moderate-to-severe CD (median CD duration, 2.58 years; CDAI, 289.5; SES-CD, 8.0). At W52, 65% of UST-treated and 61% of ADA-treated pts achieved clinical remission (Δ=4.0%; 95% CI, -5.5%, 13.5%; p=0.417). Major secondary endpoints, including endoscopic remission, were similar between groups (Table 1), as were remission rates at assessment points through W52. Some other secondary endpoints showed numerical (not statistical) differences between UST and ADA (Table 1). Key safety events are summarized in Table 2. Among UST-treated and ADA-treated pts, 34.0% and 40.5% had infections, 2.6% and 7.2% had serious adverse events (AEs) of worsening CD, and 6.3% and 11.3% had AEs that led to discontinuation (DC) of study drug, respectively. One ADA-treated pt had active pulmonary TB. Injection-site reactions associated with active treatment occurred in 1.0% of UST-treated and 10.3% of ADA-treated pts. Overall, 15.2% of UST-treated and 23.6% of ADA-treated pts DC before W52. Reasons for DC were primarily lack of efficacy (UST, 2.1% vs ADA, 5.1%), AEs (UST, 5.7% vs ADA, 10.7%), and withdrawal of consent (UST, 5.8% vs ADA, 5.1%). Time to treatment DC was longer with UST vs ADA (post hoc analysis). Conclusion Both UST and ADA were highly effective in this population of biologic-naïve pts. Rates of clinical remission at W52 were not statistically significantly different between treatment groups. DC rates were numerically lower for UST. Safety results were consistent with prior experience for both treatments.

Published
2021
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7. Mo1906 – Combination Therapy of Vedolizumab and Tofacitinib in IBD Patients with Chronic Active Refractory Disease Course and Spondylarthritis

Author

Gwendolyn vonGogh, Tanja Kuehbacher, Marco Cederqvist, Stefan Schreiber, Angele Leick, and Markus Porthun

Subjects
medicine.medical_specialty, Tofacitinib, Hepatology, Combination therapy, business.industry, Chronic Active, Gastroenterology, Refractory Disease, Spondylarthritis, Vedolizumab, Internal medicine, Medicine, business, medicine.drug
Published
2019
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8. Endoscopic ultrasound of the colon for the differentiation of Crohn's disease and ulcerative colitis in comparison with healthy controls

Author

Susanna Nikolaus, S. Dhar, Johannes Bethge, Mark Ellrichmann, L Wintermeyer, Annette Fritscher-Ravens, Wolfram Klapper, Stefan Schreiber, Katharina Balschun, P Wietzke-Braun, Alexander Arlt, and Tanja Kuehbacher

Subjects
Adult, Male, Endoscopic ultrasound, medicine.medical_specialty, Colonoscopy, Inflammatory bowel disease, Gastroenterology, Endosonography, Diagnosis, Differential, Crohn Disease, Internal medicine, Submucosa, medicine, Humans, Single-Blind Method, Pharmacology (medical), Prospective Studies, Colitis, Gastrointestinal wall, Aged, Crohn's disease, Hepatology, medicine.diagnostic_test, business.industry, Middle Aged, medicine.disease, Ulcerative colitis, digestive system diseases, medicine.anatomical_structure, Case-Control Studies, Colitis, Ulcerative, Female, business
Abstract

Summary Background Diagnosis of inflammatory bowel disease (IBD) is based on clinical presentation, colonoscopy and histology. Differentiation of Crohn's disease (CD) and ulcerative colitis (UC) can be difficult in some patients. Endoscopic ultrasound (EUS) provides high resolution images of the gastrointestinal wall (GI) and may be an alternative to differentiate CD/UC. Aim EUS of the GI layers in patients with IBD and healthy controls (HC) for the differential diagnosis of UC/CD in a prospective, blinded study. Methods Consecutive patients with CD, UC or HC underwent EUS in the mid sigmoid colon with a forward-viewing radial echoendoscope. Mucosal, submucosal, total wall thickness (TWT) and locoregional lymphnodes (LN) were assessed by EUS in a blinded fashion. TWT was correlated with macroscopic IBD scores and histological inflammation scores. Results Total wall thickness of 61 HC was 1.71 ± 0.02 mm, and 3.51 ± 0.15 mm in n = 52 with active IBD. In patients with active UC significant thickening of the mucosa was observed but nearly normal submucosa and m.propria. In active CD significant thickening of the submucosal layer was seen with nearly normal mucosa and m.propria [MucosaUC = 2.08 ± 0.11 mm, MucosaCD = 1.32 ± 0.17 mm (P = 0.0001); SubmucosaUC = 1.01 ± 0.08 mm, SubmucosaCD = 2.01 ± 0.22 mm (P = 0.0001)]. In 73.7% of patients with active CD, but in none with UC, paracolonic lymph nodes were detected. When mucosal-submucosal and TWT and LNs were combined, the sensitivity was 92.3% for the differentiation of active UC/CD. There was a strong correlation of TWT with histological inflammation scores (UC: r = 0.43; CD: r = 0.69). Conclusions Increased total wall thickness has a high positive predictive value for active IBD. EUS can differentiate active UC from CD and quantify the level of colonic inflammation.

Published
2014
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9. 817 - Topical Administration of a Gata-3 Specific Dnazyme Suppresses Mucosal Inflammation in a Randomized Trial with Moderate-To-Severe Ulcerative Colitis Patients

Author

Michael Vieth, Simon Hirschmann, Ursula Homburg, Agnieszka Turowska, Tanja Kuehbacher, Harald Renz, Sarah Fischer, Jonas Renz, Tanja Mühl, Raja Atreya, Oliver Drvarov, Benno Weigmann, Markus F. Neurath, Marcel Vetter, Heike Schmitt, Holger Garn, and Maximilian J. Waldner

Subjects
Moderate to severe, medicine.medical_specialty, Hepatology, business.industry, Gastroenterology, Mucosal inflammation, medicine.disease, Ulcerative colitis, law.invention, Randomized controlled trial, law, Internal medicine, medicine, business
Published
2018
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10. Intestinal TM7 bacterial phylogenies in active inflammatory bowel disease

Author

Patricia Lepage, Stephan J. Ott, Ateequr Rehman, Stefan Schreiber, Stephan Hellmig, Ulrich R. Fölsch, and Tanja Kuehbacher

Subjects
Adult, Male, Microbiology (medical), Adolescent, Colon, Clone (cell biology), Gram-Positive Bacteria, Microbiology, Inflammatory bowel disease, Pathogenesis, Young Adult, Antibiotic resistance, Crohn Disease, RNA, Ribosomal, 16S, Drug Resistance, Bacterial, medicine, Humans, Intestinal Mucosa, Gene, Phylogeny, Aged, biology, Sequence Analysis, DNA, General Medicine, Middle Aged, Inflammatory Bowel Diseases, medicine.disease, 16S ribosomal RNA, biology.organism_classification, Ulcerative colitis, Immunology, Colitis, Ulcerative, Female, Bacteria
Abstract

TM7 is a recently described subgroup of Gram-positive uncultivable bacteria originally found in natural environmental habitats. An association of the TM7 bacterial division with the inflammatory pathogenesis of periodontitis has been previously shown. This study investigated TM7 phylogenies in patients with inflammatory bowel diseases (IBDs). The mucosal microbiota of patients with active Crohn's disease (CD; n=42) and ulcerative colitis (UC; n=31) was compared with that of controls (n=33). TM7 consortia were examined using molecular techniques based on 16S rRNA genes, including clone libraries, sequencing and in situ hybridization. TM7 molecular signatures could be cloned from mucosal samples of both IBD patients and controls, but the composition of the clone libraries differed significantly. Taxonomic analysis of the sequences revealed a higher diversity of TM7 phylotypes in CD (23 different phylotypes) than in UC (10) and non-IBD controls (12). All clone libraries showed a high number of novel sequences (21 for controls, 34 for CD and 29 for UC). A highly atypical base substitution for bacterial 16S rRNA genes associated with antibiotic resistance was detected in almost all sequences from CD (97.3 %) and UC (100 %) patients compared to only 65.1 % in the controls. TM7 bacteria might play an important role in IBD similar to that previously described in oral inflammation. The alterations of TM7 bacteria and the genetically determined antibiotic resistance of TM7 species in IBD could be a relevant part of a more general alteration of bacterial microbiota in IBD as recently found, e.g. as a promoter of inflammation at early stages of disease.

Published
2008
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11. OP023 Maintenance of clinical effect in patients with moderate-to-severe Crohn's disease treated with filgotinib, a selective JAK1 inhibitor: exploratory 20-week data analysis of the phase 2 FITZROY study

Author

Xavier Roblin, Kremena Stoyanova, Severine Vermeire, Stefan Schreiber, L. Meuleners, Chantal Tasset, Maria Kłopocka, Tanja Kuehbacher, A Van der Aa, Xavier Hébuterne, M. Wisniewska-Jarosinska, Robert Petryka, A. Baranovsky, Adrian Goldis, P. Harrison, and Robert Sike

Subjects
Moderate to severe, medicine.medical_specialty, Crohn's disease, Filgotinib, business.industry, Gastroenterology, General Medicine, medicine.disease, 01 natural sciences, Crohn's Disease Activity Index, 0104 chemical sciences, Surgery, 010404 medicinal & biomolecular chemistry, 03 medical and health sciences, 0302 clinical medicine, Quality of life, 030220 oncology & carcinogenesis, Rheumatoid arthritis, Internal medicine, JAK1 Inhibitor, medicine, In patient, business
Published
2017
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12. DOP075 Efficacy of filgotinib, a selective JAK1 inhibitor, is independent of prior anti-TNF exposure: subgroup analysis of the phase 2 FITZROY study in moderate-to-severe Crohn's disease

Author

Severine Vermeire, G. D'Haens, Stefan Schreiber, Robert Sike, Maria Kłopocka, Chantal Tasset, Adrian Goldis, Kremena Stoyanova, Xavier Roblin, L. Meuleners, A. Baranovsky, Tanja Kuehbacher, P. Harrison, Robert Petryka, A Van der Aa, Xavier Hébuterne, and M. Wisniewska-Jarosinska

Subjects
0301 basic medicine, medicine.medical_specialty, Crohn's disease, Filgotinib, Surrogate endpoint, business.industry, Gastroenterology, Subgroup analysis, General Medicine, medicine.disease, Inflammatory bowel disease, Crohn's Disease Activity Index, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, JAK1 Inhibitor, medicine, Tumor necrosis factor alpha, business
Published
2017
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13. Efficacy of Filgotinib, a Selective jak1 Inhibitor, is Independent of Prior Anti-TNF Exposure: Subgroup Analysis of the Phase 2 Fitzroy Study in Moderate-To-Severe Crohn’s Disease

Author

Xavier Roblin, Robert Sike, Geert R. D'Haens, Annegret Van der Aa, Chantal Tasset, Severine Vermeire, Stefan Schreiber, Kremena Stoyanova, Robert Petryka, Maria Kłopocka, Tanja Kuehbacher, Andrei Baranovsky, L. Meuleners, Xavier Hébuterne, Adrian Goldis, P. Harrison, and M. Wisniewska-Jarosinska

Subjects
Moderate to severe, 030213 general clinical medicine, Crohn's disease, medicine.medical_specialty, Filgotinib, Hepatology, business.industry, Gastroenterology, Subgroup analysis, medicine.disease, 03 medical and health sciences, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, JAK1 Inhibitor, Medicine, Tumor necrosis factor alpha, business
Published
2017
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14. Combination Therapy of Vedolizumab and a TNF Antagonist in IBD Patients with Severe Chronic Active, Therapy Refractory Disease Course

Author

Tanja Kuehbacher, Stefan Schreiber, Oliver Drvarov, Natalie Langel, and Raed AbuHashem

Subjects
030203 arthritis & rheumatology, medicine.medical_specialty, Hepatology, Combination therapy, business.industry, Chronic Active, Gastroenterology, Refractory Disease, Tnf antagonists, Vedolizumab, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Medicine, 030212 general & internal medicine, business, medicine.drug
Published
2017
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15. Ustekinumab for the Treatment of Crohn S Disease Patients with TNF Antagonist Induced Psoriasis. Real Life Experience from a Tertiary Referral Center through Week 54

Author

Oliver Drvarov, Stefan Schreiber, Raed AbuHashem, Tanja Kuehbacher, and Natalie Langel

Subjects
medicine.medical_specialty, Crohn's disease, Hepatology, business.industry, Gastroenterology, medicine.disease, Tnf antagonists, Surgery, Psoriasis, Internal medicine, Ustekinumab, medicine, Referral center, business, medicine.drug
Published
2017
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16. Submucosal Injection of the Oligonucleotide STNM01 is Able to Induce Clinical Remission, Mucosal Healing and Histological Response in Left-Sided Ulcerative Colitis Patients with Moderate-to-Severe Disease

Author

Oliver Drvarov, Maximilian J. Waldner, Raed Abu Hashem, Christoph Schramm, Babett Holler, Jessica Mertens, Raja Atreya, Junji Yokoyama, Christian Maaser, Torsten Kucharzik, Markus F. Neurath, Joachim Mössner, Hitoshi Asakura, Johanna Dinter, Simon Hirschmann, Kenji Suzuki, Tanja Kuehbacher, Shuji Terai, Hiroyuki Yoneyama, and Toshifumi Hibi

Subjects
Moderate to severe, medicine.medical_specialty, Pathology, Hepatology, business.industry, Gastroenterology, Histological response, Submucosal injection, Disease, Internal medicine, Mucosal healing, medicine, Left sided ulcerative colitis, business
Published
2017
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17. P588 Ustekinumab for the treatment of Crohn's disease patients with TNF antagonist induced psoriasis. Real life experience from a tertiary referral center through week 54

Author

Tanja Kuehbacher, Stefan Schreiber, R. Abu Hashem, N. Langel, and Oliver Drvarov

Subjects
Crohn's disease, medicine.medical_specialty, Tumor necrosis factors, business.industry, medicine.medical_treatment, Gastroenterology, General Medicine, medicine.disease, Crohn's Disease Activity Index, Surgery, Tnf antagonists, Psoriasis, Internal medicine, Ustekinumab, medicine, Referral center, business, Neoadjuvant therapy, medicine.drug
Published
2017
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18. P544 Combination therapy of vedolizumab and a TNF antagonist in IBD patients with severe chronic active, therapy refractory disease course

Author

Oliver Drvarov, Tanja Kuehbacher, Stefan Schreiber, N. Langel, and R. Abu Hashem

Subjects
medicine.medical_specialty, Crohn's disease, Combination therapy, business.industry, Chronic Active, Gastroenterology, General Medicine, medicine.disease, Inflammatory bowel disease, Ulcerative colitis, Crohn's Disease Activity Index, Vedolizumab, 03 medical and health sciences, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, Medicine, Combined Modality Therapy, 030211 gastroenterology & hepatology, business, medicine.drug
Published
2017
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19. 812c Filgotinib (GLPG0634), an Oral JAK1 Selective Inhibitor, Induces Clinical Remission in Patients With Moderate-to-Severe Crohn's Disease: Results From the Phase 2 FITZROY Study Interim Analysis

Author

Andrei Baranovsky, Tanja Kuehbacher, Annegret Van der Aa, Xavier Roblin, Chantal Tasset, Maria A. Wisniewska-Jarosinska, Severine Vermeire, Robert Sike, Adrian Goldis, Xavier Hébuterne, Robert Petryka, P. Harrison, Stefan Schreiber, and Maria Kłopocka

Subjects
0301 basic medicine, Moderate to severe, medicine.medical_specialty, Crohn's disease, Filgotinib, Hepatology, business.industry, Gastroenterology, Interim analysis, medicine.disease, 03 medical and health sciences, 030104 developmental biology, Internal medicine, medicine, In patient, business
Published
2016
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20. Improvement of arthritis and arthralgia after treatment with infliximab (Remicade) in a German prospective, open-label, multicenter trial in refractory Crohn's disease

Author

Florian Obermeier, Susanna Nikolaus, T. Andus, Stefan Schreiber, Hans H Herfarth, Gerhard Rogler, and Tanja Kuehbacher

Subjects
musculoskeletal diseases, medicine.medical_specialty, Crohn's disease, Hepatology, business.industry, Gastroenterology, virus diseases, Arthritis, medicine.disease, digestive system diseases, Infliximab, Surgery, body regions, Clinical trial, Refractory, Internal medicine, Multicenter trial, Medicine, skin and connective tissue diseases, business, Prospective cohort study, After treatment, medicine.drug
Abstract

Improvement of arthritis and arthralgia after treatment with infliximab (Remicade) in a German prospective, open-label, multicenter trial in refractory Crohn's disease

Published
2002
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21. Influence of CYP3A4, CYP3A5, and ABCB1 genotype and expression on budesonide pharmacokinetics: a possible role of intestinal CYP3A4 expression

Author

Philip Rosenstiel, Robert Haesler, Stefan Schreiber, Ingolf Cascorbi, Susanna Nikolaus, Igor Mosyagin, Mike Ufer, Karin Dilger, Tanja Kuehbacher, L Leschhorn, and LM Daufresne

Subjects
Budesonide, Adult, Male, ATP Binding Cassette Transporter, Subfamily B, Genotype, medicine.drug_class, CYP3A, Administration, Oral, Biology, Pharmacology, Isozyme, Inflammatory bowel disease, Gene Expression Regulation, Enzymologic, Pharmacokinetics, medicine, Cytochrome P-450 CYP3A, Humans, Pharmacology (medical), ATP Binding Cassette Transporter, Subfamily B, Member 1, Intestinal Mucosa, CYP3A4, medicine.disease, Intestinal Absorption, Corticosteroid, Female, medicine.drug
Abstract

Budesonide treatment of chronic inflammatory bowel disease commonly leads to non-response or adverse reactions, possibly because of alterations in efflux transport mediated by the ABCB1 gene product P-glycoprotein or metabolism by CYP3A isoenzymes. Two groups, each consisting of nine healthy volunteers, one with the CYP3A5*1/*3 genotype (expressors) and the other with the CYP3A5*3/*3 genotype (non-expressors), were given a single oral dose of 9 mg budesonide. Plasma and urine concentrations of budesonide and its major metabolites were determined using liquid chromatography-tandem mass spectrometry. Subsequently, rectosigmoidal biopsies were taken for analysis of messenger RNA (mRNA) expression. Budesonide pharmacokinetics did not differ between genotype groups. However, intestinal CYP3A4 expression was shown to correlate directly with partial metabolic clearances of 16-hydroxy-prednisolone (r2 = 0.30; P = 0.010) and 6-hydroxy-budesonide (r2 = 0.25; P = 0.016), but inversely with budesonide AUC0–24 h (r2 = 0.18; P = 0.040). Interestingly, a strong correlation was found between CYP3A5 and ABCB1 expression in CYP3A5 expressors (r2 = 0.79; P = 0.001). This study suggests that intestinal CYP3A4 expression has an impact on budesonide pharmacokinetics. Moreover, CYP3A5 and ABCB1 expression appears to be coregulated. Clinical Pharmacology & Therapeutics (2008); 84, 1, 43–46 doi:10.1038/sj.clpt.6100505

Published
2008

22. Tu1346 Skin and Joint Side Effects in a Subpopulation of Anti-TNF Experienced IBD Patients, Who Respond to a Treatment With Vedolizumab, a Humanized A4b7 Integrin Antibody

Author

Stefan Schreiber, Natalie Schunk, Raed AbuHashem, Oliver Drvarov, and Tanja Kuehbacher

Subjects
Hepatology, biology, business.industry, Immunology, Integrin, Gastroenterology, biology.protein, Medicine, Tumor necrosis factor alpha, Antibody, business, Vedolizumab, medicine.drug
Published
2015
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23. Validation of treatment strategies for enterohaemorrhagic Escherichia coli O104:H4 induced haemolytic uraemic syndrome: case-control study

Author

Jan, Menne, Martin, Nitschke, Robert, Stingele, Mariam, Abu-Tair, Jan, Beneke, Jörn, Bramstedt, Jan P, Bremer, Reinhard, Brunkhorst, Veit, Busch, Reinhard, Dengler, Günther, Deuschl, Klaus, Fellermann, Helmut, Fickenscher, Christoph, Gerigk, Alexander, Goettsche, Jobst, Greeve, Carsten, Hafer, Friedrich, Hagenmüller, Hermann, Haller, Stefan, Herget-Rosenthal, Bernd, Hertenstein, Christina, Hofmann, Melanie, Lang, Jan T, Kielstein, Ulrich C, Klostermeier, Johannes, Knobloch, Markus, Kuehbacher, Ulrich, Kunzendorf, Hendrik, Lehnert, Michael P, Manns, Tobias F, Menne, Tobias N, Meyer, Claus, Michael, Thomas, Münte, Christine, Neumann-Grutzeck, Jens, Nuernberger, Hermann, Pavenstaedt, Leyla, Ramazan, Lutz, Renders, Jonas, Repenthin, Wolfgang, Ries, Axel, Rohr, Lars Christian, Rump, Ola, Samuelsson, Friedhelm, Sayk, Bernhard M W, Schmidt, Sabine, Schnatter, Harald, Schöcklmann, Stefan, Schreiber, Cay U, von Seydewitz, Jürgen, Steinhoff, Sylvia, Stracke, Sebastian, Suerbaum, Andreas, van de Loo, Martin, Vischedyk, Karin, Weissenborn, Peter, Wellhöner, Monika, Wiesner, Sebastian, Zeissig, Jürgen, Büning, Mario, Schiffer, Tanja, Kuehbacher, and Karl W, Kroencke

Subjects
Male, medicine.medical_treatment, Antibiotics, Gastroenterology, Disease Outbreaks, Mice, Germany, Child, Escherichia coli Infections, Aged, 80 and over, Plasmapheresis, General Medicine, Middle Aged, Eculizumab, Combined Modality Therapy, Anti-Bacterial Agents, Diarrhea, Treatment Outcome, Enterohemorrhagic Escherichia coli, Disease Progression, Drug Therapy, Combination, Female, medicine.symptom, medicine.drug, Adult, medicine.medical_specialty, Adolescent, medicine.drug_class, Perforation (oil well), Antibodies, Monoclonal, Humanized, Young Adult, Renal Dialysis, Internal medicine, medicine, Animals, Humans, Immunologic Factors, Glucocorticoids, Dialysis, Aged, Retrospective Studies, Mechanical ventilation, L-Lactate Dehydrogenase, Platelet Count, business.industry, Infant, Respiration, Artificial, Surgery, Case-Control Studies, Hemolytic-Uremic Syndrome, Multivariate Analysis, business, Abdominal surgery
Abstract

Objective To evaluate the effect of different treatment strategies on enterohaemorrhagic Escherichia coli O104:H4 induced haemolytic uraemic syndrome. Design Multicentre retrospective case-control study. Setting 23 hospitals in northern Germany. Participants 298 adults with enterohaemorrhagic E coli induced haemolytic uraemic syndrome. Main outcome measures Dialysis, seizures, mechanical ventilation, abdominal surgery owing to perforation of the bowel or bowel necrosis, and death. Results 160 of the 298 patients (54%) temporarily required dialysis, with only three needing treatment long term. 37 patients (12%) had seizures, 54 (18%) required mechanical ventilation, and 12 (4%) died. No clear benefit was found from use of plasmapheresis or plasmapheresis with glucocorticoids. 67 of the patients were treated with eculizumab, a monoclonal antibody directed against the complement cascade. No short term benefit was detected that could be attributed to this treatment. 52 patients in one centre that used a strategy of aggressive treatment with combined antibiotics had fewer seizures (2% v 15%, P=0.03),fewer deaths (0% v 5%, p=0.029), required no abdominal surgery, and excreted E coli for a shorter duration. Conclusions Enterohaemorrhagic E coli induced haemolytic uraemic syndrome is a severe self limiting acute condition. Our findings question the benefit of eculizumab and of plasmapheresis with or without glucocorticoids. Patients with established haemolytic uraemic syndrome seemed to benefit from antibiotic treatment and this should be investigated in a controlled trial.

Published
2012
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24. Mo1773 Resilience of the Human Intestinal Microbiota After an Antibiotic Perturbation: Influence of a Probiotic Compared to Placebo

Author

Tanja Kuehbacher, Stephan J. Ott, Philip Rosenstiel, Femke-Anouska Heinsen, Henrik Knecht, Stefan Schreiber, Anette Friedrichs, John F. Baines, and Sven C. Neulinger

Subjects
Probiotic, Hepatology, law, business.industry, medicine.drug_class, Immunology, Antibiotics, Gastroenterology, Medicine, business, Placebo, law.invention, Microbiology
Published
2012
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25. Tu1553 Endoscopic Ultrasound of the Colon Can Differentiate Between Crohn‘S Disease and Ulcerative Colitis and Reliably Quantifies the Degree of Inflammation - a Prospective, Blinded, and Controlled Comparative Study

Author

Wolfram Klapper, Mark Ellrichmann, Tanja Kuehbacher, Susanna Nikolaus, Stefan Schreiber, Alexander Arlt, Johannes Bethge, Annette Fritscher-Ravens, and Perdita Wietzke-Braun

Subjects
Endoscopic ultrasound, medicine.medical_specialty, Crohn's disease, medicine.diagnostic_test, business.industry, Gastroenterology, Inflammation, medicine.disease, Ulcerative colitis, Internal medicine, medicine, Radiology, Nuclear Medicine and imaging, medicine.symptom, business
Published
2012
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27. Endoscopic Ultrasound of the Sigmoid Colon for the Differentiation of Crohn'sDisease From Unspecific, Infectious Colitis and Healthy Controls – A Prospective, Blinded, Comparative Study

Author

Stefan Schreiber, L Wintermeyer, Alexander Arlt, Perdita Wietzke-Braun, Petr Sergueev, Annette Fritscher-Ravens, Susanna Nikolaus, Mark Ellrichmann, and Tanja Kuehbacher

Subjects
Endoscopic ultrasound, medicine.medical_specialty, medicine.anatomical_structure, Hepatology, medicine.diagnostic_test, business.industry, Internal medicine, Gastroenterology, medicine, Sigmoid colon, Infectious Colitis, business
Published
2011
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28. Serum Soluble IL2-Receptor is Increased in a Subpopulation of Crohns Disease Patients, Who Respond to Open Label Use of Ustekinumab, a Human Monoclonal Antibody to IL-12/23p40

Author

Susanna Nikolaus, Stefan Schreiber, and Tanja Kuehbacher

Subjects
medicine.medical_specialty, Intention-to-treat analysis, Hepatology, medicine.drug_class, business.industry, Gastroenterology, medicine.disease, Ulcerative colitis, Maintenance therapy, Tolerability, Internal medicine, Ustekinumab, Immunology, Clinical endpoint, medicine, Corticosteroid, Adverse effect, business, medicine.drug
Abstract

for relapse of the individual patient. Results: Of the 34 patients enrolled in this trial 26 patients (14 CD, 12 UC) were evaluable for the per protocol analysis. After completion of the 12 weeks treatment phase 14 out of 26 (53.9%) patients were in remission off corticosteroids (complete responders). Another 9 (34.6%) patients were in remission at a corticosteroid dose equal or lower than their individual threshold dose (partial responders). In total, vidofludimus met the primary endpoint in 88.5% of patients (complete and partial response). Response rates did not differ between Crohn's disease and ulcerative colitis. Vidofludimus was well tolerated, no drug-related serious adverse events were observed. Conclusions: This trial provides first evidence of clinical efficacy of vidofludimus in patients with Crohn's disease and ulcerative colitis. Considering the favorable safety and tolerability profile vidofludimus may have potential as a novel future remission maintenance therapy in IBD. These data substantiate the relevance of IL-17 suppression in IBD as a promising and innovative therapeutic approach.

Published
2011
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30. 463 Endoscopic Ultrasound of the Colon for the Differentiation of Crohn's Disease and Ulcerative Colitis in Comparison to Healthy Controls - A Prospective, Blinded, Comparative Study

Author

L Wintermeyer, Stefan Schreiber, Mark Ellrichmann, Susanna Nikolaus, Petr Sergueev, Annette Fritscher-Ravens, P Wietzke-Braun, Alexander Arlt, and Tanja Kuehbacher

Subjects
Endoscopic ultrasound, Crohn's disease, medicine.medical_specialty, medicine.diagnostic_test, business.industry, Internal medicine, Gastroenterology, medicine, Radiology, Nuclear Medicine and imaging, medicine.disease, business, Ulcerative colitis
Published
2011
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32. Improvement of arthritis/arthralgia after treatment with infliximab (Remicade®) in a German prospective open-label multicenter trial in refractory Crohn's disease

Author

Stefan Schreiber, Tilo Andus, Wolfgang Thriene, Tanja Kuehbacher, Hans H Herfarth, Silvia Mascheretti, and Florian Obermeier

Subjects
Crohn's disease, medicine.medical_specialty, Hepatology, business.industry, Gastroenterology, Arthritis, medicine.disease, language.human_language, Infliximab, German, Refractory, Multicenter trial, Internal medicine, medicine, language, Open label, business, After treatment, medicine.drug
Published
2001
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33. Prediction of response to treatment with infliximab (Remicade®) in a German prospective open-label multicenter trial in refractory Crohn's disease

Author

Wolfgang Thriene, Tanja Kuehbacher, Hans H Herfarth, Stefan Schreiber, Juergen Schoelmerich, Tilo Andus, Silvia Mascheretti, and Florian Obermeier

Subjects
medicine.medical_specialty, Crohn's disease, Hepatology, business.industry, Gastroenterology, medicine.disease, Response to treatment, language.human_language, Infliximab, German, Refractory, Multicenter trial, Internal medicine, language, medicine, Open label, business, medicine.drug
Published
2001
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34. Signaltrassduction-factor NFκB p65 is activated in patients with chronic relapsing pouchitis through probiotic therapy although healing occurs

Author

Michael A. Kamm, Ulrich R. Folesch, Ulf Helwig, Paolo Gionchetti, Toshiki Mimura, Tanja Kuehbacher, and Philip Rosensteil

Subjects
medicine.medical_specialty, Probiotic therapy, Hepatology, business.industry, Nfκb p65, Internal medicine, Gastroenterology, Medicine, In patient, Pouchitis, business, medicine.disease
Published
2001
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35. Clinical efficacy of treatment with infliximab in a german multicenter, prospective, open-label trial in refractory crohn's disease

Author

Silvia Mascheretti, Stefan Schreiber, Herbert Lochs, Wolfgang E. Fleig, Wolfgang Thriene, C. Pohl, E. Hommel, Tilo Andus, Tanja Kuehbacher, and Wolfgang Kruis

Subjects
medicine.medical_specialty, Crohn's disease, Hepatology, business.industry, Gastroenterology, medicine.disease, language.human_language, Infliximab, German, Refractory, Internal medicine, language, medicine, Clinical efficacy, Open label, business, medicine.drug
Published
2000
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