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254 results on '"Yacyshyn, Bruce"'

1. Fusobacterium nucleatum Adheres to Clostridioides difficile via the RadD Adhesin to Enhance Biofilm Formation in Intestinal Mucus

Author

Engevik, Melinda A, Danhof, Heather A, Auchtung, Jennifer, Endres, Bradley T, Ruan, Wenly, Bassères, Eugénie, Engevik, Amy C, Wu, Qinglong, Nicholson, Maribeth, Luna, Ruth Ann, Garey, Kevin W, Crawford, Sue E, Estes, Mary K, Lux, Renate, Yacyshyn, Mary Beth, Yacyshyn, Bruce, Savidge, Tor, Britton, Robert A, and Versalovic, James

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Digestive Diseases, Infectious Diseases, Emerging Infectious Diseases, Oral and gastrointestinal, Infection, Good Health and Well Being, Adhesins, Bacterial, Bacterial Adhesion, Biofilms, Bioreactors, Clostridioides difficile, Clostridium Infections, Feces, Flagella, Fusobacterium nucleatum, Gastrointestinal Microbiome, HT29 Cells, Humans, Intestinal Mucosa, Mucin-2, MUC2, Mucus, Biofilm, Clinical Sciences, Neurosciences, Paediatrics and Reproductive Medicine, Gastroenterology & Hepatology, Clinical sciences, Nutrition and dietetics
Abstract

Background & aimsAlthough Clostridioides difficile infection (CDI) is known to involve the disruption of the gut microbiota, little is understood regarding how mucus-associated microbes interact with C difficile. We hypothesized that select mucus-associated bacteria would promote C difficile colonization and biofilm formation.MethodsTo create a model of the human intestinal mucus layer and gut microbiota, we used bioreactors inoculated with healthy human feces, treated with clindamycin and infected with C difficile with the addition of human MUC2-coated coverslips.ResultsC difficile was found to colonize and form biofilms on MUC2-coated coverslips, and 16S rRNA sequencing showed a unique biofilm profile with substantial cocolonization with Fusobacterium species. Consistent with our bioreactor data, publicly available data sets and patient stool samples showed that a subset of patients with C difficile infection harbored high levels of Fusobacterium species. We observed colocalization of C difficile and F nucleatum in an aggregation assay using adult patients and stool of pediatric patients with inflammatory bowel disease and in tissue sections of patients with CDI. C difficile strains were found to coaggregate with F nucleatum subspecies in vitro; an effect that was inhibited by blocking or mutating the adhesin RadD on Fusobacterium and removal of flagella on C difficile. Aggregation was shown to be unique between F nucleatum and C difficile, because other gut commensals did not aggregate with C difficile. Addition of F nucleatum also enhanced C difficile biofilm formation and extracellular polysaccharide production.ConclusionsCollectively, these data show a unique interaction of between pathogenic C difficile and F nucleatum in the intestinal mucus layer.

Published
2021

3. Etrolizumab as induction and maintenance therapy for ulcerative colitis in patients previously treated with tumour necrosis factor inhibitors (HICKORY): a phase 3, randomised, controlled trial

Author

Aguilar, Humberto, Ahmad, Tariq, Akriviadis, Evangelos, Aldeguer Mante, Xavier, Allez, Matthieu, Altorjay, Istvan, Ananthakrishnan, Ashwin, Andersen, Vibeke, Andreu Garcia, Montserrat, Armuzzi, Alessandro, Aumais, Guy, Avni-Biron, Irit, Axler, Jeffrey, Ayub, Kamran, Jr., Baert, Filip, Bafutto, Mauro, Bamias, George, Bassan, Isaac, Baum, Curtis, Beaugerie, Laurent, Behm, Brian, Bekal, Pradeep, Bennett, Michael, Bermejo San Jose, Fernando, Bernstein, Charles, Bettenworth, Dominik, Bhaskar, Sudhir, Biancone, Livia, Bilir, Bahri, Blaeker, Michael, Bloom, Stuart, Bohman, Verle, Jr., Bosques Padilla, Francisco Javier, Bossuyt, Peter, Bouhnik, Yoram, Bouma, Gerd, Bourdages, Raymond, Brand, Stephan, Bressler, Brian, Brückner, Markus, Buening, Carsten, Carbonnel, Franck, Caves, Thomas, Chapman, Jonathon, Cheon, Jae Hee, Chiba, Naoki, Chioncel, Camelia, Christodoulou, Dimitrios, Clodi, Martin, Cohen, Albert, Corazza, Gino Roberto, Corlin, Richard, Cosintino, Rocco, Cummings, Fraser, Dalal, Robin, Danese, Silvio, De Maeyer, Marc, De Magalhães Francesconi, Carlos Fernando, De Silva, Aminda, Debinski, Henry, Desreumaux, Pierre, Dewit, Olivier, D'Haens, Geert, Di Felice Boratto, Sandra, Ding, John Nik, Dixon, Tyler, Dryden, Gerald, Jr., Du Vall, George Aaron, Ebert, Matthias, Echarri Piudo, Ana, Ehehalt, Robert, Elkhashab, Magdy, Ennis, Craig, Etzel, Jason, Fallingborg, Jan, Feagan, Brian, Fejes, Roland, Ferraz de Campos Mazo, Daniel, Ferreira de Almeida Borges, Valéria, Fischer, Andreas, Fixelle, Alan, Fleisher, Mark, Fowler, Sharyle, Freilich, Bradley, Friedenberg, Keith, Fries, Walter, Fulop, Csaba, Fumery, Mathurin, Fuster, Sergio, G Kiss, Gyula, Garcia Lopez, Santiago, Gassner, Sonja, Gill, Kanwar, Gilletta de Saint Joseph, Cyrielle, Ginsburg, Philip, Gionchetti, Paolo, Goldin, Eran, Goldis, Adrian-Eugen, Gomez Jaramillo, Hector Alejandro, Gonciarz, Maciej, Gordon, Glenn, Green, Daniel, Grimaud, Jean-Charles, Guajardo Rodriguez, Rogelio, Gurzo, Zoltan, Gutierrez, Alexandra, Gyökeres, Tibor, Hahm, Ki Baik, Hanauer, Stephen, Hanson, John, Harlan III, William, Hasselblatt, Peter, Hayee, Buhussain, Hebuterne, Xavier, Hendy, Peter, Heyman, Melvin, Higgins, Peter, Hilal, Raouf, Hindryckx, Pieter, Hoentjen, Frank, Hoffmann, Peter, Holtkamp-Endemann, Frank, Holtmann, Gerald, Horvat, Gyula, Howaldt, Stefanie, Huber, Samuel, Ibegbu, Ikechukwu, Iborra Colomino, Maria Isabel, Irving, Peter, Isaacs, Kim, Jagarlamudi, Kiran, Jain, Rajesh, Jankiel Miszputen, Sender, Jansen, Jeroen, Jones, Jennifer, Juillerat, Pascal, Karagiannis, John, Karyotakis, Nicholas, Kaser, Arthur, Katz, Lior, Katz, Seymour, Katz, Leo, Kaur, Nirmal, Kazenaite, Edita, Khanna, Reena, Khurana, Sunil, Kim, Joo Sung, Kim, Young-Ho, Kim, Sung Kook, Kim, Dongwoo, Klaus, Jochen, Kleczkowski, Dariusz, Kohout, Pavel, Korczowski, Bartosz, Kouklakis, Georgios, Koutroubakis, Ioannis, Krause, Richard, Kristof, Tunde, Kronborg, Ian, Krummenerl, Annette, Kupcinskas, Limas, Laborda Molteni, Jorge, Laharie, David, Lahat-zok, Adi, Lee, Jonghun, Lee, Kang-Moon, Leong, Rupert, Levine, Henry, Limdi, Jimmy, Lindsay, James, Lodhia, Nilesh, Loftus, Edward, Longman, Randy, Lopez Serrano, Pilar, Louis, Edouard, Louzada Pereira, Maria Helena, Lowe, John, Lueth, Stefan, Lukas, Milan, Maconi, Giovanni, Macrae, Finlay, Madi-Szabo, Laszlo, Mahadevan-Velayos, Uma, Malluta, Everson Fernando, Mana, Fazia, Mannon, Peter, Mantzaris, Gerasimos, Marin Jimenez, Ignacio, Martin Arranz, Maria Dolores, Mateescu, Radu-Bogdan, Mazzoleni, Felipe, Meder, Agnieszka, Melzer, Ehud, Mertens, Jessica, Mimidis, Konstantinos, Mitchell, Brent, Molnar, Tamas, Moore, Gregory, Morales Garza, Luis Alonso, Mountifield, Reme, Muls, Vinciane, Murray, Charles, Nagy, Bela, Neurath, Markus, Nguyen, Augustin, Panaccione, Remo, Pandak, William, Panes Diaz, Julian, Park, Jihye, Pastorelli, Luca, Patel, Bhaktasharan, Peck-Radosavljevic, Markus, Pecsi, Gyula, Peerani, Farhad, Perez Gisbert, Javier, Pesta, Martin, Petryka, Robert, Peyrin-Biroulet, Laurent, Phillips, Raymond, Pierik, Marieke, Pratha, Vijayalakshmi, Prochazka, Vlastimil, Racz, Istvan, Radford-Smith, Graham, Ramos Castañeda, Daniel, Ramos Júnior, Odery, Regula, Jaroslaw, Reimund, Jean-Marie, Robbins, Bryan, Roblin, Xavier, Rogai, Francesca, Rogler, Gerhard, Rozciecha, Jerzy, Rubin, David, Ruiz Flores, Azalia Yuriria, Rupinski, Maciej, Rydzewska, Grazyna, Saha, Sumona, Saibeni, Simone, Salamon, Agnes, Sallo, Zoltan, Salzberg, Bruce, Samuel, Douglas, Samuel, Sunil, Sandborn, William, Savarino, Edoardo Vincenzo, Schirbel, Anja, Schnabel, Robert, Schreiber, Stefan, Scott, John, Sedghi, Shahriar, Seibold, Frank, Seidelin, Jakob, Seidler, Ursula, Shaban, Ahmad, Shafran, Ira, Sheikh, Aasim, Sherman, Alex, Shirin, Haim, Smolinski, Patryk, Song, Geun Am, Soufleris, Konstantinos, Speight, Alexander, Staessen, Dirk, Stallmach, Andreas, Staun, Michael, Stein, Daniel, Steinhart, Hillary, Stifft, Jonathas, Stokesberry, David, Sturm, Andreas, Sultan, Keith, Szekely, Gyorgy, Tagore, Kuldeep, Tanno, Hugo, Thin, Lena, Thiwan, Syed, Thomas, Carlton, Tichy, Michal, Toth, Gabor Tamas, Tulassay, Zsolt, Ulbrych, Jan, Valentine, John, Varga, Marta, Vasconcellos, Eduardo, Vaughn, Byron, Velasco, Brenda, Velazquez, Francisco, Vermeire, Severine, Villa, Erica, Vincze, Aron, Vogelsang, Harald, Volfova, Miroslava, Vuitton, Lucine, Vyhnalek, Petr, Wahab, Peter, Walldorf, Jens, Waterman, Mattitiahu, Weber, John, Weiss, L. Michael, Wiechowska-Kozlowska, Anna, Wiesner, Elise, Witthoeft, Thomas, Wohlman, Robert, Wozniak-Stolarska, Barbara, Yacyshyn, Bruce, Ye, Byong-Duk, Younes, Ziad, Yukie Sassaki, Lígia, Zaltman, Cyrla, Zeuzem, Stefan, Hart, Ailsa, Long, Millie, Loftus, Edward V, Jr, Ostad-Saffari, Elham, Scalori, Astrid, Oh, Young S, Tole, Swati, Chai, Akiko, Pulley, Jennifer, Lacey, Stuart, and Sandborn, William J

Published
2022
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4. Fusobacteriumnucleatum Adheres to Clostridioides difficile via the RadD Adhesin to Enhance Biofilm Formation in Intestinal Mucus

Author

Engevik, Melinda A., Danhof, Heather A., Auchtung, Jennifer, Endres, Bradley T., Ruan, Wenly, Bassères, Eugénie, Engevik, Amy C., Wu, Qinglong, Nicholson, Maribeth, Luna, Ruth Ann, Garey, Kevin W., Crawford, Sue E., Estes, Mary K., Lux, Renate, Yacyshyn, Mary Beth, Yacyshyn, Bruce, Savidge, Tor, Britton, Robert A., and Versalovic, James

Published
2021
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7. Repurposing dried blood spot device technology to examine bile acid profiles in human dried fecal spot samples.

Author

Engevik, Melinda A., Thapa, Santosh, Lillie, Ian M., Yacyshyn, Mary Beth, Yacyshyn, Bruce, Percy, Andrew J., Chace, Donald, and Horvath, Thomas D.

Subjects
BILE acids, RESOURCE-limited settings, DRY ice, FECAL analysis, FECAL microbiota transplantation, MASS spectrometry
Abstract

Dried blood spot (DBS) analysis has existed for >50 years, but application of this technique to fecal analysis remains limited. To address whether dried fecal spots (DFS) could be used to measure fecal bile acids, we collected feces from five subjects for each of the following cohorts: 1) healthy individuals, 2) individuals with diarrhea, and 3) Clostridioides difficile-infected patients. Homogenized fecal extracts were loaded onto quantitative DBS (qDBS) devices, dried overnight, and shipped to the bioanalytical lab at ambient temperature. For comparison, source fecal extracts were shipped on dry ice and stored frozen. After 4 mo, frozen fecal extracts and ambient DFS samples were processed and subjected to targeted liquid chromatographytandem mass spectrometry (LC-MS/MS)-based metabolomics with stable isotope-labeled standards. We observed no differences in the bile acid levels measured between the traditional extraction and the qDBS-based DFS methods. This pilot data demonstrates that DFS-based analysis is feasible and warrants further development for fecal compounds and microbiome applications. NEW & NOTEWORTHY Stool analysis in remote settings can be challenging, as the samples must be stored at (80C and transported on dry ice for downstream processing. Our work indicates that dried fecal spots (DFS) on Capitainer quantitative DBS (qDBS) devices can be stored and shipped at ambient temperature and yields the same bile acid profiles as traditional samples. This approach has broad applications for patient home testing and sample collection in rural communities or resource-limited countries. [ABSTRACT FROM AUTHOR]

Published
2024
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11. Efficacy and safety of ridinilazole compared with vancomycin for the treatment of Clostridium difficile infection: a phase 2, randomised, double-blind, active-controlled, non-inferiority study

Author

Bhan, Amit, Campbell, Wayne, Chopra, Teena, Deck, Kenneth, Golan, Yoav, Gordon, Ian, Kamepalli, Ravi, Khanna, Sahil, Lee, Christine, Lucasti, Christopher, Maliakkal, Benedict, Minang, Irene, Mullane, Kathleen, Nathan, Richard, Oughton, Matthew, Pesant, Yves, Phillips, John, Pullman, John, Riska, Paul, Schrock, Christian, Siegel, Jonathan, Steinberg, Alon, Talan, David, Tamang, Stephen, Tan, Michael, Weiss, Karl, Wang, Chia, Yacyshyn, Bruce, Young, Jo-Anne, Zenilman, Jonathan, Vickers, Richard J, Tillotson, Glenn S, Hazan, Sabine, Tejura, Bina, Roblin, David, Gerding, Dale N, and Wilcox, Mark H

Published
2017
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13. CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease

Author

Ma, Christopher, primary, Hanzel, Jurij, additional, Panaccione, Remo, additional, Sandborn, William J., additional, D’Haens, Geert R., additional, Ahuja, Vineet, additional, Atreya, Raja, additional, Bernstein, Charles N., additional, Bossuyt, Peter, additional, Bressler, Brian, additional, Bryant, Robert V., additional, Cohen, Benjamin, additional, Colombel, Jean-Frederic, additional, Danese, Silvio, additional, Dignass, Axel, additional, Dubinsky, Marla C., additional, Fleshner, Phillip R., additional, Gearry, Richard B., additional, Hanauer, Stephen B., additional, Hart, Ailsa, additional, Kotze, Paulo Gustavo, additional, Kucharzik, Torsten, additional, Lakatos, Peter L., additional, Leong, Rupert W., additional, Magro, Fernando, additional, Panés, Julian, additional, Peyrin-Biroulet, Laurent, additional, Ran, Zhihua, additional, Regueiro, Miguel, additional, Singh, Siddharth, additional, Spinelli, Antonino, additional, Steinhart, A. Hillary, additional, Travis, Simon P., additional, van der Woude, C. Janneke, additional, Yacyshyn, Bruce, additional, Yamamoto, Takayuki, additional, Allez, Matthieu, additional, Bemelman, Willem A., additional, Lightner, Amy L., additional, Louis, Edouard, additional, Rubin, David T., additional, Scherl, Ellen J., additional, Siegel, Corey A., additional, Silverberg, Mark S., additional, Vermeire, Severine, additional, Parker, Claire E., additional, McFarlane, Stefanie C., additional, Guizzetti, Leonardo, additional, Smith, Michelle I., additional, Vande Casteele, Niels, additional, Feagan, Brian G., additional, and Jairath, Vipul, additional

Published
2022
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15. CORE-IBD:A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease

Author

Ma, Christopher, Hanzel, Jurij, Panaccione, Remo, Sandborn, William J., D'Haens, Geert R., Ahuja, Vineet, Atreya, Raja, Bernstein, Charles N., Bossuyt, Peter, Bressler, Brian, Bryant, Robert V., Cohen, Benjamin, Colombel, Jean Frederic, Danese, Silvio, Dignass, Axel, Dubinsky, Marla C., Fleshner, Phillip R., Gearry, Richard B., Hanauer, Stephen B., Hart, Ailsa, Kotze, Paulo Gustavo, Kucharzik, Torsten, Lakatos, Peter L., Leong, Rupert W., Magro, Fernando, Panés, Julian, Peyrin-Biroulet, Laurent, Ran, Zhihua, Regueiro, Miguel, Singh, Siddharth, Spinelli, Antonino, Steinhart, A. Hillary, Travis, Simon P., van der Woude, C. Janneke, Yacyshyn, Bruce, Yamamoto, Takayuki, Allez, Matthieu, Bemelman, Willem A., Lightner, Amy L., Louis, Edouard, Rubin, David T., Scherl, Ellen J., Siegel, Corey A., Silverberg, Mark S., Vermeire, Severine, Parker, Claire E., McFarlane, Stefanie C., Guizzetti, Leonardo, Smith, Michelle I., Vande Casteele, Niels, Ma, Christopher, Hanzel, Jurij, Panaccione, Remo, Sandborn, William J., D'Haens, Geert R., Ahuja, Vineet, Atreya, Raja, Bernstein, Charles N., Bossuyt, Peter, Bressler, Brian, Bryant, Robert V., Cohen, Benjamin, Colombel, Jean Frederic, Danese, Silvio, Dignass, Axel, Dubinsky, Marla C., Fleshner, Phillip R., Gearry, Richard B., Hanauer, Stephen B., Hart, Ailsa, Kotze, Paulo Gustavo, Kucharzik, Torsten, Lakatos, Peter L., Leong, Rupert W., Magro, Fernando, Panés, Julian, Peyrin-Biroulet, Laurent, Ran, Zhihua, Regueiro, Miguel, Singh, Siddharth, Spinelli, Antonino, Steinhart, A. Hillary, Travis, Simon P., van der Woude, C. Janneke, Yacyshyn, Bruce, Yamamoto, Takayuki, Allez, Matthieu, Bemelman, Willem A., Lightner, Amy L., Louis, Edouard, Rubin, David T., Scherl, Ellen J., Siegel, Corey A., Silverberg, Mark S., Vermeire, Severine, Parker, Claire E., McFarlane, Stefanie C., Guizzetti, Leonardo, Smith, Michelle I., and Vande Casteele, Niels

Abstract

Background & Aims: End points to determine the efficacy and safety of medical therapies for Crohn's disease (CD) and ulcerative colitis (UC) are evolving. Given the heterogeneity in current outcome measures, harmonizing end points in a core outcome set for randomized controlled trials is a priority for drug development in inflammatory bowel disease. Methods: Candidate outcome domains and outcome measures were generated from systematic literature reviews and patient engagement surveys and interviews. An iterative Delphi process was conducted to establish consensus: panelists anonymously voted on items using a 9-point Likert scale, and feedback was incorporated between rounds to refine statements. Consensus meetings were held to ratify the outcome domains and core outcome measures. Stakeholders were recruited internationally, and included gastroenterologists, colorectal surgeons, methodologists, and clinical trialists. Results: A total of 235 patients and 53 experts participated. Patient-reported outcomes, quality of life, endoscopy, biomarkers, and safety were considered core domains; histopathology was an additional domain for UC. In CD, there was consensus to use the 2-item patient-reported outcome (ie, abdominal pain and stool frequency), Crohn's Disease Activity Index, Simple Endoscopic Score for Crohn's Disease, C-reactive protein, fecal calprotectin, and co-primary end points of symptomatic remission and endoscopic response. In UC, there was consensus to use the 9-point Mayo Clinic Score, fecal urgency, Robarts Histopathology Index or Geboes Score, fecal calprotectin, and a composite primary end point including both symptomatic and endoscopic remission. Safety outcomes should be reported using the Medical Dictionary for Regulatory Activities. Conclusions: This multidisciplinary collaboration involving patients and clinical experts has produced the first core outcome set that can be applied to randomized controlled trials of CD and UC.

Published
2022

16. Etrolizumab as induction and maintenance therapy for ulcerative colitis in patients previously treated with tumour necrosis factor inhibitors (HICKORY): a phase 3, randomised, controlled trial

Author

Peyrin-Biroulet, Laurent, primary, Hart, Ailsa, additional, Bossuyt, Peter, additional, Long, Millie, additional, Allez, Matthieu, additional, Juillerat, Pascal, additional, Armuzzi, Alessandro, additional, Loftus, Edward V, additional, Ostad-Saffari, Elham, additional, Scalori, Astrid, additional, Oh, Young S, additional, Tole, Swati, additional, Chai, Akiko, additional, Pulley, Jennifer, additional, Lacey, Stuart, additional, Sandborn, William J, additional, Aguilar, Humberto, additional, Ahmad, Tariq, additional, Akriviadis, Evangelos, additional, Aldeguer Mante, Xavier, additional, Altorjay, Istvan, additional, Ananthakrishnan, Ashwin, additional, Andersen, Vibeke, additional, Andreu Garcia, Montserrat, additional, Aumais, Guy, additional, Avni-Biron, Irit, additional, Axler, Jeffrey, additional, Ayub, Kamran, additional, Baert, Filip, additional, Bafutto, Mauro, additional, Bamias, George, additional, Bassan, Isaac, additional, Baum, Curtis, additional, Beaugerie, Laurent, additional, Behm, Brian, additional, Bekal, Pradeep, additional, Bennett, Michael, additional, Bermejo San Jose, Fernando, additional, Bernstein, Charles, additional, Bettenworth, Dominik, additional, Bhaskar, Sudhir, additional, Biancone, Livia, additional, Bilir, Bahri, additional, Blaeker, Michael, additional, Bloom, Stuart, additional, Bohman, Verle, additional, Bosques Padilla, Francisco Javier, additional, Bouhnik, Yoram, additional, Bouma, Gerd, additional, Bourdages, Raymond, additional, Brand, Stephan, additional, Bressler, Brian, additional, Brückner, Markus, additional, Buening, Carsten, additional, Carbonnel, Franck, additional, Caves, Thomas, additional, Chapman, Jonathon, additional, Cheon, Jae Hee, additional, Chiba, Naoki, additional, Chioncel, Camelia, additional, Christodoulou, Dimitrios, additional, Clodi, Martin, additional, Cohen, Albert, additional, Corazza, Gino Roberto, additional, Corlin, Richard, additional, Cosintino, Rocco, additional, Cummings, Fraser, additional, Dalal, Robin, additional, Danese, Silvio, additional, De Maeyer, Marc, additional, De Magalhães Francesconi, Carlos Fernando, additional, De Silva, Aminda, additional, Debinski, Henry, additional, Desreumaux, Pierre, additional, Dewit, Olivier, additional, D'Haens, Geert, additional, Di Felice Boratto, Sandra, additional, Ding, John Nik, additional, Dixon, Tyler, additional, Dryden, Gerald, additional, Du Vall, George Aaron, additional, Ebert, Matthias, additional, Echarri Piudo, Ana, additional, Ehehalt, Robert, additional, Elkhashab, Magdy, additional, Ennis, Craig, additional, Etzel, Jason, additional, Fallingborg, Jan, additional, Feagan, Brian, additional, Fejes, Roland, additional, Ferraz de Campos Mazo, Daniel, additional, Ferreira de Almeida Borges, Valéria, additional, Fischer, Andreas, additional, Fixelle, Alan, additional, Fleisher, Mark, additional, Fowler, Sharyle, additional, Freilich, Bradley, additional, Friedenberg, Keith, additional, Fries, Walter, additional, Fulop, Csaba, additional, Fumery, Mathurin, additional, Fuster, Sergio, additional, G Kiss, Gyula, additional, Garcia Lopez, Santiago, additional, Gassner, Sonja, additional, Gill, Kanwar, additional, Gilletta de Saint Joseph, Cyrielle, additional, Ginsburg, Philip, additional, Gionchetti, Paolo, additional, Goldin, Eran, additional, Goldis, Adrian-Eugen, additional, Gomez Jaramillo, Hector Alejandro, additional, Gonciarz, Maciej, additional, Gordon, Glenn, additional, Green, Daniel, additional, Grimaud, Jean-Charles, additional, Guajardo Rodriguez, Rogelio, additional, Gurzo, Zoltan, additional, Gutierrez, Alexandra, additional, Gyökeres, Tibor, additional, Hahm, Ki Baik, additional, Hanauer, Stephen, additional, Hanson, John, additional, Harlan III, William, additional, Hasselblatt, Peter, additional, Hayee, Buhussain, additional, Hebuterne, Xavier, additional, Hendy, Peter, additional, Heyman, Melvin, additional, Higgins, Peter, additional, Hilal, Raouf, additional, Hindryckx, Pieter, additional, Hoentjen, Frank, additional, Hoffmann, Peter, additional, Holtkamp-Endemann, Frank, additional, Holtmann, Gerald, additional, Horvat, Gyula, additional, Howaldt, Stefanie, additional, Huber, Samuel, additional, Ibegbu, Ikechukwu, additional, Iborra Colomino, Maria Isabel, additional, Irving, Peter, additional, Isaacs, Kim, additional, Jagarlamudi, Kiran, additional, Jain, Rajesh, additional, Jankiel Miszputen, Sender, additional, Jansen, Jeroen, additional, Jones, Jennifer, additional, Karagiannis, John, additional, Karyotakis, Nicholas, additional, Kaser, Arthur, additional, Katz, Lior, additional, Katz, Seymour, additional, Katz, Leo, additional, Kaur, Nirmal, additional, Kazenaite, Edita, additional, Khanna, Reena, additional, Khurana, Sunil, additional, Kim, Joo Sung, additional, Kim, Young-Ho, additional, Kim, Sung Kook, additional, Kim, Dongwoo, additional, Klaus, Jochen, additional, Kleczkowski, Dariusz, additional, Kohout, Pavel, additional, Korczowski, Bartosz, additional, Kouklakis, Georgios, additional, Koutroubakis, Ioannis, additional, Krause, Richard, additional, Kristof, Tunde, additional, Kronborg, Ian, additional, Krummenerl, Annette, additional, Kupcinskas, Limas, additional, Laborda Molteni, Jorge, additional, Laharie, David, additional, Lahat-zok, Adi, additional, Lee, Jonghun, additional, Lee, Kang-Moon, additional, Leong, Rupert, additional, Levine, Henry, additional, Limdi, Jimmy, additional, Lindsay, James, additional, Lodhia, Nilesh, additional, Loftus, Edward, additional, Longman, Randy, additional, Lopez Serrano, Pilar, additional, Louis, Edouard, additional, Louzada Pereira, Maria Helena, additional, Lowe, John, additional, Lueth, Stefan, additional, Lukas, Milan, additional, Maconi, Giovanni, additional, Macrae, Finlay, additional, Madi-Szabo, Laszlo, additional, Mahadevan-Velayos, Uma, additional, Malluta, Everson Fernando, additional, Mana, Fazia, additional, Mannon, Peter, additional, Mantzaris, Gerasimos, additional, Marin Jimenez, Ignacio, additional, Martin Arranz, Maria Dolores, additional, Mateescu, Radu-Bogdan, additional, Mazzoleni, Felipe, additional, Meder, Agnieszka, additional, Melzer, Ehud, additional, Mertens, Jessica, additional, Mimidis, Konstantinos, additional, Mitchell, Brent, additional, Molnar, Tamas, additional, Moore, Gregory, additional, Morales Garza, Luis Alonso, additional, Mountifield, Reme, additional, Muls, Vinciane, additional, Murray, Charles, additional, Nagy, Bela, additional, Neurath, Markus, additional, Nguyen, Augustin, additional, Panaccione, Remo, additional, Pandak, William, additional, Panes Diaz, Julian, additional, Park, Jihye, additional, Pastorelli, Luca, additional, Patel, Bhaktasharan, additional, Peck-Radosavljevic, Markus, additional, Pecsi, Gyula, additional, Peerani, Farhad, additional, Perez Gisbert, Javier, additional, Pesta, Martin, additional, Petryka, Robert, additional, Peyrin-Biroulet, Laurent, additional, Phillips, Raymond, additional, Pierik, Marieke, additional, Pratha, Vijayalakshmi, additional, Prochazka, Vlastimil, additional, Racz, Istvan, additional, Radford-Smith, Graham, additional, Ramos Castañeda, Daniel, additional, Ramos Júnior, Odery, additional, Regula, Jaroslaw, additional, Reimund, Jean-Marie, additional, Robbins, Bryan, additional, Roblin, Xavier, additional, Rogai, Francesca, additional, Rogler, Gerhard, additional, Rozciecha, Jerzy, additional, Rubin, David, additional, Ruiz Flores, Azalia Yuriria, additional, Rupinski, Maciej, additional, Rydzewska, Grazyna, additional, Saha, Sumona, additional, Saibeni, Simone, additional, Salamon, Agnes, additional, Sallo, Zoltan, additional, Salzberg, Bruce, additional, Samuel, Douglas, additional, Samuel, Sunil, additional, Sandborn, William, additional, Savarino, Edoardo Vincenzo, additional, Schirbel, Anja, additional, Schnabel, Robert, additional, Schreiber, Stefan, additional, Scott, John, additional, Sedghi, Shahriar, additional, Seibold, Frank, additional, Seidelin, Jakob, additional, Seidler, Ursula, additional, Shaban, Ahmad, additional, Shafran, Ira, additional, Sheikh, Aasim, additional, Sherman, Alex, additional, Shirin, Haim, additional, Smolinski, Patryk, additional, Song, Geun Am, additional, Soufleris, Konstantinos, additional, Speight, Alexander, additional, Staessen, Dirk, additional, Stallmach, Andreas, additional, Staun, Michael, additional, Stein, Daniel, additional, Steinhart, Hillary, additional, Stifft, Jonathas, additional, Stokesberry, David, additional, Sturm, Andreas, additional, Sultan, Keith, additional, Szekely, Gyorgy, additional, Tagore, Kuldeep, additional, Tanno, Hugo, additional, Thin, Lena, additional, Thiwan, Syed, additional, Thomas, Carlton, additional, Tichy, Michal, additional, Toth, Gabor Tamas, additional, Tulassay, Zsolt, additional, Ulbrych, Jan, additional, Valentine, John, additional, Varga, Marta, additional, Vasconcellos, Eduardo, additional, Vaughn, Byron, additional, Velasco, Brenda, additional, Velazquez, Francisco, additional, Vermeire, Severine, additional, Villa, Erica, additional, Vincze, Aron, additional, Vogelsang, Harald, additional, Volfova, Miroslava, additional, Vuitton, Lucine, additional, Vyhnalek, Petr, additional, Wahab, Peter, additional, Walldorf, Jens, additional, Waterman, Mattitiahu, additional, Weber, John, additional, Weiss, L. Michael, additional, Wiechowska-Kozlowska, Anna, additional, Wiesner, Elise, additional, Witthoeft, Thomas, additional, Wohlman, Robert, additional, Wozniak-Stolarska, Barbara, additional, Yacyshyn, Bruce, additional, Ye, Byong-Duk, additional, Younes, Ziad, additional, Yukie Sassaki, Lígia, additional, Zaltman, Cyrla, additional, and Zeuzem, Stefan, additional

Published
2022
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18. Etrolizumab versus adalimumab or placebo as induction therapy for moderately to severely active ulcerative colitis (HIBISCUS): two phase 3 randomised, controlled trials

Author

David T Rubin, Iris Dotan, Aaron DuVall, Yoram Bouhnik, Graham Radford-Smith, Peter D R Higgins, Daniel S Mishkin, Pablo Arrisi, Astrid Scalori, Young S Oh, Swati Tole, Akiko Chai, Kirsten Chamberlain-James, Stuart Lacey, Jacqueline McBride, Julian Panés, Abdulkhakov Rustem, Abu Bakar Norasiah, Aguilar Humberto, Aizenberg Diego, Akpinar Hale, Akriviadis Evangelos, Alexeeva Olga, Alikhanov Bagdadi, Alvarisqueta Andres, Ananthakrishnan Ashwin, Andrews Jane, Arlukowicz Tomasz, Atkinson Nathan, Atug Ozlen, Bafutto Mauro, Balaz Jozef, Bamias George, Banic Marko, Baranovsky Andrey, Barbalaco Neto Guerino, Basaranoglu Metin, Baum Curtis, Baydanov Stefan, Bennetts William, Besisik Fatih, Bhaskar Sudhir, Bielasik Andrzej, Bilianskyi Leonid, Bilir Bahri, Blaha Pavol, Bohman Verle, Borissova Julia, Borzan Vladimir, Bosques-Padilla Francisco, Bouhnik Yoram, Brooker James, Budko Tetiana, Budzak Igor, Bunganic Ivan, Chapman Jonathon, Che' Aun Azlida, Chernykh Tatiana, Chiorean Michael, Chopey Ivan, Christodoulou Dimitrios, Chu Pui Shan, Chumakova Galina, Cummins Andrew, Cunliffe Robert, Cvetkovic Mirjana, Dagli Ulku, Danilkiewicz Wit Cezary, Datsenko Olena, de Magalhães Francesconi Carlos Fernando, Debinski Henry, Deminova Elena, Derova Jelena, Ding John Nik, Dmitrieva Julia, Dolgikh Oleg, Douda Tomas, Drobinski Piotr, Dryden Gerald, Duarte Gaburri Pedro, DuVall George Aaron, Dvorkin Mikhail, Ennis Craig, Erzin Yusuf, Fadieienko Galyna, Fediv Oleksandr, Fedorishina Olga, Fedurco Miroslav, Fejes Roland, Fernandez Jorge, Fernandez Monica Lorena, Flores Lucky, Freilich Bradley, Friedenberg Keith, Fuster Sergio, Gawdis-Wojnarska Beata, Gil Parada Fabio Leonel, Gimenez Edgardo Daniel, Golovchenko Nataliia, Golovchenko Oleksandr, Gonciarz Maciej, Gonen Can, Gordon Glenn, Gregus Milos, Grinevich Vladimir, Guajardo Rodriguez Rogelio, Hall Stephen, Hanson John, Hartleb Marek, Hebuterne Xavier, Hendy Peter, Herring Robert, Hetzel David, Higgins Peter, Hilal Raouf, Hilmi Ida Normiha, Hlavaty Tibor, Holman Richard, Holtmann Gerald, Hong John, Horvath Frantisek, Hospodarskyy Ihor, Hrstic Irena, Hulagu Sadettin, Ibarra Verdugo Luis Alberto, Ibegbu Ikechukwu, Inns Stephen, Ivashkin Vladimir, Izanec James, Jain Rajesh, Jamrozik-Kruk Zofia, Kamburov Victor, Karagiannis John, Karakan Tarkan, Karczewski Marek, Kasherininova Irina, Katz Seymour, Kaufman Barry, Kazenaite Edita, Kholina Irina, Khurana Sunil, Kierkus Jaroslaw, Kiselevska Anzela, Kleczkowski Dariusz, Klymenko Volodymyr, Knezevic Slavko, Kondusz-Szklarz Malgorzata, Korablina Natalya, Korczowski Bartosz, Kosturkov Lyubomir, Kotzev Iskren, Kouklakis Georgios, Koutroubakis Ioannis, Krause Richard, Kronborg Ian, Krstic Miodrag, Krznaric Zeljko, Krzyzanowski Mikolaj, Kulig Grazyna, Kull Karin, Kupcinskas Limas, Lamet Mark, Latinovic Radakovic Tatjana, Leong Rupert, Leung Wai Keung, Levine Henry, Li Michael Kin Kong, Libanez Bessa Campelo Braga Lúcia, Livzan Maria, Lohdanidi Tetiana, Louzada Pereira Maria Helena, Lowe John, Luetic Kresimir, Lukas Milan, Lymar Yurii, Macrae Finlay, Mäelt Anu, Maev Igor, Mamos Arkadiusz, Mantzaris Gerasimos, Margus Benno, Marinova Ivanka, Markevych Inna, Markov Mario, Markovic Srdjan, Marquez Velasquez Juan Ricardo, Mazzoleni Felipe, Mimidis Konstantinos, Mitchell Brent, Moore Gregory, Morales Garza Luis Alonso, Moscatello Salvatore, Mostovoy Yuriy, Mountifield Reme, Nagorni Aleksandar, Neshta Viacheslav, Obrezan Andrey, Oliinyk Oleksandr, Oliveira Santana Silva Genoile, Orzeszko Maria, Pavlenko Vladimir, Pavlov Dimitar, Penkova Mariana, Peric Sasa, Petkov Plamen, Petrov Asen, Petrov Plamen, Petrova Michaela, Phillips Raymond, Pintor Chacon Sergio, Polianskyi Igor, Prystupa Ludmyla, Pugach Mykhailo, Pugas Carvalho Ana Teresa, Pukitis Aldis, Pumprla Jiri, Pyrogovskyy Volodymyr, Racz Istvan, Radford-Smith Graham, Raja Ali Raja Affendi, Ramos Castañeda Daniel, Ramos Júnior Odery, Rausher David, Rebrov Andrey, Regula Jaroslaw, Rezk Amir, Reznikova Viktoriia, Rishko Iaroslava, Roblin Xavier, Rodoman Grigory, Rojas Rodriguez Carlos Arturo, Rozciecha Jerzy, Rubin David, Rupinski Maciej, Rzucidlo Jacek, Sablin Oleg, Sahin Halil, Salleh Rosemi, Samuel Douglas, Scafuto Scotton Antonio, Schnabel Robert, Schulman Michael, Schultz Michael, Scott John, Sedghi Shahriar, Shaban Ahmad, Shapina Marina, Shaposhnikova Natalia, Shchukina Oksana, Sherman Alex, Shumikhina Irina, Simanenkov Vladimir, Simonov Vladislav, Simulionis Giedrius, Skrypnyk Igor, Sliwowski Zbigniew, Smid Jan, Solaiman Mahmood, Soofi Najm, Soufleris Konstantinos, Spassova Zoia, Stanislavchuk Mykola, Stec-Michalska Krystyna, Stifft Jonathas, Stoinov Simeon, Stoyanova Girgina, Sultan Keith, Surace Lindsey, Takov Dimitar, Tälli Jaak, Tankova Ludmila, Tanno Hugo, Tarabar Dino, Tarakji Elias, Tchernev Konstantin, Tee Hoi Poh, Thin Lena, Thomas Carlton, Tishaeva Irina, Todorova Tsveta, Tokarenko Oleksandr, Tolmanis Ivars, Tomasevic Ratko, Trofimov Vasiliy, Tulassay Zsolt, Unsal Belkis, Uzunova-Genova Alma, Valentine John, Valuyskikh Ekaterina, Vasconcellos Eduardo, Vasileva Galina, Vasylyuk Sergiy, Vaughn Byron, Velazquez Francisco, Vizir Vadym, Vladimirov Borislav, Volfova Miroslava, Vyhnalek Petr, Wallace Ian, Waluga Marek, Watkins William, Weber John, Wiechowska-Kozlowska Anna, Winstead Nathaniel, Wojtkiewicz Pawel, Wozniak-Stolarska Barbara, Yacyshyn Bruce, Yakovlev Alexey, Younes Ziad, Yukie Sassaki Lígia, Yuksel Ilhami, Zachar Jan, Zaltman Cyrla, Zdravkovic Petrovic Natasa, Zhdan Vyacheslav, Zinchenko Maryna, and Zymla Maciej

Subjects
Ulcerative Colitis Flare, Adult, Male, medicine.medical_specialty, Adolescent, Population, Placebo, Antibodies, Monoclonal, Humanized, Gastroenterology, Severity of Illness Index, Placebos, Young Adult, Double-Blind Method, Gastrointestinal Agents, Internal medicine, Adalimumab, Medicine, Humans, Adverse effect, education, Aged, education.field_of_study, Hepatology, business.industry, Remission Induction, Colonoscopy, Induction Chemotherapy, Middle Aged, medicine.disease, Symptom Flare Up, Ulcerative colitis, Concomitant, Etrolizumab, Colitis, Ulcerative, Female, business, medicine.drug
Abstract

Summary Background Etrolizumab is a gut-targeted anti-β7 integrin monoclonal antibody. In an earlier phase 2 induction study, etrolizumab significantly improved clinical remission relative to placebo in patients with moderately to severely active ulcerative colitis. The HIBISCUS studies aimed to compare the efficacy and safety of etrolizumab to adalimumab and placebo for induction of remission in patients with moderately to severely active ulcerative colitis. Methods HIBISCUS I and HIBISCUS II were identically designed, multicentre, phase 3, randomised, double-blind, placebo-controlled and active-controlled studies of etrolizumab, adalimumab, and placebo in adult (18–80 years) patients with moderately to severely active ulcerative colitis (Mayo Clinic total score [MCS] of 6–12 with an endoscopic subscore of ≥2, a rectal bleeding subscore of ≥1, and a stool frequency subscore of ≥1) who were naive to tumour necrosis factor inhibitors. All patients had an established diagnosis of ulcerative colitis for at least 3 months, corroborated by both clinical and endoscopic evidence, and evidence of disease extending at least 20 cm from the anal verge. In both studies, patients were randomly assigned (2:2:1) to receive subcutaneous etrolizumab 105 mg once every 4 weeks; subcutaneous adalimumab 160 mg on day 1, 80 mg at week 2, and 40 mg at weeks 4, 6, and 8; or placebo. Randomisation was stratified by baseline concomitant treatment with corticosteroids, concomitant treatment with immunosuppressants, and baseline disease activity. All patients and study site personnel were masked to treatment assignment. The primary endpoint was induction of remission at week 10 (defined as MCS of 2 or lower, with individual subscores of 1 or lower, and rectal bleeding subscore of 0) with etrolizumab compared with placebo. Pooled analyses of both studies comparing etrolizumab and adalimumab were examined for several clinical and endoscopic endpoints. Efficacy was analysed using a modified intent-to-treat population, defined as all randomly assigned patients who received at least one dose of study drug. These trials are registered with ClinicalTrials.gov , NCT02163759 (HIBISCUS I), NCT02171429 (HIBISCUS II). Findings Between Nov 4, 2014, and May 25, 2020, each study screened 652 patients (HIBISCUS I) and 613 patients (HIBISCUS II). Each study enrolled and randomly assigned 358 patients (HIBISCUS I etrolizumab n=144, adalimumab n=142, placebo n=72; HIBISCUS II etrolizumab n=143; adalimumab n=143; placebo n=72). In HIBISCUS I, 28 (19·4%) of 144 patients in the etrolizumab group and five (6·9%) of 72 patients in the placebo group were in remission at week 10, with an adjusted treatment difference of 12·3% (95% CI 1·6 to 20·6; p=0·017) in favour of etrolizumab. In HIBISCUS II, 26 (18·2%) of 143 patients in the etrolizumab group and eight (11·1%) of 72 patients in the placebo group were in remission at week 10, with an adjusted treatment difference of 7·2% (95% CI –3·8 to 16·1; p=0·17). In the pooled analysis, etrolizumab was not superior to adalimumab for induction of remission, endoscopic improvement, clinical response, histological remission, or endoscopic remission; however, similar numerical results were observed in both groups. In HIBISCUS I, 50 (35%) of 144 patients in the etrolizumab group reported any adverse event, compared with 61 (43%) of 142 in the adalimumab group and 26 (36%) of 72 in the placebo group. In HIBISCUS II, 63 (44%) of 143 patients in the etrolizumab group reported any adverse event, as did 62 (43%) of 143 in the adalimumab group and 33 (46%) in the placebo group. The most common adverse event in all groups was ulcerative colitis flare. The incidence of serious adverse events in the pooled patient population was similar for etrolizumab (15 [5%] of 287) and placebo (seven [5%] of 144) and lower for adalimumab (six [2%] of 285). Two patients in the etrolizumab group died; neither death was deemed to be treatment related. Interpretation Etrolizumab was superior to placebo for induction of remission in HIBISCUS I, but not in HIBISCUS II. Etrolizumab was well tolerated in both studies. Funding F Hoffmann-La Roche.

Published
2021

20. A Randomized Trial Comparing the Specific Carbohydrate Diet to a Mediterranean Diet in Adults With Crohn’s Disease

Author

Lewis, James D., primary, Sandler, Robert S., additional, Brotherton, Carol, additional, Brensinger, Colleen, additional, Li, Hongzhe, additional, Kappelman, Michael D., additional, Daniel, Scott G., additional, Bittinger, Kyle, additional, Albenberg, Lindsey, additional, Valentine, John F., additional, Hanson, John S., additional, Suskind, David L., additional, Meyer, Andrea, additional, Compher, Charlene W., additional, Bewtra, Meenakshi, additional, Saxena, Akriti, additional, Dobes, Angela, additional, Cohen, Benjamin L., additional, Flynn, Ann D., additional, Fischer, Monika, additional, Saha, Sumona, additional, Swaminath, Arun, additional, Yacyshyn, Bruce, additional, Scherl, Ellen, additional, Horst, Sara, additional, Curtis, Jeffrey R., additional, Braly, Kimberly, additional, Nessel, Lisa, additional, McCauley, Maureen, additional, McKeever, Liam, additional, and Herfarth, Hans, additional

Published
2021
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22. Fusobacteriumnucleatum Adheres to Clostridioides difficile via the RadD Adhesin to Enhance Biofilm Formation in Intestinal Mucus

Author

Engevik, Melinda A, Danhof, Heather A, Auchtung, Jennifer, Endres, Bradley T, Ruan, Wenly, Bassères, Eugénie, Engevik, Amy C, Wu, Qinglong, Nicholson, Maribeth, Luna, Ruth Ann, Garey, Kevin W, Crawford, Sue E, Estes, Mary K, Lux, Renate, Yacyshyn, Mary Beth, Yacyshyn, Bruce, Savidge, Tor, Britton, Robert A, and Versalovic, James

Subjects
Clinical Sciences, Bacterial Adhesion, Oral and gastrointestinal, Paediatrics and Reproductive Medicine, Feces, Bioreactors, Humans, Intestinal Mucosa, Mucin-2, Fusobacterium nucleatum, Gastroenterology & Hepatology, Clostridioides difficile, Biofilm, Bacterial, Neurosciences, Adhesins, Gastrointestinal Microbiome, Mucus, Emerging Infectious Diseases, Infectious Diseases, Good Health and Well Being, Flagella, Biofilms, MUC2, Clostridium Infections, Digestive Diseases, Infection, HT29 Cells
Abstract

Background & aimsAlthough Clostridioides difficile infection (CDI) is known to involve the disruption of the gut microbiota, little is understood regarding how mucus-associated microbes interact with C difficile. We hypothesized that select mucus-associated bacteria would promote C difficile colonization and biofilm formation.MethodsTo create a model of the human intestinal mucus layer and gut microbiota, we used bioreactors inoculated with healthy human feces, treated with clindamycin and infected with C difficile with the addition of human MUC2-coated coverslips.ResultsC difficile was found to colonize and form biofilms on MUC2-coated coverslips, and 16S rRNA sequencing showed a unique biofilm profile with substantial cocolonization with Fusobacterium species. Consistent with our bioreactor data, publicly available data sets and patient stool samples showed that a subset of patients with C difficile infection harbored high levels of Fusobacterium species. We observed colocalization of C difficile and F nucleatum in an aggregation assay using adult patients and stool of pediatric patients with inflammatory bowel disease and in tissue sections of patients with CDI. C difficile strains were found to coaggregate with F nucleatum subspecies invitro; an effect that was inhibited by blocking or mutating the adhesin RadD on Fusobacterium and removal of flagella on C difficile. Aggregation was shown to be unique between F nucleatum and C difficile, because other gut commensals did not aggregate with C difficile. Addition of F nucleatum also enhanced C difficile biofilm formation and extracellular polysaccharide production.ConclusionsCollectively, these data show a unique interaction of between pathogenic C difficile and F nucleatum in the intestinal mucus layer.

Published
2021

25. Transition to Adult IBD Care: A Pilot Multi-Site, Telehealth Hybrid Intervention

Author

Gray, Wendy N, primary, Wagoner, Scott T, additional, Schaefer, Megan R, additional, Reed, Bonney, additional, Morgan, Pamela, additional, Holbrook, Erin, additional, Yacyshyn, Bruce, additional, Mackner, Laura, additional, Young, Margaret, additional, Maddux, Michele, additional, Saeed, Shehzad A, additional, Denson, Lee A, additional, and Hommel, Kevin, additional

Published
2020
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27. Developing an instrument to assess the endoscopic severity of ulcerative colitis: the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)

Author

Travis, Simon P L, Schnell, Dan, Krzeski, Piotr, Abreu, Maria T, Altman, Douglas G, Colombel, Jean-Frédéric, Feagan, Brian G, Hanauer, Stephen B, Lémann, Marc, Lichtenstein, Gary R, Marteau, Phillippe R, Reinisch, Walter, Sands, Bruce E, Yacyshyn, Bruce R, Bernhardt, Christian A, Mary, Jean-Yves, and Sandborn, William J

Published
2012
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29. Safety, Pharmacokinetics, and Efficacy of Olorinab, a Peripherally Acting, Highly Selective, Full Agonist of the Cannabinoid Receptor 2, in a Phase 2a Study of Patients With Chronic Abdominal Pain Associated With Crohn’s Disease

Author

Yacyshyn, Bruce R, primary, Hanauer, Stephen, additional, Klassen, Preston, additional, English, Brett A, additional, Stauber, Kathe, additional, Barish, Charles F, additional, Gilder, Kye, additional, Turner, Stewart, additional, and Higgins, Peter D R, additional

Published
2020
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34. Efficacy and Safety of Etrasimod in a Phase 2 Randomized Trial of Patients With Ulcerative Colitis

Author

Sandborn, William J., primary, Peyrin-Biroulet, Laurent, additional, Zhang, Jinkun, additional, Chiorean, Michael, additional, Vermeire, Séverine, additional, Lee, Scott D., additional, Kühbacher, Tanja, additional, Yacyshyn, Bruce, additional, Cabell, Christopher H., additional, Naik, Snehal U., additional, Klassen, Preston, additional, and Panés, Julián, additional

Published
2020
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41. Su1930 – Safety and Efficacy of Olorinab, a Peripherally Restricted, Highly Selective, Cannabinoid Receptor 2 Agonist in a Phase 2A Study in Chronic Abdominal Pain Associated with Crohn’s Disease

Author

Yacyshyn, Bruce, primary, Ginsberg, Daniel C., additional, Gilder, Kye, additional, Walsh, Brandon, additional, English, Brett, additional, Turner, Stewart A., additional, Klassen, Preston, additional, Hanauer, Stephen B., additional, Barish, Charles F., additional, and Higgins, Peter D., additional

Published
2019
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44. Etrolizumab versus adalimumab or placebo as induction therapy for moderately to severely active ulcerative colitis (HIBISCUS): two phase 3 randomised, controlled trials

Author

Rubin, David T, Dotan, Iris, DuVall, Aaron, Bouhnik, Yoram, Radford-Smith, Graham, Higgins, Peter D R, Mishkin, Daniel S, Arrisi, Pablo, Scalori, Astrid, Oh, Young S, Tole, Swati, Chai, Akiko, Chamberlain-James, Kirsten, Lacey, Stuart, McBride, Jacqueline, Panés, Julian, Abdulkhakov, Rustem, Abu Bakar, Norasiah, Aguilar, Humberto, Aizenberg, Diego, Akpinar, Hale, Akriviadis, Evangelos, Alexeeva, Olga, Alikhanov, Bagdadi, Alvarisqueta, Andres, Ananthakrishnan, Ashwin, Andrews, Jane, Arlukowicz, Tomasz, Atkinson, Nathan, Atug, Ozlen, Bafutto, Mauro, Balaz, Jozef, Bamias, George, Banic, Marko, Baranovsky, Andrey, Barbalaco Neto, Guerino, Basaranoglu, Metin, Baum, Curtis, Baydanov, Stefan, Bennetts, William, Besisik, Fatih, Bhaskar, Sudhir, Bielasik, Andrzej, Bilianskyi, Leonid, Bilir, Bahri, Blaha, Pavol, Bohman, Verle, Borissova, Julia, Borzan, Vladimir, Bosques-Padilla, Francisco, Bouhnik, Yoram, Brooker, James, Budko, Tetiana, Budzak, Igor, Bunganic, Ivan, Chapman, Jonathon, Che' Aun, Azlida, Chernykh, Tatiana, Chiorean, Michael, Chopey, Ivan, Christodoulou, Dimitrios, Chu, Pui Shan, Chumakova, Galina, Cummins, Andrew, Cunliffe, Robert, Cvetkovic, Mirjana, Dagli, Ulku, Danilkiewicz, Wit Cezary, Datsenko, Olena, de Magalhães Francesconi, Carlos Fernando, Debinski, Henry, Deminova, Elena, Derova, Jelena, Ding, John Nik, Dmitrieva, Julia, Dolgikh, Oleg, Douda, Tomas, Drobinski, Piotr, Dryden, Gerald, Duarte Gaburri, Pedro, DuVall, George Aaron, Dvorkin, Mikhail, Ennis, Craig, Erzin, Yusuf, Fadieienko, Galyna, Fediv, Oleksandr, Fedorishina, Olga, Fedurco, Miroslav, Fejes, Roland, Fernandez, Jorge, Fernandez, Monica Lorena, Flores, Lucky, Freilich, Bradley, Friedenberg, Keith, Fuster, Sergio, Gawdis-Wojnarska, Beata, Gil Parada, Fabio Leonel, Gimenez, Edgardo Daniel, Golovchenko, Nataliia, Golovchenko, Oleksandr, Gonciarz, Maciej, Gordon, Glenn, Gregus, Milos, Grinevich, Vladimir, Guajardo Rodriguez, Rogelio, Hall, Stephen, Hanson, John, Hartleb, Marek, Hebuterne, Xavier, Hendy, Peter, Herring, Robert, Higgins, Peter, Hilal, Raouf, Hilmi, Ida Normiha, Hlavaty, Tibor, Holman, Richard, Holtmann, Gerald, Hong, John, Horvath, Frantisek, Hospodarskyy, Ihor, Hrstic, Irena, Hulagu, Sadettin, Ibarra Verdugo, Luis Alberto, Ibegbu, Ikechukwu, Inns, Stephen, Ivashkin, Vladimir, Izanec, James, Jain, Rajesh, Jamrozik-Kruk, Zofia, Kamburov, Victor, Karagiannis, John, Karakan, Tarkan, Karczewski, Marek, Kasherininova, Irina, Katz, Seymour, Kaufman, Barry, Kazenaite, Edita, Kholina, Irina, Khurana, Sunil, Kiselevska, Anzela, Kleczkowski, Dariusz, Klymenko, Volodymyr, Knezevic, Slavko, Kondusz-Szklarz, Malgorzata, Korablina, Natalya, Korczowski, Bartosz, Kosturkov, Lyubomir, Kotzev, Iskren, Kouklakis, Georgios, Koutroubakis, Ioannis, Krause, Richard, Kronborg, Ian, Krstic, Miodrag, Krznaric, Zeljko, Krzyzanowski, Mikolaj, Kulig, Grazyna, Kull, Karin, Kupcinskas, Limas, Lamet, Mark, Latinovic Radakovic, Tatjana, Leong, Rupert, Leung, Wai Keung, Levine, Henry, Li, Michael Kin Kong, Libanez Bessa Campelo Braga, Lúcia, Livzan, Maria, Lohdanidi, Tetiana, Louzada Pereira, Maria Helena, Lowe, John, Luetic, Kresimir, Lukas, Milan, Lymar, Yurii, Macrae, Finlay, Mäelt, Anu, Maev, Igor, Mamos, Arkadiusz, Mantzaris, Gerasimos, Margus, Benno, Marinova, Ivanka, Markevych, Inna, Markov, Mario, Markovic, Srdjan, Marquez Velasquez, Juan Ricardo, Mazzoleni, Felipe, Mimidis, Konstantinos, Mitchell, Brent, Moore, Gregory, Morales Garza, Luis Alonso, Moscatello, Salvatore, Mostovoy, Yuriy, Mountifield, Reme, Nagorni, Aleksandar, Neshta, Viacheslav, Obrezan, Andrey, Oliinyk, Oleksandr, Oliveira Santana Silva, Genoile, Orzeszko, Maria, Pavlenko, Vladimir, Pavlov, Dimitar, Penkova, Mariana, Peric, Sasa, Petkov, Plamen, Petrov, Asen, Petrov, Plamen, Petrova, Michaela, Phillips, Raymond, Pintor Chacon, Sergio, Polianskyi, Igor, Prystupa, Ludmyla, Pugach, Mykhailo, Pukitis, Aldis, Pumprla, Jiri, Pyrogovskyy, Volodymyr, Racz, Istvan, Radford-Smith, Graham, Raja Ali, Raja Affendi, Ramos Castañeda, Daniel, Ramos Júnior, Odery, Rausher, David, Rebrov, Andrey, Regula, Jaroslaw, Rezk, Amir, Reznikova, Viktoriia, Rishko, Iaroslava, Roblin, Xavier, Rodoman, Grigory, Rojas Rodriguez, Carlos Arturo, Rozciecha, Jerzy, Rubin, David, Rupinski, Maciej, Rzucidlo, Jacek, Sablin, Oleg, Sahin, Halil, Samuel, Douglas, Scafuto Scotton, Antonio, Schnabel, Robert, Schulman, Michael, Schultz, Michael, Scott, John, Sedghi, Shahriar, Shaban, Ahmad, Shapina, Marina, Shaposhnikova, Natalia, Shchukina, Oksana, Sherman, Alex, Shumikhina, Irina, Simanenkov, Vladimir, Simonov, Vladislav, Simulionis, Giedrius, Skrypnyk, Igor, Sliwowski, Zbigniew, Smid, Jan, Solaiman, Mahmood, Soofi, Najm, Soufleris, Konstantinos, Spassova, Zoia, Stanislavchuk, Mykola, Stec-Michalska, Krystyna, Stifft, Jonathas, Stoinov, Simeon, Stoyanova, Girgina, Sultan, Keith, Surace, Lindsey, Takov, Dimitar, Tälli, Jaak, Tankova, Ludmila, Tanno, Hugo, Tarabar, Dino, Tarakji, Elias, Tchernev, Konstantin, Thin, Lena, Thomas, Carlton, Tishaeva, Irina, Todorova, Tsveta, Tokarenko, Oleksandr, Tolmanis, Ivars, Tomasevic, Ratko, Trofimov, Vasiliy, Tulassay, Zsolt, Unsal, Belkis, Uzunova-Genova, Alma, Valentine, John, Valuyskikh, Ekaterina, Vasconcellos, Eduardo, Vasileva, Galina, Vasylyuk, Sergiy, Vaughn, Byron, Velazquez, Francisco, Vizir, Vadym, Vladimirov, Borislav, Volfova, Miroslava, Vyhnalek, Petr, Wallace, Ian, Waluga, Marek, Watkins, William, Weber, John, Wiechowska-Kozlowska, Anna, Winstead, Nathaniel, Wojtkiewicz, Pawel, Wozniak-Stolarska, Barbara, Yacyshyn, Bruce, Yakovlev, Alexey, Younes, Ziad, Yukie Sassaki, Lígia, Yuksel, Ilhami, Zachar, Jan, Zaltman, Cyrla, Zdravkovic Petrovic, Natasa, Zhdan, Vyacheslav, Zinchenko, Maryna, and Zymla, Maciej

Abstract

Etrolizumab is a gut-targeted anti-β7 integrin monoclonal antibody. In an earlier phase 2 induction study, etrolizumab significantly improved clinical remission relative to placebo in patients with moderately to severely active ulcerative colitis. The HIBISCUS studies aimed to compare the efficacy and safety of etrolizumab to adalimumab and placebo for induction of remission in patients with moderately to severely active ulcerative colitis.

Published
2022
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47. Therapeutic Opportunities for Intestinal Angioectasia‐ Targeting PPARγ and Oxidative Stress.

Author

Sarangdhar, Mayur, Yacyshyn, Mary B., Gruenzel, Andrew R., Engevik, Melinda A., Harris, Nathaniel L., Aronow, Bruce J., and Yacyshyn, Bruce R.

Subjects
OXIDATIVE stress, INTESTINES, TREATMENT effectiveness, ELECTRONIC health records, DRUG utilization
Abstract

Recurrent and acute bleeding from intestinal tract angioectasia (AEC) presents a major challenge for clinical intervention. Current treatments are empiric, with frequent poor clinical outcomes. Improvements in understanding the pathophysiology of these lesions will help guide treatment. Using data from the US Food and Drug Administration (FDA)'s Adverse Event Reporting System (FAERS), we analyzed 12 million patient reports to identify drugs inversely correlated with gastrointestinal bleeding and potentially limiting AEC severity. FAERS analysis revealed that drugs used in patients with diabetes and those targeting PPARγ‐related mechanisms were associated with decreased AEC phenotypes (P < 0.0001). Electronic health records (EHRs) at University of Cincinnati Hospital were analyzed to validate FAERS analysis. EHR data showed a 5.6% decrease in risk of AEC and associated phenotypes in patients on PPARγ agonists. Murine knockout models of AEC phenotypes were used to construct a gene‐regulatory network of candidate drug targets and pathways, which revealed that wound healing, vasculature development and regulation of oxidative stress were impacted in AEC pathophysiology. Human colonic tissue was examined for expression differences across key pathway proteins, PPARγ, HIF1α, VEGF, and TGFβ1. In vitro analysis of human AEC tissues showed lower expression of PPARγ and TGFβ1 compared with controls (0.55 ± 0.07 and 0.49 ± 0.05). National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO) RNA‐Seq data was analyzed to substantiate human tissue findings. This integrative discovery approach showing altered expression of key genes involved in oxidative stress and injury repair mechanisms presents novel insight into AEC etiology, which will improve targeted mechanistic studies and more optimal medical therapy for AEC. [ABSTRACT FROM AUTHOR]

Published
2021
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48. Transition to Adult IBD Care: A Pilot Multi-Site, Telehealth Hybrid Intervention.

Author

Gray, Wendy N, Wagoner, Scott T, Schaefer, Megan R, Reed, Bonney, Morgan, Pamela, Holbrook, Erin, Yacyshyn, Bruce, Mackner, Laura, Young, Margaret, Maddux, Michele, Saeed, Shehzad A, Denson, Lee A, and Hommel, Kevin

Subjects
TRANSITIONAL care, TELEMEDICINE, YOUNG adults, ADULTS, CROHN'S disease, INFLAMMATORY bowel disease treatment, RESEARCH, RESEARCH methodology, MEDICAL cooperation, EVALUATION research, CONTINUUM of care, COMPARATIVE studies, LONGITUDINAL method
Abstract

Objective: Transition to adult IBD care continues to be a challenge. Efficacious models of improving transition to adult care in the United States are lacking. We present data from a pilot, prospective, non-randomized, intervention implemented at IBD centers in the Midwest and Southeast United States.Design and Methods: Adolescents and young adults (AYAs; 16-20 years) with IBD and their parents completed a 4- to 5-month transition program (1 in-person group session; 4 individual telehealth sessions). Primary outcomes were feasibility (i.e., recruitment, retention, fidelity) and acceptability (i.e., program satisfaction). Secondary outcomes were changes in transition readiness, self-management skill acquisition, perceived readiness to transfer to adult care, and disease knowledge.Results: The study exceeded goals for recruitment (target N = 20; actual: 36) and retention (target: 80%; actual: 86.11%). On average, it took participants 20.91 ± 3.15 weeks to complete our 4- to 5-month intervention and there were no deviations from the study protocol. Participant ratings for overall program satisfaction, perceived helpfulness, and program length and format were positive. Increases in transition readiness, t(30) = 8.30, d = 1.49, p < .001, self-management skill acquisition, t(30) = 3.93, d = 0.70, p < .001, and disease knowledge, t(30) = 8.20, d = 1.58, p < .001 were noted. AYA- and parent-perceived transfer readiness also improved (p's < .05; d's = 0.76-1.68).Conclusions: This article presents feasibility and acceptability data for a 4- to 5-month transition intervention. Improvements in AYA transition readiness, self-management skill acquisition, IBD knowledge, and AYA/parent perceived transfer readiness were also observed. [ABSTRACT FROM AUTHOR]

Published
2021
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