Citations 4
Efficacy of Mirikizumab in Comparison to Ustekinumab in Patients With Moderate-to-Severe Crohn’s Disease: Results From the Phase 3 VIVID-1 Study
Ferrante, M., Kaser, Arthur , Reinisch, Walter, Bragg, S. M., Lin, Zhantao, Lopes, Michelle Ugolini, Protić, Marijana , Jairath, Vipul , Sands, Bruce E , Bossuyt, Peter , Farraye, Francis A. , Hisamatsu, T., Kierkuś, Jarosław , Laharie, David , Siegmund, Britta , Hon, Kam‐Lun Ellis , Morris, Nathan , Danese, Silvio
Zeitschrift für Gastroenterologie | November 27, 2025 | Volume: 62 | Issue: 05 | Pages: e481-e482
Effects of Mirikizumab Versus Placebo on Histologic Inflammation Evaluated by Comprehensive Assessment in 5 Intestinal Segments in a Randomized Controlled Phase 3 Trial of Participants with Crohn’s Disease
Feagan, B., Hisamatsu, Tadakazu , D’Haens, Geert , Pai, Rish K. , Lin, Z, Protić, Marijana , Escobar, Rodrigo , Reinisch, Walter, Jairath, Vipul , Magro, Fernando , Hertogh, Gert D. , Harpaz, Noam , Lin, Z, Morris, Nathan , Hon, Kam‐Lun Ellis , Owen, C
Zeitschrift für Gastroenterologie | May 13, 2025 | Volume: 63 | Issue: 05 | Pages: e360-e361
Clinical Trials for Inflammatory Bowel Disease: Global Guidance During the COVID-19 Pandemic
Reinisch, Walter, Danese, Silvio , Peyrin‐Biroulet, Laurent , Loftus, Edward V. , Loftus, Edward V , Danese, Silvio , Peyrin-Biroulet, Laurent
Journal of Crohn's and Colitis | June 5, 2020 | Volume: 14 | Issue: Supplement_3 | Pages: S815-S819
Abstract The severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]-causing coronavirus disease [COVID]-19 pandemic poses major challenges for patients with inflammatory bowel disease [IBD] to be recruited and maintained in clinical trials. However, clinical trials offer patients who have failed multiple drugs access to study medications with alternative modes of action and the potential for relief from inflammation-mediated symptoms. Therefore, the continuation of clinical trials in IBD during the COVID-19 pandemic is important both for participants and for the community of IBD patients, due to the dire need for an expanded therapeutic armamentarium. As the safety of patients in clinical trials is the leading principle, we are providing ten specific rules to guide patients and principal investigators safely through the challenging time.
Development of an index to define overall disease severity in IBD
Whitman, Cynthia B. , Spiegel, Brennan , Feagan, Brian G. , Loftus, Edward V. , D’Haens, Geert , Bernstein, Çharles N. , Gearry, Richard B. , Mantzaris, Gerassimos J. , Sartor, Balfour R., Silverberg, Mark S. , Riddell, Robert H. , O’Morain, Colm, Lakatos, Péter L. , Halfvarson, Jonas , Reinisch, Walter, Rogler, Gerhard , Kruis, Wolfgang , Tysk, Curt , Danese, Silvio , Sandborn, William J. , Gasché, Christoph , Pallone, Francesco, Travis, Simon , Peyrin‐Biroulet, Laurent , Siegel, Corey A , Sands, Bruce E , Panaccione, Remo , Bernstein, Charles Noah , Ng, Siew C. , Κoutroubakis, Ioannis E. , McGovern, Dermot , Halfvarson, Jonas , Schreiber, Stefan , Griffiths, Anne Marie , Moum, Bjørn Allan , Panés, Julián , Colombel, Jean‐Frédéric , Hanauer, Stephen B. , Loftus, Edward V , Danese, Silvio , Peyrin-Biroulet, Laurent , Spiegel, Brennan , Lakatos, Peter L
Gut | October 25, 2016 | Volume: 67 | Issue: 2 | Pages: 244-254
Background and aim Disease activity for Crohn's disease (CD) and UC is typically defined based on symptoms at a moment in time, and ignores the long-term burden of disease. The aims of this study were to select the attributes determining overall disease severity, to rank the importance of and to score these individual attributes for both CD and UC. Methods Using a modified Delphi panel, 14 members of the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) selected the most important attributes related to IBD. Eighteen IOIBD members then completed a statistical exercise (conjoint analysis) to create a relative ranking of these attributes. Adjusted utilities were developed by creating proportions for each level within an attribute. Results For CD, 15.8% of overall disease severity was attributed to the presence of mucosal lesions, 10.9% to history of a fistula, 9.7% to history of abscess and 7.4% to history of intestinal resection. For UC, 18.1% of overall disease severity was attributed to mucosal lesions, followed by 14.0% for impact on daily activities, 11.2% C reactive protein and 10.1% for prior experience with biologics. Overall disease severity indices were created on a 100-point scale by applying each attribute's average importance to the adjusted utilities. Conclusions Based on specialist opinion, overall CD severity was associated more with intestinal damage, in contrast to overall UC disease severity, which was more dependent on symptoms and impact on daily life. Once validated, disease severity indices may provide a useful tool for consistent assessment of overall disease severity in patients with IBD.