Full Text Journal Articles by
Author Brian G Feagan

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Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials.

Brian G Feagan, Reena Khanna, William J Sandborn, Séverine Vermeire, Walter Reinisch, Chinyu Su, Leonardo Salese, Haiyun Fan, Jerome Paulissen, Deborah A Woodworth, Wojciech Niezychowski, Bruce E Sands,

<h4>Background</h4>Endoscopy is routine in trials of ulcerative colitis therapies.<h4>Aim</h4>To investigate agreement between central and local Mayo endoscopic subscore (MES) reads in the OCTAVE programme METHODS: Flexible sigmoidoscopy was performed in tofacitinib induction (OCTAVE Induction 1&2, NCT01465763 and NCT01458951), maintenance (OCTAVE Sustain, NCT01458574) and open-label, long-term extension (OCTAVE Open, NCT01470612) studies. ... Read more >>

Aliment Pharmacol Ther (Alimentary pharmacology & therapeutics)
[2021, :]

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Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis.

William J Sandborn, Brian G Feagan, Geert D'Haens, Douglas C Wolf, Igor Jovanovic, Stephen B Hanauer, Subrata Ghosh, AnnKatrin Petersen, Steven Y Hua, Ji Hwan Lee, Lorna Charles, Denesh Chitkara, Keith Usiskin, Jean-Frederic Colombel, Loren Laine, Silvio Danese, ,

<h4>Background</h4>Ozanimod, a selective sphingosine-1-phosphate receptor modulator, is under investigation for the treatment of inflammatory bowel disease.<h4>Methods</h4>We conducted a phase 3, multicenter, randomized, double-blind, placebo-controlled trial of ozanimod as induction and maintenance therapy in patients with moderately to severely active ulcerative colitis. In the 10-week induction period, patients in cohort 1 ... Read more >>

N Engl J Med (The New England journal of medicine)
[2021, 385(14):1280-1291]

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Meta-analysis of gene expression disease signatures in colonic biopsy tissue from patients with ulcerative colitis.

Bryan Linggi, Vipul Jairath, Guangyong Zou, Lisa M Shackelton, Dermot P B McGovern, Azucena Salas, Bram Verstockt, Mark S Silverberg, Shadi Nayeri, Brian G Feagan, Niels Vande Casteele,

Publicly available ulcerative colitis (UC) gene expression datasets from observational studies and clinical trials include inherently heterogeneous disease characteristics and methodology. We used meta-analysis to identify a robust UC gene signature from inflamed biopsies. Eight gene expression datasets derived from biopsy tissue samples from noninflammatory bowel disease (IBD) controls and ... Read more >>

Sci Rep (Scientific reports)
[2021, 11(1):18243]

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The relationship between endoscopic and clinical recurrence in postoperative Crohn's disease: a systematic review and meta-analysis.

Alessandro Ble, Cecilia Renzulli, Fabio Cenci, Maria Grimaldi, Michelangelo Barone, Rocio Sedano, Joshua Chang, Tran M Nguyen, Malcolm Hogan, G Y Zou, John K MacDonald, Christopher Ma, William J Sandborn, Brian G Feagan, Emilio Merlo Pich, Vipul Jairath,

<h4>Background and aims</h4>We aimed to quantify the magnitude of the association between endoscopic recurrence and clinical recurrence [symptom relapse] in patients with postoperative Crohn's disease.<h4>Methods</h4>Databases were searched to October 2, 2020 for randomised controlled trials [RCTs] and cohort studies of adult patients with Crohn's disease with ileocolonic resection and anastomosis. ... Read more >>

J Crohns Colitis (Journal of Crohn's & colitis)
[2021, :]

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Association Between Proposed Definitions of Clinical Remission/Response and Well-Being in Patients With Crohn's Disease.

William J Sandborn, James D Lewis, Julian Panes, Edward V Loftus, Geert D'Haens, Zhuqing Yu, Bidan Huang, Ana P Lacerda, Aileen L Pangan, Brian G Feagan,

<h4>Background and aims</h4>Patient-reported outcomes are recommended endpoints in Crohn's disease (CD) trials. The association between patient-reported general well-being relative to symptoms of diarrhea and abdominal pain (AP) in patients with moderate-to-severe CD was explored.<h4>Methods</h4>Patients from 3 randomized, placebo-controlled, double-blind adalimumab or upadacitinib studies with average daily very soft/liquid stool frequency ... Read more >>

J Crohns Colitis (Journal of Crohn's & colitis)
[2021, :]

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Systematic Review of Outcome Measures Used in Observational Studies of Adults with Eosinophilic Esophagitis.

Alain M Schoepfer, Camilla Schürmann, Sven Trelle, Marcel Zwahlen, Christopher Ma, Mirna Chehade, Evan S Dellon, Vipul Jairath, Brian G Feagan, Albert J Bredenoord, Luc Biedermann, Thomas Greuter, Philipp Schreiner, Alex Straumann, Ekaterina Safroneeva,

<h4>Background</h4>Over the last 20 years, diverse outcome measures have been used to evaluate the effectiveness of therapies for eosinophilic esophagitis (EoE). This systematic review aims to identify the readouts used in observational studies of topical corticosteroids, diet, and dilation in adult EoE patients.<h4>Methods</h4>We searched MEDLINE and Embase for prospective and ... Read more >>

Int Arch Allergy Immunol (International archives of allergy and immunology)
[2021, :1-25]

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Impact of Drug Approval Pathways for Paediatric Inflammatory Bowel Disease.

Eileen Crowley, Christopher Ma, Marija Andic, Brian G Feagan, Anne M Griffiths, Vipul Jairath,

<h4>Background and aims</h4>Timely access to approved medications is a priority in paediatric inflammatory bowel disease (IBD). To date, the timing of drug studies in paediatric IBD has been suboptimal with most studies conducted long after approval has been granted for adult IBD. This delay in approval leads to extensive off-label ... Read more >>

J Crohns Colitis (Journal of Crohn's & colitis)
[2021, :]

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Correction to: Vedolizumab and Extraintestinal Manifestations in Inflammatory Bowel Disease.

Jurij Hanzel, Christopher Ma, Niels Vande Casteele, Reena Khanna, Vipul Jairath, Brian G Feagan,

Drugs (Drugs)
[2021, 81(14):1697]

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Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS).

, Christopher Ma, Alain M Schoepfer, Evan S Dellon, Albert J Bredenoord, Mirna Chehade, Margaret H Collins, Brian G Feagan, Glenn T Furuta, Sandeep K Gupta, Ikuo Hirano, Vipul Jairath, David A Katzka, Rish K Pai, Marc E Rothenberg, Alex Straumann, Seema S Aceves, Jeffrey A Alexander, Nicoleta C Arva, Dan Atkins, Luc Biedermann, Carine Blanchard, Antonella Cianferoni, Constanza Ciriza de Los Rios, Frederic Clayton, Carla M Davis, Nicola de Bortoli, Jorge A Dias, Gary W Falk, Robert M Genta, Gisoo Ghaffari, Nirmala Gonsalves, Thomas Greuter, Russell Hopp, Karen S Hsu Blatman, Elizabeth T Jensen, Doug Johnston, Amir F Kagalwalla, Helen M Larsson, John Leung, Hubert Louis, Joanne C Masterson, Calies Menard-Katcher, Paul A Menard-Katcher, Fouad J Moawad, Amanda B Muir, Vincent A Mukkada, Roberto Penagini, Robert D Pesek, Kathryn Peterson, Philip E Putnam, Alberto Ravelli, Edoardo V Savarino, Christoph Schlag, Philipp Schreiner, Dagmar Simon, Thomas C Smyrk, Jonathan M Spergel, Tiffany H Taft, Ingrid Terreehorst, Tim Vanuytsel, Carina Venter, Mario C Vieira, Michael Vieth, Berber Vlieg-Boerstra, Ulrike von Arnim, Marjorie M Walker, Joshua B Wechsler, Philip Woodland, John T Woosley, Guang-Yu Yang, Noam Zevit, Ekaterina Safroneeva,

<h4>Background</h4>End points used to determine treatment efficacy in eosinophilic esophagitis (EoE) have evolved over time. With multiple novel therapies in development for EoE, harmonization of outcomes measures will facilitate evidence synthesis and appraisal when comparing different treatments.<h4>Objective</h4>We sought to develop a core outcome set (COS) for controlled and observational studies of ... Read more >>

J Allergy Clin Immunol (The Journal of allergy and clinical immunology)
[2021, :]

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Therapeutic Drug Monitoring of Tumor Necrosis Factor Antagonists in Crohn Disease: A Theoretical Construct to Apply Pharmacokinetics and Guidelines to Clinical Practice.

Niels Vande Casteele, Brian G Feagan, Douglas C Wolf, Anca Pop, Mohamed Yassine, Sara N Horst, Timothy E Ritter, William J Sandborn,

Therapeutic drug monitoring (TDM) is the measurement of drug and antidrug antibody concentrations in individuals to guide treatment decisions. In patients with Crohn disease (CD), TDM, used either reactively or proactively, is emerging as a valuable tool for optimization of tumor necrosis factor (TNF) antagonist therapy. Reactive TDM is carried ... Read more >>

Inflamm Bowel Dis (Inflammatory bowel diseases)
[2021, 27(8):1346-1355]

Cited: 1 time

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Medical Management Following Surgical Therapy in Inflammatory Bowel Disease: Evidence from Cochrane Reviews.

Nilesh Chande, Siddharth Singh, Neeraj Narula, Morris Gordon, M Ellen Kuenzig, Tran M Nguyen, John K MacDonald, Brian G Feagan,

Inflamm Bowel Dis (Inflammatory bowel diseases)
[2021, 27(9):1513-1524]

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Systematic review and Meta-analysis: Clinical, Endoscopic, Histologic and Safety Placebo Rates in Induction and Maintenance trials of Ulcerative Colitis.

Rocio Sedano, Malcolm Hogan, Tran M Nguyen, Joshua Chang, G Y Zou, John K Macdonald, Niels Vande Casteele, Jurij Hanzel, Eileen Crowley, Robert Battat, Parambir S Dulai, Siddharth Singh, Geert D'Haens, William Sandborn, Brian G Feagan, Christopher Ma, Vipul Jairath,

<h4>Background and aims</h4>Quantifying placebo rates and the factors influencing them are essential to inform trial design. We provided a contemporary summary of clinical, endoscopic, histologic and safety placebo rates in induction and maintenance clinical trials of ulcerative colitis, and identify factors influencing them.<h4>Methods</h4>MEDLINE, EMBASE, and the Cochrane library were searched ... Read more >>

J Crohns Colitis (Journal of Crohn's & colitis)
[2021, :]

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Long-Term Efficacy and Safety of Ozanimod in Moderately to Severely Active Ulcerative Colitis: Results From the Open-Label Extension of the Randomized, Phase 2 TOUCHSTONE Study.

William J Sandborn, Brian G Feagan, Stephen Hanauer, Severine Vermeire, Subrata Ghosh, Wenzhong J Liu, AnnKatrin Petersen, Lorna Charles, Vivian Huang, Keith Usiskin, Douglas C Wolf, Geert D'Haens,

<h4>Background and aims</h4>This analysis examined the long-term safety and efficacy of ozanimod in patients with moderately to severely active ulcerative colitis [UC] with ≥ 4 years of follow-up in the phase 2 TOUCHSTONE open-label extension [OLE].<h4>Methods</h4>Patients receiving placebo or ozanimod HCl 0.5 mg or 1 mg during the double-blind period could ... Read more >>

J Crohns Colitis (Journal of Crohn's & colitis)
[2021, 15(7):1120-1129]

Cited: 3 times

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Disease Activity Indices for Pouchitis: A Systematic Review.

Rocio Sedano, Tran M Nguyen, Ahmed Almradi, Florian Rieder, Claire E Parker, Lisa M Shackelton, Geert D'Haens, William J Sandborn, Brian G Feagan, Christopher Ma, Vipul Jairath,

<h4>Background</h4>Several indices exist to measure pouchitis disease activity; however, none are fully validated. As an initial step toward creating a validated instrument, we identified pouchitis disease activity indices, examined their operating properties, and assessed their value as outcome measures in clinical trials.<h4>Methods</h4>Electronic databases were searched to identify randomized controlled trials ... Read more >>

Inflamm Bowel Dis (Inflammatory bowel diseases)
[2021, :]

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Histologic Remission Is Associated With Lower Risk of Treatment Failure in Patients With Crohn Disease in Endoscopic Remission.

Hyuk Yoon, Sushrut Jangi, Parambir S Dulai, Brigid S Boland, Vipul Jairath, Brian G Feagan, William J Sandborn, Siddharth Singh,

<h4>Background</h4>Although achieving histologic remission in ulcerative colitis is established, the incremental benefit of achieving histologic remission in patients with Crohn disease (CD) treated to a target of endoscopic remission is unclear. We evaluated the risk of treatment failure in patients with CD in clinical and endoscopic remission by histologic activity ... Read more >>

Inflamm Bowel Dis (Inflammatory bowel diseases)
[2021, 27(8):1277-1284]

Cited: 1 time

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Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double-blind, randomised, placebo-controlled trial.

Brian G Feagan, Silvio Danese, Edward V Loftus, Séverine Vermeire, Stefan Schreiber, Timothy Ritter, Ronald Fogel, Rajiv Mehta, Sandeep Nijhawan, Radosław Kempiński, Rafał Filip, Ihor Hospodarskyy, Ursula Seidler, Frank Seibold, Ian L P Beales, Hyo Jong Kim, John McNally, Chohee Yun, Sally Zhao, Xiaopeng Liu, Chia-Hsiang Hsueh, Chantal Tasset, Robin Besuyen, Mamoru Watanabe, William J Sandborn, Gerhard Rogler, Toshifumi Hibi, Laurent Peyrin-Biroulet,

<h4>Background</h4>The global prevalence of ulcerative colitis is increasing, and induction and maintenance of remission is a crucial therapeutic goal. We assessed the efficacy and safety of filgotinib, a once-daily, oral Janus kinase 1 preferential inhibitor, for treatment of ulcerative colitis.<h4>Methods</h4>This phase 2b/3, double-blind, randomised, placebo-controlled trial including two induction studies ... Read more >>

Lancet (Lancet (London, England))
[2021, 397(10292):2372-2384]

Cited: 1 time

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Biomarkers for the Prediction and Diagnosis of Fibrostenosing Crohn's Disease: A Systematic Review.

Calen A Steiner, Jeffrey A Berinstein, Jeremy Louissaint, Peter D R Higgins, Jason R Spence, Carol Shannon, Cathy Lu, Ryan W Stidham, Joel G Fletcher, David H Bruining, Brian G Feagan, Vipul Jairath, Mark E Baker, Dominik Bettenworth, Florian Rieder, ,

<h4>Background and aims</h4>Intestinal strictures are a common complication of Crohn's disease (CD). Biomarkers of intestinal strictures would assist in their prediction, diagnosis, and monitoring. Herein we provide a comprehensive systematic review of studies assessing biomarkers that may predict or diagnose CD-associated strictures.<h4>Methods</h4>We performed a systematic review of PubMed, EMBASE, ISI ... Read more >>

Clin Gastroenterol Hepatol (Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association)
[2021, :]

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Long-Term Safety and Efficacy of Risankizumab Treatment in Patients with Crohn's Disease: Results from the Phase 2 Open-Label Extension Study.

Marc Ferrante, Brian G Feagan, Julián Panés, Filip Baert, Edouard Louis, Olivier Dewit, Arthur Kaser, W Rachel Duan, Yinuo Pang, Wan-Ju Lee, Dawn Gustafson, Xiaomei Liao, Kori Wallace, Jasmina Kalabic, Geert R D'Haens,

<h4>Background and aims</h4>Risankizumab, an interleukin-23 antibody, demonstrated efficacy and acceptable safety in a phase 2 study of patients with moderate-to-severe refractory Crohn's disease. This open-label extension investigated the long-term safety, pharmacokinetics, immunogenicity, and efficacy of risankizumab in responders to risankizumab in the parent phase 2 study.<h4>Methods</h4>Enrolled patients had achieved clinical ... Read more >>

J Crohns Colitis (Journal of Crohn's & colitis)
[2021, :]

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A Summary of the Meetings of the Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) International Multidisciplinary Consensus.

Christopher Ma, Alain M Schoepfer, Ekaterina Safroneeva, ,

Gastroenterology (Gastroenterology)
[2021, 161(3):778-784]

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Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies.

William J Sandborn, Brian G Feagan, Silvio Danese, Christopher D O'Brien, Elyssa Ott, Colleen Marano, Thomas Baker, Yiying Zhou, Sheri Volger, Ilia Tikhonov, Christopher Gasink, Bruce E Sands, Subrata Ghosh,

<h4>Background</h4>Ustekinumab is currently approved globally in Crohn's disease (CD) and psoriatic diseases. Recent phase 3 data demonstrate safety/efficacy in ulcerative colitis (UC). Crohn's disease and UC phase 3 programs had similar study designs, facilitating integrated safety analyses.<h4>Methods</h4>Data from 6 ustekinumab phase 2/3 CD and UC studies were pooled, and safety ... Read more >>

Inflamm Bowel Dis (Inflammatory bowel diseases)
[2021, 27(7):994-1007]

Cited: 5 times

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Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS): An International Multidisciplinary Consensus.

Christopher Ma, Alain M Schoepfer, Ekaterina Safroneeva, , ,

Gastroenterology (Gastroenterology)
[2021, 161(3):748-755]

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Early Combined Immunosuppression May Be More Effective for Reducing Complications in Isolated Colonic- vs Ileal-Dominant Crohn Disease.

Parambir S Dulai, Vipul Jairath, Guangyong Zou, Larry W Stitt, Reena Khanna, William J Sandborn, Brian G Feagan, Siddharth Singh,

<h4>Background</h4>We assessed whether differential efficacy of early combined immunosuppression (ECI) in comparison with conventional management (CM) is present in patients with Crohn disease (CD) according to disease location.<h4>Methods</h4>In this posthoc analysis of the Randomized Evaluation of an Algorithm for Crohn's Treatment trial, the effect of ECI vs CM modified by ... Read more >>

Inflamm Bowel Dis (Inflammatory bowel diseases)
[2021, 27(5):639-646]

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International consensus to standardise histopathological scoring for small bowel strictures in Crohn's disease.

Ilyssa O Gordon, Dominik Bettenworth, Arne Bokemeyer, Amitabh Srivastava, Christophe Rosty, Gert de Hertogh, Marie E Robert, Mark A Valasek, Ren Mao, Jiannan Li, Noam Harpaz, Paula Borralho, Reetesh K Pai, Robert Odze, Roger Feakins, Claire E Parker, Leonardo Guizzetti, Tran Nguyen, Lisa M Shackelton, William J Sandborn, Vipul Jairath, Mark Baker, David Bruining, Joel G Fletcher, Brian G Feagan, Rish K Pai, Florian Rieder, ,

<h4>Objective</h4>Effective medical therapy and validated trial outcomes are lacking for small bowel Crohn's disease (CD) strictures. Histopathology of surgically resected specimens is the gold standard for correlation with imaging techniques. However, no validated histopathological scoring systems are currently available for small bowel stricturing disease. We convened an expert panel to ... Read more >>

Gut (Gut)
[2021, :]

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Pharmacological Interventions for the Prevention and Treatment of Immune Checkpoint Inhibitor-Associated Enterocolitis: A Systematic Review.

Christopher Ma, John K MacDonald, Tran M Nguyen, Niels Vande Casteele, Bryan Linggi, Pavine Lefevre, Yinghong Wang, Brian G Feagan, Vipul Jairath,

<h4>Background</h4>Patients treated with immune checkpoint inhibitors (ICIs) may develop ICI-associated enterocolitis, for which there is no approved treatment.<h4>Aims</h4>We aimed to systematically review the efficacy and safety of medical interventions for the prevention and treatment of ICI-associated enterocolitis.<h4>Methods</h4>MEDLINE, EMBASE, and the Cochrane Library were searched to identify randomized controlled trials (RCTs), ... Read more >>

Dig Dis Sci (Digestive diseases and sciences)
[2021, :]

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Methods for handling missing segments in Crohn's disease clinical trials: analysis from the EXTEND trial.

Christopher Ma, Reena Khanna, Leonardo Guizzetti, Guangyong Zou, Brian G Feagan, Vipul Jairath,

Gut (Gut)
[2021, :]

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