Full Text Journal Articles by
Author Bruce E Sands

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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, :]

Cited: 0 times

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Factors Associated With Longitudinal Psychological and Physiological Stress in Health Care Workers During the COVID-19 Pandemic: Observational Study Using Apple Watch Data.

Robert P Hirten, Matteo Danieletto, Lewis Tomalin, Katie Hyewon Choi, Micol Zweig, Eddye Golden, Sparshdeep Kaur, Drew Helmus, Anthony Biello, Renata Pyzik, Claudia Calcagno, Robert Freeman, Bruce E Sands, Dennis Charney, Erwin P Bottinger, James W Murrough, Laurie Keefer, Mayte Suarez-Farinas, Girish N Nadkarni, Zahi A Fayad,

<h4>Background</h4>The COVID-19 pandemic has resulted in a high degree of psychological distress among health care workers (HCWs). There is a need to characterize which HCWs are at an increased risk of developing psychological effects from the pandemic. Given the differences in the response of individuals to stress, an analysis of ... Read more >>

J Med Internet Res (Journal of medical Internet research)
[2021, 23(9):e31295]

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Molecular Characterization of Limited Ulcerative Colitis Reveals Novel Biology and Predictors of Disease Extension.

Carmen Argmann, Minami Tokuyama, Ryan C Ungaro, Ruiqi Huang, Ruixue Hou, Sakteesh Gurunathan, Roman Kosoy, Antonio Di'Narzo, Wenhui Wang, Bojan Losic, Haritz Irizar, Lauren Peters, Aleksandar Stojmirovic, Gabrielle Wei, Phillip H Comella, Mark Curran, Carrie Brodmerkel, Joshua R Friedman, Ke Hao, Eric E Schadt, Jun Zhu, Judy Cho, Noam Harpaz, Marla C Dubinsky, Bruce E Sands, Andrew Kasarskis, Saurabh Mehandru, Jean-Frederic Colombel, Mayte Suárez-Fariñas,

<h4>Background and aims</h4>Disease extent varies in ulcerative colitis (UC) from proctitis to left-sided colitis to pancolitis and is a major prognostic factor. When the extent of UC is limited there is often a sharp demarcation between macroscopically involved and uninvolved areas and what defines this or subsequent extension is unknown. ... Read more >>

Gastroenterology (Gastroenterology)
[2021, :]

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Histologic Outcomes With Vedolizumab Versus Adalimumab in Ulcerative Colitis: Results From An Efficacy and Safety Study of Vedolizumab Intravenous Compared to Adalimumab Subcutaneous in Participants With Ulcerative Colitis (VARSITY).

Laurent Peyrin-Biroulet, Edward V Loftus, Jean-Frédéric Colombel, Silvio Danese, Raquel Rogers, Jeffrey D Bornstein, Jingjing Chen, Stefan Schreiber, Bruce E Sands, Richard A Lirio,

<h4>Background and aims</h4>VARSITY (An Efficacy and Safety Study of Vedolizumab Intravenous [IV] Compared to Adalimumab Subcutaneous [SC] in Participants With Ulcerative Colitis) showed superior clinical remission and endoscopic improvement in ulcerative colitis with vedolizumab vs adalimumab. This analysis compared histologic outcomes.<h4>Methods</h4>Patients in VARSITY were randomized 1:1 to maintenance with vedolizumab ... Read more >>

Gastroenterology (Gastroenterology)
[2021, 161(4):1156-1167.e3]

Cited: 1 time

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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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Long-term Safety and Efficacy of Etrasimod for Ulcerative Colitis: Results from the Open-label Extension of the OASIS Study.

Séverine Vermeire, Michael Chiorean, Julián Panés, Laurent Peyrin-Biroulet, Jinkun Zhang, Bruce E Sands, Krisztina Lazin, Preston Klassen, Snehal U Naik, Christopher H Cabell, William J Sandborn,

<h4>Background and aims</h4>Etrasimod is an oral, selective, sphingosine 1-phosphate receptor modulator. In a phase 2, randomised, double-blind, placebo-controlled trial in adults with moderately-to-severely active ulcerative colitis [OASIS], etrasimod 2 mg provided significant benefit versus placebo and was generally well tolerated. This open-label extension [OLE] evaluated safety and efficacy of etrasimod ... Read more >>

J Crohns Colitis (Journal of Crohn's & colitis)
[2021, 15(6):950-959]

Cited: 1 time

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Older Adult Patients Use More Aminosalicylate Monotherapy Compared With Younger Patients With Inflammatory Bowel Disease: TARGET-IBD.

Edward L Barnes, John S Hanson, Miguel D Regueiro, Sumona Saha, Bruce E Sands, David T Rubin, Marla C Dubinsky, Corey A Siegel, Derek R Gazis, Julie M Crawford, Millie D Long,

<h4>Goal</h4>The goal of this study was to describe medication utilization patterns in older inflammatory bowel disease (IBD) patients.<h4>Background</h4>Despite a growing population of older patients with Crohn's disease (CD) and ulcerative colitis (UC), questions remain regarding medication utilization patterns in comparison to younger populations.<h4>Materials and methods</h4>We collected data from the 34 ... Read more >>

J Clin Gastroenterol (Journal of clinical gastroenterology)
[2021, :]

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Adverse events of special interest in clinical trials of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and psoriasis with 37 066 patient-years of tofacitinib exposure.

Gerd R Burmester, Peter Nash, Bruce E Sands, Kim Papp, Lori Stockert, Thomas V Jones, Huaming Tan, Ann Madsen, Hernan Valdez, Stanley B Cohen,

<h4>Objectives</h4>To analyse adverse events (AEs) of special interest across tofacitinib clinical programmes in rheumatoid arthritis (RA), psoriatic arthritis (PsA), ulcerative colitis (UC) and psoriasis (PsO), and to determine whether the incidence rates (IRs; unique patients with events per 100 patient-years) of these events are consistent across diseases.<h4>Methods</h4>The analysis included data ... Read more >>

RMD Open (RMD open)
[2021, 7(2):]

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Improved Smoking Cessation Rates in a Pharmacist-Led Program Embedded in an Inflammatory Bowel Disease Specialty Medical Home.

Stacy Saithy Tse, Bruce E Sands, Laurie Keefer, Benjamin L Cohen, Elana Maser, Ryan C Ungaro, James F Marion, Jean-Frédéric Colombel, Steven H Itzkowitz, Jessica Gelman, Marla C Dubinsky,

<h4>Background</h4>Cigarette smoking is associated with disease progression, poor outcomes, and increased biologic use in Crohn's Disease (CD). In this prospective study, we describe the structure and results of a pharmacist-driven smoking cessation program in an Inflammatory Bowel Disease (IBD) Specialty Medical Home.<h4>Methods</h4>One pharmacist designed and implemented a collaborative drug therapy ... Read more >>

J Pharm Pract (Journal of pharmacy practice)
[2021, :8971900211000682]

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Deep Analysis of the Peripheral Immune System in IBD Reveals New Insight in Disease Subtyping and Response to Monotherapy or Combination Therapy.

Roman Kosoy, Seunghee Kim-Schulze, Adeeb Rahman, Joshua R Friedman, Ruiqi Huang, Lauren A Peters, El-Ad Amir, Jacqueline Perrigoue, Aleksandar Stojmirovic, Won-Min Song, Hao Ke, Ryan Ungaro, Saurabh Mehandru, Judy Cho, Marla Dubinsky, Mark Curran, Carrie Brodmerkel, Eric E Schadt, Bruce E Sands, Jean-Frederic Colombel, Andrew Kasarskis, Carmen A Argmann, Mayte Suárez-Fariñas,

<h4>Background</h4>Inflammatory bowel disease (IBD) is a complex disease with variable presentation, progression, and response to therapies. Current disease classification is based on subjective clinical phenotypes. The peripheral blood immunophenome can reflect local inflammation, and thus we measured 39 circulating immune cell types in a large cohort of IBD and control ... Read more >>

Cell Mol Gastroenterol Hepatol (Cellular and molecular gastroenterology and hepatology)
[2021, 12(2):599-632]

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Tofacitinib for the Treatment of Ulcerative Colitis: Analysis of Nonmelanoma Skin Cancer Rates From the Ulcerative Colitis Clinical Program.

Bruce E Sands, Millie D Long, Walter Reinisch, Julian Panés, Edward V Loftus, Chudy I Nduaka, Arif Soonasra, Rajiv Mundayat, Nervin Lawendy, Gary Chan, Gary S Friedman, Chinyu Su,

<h4>Background</h4>Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We present integrated analyses of nonmelanoma skin cancer (NMSC) incidence in the tofacitinib UC clinical program.<h4>Methods</h4>Nonmelanoma skin cancer events were evaluated from 3 randomized, placebo-controlled studies: 2 identical, 8-week induction studies (NCT01465763, NCT01458951), a ... Read more >>

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

Cited: 0 times

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Five-Year Efficacy and Safety of Ustekinumab Treatment in Crohn's Disease: The IM-UNITI Trial.

William J Sandborn, Rory Rebuck, Yuhua Wang, Bin Zou, Omoniyi J Adedokun, Christopher Gasink, Bruce E Sands, Stephen B Hanauer, Stephan Targan, Subrata Ghosh, Willem J S de Villiers, Jean-Frederic Colombel, Brian G Feagan, John P Lynch,

<h4>Background & aims</h4>The IM-UNITI study and long-term extension (LTE) evaluated the long-term efficacy, safety, and immunogenicity of subcutaneous ustekinumab maintenance therapy in patients with Crohn's disease. Here, we report the final results of IM-UNITI LTE through 5 years.<h4>Methods</h4>Patients completing safety and efficacy evaluations at week 44 of the maintenance study ... Read more >>

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

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An International Consensus to Standardize Integration of Histopathology in Ulcerative Colitis Clinical Trials.

Christopher Ma, Rocio Sedano, Ahmed Almradi, Niels Vande Casteele, Claire E Parker, Leonardo Guizzetti, David F Schaeffer, Robert H Riddell, Reetesh K Pai, Robert Battat, Bruce E Sands, Christophe Rosty, Marla C Dubinsky, Florian Rieder, Noam Harpaz, Maria T Abreu, Robert V Bryant, Gregory Y Lauwers, Richard Kirsch, Mark A Valasek, Eileen Crowley, William J Sandborn, Brian G Feagan, Rish K Pai, Vipul Jairath,

<h4>Background & aims</h4>Histopathology is an emerging treatment target in ulcerative colitis (UC) clinical trials. Our aim was to provide guidance on standardizing biopsy collection protocols, identifying optimal evaluative indices, and defining thresholds for histologic response and remission after treatment.<h4>Methods</h4>An international, interdisciplinary expert panel of 19 gastroenterologists and gastrointestinal pathologists was ... Read more >>

Gastroenterology (Gastroenterology)
[2021, 160(7):2291-2302]

Cited: 1 time

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Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status.

William J Sandborn, Laurent Peyrin-Biroulet, Ala I Sharara, Chinyu Su, Irene Modesto, Rajiv Mundayat, L Mert Gunay, Leonardo Salese, Bruce E Sands,

<h4>Background & aims</h4>Tofacitinib is an oral, small-molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We summarize the efficacy and safety data of tofacitinib 5 or 10 mg twice daily in the UC clinical program, stratified by prior tumor necrosis factor inhibitor (TNFi) failure status.<h4>Methods</h4>Efficacy was assessed in ... Read more >>

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

Cited: 0 times

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STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD.

Dan Turner, Amanda Ricciuto, Ayanna Lewis, Ferdinando D'Amico, Jasbir Dhaliwal, Anne M Griffiths, Dominik Bettenworth, William J Sandborn, Bruce E Sands, Walter Reinisch, Jürgen Schölmerich, Willem Bemelman, Silvio Danese, Jean Yves Mary, David Rubin, Jean-Frederic Colombel, Laurent Peyrin-Biroulet, Iris Dotan, Maria T Abreu, Axel Dignass, ,

<h4>Background</h4>The Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) initiative of the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) has proposed treatment targets in 2015 for adult patients with inflammatory bowel disease (IBD). We aimed to update the original STRIDE statements for incorporating treatment targets in both ... Read more >>

Gastroenterology (Gastroenterology)
[2021, 160(5):1570-1583]

Cited: 17 times

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SARS-CoV-2 vaccination for patients with inflammatory bowel diseases: recommendations from an international consensus meeting.

Corey A Siegel, Gil Y Melmed, Dermot Pb McGovern, Victoria Rai, Florian Krammer, David T Rubin, Maria T Abreu, Marla C Dubinsky, , ,

Gut (Gut)
[2021, 70(4):635-640]

Cited: 25 times

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Selecting End Points for Disease-Modification Trials in Inflammatory Bowel Disease: the SPIRIT Consensus From the IOIBD.

Catherine Le Berre, Laurent Peyrin-Biroulet, ,

<h4>Background and aims</h4>Inflammatory bowel diseases (IBD), encompassing Crohn's disease (CD) and ulcerative colitis (UC), are chronic and disabling disorders. Prospective disease-modification trials to prevent disease progression are eagerly awaited. However, disease progression is not clearly defined. The objective of the Selecting End PoInts foR Disease-ModIfication Trials (SPIRIT) initiative was to ... Read more >>

Gastroenterology (Gastroenterology)
[2021, 160(5):1452-1460.e21]

Cited: 2 times

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New Therapeutics for Ulcerative Colitis.

Robert P Hirten, Bruce E Sands,

Ulcerative colitis (UC) is a relapsing and remitting inflammatory disease of the colon with a variable course. Despite advances in treatment, only approximately 40% of patients achieve clinical remission at the end of a year, prompting the exploration of new treatment modalities. This review explores novel therapeutic approaches to UC, ... Read more >>

Annu Rev Med (Annual review of medicine)
[2021, 72:199-213]

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Longitudinal Autonomic Nervous System Measures Correlate With Stress and Ulcerative Colitis Disease Activity and Predict Flare.

Robert P Hirten, Matteo Danieletto, Robert Scheel, Mark Shervey, Jiayi Ji, Liangyuan Hu, Jenny Sauk, Lin Chang, Bert Arnrich, Erwin Bӧttinger, Joel Dudley, Laurie Keefer, Bruce E Sands,

<h4>Background</h4>Differences in autonomic nervous system function, measured by heart rate variability (HRV), have been observed between patients with inflammatory bowel disease and healthy control patients and have been associated in cross-sectional studies with systemic inflammation. High HRV has been associated with low stress.<h4>Methods</h4>Patients with ulcerative colitis (UC) were followed for ... Read more >>

Inflamm Bowel Dis (Inflammatory bowel diseases)
[2020, :]

Cited: 0 times

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Factors Associated with Longitudinal Psychological and Physiological Stress in Health Care Workers During the COVID-19 Pandemic

Robert Hirten, Matteo Danieletto, Lewis Tomalin, Katie Hyewon Choi, Micol Zweig, Eddye Golden, Sparshdeep Kaur, Drew Helmus, Anthony Biello, Renata Pyzik, Claudia Calcogna, Robert Freeman, Bruce Sands, Dennis Charney, Erwin Bottinger, Laurie Keefer, Mayte Suarez-Farinas, Girish Nadkarni, Zahi Fayad,

<h4>ABSTRACT</h4> <h4>Introduction</h4> The Coronavirus Disease 2019 (COVID-19) pandemic has resulted in psychological distress in health care workers (HCWs). There is a need to characterize which HCWs are at increased risk of psychological sequela from the pandemic. <h4>Methods</h4> HCWs across seven hospitals in New York City were prospectively followed in an ... Read more >>

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Immunoglobulin A Targets a Unique Subset of the Microbiota in Inflammatory Bowel Disease.

Jason M Shapiro, Marcel R de Zoete, Noah W Palm, Yaro Laenen, Rene Bright, Meaghan Mallette, Kevin Bu, Agata A Bielecka, Fang Xu, Andres Hurtado-Lorenzo, Samir A Shah, Judy H Cho, Neal S LeLeiko, Bruce E Sands, Richard A Flavell, J C Clemente,

The immunopathogenesis of inflammatory bowel disease (IBD) has been attributed to a combination of host genetics and intestinal dysbiosis. Previous work in a small cohort of IBD patients suggested that pro-inflammatory bacterial taxa are highly coated with secretory immunoglobulin IgA. Using bacterial fluorescence-activated cell sorting coupled with 16S rRNA gene ... Read more >>

Cell Host Microbe (Cell host & microbe)
[2021, 29(1):83-93.e3]

Cited: 4 times

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Correction to: Presenting symptoms in inflammatory bowel disease: descriptive analysis of a community-based inception cohort.

Bryce K Perler, Ryan Ungaro, Grayson Baird, Meaghan Mallette, Renee Bright, Samir Shah, Jason Shapiro, Bruce E Sands,

An amendment to this paper has been published and can be accessed via the original article. ... Read more >>

BMC Gastroenterol (BMC gastroenterology)
[2020, 20(1):406]

Cited: 0 times

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Pregnancy and Neonatal Outcomes After Fetal Exposure to Biologics and Thiopurines Among Women With Inflammatory Bowel Disease.

Uma Mahadevan, Millie D Long, Sunanda V Kane, Abhik Roy, Marla C Dubinsky, Bruce E Sands, Russell D Cohen, Christina D Chambers, William J Sandborn, ,

<h4>Background & aims</h4>Pregnant women with inflammatory bowel disease (IBD) may require biologic or thiopurine therapy to control disease activity. Lack of safety data has led to therapy discontinuation during pregnancy, with health repercussions to mother and child.<h4>Methods</h4>Between 2007 and 2019, pregnant women with IBD were enrolled in a prospective, observational, ... Read more >>

Gastroenterology (Gastroenterology)
[2021, 160(4):1131-1139]

Cited: 8 times

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Machine learning identifies novel blood protein predictors of penetrating and stricturing complications in newly diagnosed paediatric Crohn's disease.

Ryan C Ungaro, Liangyuan Hu, Jiayi Ji, Shikha Nayar, Subra Kugathasan, Lee A Denson, Jeffrey Hyams, Marla C Dubinsky, Bruce E Sands, Judy H Cho,

<h4>Background</h4>There is a need for improved risk stratification in Crohn's disease.<h4>Aim</h4>To identify novel blood protein biomarkers associated with future Crohn's disease complications METHODS: We performed a case-cohort study utilising a paediatric inception cohort, the Risk Stratification and Identification of Immunogenetic and Microbial Markers of Rapid Disease Progression in Children with ... Read more >>

Aliment Pharmacol Ther (Alimentary pharmacology & therapeutics)
[2021, 53(2):281-290]

Cited: 1 time

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Efficacy and Safety of Extended Induction With Tofacitinib for the Treatment of Ulcerative Colitis.

William J Sandborn, Laurent Peyrin-Biroulet, Daniel Quirk, Wenjin Wang, Chudy I Nduaka, Arnab Mukherjee, Chinyu Su, Bruce E Sands,

<h4>Background & aims</h4>Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). The efficacy and safety of tofacitinib were demonstrated in a dose-ranging phase 2 induction trial, 3 phase 3 randomized, placebo-controlled trials (OCTAVE Induction 1 and 2; and OCTAVE Sustain), and an ongoing, ... Read more >>

Clin Gastroenterol Hepatol (Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association)
[2020, :]

Cited: 0 times

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