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stephen hanauer

Kevin Liu, Meena A Prasad, Amy Lo, Emanuelle Bellaguarda, Scott Strong, Stephen B Hanauer
Although Crohn's disease has been associated with an increased risk of small bowel adenocarcinoma, primary adenocarcinoma arising from an ileostomy is a complication that has been rarely documented in Crohn's disease. Chronic small bowel inflammation may lead to development of malignancy through the dysplasia-carcinoma sequence. We report a case of a 61-year-old woman with Crohn's ileocolitis diagnosed with a primary adenocarcinoma at the ileostomy with metastases to the liver 47 years after proctocolectomy, and review the literature...
July 2016: ACG Case Reports Journal
Subrata Ghosh, William J Sandborn, Jean-Frederic Colombel, Brian G Feagan, Remo Panaccione, Stephen Hanauer, Stefan Schreiber, Laurent Peyrin-Biroulet, Severine Vermeire, Samantha Eichner, Bidan Huang, Anne M Robinson, Brandee Pappalardo
BACKGROUND: The use of biologics to treat inflammatory bowel disease is supported by robust randomized controlled trials in both ulcerative colitis and Crohn's disease. Nonetheless, an understanding of the principles of clinical trial design is necessary to extrapolate study findings to clinical practice. METHODS: We conducted a review of inflammatory bowel disease registrational clinical trials of biologics to determine how differences in trial design potentially influence results and interpretation...
November 2016: Inflammatory Bowel Diseases
Scott D Lee, David T Rubin, William J Sandborn, Charles Randall, Ziad Younes, Stefan Schreiber, David A Schwartz, Robert Burakoff, David Binion, Themos Dassopoulos, Razvan Arsenescu, Alexandra Gutierrez, Ellen Scherl, Cem Kayhan, Iram Hasan, Gordana Kosutic, Marshall Spearman, David Sen, Jason Coarse, Stephen Hanauer
BACKGROUND: Patients with Crohn's disease in whom tumor necrosis factor antagonist therapy fails have limited treatment options, and the benefit of reintroducing the same therapy remains unclear. Here, we report results from PRECiSE 4 (NCT00160706), an open-label extension study of certolizumab pegol in patients who withdrew from the placebo-controlled studies PRECiSE 1 or 2. METHODS: Patients eligible for PRECiSE 4 had Crohn's disease exacerbation on placebo or primary or secondary failure to certolizumab pegol in PRECiSE 1 or 2, and received 400 mg certolizumab pegol subcutaneously at weeks 0, 2, and 4 and every 4 weeks thereafter up to 360 weeks...
August 2016: Inflammatory Bowel Diseases
Wee-Chian Lim, Yongjun Wang, John K MacDonald, Stephen Hanauer
BACKGROUND: Randomized trials investigating the efficacy of aminosalicylates for the treatment of mildly to moderately active Crohn's disease have yielded conflicting results. A systematic review was conducted to critically examine current available data on the efficacy of sulfasalazine and mesalamine for inducing remission or clinical response in these patients. OBJECTIVES: To evaluate the efficacy of aminosalicylates compared to placebo, corticosteroids, and other aminosalicylates (alone or in combination with corticosteroids) for the treatment of mildly to moderately active Crohn's disease...
2016: Cochrane Database of Systematic Reviews
Jacqueline Fontaine, Kai Zheng, Cosmas Van De Ven, Huiyang Li, James Hiner, Kathy Mitchell, Stephen Gendler, David A Hanauer
BACKGROUND: Multiple users access computer workstations in busy clinical settings, requiring many logins throughout the day as users switch from one computer to another. This can lead to workflow inefficiencies as well as security concerns resulting from users sharing login sessions to save time. Proximity cards and readers have the potential to improve efficiency and security by allowing users to access clinical workstations simply by bringing the card near the reader, without the need for manual entry of a username and password...
August 2016: International Journal of Medical Informatics
Katherine Meckel, Yan Chun Li, John Lim, Masha Kocherginsky, Chris Weber, Anas Almoghrabi, Xindi Chen, Austin Kaboff, Farhana Sadiq, Stephen B Hanauer, Russell D Cohen, John Kwon, David T Rubin, Ira Hanan, Atsushi Sakuraba, Eugene Yen, Marc Bissonnette, Joel Pekow
BACKGROUND: Vitamin D exerts anti-inflammatory actions both in vitro and in murine models of colitis. In previous studies, we demonstrated that vitamin D protects against the development of colitis by maintaining the integrity of the intestinal mucosal barrier. OBJECTIVE: We sought to evaluate whether deficient serum 25 hydroxyvitamin D [25(OH)D] concentrations are associated with increased mucosal inflammation, a loss of epithelial junctional proteins, and an increase in mucosal inflammatory cytokines in patients with ulcerative colitis (UC)...
July 2016: American Journal of Clinical Nutrition
William J Sandborn, Brian G Feagan, Douglas C Wolf, Geert D'Haens, Severine Vermeire, Stephen B Hanauer, Subrata Ghosh, Heather Smith, Matthew Cravets, Paul A Frohna, Richard Aranda, Sheila Gujrathi, Allan Olson
BACKGROUND: Ozanimod (RPC1063) is an oral agonist of the sphingosine-1-phosphate receptor subtypes 1 and 5 that induces peripheral lymphocyte sequestration, potentially decreasing the number of activated lymphocytes circulating to the gastrointestinal tract. METHODS: We conducted a double-blind, placebo-controlled phase 2 trial of ozanimod in 197 adults with moderate-to-severe ulcerative colitis. Patients were randomly assigned, in a 1:1:1 ratio, to receive ozanimod at a dose of 0...
May 5, 2016: New England Journal of Medicine
Itishree Trivedi, Jane L Holl, Stephen Hanauer, Laurie Keefer
Planned healthcare transition, initiated in pediatric care, is a gradual process aimed at fostering the adolescent patient's disease knowledge and skills with the ultimate objective of preparing patients and families for adult-centered care. The process is critical in inflammatory bowel diseases (IBD) where there is an increased risk of non-adherence, hospitalizations, and emergency department use as young adult patients graduate from pediatric to adult-centered care. While evidence for healthcare transition in IBD is mounting, important gaps remain in the understanding of this process from the perspective of the adult gastroenterologist...
May 2016: Current Gastroenterology Reports
Stephen B Hanauer
No abstract text is available yet for this article.
June 2016: Clinical Gastroenterology and Hepatology
Stephen B Hanauer
Aminosalicylates (5-ASAs) are foundational therapies for patients with mild-moderate active ulcerative colitis (UC) and to maintain remissions. A variety of oral and topical formulations have been evaluated in both active and quiescent disease in both extensive and distal UC. This review summarizes data on pharmacokinetics and applications of oral and topical 5-ASA therapies in active and quiescent, extensive colitis and distal disease, both as monotherapies and in combination and reviews dosing and dosing intervals for oral 5-ASA in both active disease and to maintain remissions...
2016: Digestive Diseases
Emma Calabrese, Christian Maaser, Francesca Zorzi, Klaus Kannengiesser, Stephen B Hanauer, David H Bruining, Marietta Iacucci, Giovanni Maconi, Kerri L Novak, Remo Panaccione, Deike Strobel, Stephanie R Wilson, Mamoru Watanabe, Francesco Pallone, Subrata Ghosh
BACKGROUND: Bowel ultrasonography (US) is considered a useful technique for assessing mural inflammation and complications in Crohn's disease (CD). The aim of this review is to appraise the evidence on the accuracy of bowel US for CD. In addition, we aim to provide recommendations for its optimal use. METHODS: Publications were identified by literature search from 1992 to 2014 and selected based on predefined criteria: 15 or more patients; bowel US for diagnosing CD, complications, postoperative recurrence, activity; adequate reference standards; prospective study design; data reported to allow calculation of sensitivity, specificity, agreement, or correlation values; articles published in English...
May 2016: Inflammatory Bowel Diseases
Geert D'Haens, Brian Bressler, Silvio Danese, Peter Gibson, Stephen B Hanauer, William Sandborn
No abstract text is available yet for this article.
April 2016: Clinical Gastroenterology and Hepatology
William Sandborn, Christopher Gasink, Marion Blank, Yinghua Lang, Jewel Johanns, Long-Long Gao, Bruce Sands, Stephen Hanauer, Brian Feagan, Stephan Targan, Subrata Ghosh, Wim de Villiers, Jean-Frédéric Colombel, Scott Lee, Pierre Desreumaux, Edward Loftus, Severine Vermeire, Paul Rutgeerts
BACKGROUND: Interleukins 12&23 are implicated in the pathophysiology of Crohn's disease (CD). These pro-inflammatory cytokines are blocked by ustekinumab (UST). In a previous Phase 2b study (CERTIFI), UST IV induction followed by SC maintenance was shown effective in moderate-severe CD refractory to anti-TNF therapy. This Phase 3 study examined the efficacy and safety of IV UST induction in these patients. METHODS: Patients with moderate-severely active CD (CDAI 220-450) who previously failed or were intolerant to at least 1 TNF-antagonist were randomized (1:1:1) at Week (Wk) 0 to a single dose of IV placebo (PBO), UST 130 mg, or weight-based tiered UST dosing approximating 6 mg/kg (260mg [weight ≤55 kg], 390mg [weight >55 kg and ≤85 kg], 520mg [weight >85 kg])...
March 2016: Inflammatory Bowel Diseases
Noa Krugliak Cleveland, Ruben J Colman, Dylan Rodriquez, Ayal Hirsch, Russell D Cohen, Stephen B Hanauer, John Hart, David T Rubin
BACKGROUND: Historically, limits to the ability to detect dysplasia in chronic inflammatory bowel disease (IBD)-associated colitis resulted in the recommendation that neoplasia of any grade be treated by proctocolectomy. We hypothesized that with improved optical technologies, most neoplasia in colitis is now detectable and reassessed the prevalence of colitis-associated neoplasia. METHODS: We retrospectively reviewed all our patients with IBD who had pathologist-confirmed neoplasia on surveillance colonoscopy and underwent a subsequent colectomy...
March 2016: Inflammatory Bowel Diseases
Itishree Trivedi, Rishi Raj, Stephen Hanauer
No abstract text is available yet for this article.
March 2016: Clinical Gastroenterology and Hepatology
Itishree Trivedi, Stephen B Hanauer
INTRODUCTION: The incidence of Inflammatory Bowel Diseases (IBD) is rising and overall epidemiology is changing. Goals of IBD therapy are also fast changing to reflect the concept of mucosal healing. IBD management is increasingly revolving around questions of ideal positioning of biologic therapies. AREAS COVERED: This paper covers important concepts regarding two classes of biologic medications approved for treatment of IBD in the United States - anti-TNF-α agents and lymphocyte-homing antagonists...
2015: Expert Opinion on Drug Safety
Gary R Lichtenstein, Stephen B Hanauer, William J Sandborn
Ulcerative colitis (UC) is a chronic inflammatory condition associated with rectal bleeding and urgency, tenesmus, and diarrhea. Several medical therapies can be used in the treatment of UC. Aminosalicylates are widely used based on their efficacy in the induction and maintenance of remission. Although corticosteroids are effective in patients with more severe disease, systemic use is associated with significant safety concerns. The newer corticosteroid budesonide has lower systemic bioavailability and, consequently, a more favorable safety profile...
March 2015: Gastroenterology & Hepatology
Stephen B Hanauer
No abstract text is available yet for this article.
October 2015: Clinical Gastroenterology and Hepatology
Laurent Peyrin-Biroulet, Julián Panés, William J Sandborn, Séverine Vermeire, Silvio Danese, Brian G Feagan, Jean-Frédéric Colombel, Stephen B Hanauer, Beth Rycroft
Although most treatment algorithms in inflammatory bowel disease (IBD) begin with classifying patients according to disease severity, no formal validated or consensus definitions of mild, moderate, or severe IBD currently exist. There are 3 main domains relevant to the evaluation of disease severity in IBD: impact of the disease on the patient, disease burden, and disease course. These measures are not mutually exclusive and the correlations and interactions between them are not necessarily proportionate. A comprehensive literature search was performed regarding current definitions of disease severity in both Crohn's disease and ulcerative colitis, and the ability to categorize disease severity in a particular patient...
March 2016: Clinical Gastroenterology and Hepatology
Remo Panaccione, William J Sandborn, Glenn L Gordon, Scott D Lee, Alan Safdi, Shahriar Sedghi, Brian G Feagan, Stephen Hanauer, Walter Reinisch, John F Valentine, Bidan Huang, Roberto Carcereri
BACKGROUND: This study assessed the efficacy and safety of briakinumab, a human anti-IL-12/23p40 monoclonal antibody, compared with placebo for the induction and maintenance of remission in patients with moderately to severely active Crohn's disease. METHODS: In this phase 2b, multicenter, double-blind, parallel group study, 246 patients stratified by prior tumor necrosis factor-antagonist use and response, were randomized (1:1:1:3) to 4 intravenous induction regimens: placebo, 200, 400, or 700 mg briakinumab, at weeks 0/4/8...
June 2015: Inflammatory Bowel Diseases
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