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https://www.readbyqxmd.com/read/28267049/the-influence-of-methotrexate-treatment-on-male-fertility-and-pregnancy-outcome-after-paternal-exposure
#1
Anne Grosen, Jens Kelsen, Christian Lodberg Hvas, Emanuelle Bellaguarda, Stephen B Hanauer
BACKGROUND: Inflammatory bowel disease incidence peaks during the reproductive years. Methotrexate (MTX) is frequently used for inflammatory bowel disease, but its use during pregnancy is contraindicated in women because of teratogenic effects. The aim of this review is to investigate the influence of MTX on male fertility and pregnancy outcomes after paternal MTX exposure. METHODS: A systematic literature search was performed by applying 2 focus areas, "methotrexate" and "male fertility or pregnancy outcome...
April 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28238954/histologic-normalization-occurs-in-ulcerative-colitis-and-is-associated-with-improved-clinical-outcomes
#2
Britt Christensen, Stephen B Hanauer, Jonathan Erlich, Olufemi Kassim, Peter R Gibson, Jerrold R Turner, John Hart, David T Rubin
BACKGROUND & AIMS: Mucosal healing, determined by histologic analysis, is a potential therapeutic target for patients with ulcerative colitis (UC). However, the histologic features of tissue normalization, as an outcome of treatment, have not been well described. We examined the prevalence and predictive values of normalization of the colonic mucosa, based on histologic analysis (histologic normalization) in patients with UC, and determined its association with risk of clinical relapse, compared to disease quiescence and mucosal healing...
February 23, 2017: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28164249/extrapolation-and-interchangeability-of-infliximab-and-adalimumab-in-inflammatory-bowel-disease
#3
REVIEW
Shannon Chang, Stephen Hanauer
Infliximab and adalimumab biosimilars have been approved by the FDA and European Medicines Agency and have already been introduced to the international market. Availability into the US market is imminent. Biosimilars are highly similar to the reference biologic product but should not be referred to as, nor equated with, generic medications as no two biosimilars can ever be identical. Regulatory pathways for biosimilar approval consider the totality of evidence for biosimilar approvals, but the preponderance of development relies on analytic and functional testing and allows extrapolation between indications to reduce the financial burden of completing comparative clinical trials for each indication...
March 2017: Current Treatment Options in Gastroenterology
https://www.readbyqxmd.com/read/27986473/issue-highlights
#4
Stephen B Hanauer
No abstract text is available yet for this article.
December 13, 2016: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/27959607/ustekinumab-as-induction-and-maintenance-therapy-for-crohn-s-disease
#5
RANDOMIZED CONTROLLED TRIAL
Brian G Feagan, William J Sandborn, Christopher Gasink, Douglas Jacobstein, Yinghua Lang, Joshua R Friedman, Marion A Blank, Jewel Johanns, Long-Long Gao, Ye Miao, Omoniyi J Adedokun, Bruce E Sands, Stephen B Hanauer, Severine Vermeire, Stephan Targan, Subrata Ghosh, Willem J de Villiers, Jean-Frédéric Colombel, Zsolt Tulassay, Ursula Seidler, Bruce A Salzberg, Pierre Desreumaux, Scott D Lee, Edward V Loftus, Levinus A Dieleman, Seymour Katz, Paul Rutgeerts
Background Ustekinumab, a monoclonal antibody to the p40 subunit of interleukin-12 and interleukin-23, was evaluated as an intravenous induction therapy in two populations with moderately to severely active Crohn's disease. Ustekinumab was also evaluated as subcutaneous maintenance therapy. Methods We randomly assigned patients to receive a single intravenous dose of ustekinumab (either 130 mg or approximately 6 mg per kilogram of body weight) or placebo in two induction trials. The UNITI-1 trial included 741 patients who met the criteria for primary or secondary nonresponse to tumor necrosis factor (TNF) antagonists or had unacceptable side effects...
November 17, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27825894/vitamin-d-levels-and-outcomes-in-inflammatory-bowel-disease-chicken-or-egg
#6
EDITORIAL
Stephen B Hanauer
No abstract text is available yet for this article.
November 5, 2016: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/27780886/development-of-an-index-to-define-overall-disease-severity-in-ibd
#7
Corey A Siegel, Cynthia B Whitman, Brennan M R Spiegel, Brian Feagan, Bruce Sands, Edward V Loftus, Remo Panaccione, Geert D'Haens, Charles N Bernstein, Richard Gearry, Siew C Ng, Gerassimos J Mantzaris, Balfour Sartor, Mark S Silverberg, Robert Riddell, Ioannis E Koutroubakis, Colm O'Morain, Peter L Lakatos, Dermot P B McGovern, Jonas Halfvarson, Walter Reinisch, Gerhard Rogler, Wolfgang Kruis, Curt Tysk, Stefan Schreiber, Silvio Danese, William Sandborn, Anne Griffiths, Bjorn Moum, Christoph Gasche, Francesco Pallone, Simon Travis, Julian Panes, Jean-Frederic Colombel, Stephen Hanauer, Laurent Peyrin-Biroulet
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...
October 25, 2016: Gut
https://www.readbyqxmd.com/read/27622191/primary-adenocarcinoma-of-an-ileostomy-in-crohn-s-disease
#8
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
https://www.readbyqxmd.com/read/27585411/interpreting-registrational-clinical-trials-of-biological-therapies-in-adults-with-inflammatory-bowel-diseases
#9
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
https://www.readbyqxmd.com/read/27400222/reinduction-with-certolizumab-pegol-in-patients-with-crohn-s-disease-experiencing-disease-exacerbation-7-year-data-from-the-precise-4-study
#10
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
https://www.readbyqxmd.com/read/27372735/aminosalicylates-for-induction-of-remission-or-response-in-crohn-s-disease
#11
REVIEW
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...
July 3, 2016: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/27318066/evaluation-of-a-proximity-card-authentication-system-for-health-care-settings
#12
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
https://www.readbyqxmd.com/read/27281309/serum-25-hydroxyvitamin-d-concentration-is-inversely-associated-with-mucosal-inflammation-in-patients-with-ulcerative-colitis
#13
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
https://www.readbyqxmd.com/read/27144850/ozanimod-induction-and-maintenance-treatment-for-ulcerative-colitis
#14
RANDOMIZED CONTROLLED TRIAL
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
https://www.readbyqxmd.com/read/27086002/integrating-adolescents-and-young-adults-into-adult-centered-care-for-ibd
#15
REVIEW
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
https://www.readbyqxmd.com/read/27084110/issue-highlights
#16
Stephen B Hanauer
No abstract text is available yet for this article.
June 2016: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/26982709/oral-or-topical-5-asa-in-ulcerative-colitis
#17
REVIEW
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
https://www.readbyqxmd.com/read/26958988/bowel-ultrasonography-in-the-management-of-crohn-s-disease-a-review-with-recommendations-of-an-international-panel-of-experts
#18
REVIEW
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
https://www.readbyqxmd.com/read/26850690/the-crohn-s-disease-ulcerative-colitis-clinical-appraisal
#19
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
https://www.readbyqxmd.com/read/26849718/o-001%C3%A2-a-multicenter-double-blind-placebo-controlled-phase3-study-of-ustekinumab-a-human-il-12-23p40-mab-in-moderate-service-crohn-s-disease-refractory-to-anti-tfn%C3%AE-uniti-1
#20
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
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