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B Eksteen, J Heatherington, J Oshiomogo, R Panaccione, G Kaplan, S Ghosh
This article has been retracted: please see Elsevier Policy on Article Withdrawal ( The abstract authors and presenters of PS124 - EFFICACY AND SAFETY OF INDUCTION DOSING OF VEDOLIZUMAB FOR REDUCING BILIARY INFLAMMATION IN PRIMARY SCLEROSING CHOLANGITIS (PSC) IN INDIVIDUALS WITH INFLAMMATORY BOWEL DISEASE submitted and presented at ILC 2016 have raised concerns that the source data in some cases are inconsistent and requires further evaluation to determine the true magnitude of effect...
2016: Journal of Hepatology
Her Hsin Tsai, Christopher Black
Introduction Vedolizumab is a novel humanised monoclonal IgG1 antibody gut selective anti-integrin specifically targeting α4β7 integrins in the gut and found to be efficacious in the treatment of ulcerative colitis. Areas covered Research investigating the cost-effectiveness of vedolizumab is limited. This review considers data from the manufacturers, the evidence research group commissioned by NICE to conduct a single technology appraisal, and the decision of NICE itself to appraise what is currently known about the cost-effectiveness of vedolizumab for moderately to severely active ulcerative from a UK perspective...
October 11, 2016: Expert Review of Pharmacoeconomics & Outcomes Research
A Stallmach, C Langbein, R Atreya, T Bruns, A Dignass, K Ende, J Hampe, F Hartmann, M F Neurath, J Maul, J C Preiss, R Schmelz, B Siegmund, H Schulze, N Teich, U von Arnim, D C Baumgart, C Schmidt
BACKGROUND: Vedolizumab, a monoclonal antibody targeting the α4β7-integrin, is effective in inducing and maintaining clinical remission in Crohn's disease and ulcerative colitis according to randomised clinical trials. AIM: To determine the long-term effectiveness of vedolizumab in a real-world clinical setting. METHODS: This observational registry assessed the clinical outcome in patients treated with vedolizumab for clinically active Crohn's disease (n = 67) or ulcerative colitis (n = 60)...
October 7, 2016: Alimentary Pharmacology & Therapeutics
Makoto Naganuma, Shinta Mizuno, Kosaku Nanki, Shinya Sugimoto, Takanori Kanai
Recently, several medical treatments for ulcerative colitis (UC) have been developed, including 5-aminosalicylic acids (5-ASAs), corticosteroids, thiopurine, calcineurin inhibitors, and anti-tumor necrosis factor (TNF) α treatments. Treatment options including calcineurin inhibitors and anti-TNF treatment for refractory UC are discussed in this article. Furthermore, upcoming treatments are introduced, such as golimumab, vedolizumab, AJM300, tofacitinib. Budesonide foamwill be used as one treatment option in patients with distal colitis...
October 3, 2016: Clinical Journal of Gastroenterology
Paweł Moćko, Paweł Kawalec, Beata Smela-Lipińska, Andrzej Pilc
INTRODUCTION: The aim of this systematic review (SR) and meta-analysis was to assess the efficacy and safety of vedolizumab in the treatment of Crohn's disease (CD). MATERIAL AND METHODS: A systematic literature search was conducted in Medline/PubMed, Embase and Cochrane Library until 25 January, 2015. Included studies were critically appraised according to the PRISMA protocol. Assessment in specified subgroups of CD patients and meta-analysis with Revman software were performed...
October 1, 2016: Archives of Medical Science: AMS
Paweł Moćko, Paweł Kawalec, Andrzej Pilc
BACKGROUND: Crohn disease (CD) is an inflammatory bowel disease which occurs especially in developed countries of Western Europe and North America. The aim of the study was to compare the safety profile of biologic drugs in patients with CD. METHODOLOGY: A systematic literature search was performed using PubMed, Embase, and CENTRAL databases, until April 27, 2016. We included randomized controlled trials (RCTs) that compared the safety of biologic drugs (infliximab, adalimumab, vedolizumab, certolizumab pegol, and ustekinumab) with one another or with placebo in patients with CD...
August 1, 2016: Pharmacological Reports: PR
Edward V Loftus, Jean-Frédéric Colombel, Brian G Feagan, Severine Vermeire, William J Sandborn, Bruce E Sands, Silvio Danese, Geert R D'Haens, Arthur Kaser, Remo Panaccione, David T Rubin, Ira Shafran, Megan McAuliffe, Arpeat Kaviya, Serap Sankoh, Reema Mody, Brihad Abhyankar, Michael Smyth
BACKGROUND AND AIMS: The GEMINI long-term safety (LTS) study is a continuing phase 3 trial investigating the safety and efficacy of vedolizumab, an α4β7 integrin antagonist for ulcerative colitis (UC) and Crohn's disease. We provide an interim analysis of efficacy in patients with UC. METHODS: Patients from the C13004 and GEMINI 1 studies and a cohort of vedolizumab-naïve patients received open-label vedolizumab every 4 weeks. Interim data were collected from 22 May 2009 to 27 June 2013...
September 28, 2016: Journal of Crohn's & Colitis
Severine Vermeire, Edward V Loftus, Jean-Frédéric Colombel, Brian G Feagan, William J Sandborn, Bruce E Sands, Silvio Danese, Geert R D'Haens, Arthur Kaser, Remo Panaccione, David T Rubin, Ira Shafran, Megan McAuliffe, Arpeat Kaviya, Serap Sankoh, Reema Mody, Brihad Abhyankar, Michael Smyth
BACKGROUND AND AIMS: Vedolizumab is a gut-selective α4β7 integrin antagonist therapy for ulcerative colitis and Crohn's disease. The GEMINI long-term safety (LTS) trial is an ongoing open-label study investigating the safety of vedolizumab. We present interim exploratory analyses of efficacy in patients with Crohn's disease. METHODS: Patients from the C13004, GEMINI 2, and GEMINI 3 studies and vedolizumab-naïve patients could enrol in GEMINI LTS and received vedolizumab every 4 weeks...
September 28, 2016: Journal of Crohn's & Colitis
Philippe A R R Pijls, Lennard P L Gilissen
BACKGROUND: The treatment of patients with inflammatory bowel diseases has been revolutionized by the introduction of biological therapy with TNF-alpha blockers. However, TNF-alpha blockers are also associated with a wide variety of dermatological side effects, such as local skin infections, psoriasis and eczema. A new biological therapy, targeting the gut-specific adhesion molecule alpha4beta7 integrin, is the humanized monoclonal IgG1 antibody vedolizumab. Vedolizumab prevents leukocyte migration to the gastrointestinal tract, thereby reducing inflammation...
September 1, 2016: Digestive and Liver Disease
Brian G Feagan, David T Rubin, Silvio Danese, Severine Vermeire, Brihad Abhyankar, Serap Sankoh, Alexandra James, Michael Smyth
BACKGROUND & AIMS: The efficacy and safety of vedolizumab, a humanized immunoglobulin G1 monoclonal antibody against the integrin α4β7, was demonstrated in multicenter, phase 3, randomized, placebo-controlled trials in patients with moderately to severely active ulcerative colitis (UC) or Crohn's disease. We analyzed data from 1 of these trials to determine the effects of vedolizumab therapy in patients with UC, based on past exposure to anti-tumor necrosis factor (TNF) agents. METHODS: We performed a post-hoc analysis data from the GEMINI 1 study, collected from 464 patients who received vedolizumab or placebo but had not received a previous TNF antagonist (naïve to TNF antagonists) and 367 patients with an inadequate response, loss of response, or intolerance to TNF antagonists (failure of TNF antagonists)...
September 14, 2016: Clinical Gastroenterology and Hepatology
Paweł Moćko, Paweł Kawalec, Andrzej Pilc
BACKGROUND AND OBJECTIVES: Biologic drugs are used in innovative therapies for the management of inflammatory bowel diseases (IBDs). The aim of this study was to compare the safety profile of biologic drugs in patients with IBD. METHODS: A systematic literature search was performed using PubMed, Embase, and CENTRAL databases, up to 22 August 2016. We included randomized, placebo-controlled, or head-to-head clinical trials that compared the safety of different biologics in patients with IBDs...
September 7, 2016: Clinical Drug Investigation
Máire A Conrad, Ronen E Stein, Elizabeth C Maxwell, Lindsey Albenberg, Robert N Baldassano, Noor Dawany, Andrew B Grossman, Petar Mamula, David A Piccoli, Judith R Kelsen
BACKGROUND: Vedolizumab is effective for inducing and maintaining remission in adults with inflammatory bowel disease (IBD); however, there is limited pediatric data. This study aimed to describe the adverse events and clinical response to vedolizumab in refractory pediatric IBD. METHODS: Disease activity indices, clinical response, concomitant medication use, and adverse events were measured over 22 weeks in an observational prospective cohort study of children with refractory IBD who had failed anti-tumor necrosis factor therapy and subsequently initiated vedolizumab therapy...
October 2016: Inflammatory Bowel Diseases
Tiong Yeng Lim, Polychronis Pavlidis, Shraddha Gulati, Tasneem Pirani, Mark Samaan, Guy Chung-Faye, Patrick Dubois, Peter Irving, Michael Heneghan, BuʼHussain Hayee
No abstract text is available yet for this article.
October 2016: Inflammatory Bowel Diseases
Alessandro Armuzzi, Paolo Gionchetti, Marco Daperno, Silvio Danese, Ambrogio Orlando, Maria Lia Scribano, Maurizio Vecchi, Fernando Rizzello
No abstract text is available yet for this article.
September 2016: Digestive and Liver Disease
Amy L Lightner, Laura E Raffals, Kellie L Mathis, Robert R Cima, Chung Sang Tse, John H Pemberton, Eric J Dozois, Edward V Loftus
INTRODUCTION: Vedolizumab was recently approved by the Food and Drug Administration for the treatment of moderate to severe ulcerative colitis [UC] and Crohn's disease [CD]. No study to date has examined the rate of postoperative infectious complications among patients who received vedolizumab in the perioperative period. We sought to determine the 30-day postoperative infectious complication rate among inflammatory bowel disease [IBD] patients who received vedolizumab within 12 weeks of an abdominal operation as compared to patients who received tumour necrosis factor α [TNFα] inhibitors or no biological therapy...
August 19, 2016: Journal of Crohn's & Colitis
Sebastian Zundler, Daniela Schillinger, Anika Fischer, Raja Atreya, Rocío López-Posadas, Alastair Watson, Clemens Neufert, Imke Atreya, Markus F Neurath
OBJECTIVE: Therapeutically targeting lymphocyte adhesion is of increasing relevance in IBD. Yet, central aspects of the action of antiadhesion compounds are incompletely understood. We investigated the role of αEβ7 and α4β7 integrins and their blockade by vedolizumab and etrolizumab for trafficking of IBD T lymphocytes in an in vivo model of homing to and retention in the inflamed gut. DESIGN: We explored integrin expression in patients with IBD by flow cytometry and immunohistochemistry, while regulation of integrins was studied in T cell cultures...
August 19, 2016: Gut
Namita Singh, Shervin Rabizadeh, Jacqueline Jossen, Nanci Pittman, Morgan Check, Ghonche Hashemi, Becky L Phan, Jeffrey S Hyams, Marla C Dubinsky
BACKGROUND: Though vedolizumab has received regulatory approval for the treatment of Crohn's disease (CD) and ulcerative colitis (UC) in adults, there is increasing off-label use in children. AIMS: To describe the experience with vedolizumab in pediatric inflammatory bowel disease (IBD) patients at 3 tertiary IBD centers and examine predictors of remission. METHODS: A retrospective review identified pediatric IBD patients (age < 18 yrs) receiving vedolizumab...
September 2016: Inflammatory Bowel Diseases
Amy Hsin-Chieh Hsieh, Mutaz Ferman, Michael P Brown, Jane M Andrews
Use of the immune checkpoint inhibitors, ipilimumab and nivolumab, has revolutionised treatment in patients with metastatic melanoma. However, these drugs can cause an autoimmune enterocolitis, with diarrhoea as the presenting symptom. This is conventionally managed by prompt institution of corticosteroid therapy if moderate diarrhoea (3-6 times/day; grade 2) is present for >5 days or if diarrhoea is severe (>6 times/day; grade 3). We report a case of steroid-dependent ipilimumab-induced colitis successfully treated with vedolizumab (an inhibitor of memory T-cell trafficking to the gut), after which complete withdrawal of corticosteroid was achieved...
2016: BMJ Case Reports
Rachid Rafia, Alison Scope, Sue Harnan, John W Stevens, Matt Stevenson, Alan Lobo
As part of its single technology appraisal process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer of vedolizumab (Takeda UK) to submit evidence of the clinical effectiveness and cost effectiveness of vedolizumab for the treatment of patients with moderate-to-severe, active Crohn's disease. The School of Health and Related Research (ScHARR) at the University of Sheffield was commissioned as the Evidence Review Group (ERG) and produced a critical review of the evidence of the clinical effectiveness and cost effectiveness of the technology, based upon the company's submission to NICE...
August 1, 2016: PharmacoEconomics
Bart Lemmens, Anthony de Buck van Overstraeten, Ingrid Arijs, Xavier Sagaert, Gert Van Assche, Séverine Vermeire, Alexander Tertychnyy, Karel Geboes, Albert Wolthuis, Andre D'Hoore, Gert De Hertogh, Marc Ferrante
AIM: Ileocolonoscopy allows early detection of recurrence after surgical resection for Crohn's disease [CD]. Plexitis, defined as presence of inflammatory cells in or around enteric ganglia or nerve bundles, in the proximal surgical margin has been associated with an increased overall recurrence risk. We investigated prospectively whether plexitis can predict endoscopic recurrence [ER] in a consecutive cohort of CD patients undergoing ileocolonic resection. METHODS: All CD patients undergoing ileocolonic resection in our institution between October 2009 and December 2012 were eligible for this study...
July 27, 2016: Journal of Crohn's & Colitis
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