Read by QxMD icon Read

vedolizumab crohn's

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
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
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
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
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
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
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
Maria Rosario, Timothy Wyant, Timothy Leach, Serap Sankoh, Catherine Scholz, Asit Parikh, Irving Fox, Brian G Feagan
BACKGROUND AND OBJECTIVES: Vedolizumab, a humanized monoclonal antibody against the α4β7 integrin, is indicated for treatment of moderately to severely active ulcerative colitis or Crohn's disease. In this placebo-controlled, double-blind, randomized, single ascending-dose study, the pharmacokinetics, pharmacodynamics, safety, and tolerability of vedolizumab were evaluated in healthy volunteers. METHODS: Forty-nine participants (in five cohorts) were randomly assigned in a 4:1 ratio to receive a single intravenous infusion of either vedolizumab (0...
November 2016: Clinical Drug Investigation
Elizabeth S John, Kristina Katz, Mark Saxena, Sita Chokhavatia, Seymour Katz
A substantial and growing proportion of patients with inflammatory bowel disease (IBD) are elderly, and these patients require tailored treatment strategies. However, significant challenges exist in the management of this population due to the paucity of data. Establishing the initial diagnosis and assessing the etiology of future symptoms and flares can be challenging as several other prevalent diseases can masquerade as IBD, such as ischemic colitis, diverticular disease, and infectious colitis. Important pharmacologic considerations include reduced glomerular filtration rate and drug-drug interactions in the elderly...
September 2016: Current Treatment Options in Gastroenterology
Francesco Pallone, Emma Calabrese
Crohn's disease (CD) is a chronic inflammatory disorder that primarily affects small intestine and colon and causes tissue damage. The aetiology of CD is unknown, but a large body of evidence suggests that the pathological process is driven by excessive immune response, which is direct against components of the luminal flora and sustained by defects in counter-regulatory mechanisms. CD is a transmural progressive and destructive disease leading to irreversible bowel damage characterized by stenosis of the intestinal lumen and penetrating lesions such as fistulas and abscesses...
June 2016: Recenti Progressi in Medicina
Reena Khanna, Nilesh Chande, Séverine Vermeire, William J Sandborn, Claire E Parker, Brian G Feagan
Multiple new biological treatments for Crohn's disease and ulcerative colitis are becoming available. Specifically, vedolizumab and ustekinumab are monoclonal antibodies that target molecular pathways relevant to disease pathogenesis. What can Cochrane reviews tell us about the efficacy, safety, and immunogenicity of these new agents? A Cochrane inflammatory bowel disease group symposium held at the 2015 Digestive Diseases Week annual meeting addressed these questions. This article reviews the data presented at that session...
July 2016: Inflammatory Bowel Diseases
Parambir S Dulai, Siddharth Singh, Xiaoqian Jiang, Farhad Peerani, Neeraj Narula, Khadija Chaudrey, Diana Whitehead, David Hudesman, Dana Lukin, Arun Swaminath, Eugenia Shmidt, Shuang Wang, Brigid S Boland, John T Chang, Sunanda Kane, Corey A Siegel, Edward V Loftus, William J Sandborn, Bruce E Sands, Jean-Frederic Colombel
OBJECTIVES: We assessed the real-world effectiveness and safety of vedolizumab (VDZ) in moderate-severe Crohn's disease (CD). METHODS: Retrospective cohort study of seven medical centers, from May 2014 to December 2015. Adults with moderate-severe CD treated with VDZ, with follow-up after initiation of therapy, were included. Using the multivariable Cox proportional hazard analyses, we identified independent predictors of clinical remission or mucosal healing with VDZ...
August 2016: American Journal of Gastroenterology
Paweł Kawalec, Pawel Moćko, Andrzej Pilc, Maria Radziwon-Zalewska, Iwona Malinowska-Lipień
OBJECTIVES: The increasing prevalence of Crohn disease (CD) underscores the need to identify new effective drugs, which is particularly important for patients who do not respond or do not tolerate standard biologic therapies. The purpose of this analysis was to compare the efficacy and safety of vedolizumab and certolizumab pegol in patients with active moderate to severe CD. METHODS: This analysis was prepared according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines...
August 2016: Pharmacotherapy
Bryan L Love
Moderate to severe disease causes substantial morbidity in inflammatory bowel disease (IBD). The approach to pharmacotherapy for patients with moderate to severe ulcerative colitis and Crohn's disease is undergoing a fundamental transformation to change the course of disease in these patients. Disease severity is being redefined to consider the impact on the patient, its inflammatory burden, and the disease course. Prevention of disease progression and complications are replacing symptomatic remission as the goal of therapy...
March 2016: American Journal of Managed Care
Tim Wyant, Eric Fedyk, Brihad Abhyankar
Vedolizumab is a novel therapeutic monoclonal antibody recently approved for the treatment of moderately to severely active ulcerative colitis and Crohn's disease in adults who have failed at least one conventional therapy. An integrin antagonist, vedolizumab binds to the α4β7 integrin which is expressed specifically by a subset of gastrointestinal-homing T lymphocytes. The binding of α4β7 integrin to mucosal addressin cell adhesion molecule-1 expressed on the surface of mucosal endothelial cells is a crucial component of the gut-selective homing mechanism for lymphocytes...
June 1, 2016: Journal of Crohn's & Colitis
Namita Singh, Rasika Deshpande, Shervin Rabizadeh, Marla Dubinsky
OBJECTIVES: Natalizumab is a humanized monoclonal antibody inhibiting lymphocyte migration and prescribed in patients with Crohn disease (CD) failing anti-tumor necrosis factor (TNF) therapies. Because of the risk of progressive multifocal leukoencephalopathy in patients with John Cunningham virus (JCV) positive, natalizumab is not widely used in clinical practice. Published experience of the use of natalizumab in pediatric patients is lacking. We aimed to describe the experience of natalizumab in patients with CD, including those who are JCV positive, at a tertiary care pediatric inflammatory bowel disease center...
June 2016: Journal of Pediatric Gastroenterology and Nutrition
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"