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https://www.readbyqxmd.com/read/27917076/the-cost-effectiveness-of-vedolizumab-for-inflammatory-bowel-disease-a-review-of-the-current-literature
#1
Yecheskel Schneider, Monica Saumoy, Shirley Cohen-Mekelburg, Adam F Steinlauf, Ellen J Scherl
The United States spends a greater share per gross domestic product on health care than any other developed country in the world. Cost-conscious, high-value care has an important role in the practice of medicine. Inflammatory bowel disease (IBD) affects 1.6 million people in the United States and is responsible for significant health care costs, with estimates as high as $31.6 billion annually, a large portion of which is attributable to the use of biologic therapies. As the number of therapeutic targets for IBD expands, gastroenterologists can anticipate the arrival of novel therapeutic agents on the market, and these may carry significant costs...
October 2016: Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/27890854/association-between-low-trough-levels-of-vedolizumab-during-induction-therapy-for-inflammatory-bowel-diseaseswith-need-for-additional-doses-within-6-months
#2
Nicolas Williet, Gilles Boschetti, Marion Fovet, Thomas Di Bernado, Pierre Claudez, Emilie Del Tedesco, Camille Jarlot, Leslie Rinaldi, Anne Berger, Jean-Marc Phelip, Bernard Flourie, Stéphane Nancey, Stéphane Paul, Xavier Roblin
BACKGROUND & AIMS: We investigated whether serum trough levels of vedolizumab, a humanized monoclonal antibody against integrin alpha 4 beta 7, during the induction phase of treatment can determine whether patients will need additional doses (optimization of therapy) within the first 6 months. METHODS: We conducted an observational study of 47 consecutive patients with Crohn's disease (CD; n=31) or ulcerative colitis (UC; n=16) who had not responded to 2 previous treatment regimens with antagonists of tumor necrosis factor and were starting therapy with vedolizumab at 2 hospitals in France, from June 2014 through April 2016...
November 24, 2016: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/27862107/systematic-review-with-meta-analysis-comparative-efficacy-of-immunosuppressants-and-biologics-for-reducing-hospitalisation-and-surgery-in-crohn-s-disease-and-ulcerative-colitis
#3
REVIEW
E J Mao, G S Hazlewood, G G Kaplan, L Peyrin-Biroulet, A N Ananthakrishnan
INTRODUCTION: Crohn's disease (CD) and ulcerative colitis (UC) have a progressive course leading to hospitalisation and surgery. The ability of existing therapies to alter disease course is not clearly defined. AIM: To investigate the comparative efficacy of currently available inflammatory bowel disease (IBD) therapies to reduce hospitalisation and surgery. METHODS: We conducted a systematic review in MEDLINE/PubMed for randomised controlled trials (RCT) published between January 1980 and May 2016 examining efficacy of biological or immunomodulator therapy in IBD...
January 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/27714831/vedolizumab-provides-clinical-benefit-over-1-year-in-patients-with-active-inflammatory-bowel-disease-a-prospective-multicenter-observational-study
#4
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)...
December 2016: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/27695501/effectiveness-and-safety-of-vedolizumab-for-treatment-of-crohn-s-disease-a-systematic-review-and-meta-analysis
#5
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
https://www.readbyqxmd.com/read/27686963/safety-profile-of-biologic-drugs-in-the-therapy-of-crohn-disease-a-systematic-review-and-network-meta-analysis
#6
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
https://www.readbyqxmd.com/read/27683800/long-term-efficacy-of-vedolizumab-for-ulcerative-colitis
#7
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 May 22, 2009 to June 27, 2013...
September 28, 2016: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/27683798/long-term-efficacy-of-vedolizumab-for-crohn-s-disease
#8
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
https://www.readbyqxmd.com/read/27639327/efficacy-of-vedolizumab-induction-and-maintenance-therapy-in-patients-with-ulcerative-colitis-regardless-of-prior-exposure-to-tnf-antagonists
#9
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
https://www.readbyqxmd.com/read/27598742/vedolizumab-therapy-in-severe-pediatric-inflammatory-bowel-disease
#10
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
https://www.readbyqxmd.com/read/27543504/postoperative-outcomes-in-vedolizumab-treated-patients-undergoing-abdominal-operations-for-inflammatory-bowel-disease
#11
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
https://www.readbyqxmd.com/read/27542130/multi-center-experience-of-vedolizumab-effectiveness-in-pediatric-inflammatory-bowel-disease
#12
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
https://www.readbyqxmd.com/read/27466173/submucosal-plexitis-as-a-predictive-factor-for-postoperative-endoscopic-recurrence-in-patients-with-crohn-s-disease-undergoing-a-resection-with-ileocolonic-anastomosis-results-from-a-prospective-single-centre-study
#13
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
https://www.readbyqxmd.com/read/27422740/vedolizumab-pharmacokinetics-pharmacodynamics-safety-and-tolerability-following-administration-of-a-single-ascending-intravenous-dose-to-healthy-volunteers
#14
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
https://www.readbyqxmd.com/read/27387455/management-of-inflammatory-bowel-disease-in-the-elderly
#15
REVIEW
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
https://www.readbyqxmd.com/read/27362721/-ibd-crohn-s-disease
#16
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
https://www.readbyqxmd.com/read/27306074/the-next-wave-of-biological-agents-for-the-treatment-of-ibd-evidence-from-cochrane-reviews
#17
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
https://www.readbyqxmd.com/read/27296941/the-real-world-effectiveness-and-safety-of-vedolizumab-for-moderate-severe-crohn-s-disease-results-from-the-us-victory-consortium
#18
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
https://www.readbyqxmd.com/read/27292108/vedolizumab-compared-with-certolizumab-in-the-therapy-of-crohn-disease-a-systematic-review-and-indirect-comparison
#19
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
https://www.readbyqxmd.com/read/27269902/report-pharmacotherapy-for-moderate-to-severe-inflammatory-bowel-disease-evolving-strategies
#20
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
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