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Clinical trials in ibd

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https://www.readbyqxmd.com/read/28209624/tofacitinib-for-induction-and-maintenance-therapy-of-crohn-s-disease-results-of-two-phase-iib-randomised-placebo-controlled-trials
#1
Julian Panés, William J Sandborn, Stefan Schreiber, Bruce E Sands, Séverine Vermeire, Geert D'Haens, Remo Panaccione, Peter D R Higgins, Jean-Frederic Colombel, Brian G Feagan, Gary Chan, Michele Moscariello, Wenjin Wang, Wojciech Niezychowski, Amy Marren, Paul Healey, Eric Maller
OBJECTIVE: Tofacitinib is an oral, small-molecule Janus kinase inhibitor that is being investigated for IBD. We evaluated the efficacy and safety of tofacitinib for induction and maintenance treatment in patients with moderate-to-severe Crohn's disease (CD). DESIGN: We conducted two randomised, double-blind, placebo-controlled, multicentre phase IIb studies. Adult patients with moderate-to-severe CD were randomised to receive induction treatment with placebo, tofacitinib 5 or 10 mg twice daily for 8 weeks...
February 16, 2017: Gut
https://www.readbyqxmd.com/read/28193515/infliximab-not-associated-with-increased-risk-of-malignancy-or-hemophagocytic-lymphohistiocytosis-in-pediatric-patients-with-inflammatory-bowel-disease
#2
Jeffrey S Hyams, Marla C Dubinsky, Robert N Baldassano, Richard B Colletti, Salvatore Cucchiara, Johanna Escher, William Faubion, John Fell, Benjamin D Gold, Anne Griffiths, Sibylle Koletzko, Subra Kugathasan, James Markowitz, Frank M Ruemmele, Gigi Veereman, Harland Winter, Nicholas Masel, Chu Ri Shin, Kezhen L Tang, Meena Thayu
BACKGROUND AND AIMS: Immunosuppressive therapy for inflammatory bowel disease (IBD) in pediatric patients is thought to increase risk of malignancy and lymphoproliferative disorders, including hemophagocytic lymphohistiocytosis (HLH). We compared unadjusted incidence rates and of malignancy and HLH in pediatric patients with IBD exposed to infliximab compared with patients not exposed to biologics and calculated standardized incidence ratios (SIRs). METHODS: We collected and analyzed data from 5766 participants in a prospective study of long-term outcomes of pediatric patients with IBD (NCT00606346), from 2007 through 30 June 2016...
February 10, 2017: Gastroenterology
https://www.readbyqxmd.com/read/28178876/designing-fecal-microbiota-transplant-trials-that-account-for-differences-in-donor-stool-efficacy
#3
Scott W Olesen, Thomas Gurry, Eric J Alm
Fecal microbiota transplantation is a highly effective intervention for patients suffering from recurrent Clostridium difficile, a common hospital-acquired infection. Fecal microbiota transplantation's success as a therapy for C. difficile has inspired interest in performing clinical trials that experiment with fecal microbiota transplantation as a therapy for other conditions like inflammatory bowel disease, obesity, diabetes, and Parkinson's disease. Results from clinical trials that use fecal microbiota transplantation to treat inflammatory bowel disease suggest that, for at least one condition beyond C...
January 1, 2017: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/28176515/biosimilars-in-inflammatory-bowel-disease
#4
Carla J Gargallo, Alberto Lue, Fernando Gomollón
The introduction of biologic therapies has revolutionized the treatment of inflammatory bowel disease (IBD) and has significantly improved the disease course and outcomes for many patients. Biologics are the main drivers of cost in many IBD units and biosimilars, although are not better than originators, are usually cheaper and thus can increase the availability of this type of therapy. Biosimilar are highly similar to innovator but, due to the complex structures of innovators and the variability inherent in the manufacturing process, they are no identical...
February 7, 2017: Minerva Medica
https://www.readbyqxmd.com/read/28172699/p051-use-of-digital-technology-to-boost-patient-recruitment-in-inflammatory-bowel-disease-clinical-trials
#5
Y Bouhnik, A Amiot, N Alexandre, A Attar, P K Kondamudi, C Stéfanescu
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28172524/p205-a-telemanagement-system-web-in-patients-with-complex-inflammatory-bowel-disease-design-and-implementation-of-a-randomized-clinical-trial
#6
M Aguas, J Del Hoyo, D Muñoz, R Faubel, A Barrios, B Navarro, G Bastida, B Valdivieso, P Nos
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28165883/the-role-of-il-23-in-the-treatment-of-psoriasis
#7
Lluís Puig
The IL-23/IL-17 axis is currently considered to be crucial in the pathogenesis of psoriasis. Human IL-23 is primarily produced by antigen-presenting cells and induces and maintains differentiation of Th17 cells and Th22 cells, a primary cellular source of proinflammatory cytokines such as IL-17 and IL-22, which mediate the epidermal hyperplasia, keratinocyte immune activation and tissue inflammation inherent in psoriasis. Agents that target the p40 subunit common to both IL-12 and IL-23 have shown robust clinical activity, but selectivity for IL-23p19 could offer advantages in efficacy and safety with respect to anti-p40 blockade...
February 6, 2017: Expert Review of Clinical Immunology
https://www.readbyqxmd.com/read/28165466/tauroursodeoxycholic-acid-protects-bile-acid-homeostasis-under-inflammatory-conditions-and-dampens-crohn-s-disease-like-ileitis
#8
Lien Van den Bossche, Daniel Borsboom, Sarah Devriese, Sophie Van Welden, Tom Holvoet, Lindsey Devisscher, Pieter Hindryckx, Martine De Vos, Debby Laukens
Bile acids regulate the expression of intestinal bile acid transporters and are natural ligands for nuclear receptors controlling inflammation. Accumulating evidence suggests that signaling through these receptors is impaired in inflammatory bowel disease. We investigated whether tauroursodeoxycholic acid (TUDCA), a secondary bile acid with cytoprotective properties, regulates ileal nuclear receptor and bile acid transporter expression and assessed its therapeutic potential in an experimental model of Crohn's disease (CD)...
February 6, 2017: Laboratory Investigation; a Journal of Technical Methods and Pathology
https://www.readbyqxmd.com/read/28164249/extrapolation-and-interchangeability-of-infliximab-and-adalimumab-in-inflammatory-bowel-disease
#9
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...
February 6, 2017: Current Treatment Options in Gastroenterology
https://www.readbyqxmd.com/read/28147380/promises-and-dangers-of-combination-therapy
#10
REVIEW
Wolfgang Kruis, Phuong G Nguyen, Julia Morgenstern
The efficiency of the existing methods of treating inflammatory bowel disease (IBD) is limited. There are 2 ways to address this problem - either create new treatment modalities or optimize current therapies. Optimisation may be accomplished by using combinations of established therapeutic strategies. With regard to topically acting compounds such as 5-aminosalicylic acid, combining oral and rectal preparations is a commonly used method. Another commonly used combination is anti-tumor necrosis factor (TNF)-α antibody modalities together with immunosuppressants (thiopurines, methotrexate)...
2017: Digestive Diseases
https://www.readbyqxmd.com/read/28146002/development-of-the-ibd-disk-a-visual-self-administered-tool-for-assessing-disability-in-inflammatory-bowel-diseases
#11
Subrata Ghosh, Edouard Louis, Laurent Beaugerie, Peter Bossuyt, Guillaume Bouguen, Arnaud Bourreille, Marc Ferrante, Denis Franchimont, Karen Frost, Xavier Hebuterne, John K Marshall, Ciara OʼShea, Greg Rosenfeld, Chadwick Williams, Laurent Peyrin-Biroulet
BACKGROUND: The Inflammatory bowel disease (IBD) Disability Index is a validated tool that evaluates functional status; however, it is used mainly in the clinical trial setting. We describe the use of an iterative Delphi consensus process to develop the IBD Disk-a shortened, self-administered adaption of the validated IBD Disability Index-to give immediate visual representation of patient-reported IBD-related disability. METHODS: In the preparatory phase, the IBD CONNECT group (30 health care professionals) ranked IBD Disability Index items in the perceived order of importance...
January 31, 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28144028/current-and-emerging-therapeutic-targets-for-ibd
#12
REVIEW
Markus F Neurath
Various therapeutic advances have led to a paradigm shift in the clinical management of patients with IBD. The introduction of immunosuppressive (such as azathioprine) and biologic agents (such as TNF blockers) has markedly reduced the need to use corticosteroids for therapy. Furthermore, the α4β7 integrin blocker vedolizumab has been introduced for clinical IBD therapy. Moreover, various new inhibitors of cytokines (for example, IL-6-IL-6R and IL-12-IL-23 blockers or apremilast), modulators of cytokine signalling events (for example, JAK inhibitors or SMAD7 blocker), inhibitors of transcription factors (for example, GATA3 or RORγt) and new anti-adhesion and anti-T-cell-activation and migration strategies (for example, β7 integrin, sphingosine 1-phosphate receptors and MAdCAM1 inhibitors, regulatory T-cell therapy and stem cells) are currently being evaluated in controlled clinical trials...
February 1, 2017: Nature Reviews. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28134690/mesenchymal-stem-stromal-cell-therapy-for-inflammatory-bowel-disease-an-updated-review-with-maintenance-of-remission
#13
Maneesh Dave, Palashkumar Jaiswal, Fabio Cominelli
PURPOSE OF REVIEW: There is a need for novel therapies for inflammatory bowel diseases (IBDs) that are well tolerated and effective. Currently, mesenchymal stem/stromal cells (MSCs) are being investigated in clinical trials for treatment of IBD. In this review, we update the recently published studies with an emphasis on the long-term efficacy of MSC therapy for IBD. RECENT FINDINGS: A cumulative body of data, including a recent phase III randomized controlled trial demonstrated excellent fistula healing in patients with refractory Crohn's perianal fistulae treated via local injections of MSCs and with a good safety profile...
January 2017: Current Opinion in Gastroenterology
https://www.readbyqxmd.com/read/28112419/defining-endoscopic-response-and-remission-in-ulcerative-colitis-clinical-trials-an-international-consensus
#14
L Vuitton, L Peyrin-Biroulet, J F Colombel, B Pariente, G Pineton de Chambrun, A J Walsh, J Panes, S P L Travis, J Y Mary, P Marteau
BACKGROUND: Recently, endpoints for clinical trials have been changing from measuring clinical response to mucosal healing in ulcerative colitis. Endoscopic evaluation is the current gold standard to assess mucosal lesions and has become a major measure of therapeutic efficacy in addition to patients reported outcomes. AIM: To achieve consensus on endoscopic definitions of remission and response for clinical trials in patients with ulcerative colitis. METHODS: In reaching the current international recommendations on an International Organization For the Study of Inflammatory Bowel Disease (IOIBD) initiative, we first performed a systematic review of technical aspects of endoscopic scoring systems...
January 23, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28107082/mechanistic-insight-of-probiotics-derived-anticancer-pharmaceuticals-a-road-forward-for-cancer-therapeutics
#15
Raman Kumar, Suman Dhanda
Probiotics are living organisms that confer health benefits when administered in adequate amounts. Probiotics are continuously being explored for their different health beneficiary activities. Anticancer activity is one of the most important benefits both from a preventive and therapeutic point of view. Though not many studies have been conducted to date in this area, a number suggest using laboratory animal models and different cell lines that there may be a mechanistic basis for the anticancer effects of probiotics and require more scientific justification and clinical trials...
January 20, 2017: Nutrition and Cancer
https://www.readbyqxmd.com/read/28102115/can-probiotics-modulate-human-disease-by-impacting-intestinal-barrier-function
#16
Peter A Bron, Michiel Kleerebezem, Robert-Jan Brummer, Patrice D Cani, Annick Mercenier, Thomas T MacDonald, Clara L Garcia-Ródenas, Jerry M Wells
Intestinal barrier integrity is a prerequisite for homeostasis of mucosal function, which is balanced to maximise absorptive capacity, while maintaining efficient defensive reactions against chemical and microbial challenges. Evidence is mounting that disruption of epithelial barrier integrity is one of the major aetiological factors associated with several gastrointestinal diseases, including infection by pathogens, obesity and diabetes, necrotising enterocolitis, irritable bowel syndrome and inflammatory bowel disease...
January 2017: British Journal of Nutrition
https://www.readbyqxmd.com/read/28095262/biosimilars-in-inflammatory-bowel-disease-accumulating-clinical-evidence
#17
Sean McConachie, Sheila M Wilhelm, Pramodini B Kale-Pradhan
Biologic antagonists to tumor necrosis factor alpha (TNF- α) are effective medications and have become well established in the treatment of both Crohn's disease and ulcerative colitis. Biosimilar medications, which are medications deemed to be equivalent to reference biologic products in terms of clinical effectiveness, safety, pharmacokinetic analysis, and immunogenicity, have now been approved in inflammatory bowel diseases (IBD) based on indication exploration from clinical data in alternate disease states...
January 29, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28079619/the-importance-and-challenges-of-dietary-intervention-trials-for-inflammatory-bowel-disease
#18
James D Lewis, Lindsey Albenberg, Dale Lee, Mario Kratz, Klaus Gottlieb, Walter Reinisch
Inflammatory bowel disease is believed to be caused by a combination of genetic and environmental stimuli such as our diet. Diets high in meat and fats and low in fruits and vegetables have been associated with new-onset inflammatory bowel disease. This has triggered interest in using dietary modification as a treatment. The 3 principle models of dietary intervention are supplementation with selected dietary components, exclusion of selected dietary components, or use of dietary formulas in place of a normal diet...
February 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28078997/lipoprotein-a-and-cardiovascular-risk-the-show-must-go-on
#19
Niki Katsiki, Khalid Al-Rasadi, Dimitri P Mikhailidis
Lipoprotein (a) [Lp(a)] is an independent but moderate, predictor for coronary heart disease (CHD) prevalence and severity. Several established and emerging cardiovascular (CV) risk factors including age, gender, ethnicity, smoking, dyslipidemia, hypertension, obesity, type 2 diabetes mellitus, alcohol consumption, arterial stiffness and hyperuricemia have been linked to Lp(a) metabolism. Apart from CHD, Lp(a) has been also associated with non-cardiac vascular diseases and diseases associated with increased CV risk such as chronic kidney disease, metabolic syndrome, non-alcoholic fatty liver disease, erectile dysfunction, obstructive sleep apnea syndrome, inflammatory bowel diseases and human immunodeficiency virus infection...
January 12, 2017: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/28042386/endoscopic-evaluation-in-diagnosis-and-management-of-inflammatory-bowel-disease
#20
REVIEW
Carthage P Moran, Barra Neary, Glen A Doherty
Endoscopy is a keystone in the management of patients with inflammatory bowel disease (IBD). It is the fundamental diagnostic tool for IBD, and can help discern between ulcerative colitis and Crohn's disease. Endoscopic assessment provides an objective end point in clinical trials, and identifies patients in clinical practice who may benefit from treatment escalation and may assist risk stratification in patients seeking to discontinue therapy. Recent advances in endoscopic assessment of patients with IBD include video capsule endoscopy, and chromoendoscopy...
December 16, 2016: World Journal of Gastrointestinal Endoscopy
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