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Sandro Ardizzone, Gerolamo Bevivino, Giovanni Monteleone
In Crohn's disease (CD), the tissue-damaging inflammation is sustained by defects of counter-regulatory mechanisms, which normally inhibit immune-inflammatory signals and promote repair of mucosal injury. In particular, in inflamed gut of CD patients there are elevated levels of Smad7, an intracellular protein that inhibits the function of transforming growth factor (TGF)-β1. Knockdown of Smad7 with a specific antisense oligonucleotide, named mongersen, restores TGF-β1 activity thus leading to suppression of inflammatory pathways and resolution of colitis in mice...
July 2016: Therapeutic Advances in Gastroenterology
Ole Haagen Nielsen, Jakob Benedict Seidelin, Mark Ainsworth, Mehmet Coskun
INTRODUCTION: The traditional management of inflammatory bowel disease (IBD) with sulphasalazine/5-aminosalicylic acid, glucocorticoids and immunomodulators (i.e., thiopurines and methotrexate) was nearly two decades ago extended with intravenously or subcutaneously administered biologics (i.e., tumor necrosis factor inhibitors and later gut-selective integrin antagonists). However, recently, orally administered treatments with simple, well-characterized, and stable structures consisting of either small molecules or anti-sense therapy have been devised...
June 2016: Expert Opinion on Investigational Drugs
J Kirchgesner, H Sokol
No abstract text is available yet for this article.
April 2016: Alimentary Pharmacology & Therapeutics
G Monteleone, A Di Sabatino, S Ardizzone, F Pallone, K Usiskin, X Zhan, G Rossiter, M F Neurath
BACKGROUND: In a phase 2 study, mongersen, an oral antisense oligonucleotide targeting Smad7, was effective in inducing clinical remission in approximately 60% of patients with active Crohn's disease (CD). AIM: In a post hoc analysis to evaluate those patient disease characteristics that may have influenced the efficacy and safety of mongersen therapy. METHODS: Patients with steroid-dependent/resistant, active CD were randomised to mongersen 10, 40 or 160 mg/day or placebo for 2 weeks; patients were followed for 10 weeks...
March 2016: Alimentary Pharmacology & Therapeutics
Federica Laudisi, Vincenzo Dinallo, Davide Di Fusco, Giovanni Monteleone
BACKGROUND: The etiology of Crohn's disease (CD) and ulcerative colitis (UC), the two major forms of inflammatory bowel disease (IBD) in humans, is still unknown, but evidence suggests that genetic and environmental factors interact to promote an excessive immune response that leads to tissue damage. Defects in the counter-regulatory mechanisms are also supposed to make a major contribution to the amplification and maintenance of the IBD-related inflammatory response. One such a mechanism involves TGF-β1, a cytokine synthesized by both immune and non-immune cells in the gut, which is essential in the maintenance of immune homeostasis...
2016: Current Drug Metabolism
Fernando Gomollón
In addition to immunosuppressive drugs and anti-TNF, there are a number of new options in the treatment of inflammatory bowel diseases. Vedolizumab has been approved by the FDA and EMA and has demonstrated utility both in the treatment of ulcerative colitis (UC) and Crohn's disease (CD), even in anti-TNF refractory patients. Other monoclonal antibodies with different targets such as PF-005447659 (antiMAd-CAM1), ustekinumab (anti-IL23/IL12) or MEDI2070 (anti-IL23) have shown promising results in distinct clinical scenarios...
September 2015: Gastroenterología y Hepatología
Silvio Danese, Gionata Fiorino, Laurent Peyrin-Biroulet
No abstract text is available yet for this article.
October 2015: Gastroenterology
Gerhard Rogler
After a relatively long time of failed developments and negative clinical trials in pharmacological inflammatory bowel disease (IBD) therapy we now phase a time of a great number of successful studies and new therapy principles that will most likely make it into clinical practice. This will change the landscape of IBD therapy in future markedly. Many new therapeutic principles have been developed and old ones that seemed to have failed such as anti-sense technology suddenly now provide promising results. Some initially promising therapies will need further development or have failed such as Trichuris suis ova therapy (but not helminth therapy in general), CCR9 targeted therapies or recombinant IL-10...
October 2015: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
Maria Moskaleva
No abstract text is available yet for this article.
May 2015: Deutsche Medizinische Wochenschrift
Irene Marafini, Davide Di Fusco, Emma Calabrese, Silvia Sedda, Francesco Pallone, Giovanni Monteleone
Despite the great success of anti-tumour necrosis factor-based therapies, the treatment of Crohn's disease (CD) and ulcerative colitis (UC) still remains a challenge for clinicians, as these drugs are not effective in all patients, their efficacy may wane with time, and their use can increase the risk of adverse events and be associated with the development of new immune-mediated diseases. Therefore, new therapeutic targets are currently being investigated both in pre-clinical studies and in clinical trials...
May 2015: Drugs
Giovanni Monteleone, Markus F Neurath, Sandro Ardizzone, Antonio Di Sabatino, Massimo C Fantini, Fabiana Castiglione, Maria L Scribano, Alessandro Armuzzi, Flavio Caprioli, Giacomo C Sturniolo, Francesca Rogai, Maurizio Vecchi, Raja Atreya, Fabrizio Bossa, Sara Onali, Maria Fichera, Gino R Corazza, Livia Biancone, Vincenzo Savarino, Roberta Pica, Ambrogio Orlando, Francesco Pallone
BACKGROUND: Crohn's disease-related inflammation is characterized by reduced activity of the immunosuppressive cytokine transforming growth factor β1 (TGF-β1) due to high levels of SMAD7, an inhibitor of TGF-β1 signaling. Preclinical studies and a phase 1 study have shown that an oral SMAD7 antisense oligonucleotide, mongersen, targets ileal and colonic SMAD7. METHODS: In a double-blind, placebo-controlled, phase 2 trial, we evaluated the efficacy of mongersen for the treatment of persons with active Crohn's disease...
March 19, 2015: New England Journal of Medicine
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