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Clinical trials in ibd

Rene Y Choi, Mark Asquith, James T Rosenbaum
PURPOSE OF REVIEW: The intestinal microbiome is thought to play a role in the pathogenesis of inflammatory bowel disease (IBD). There are many shared clinical manifestations between IBD and spondyloarthritis (SpA), of which the most common are peripheral arthritis and uveitis. Clinical overlap along with similar genetics between these diseases suggests a possible shared pathogenetic mechanism, which might center on the intestinal microbiota. In this review, we discuss the available evidence that SpA is a microbiome-driven disease and indicate how SpA-associated uveitis could be tied to gut dysbiosis...
March 13, 2018: Current Opinion in Rheumatology
Lesley J Scott
Intravenous ferric carboxymaltose (Ferinject® ; Injectafer® ) is a colloidal solution of nanoparticles which consist of a polynuclear iron (III)-(oxyhydr)oxide core stabilized by carboxymaltose and may be given as a single high-dose, 15-min infusion. This article reviews the clinical use of ferric carboxymaltose in various patient populations with iron deficiency (ID) [± anaemia] and briefly summarizes its pharmacological properties. Based on extensive experience in the clinical trial and real-world settings, ferric carboxymaltose is an effective and generally well tolerated treatment for rapidly replenishing iron stores and correcting anaemia in patients with ID (± anaemia) of various aetiologies, including patients with chronic heart failure (CHF), chronic kidney disease, inflammatory bowel disease or perioperative anaemia, and women with ID during pregnancy, postpartum or associated with heavy uterine bleeding...
March 2018: Drugs
Violeta Balbas-Martinez, Leire Ruiz-Cerdá, Itziar Irurzun-Arana, Ignacio González-García, An Vermeulen, José David Gómez-Mantilla, Iñaki F Trocóniz
MOTIVATION: The literature on complex diseases is abundant but not always quantitative. This is particularly so for Inflammatory Bowel Disease (IBD), where many molecular pathways are qualitatively well described but this information cannot be used in traditional quantitative mathematical models employed in drug development. We propose the elaboration and validation of a logic network for IBD able to capture the information available in the literature that will facilitate the identification/validation of therapeutic targets...
2018: PloS One
M P Sparrow
No abstract text is available yet for this article.
April 2018: Alimentary Pharmacology & Therapeutics
Frank I Scott, Gary R Lichtenstein
PURPOSE OF REVIEW: Monoclonal antibodies targeting tumor necrosis factor-alpha, integrin molecules, and interleukin-12/23 have become backbone therapies for Crohn's disease and ulcerative colitis. While clinically effective, these biologic therapies come with significant expense, contributing to overall healthcare spending in the USA. Biosimilars have the potential to significantly reduce expenditures secondary to the use of biologic medications such as infliximab and adalimumab, though their complicated manufacturing process results in inherent differences in structure when compared to the originator compounds...
March 1, 2018: Current Treatment Options in Gastroenterology
Robert P Hirten, Marietta Iacucci, Shailja Shah, Subrata Ghosh, Jean-Frederic Colombel
Current therapies used in the treatment of inflammatory bowel disease (IBD) are not effective in all patients. Biologic agents result in approximately 40% remission rates at 1 year in selected populations, prompting a growing interest in combining biologic therapy to improve outcomes. There are limited published data regarding the efficacy and safety of combination targeted therapy in IBD specifically, which include only one exploratory randomized control trial and three case reports or series. This review evaluates the published literature regarding this therapeutic paradigm in IBD and its extensive utilization in the treatment of other immune-mediated inflammatory disorders...
February 23, 2018: Clinical Gastroenterology and Hepatology
A C R Partridge, J W Bai, C F Rosen, S R Walsh, W P Gulliver, P Fleming
BACKGROUND: Pyoderma gangrenosum (PG) is a neutrophilic dermatosis with substantial morbidity. Currently, there is no consensus on gold-standard treatments. OBJECTIVES: Our primary objective was to review the effectiveness of systemic therapy for PG. METHODS: We searched Cochrane Central, Cochrane DSR, EMBASE, MEDLINE, PubMed, and Web of Science for 24 systemic therapies for PG. Primary outcomes were complete healing and clinical improvement; secondary outcomes were time-to-healing and adverse effects...
February 25, 2018: British Journal of Dermatology
Soo Young Na, Won Moon
It is important to have effective therapeutic strategies and goals in clinical practice and research of inflammatory bowel disease. Conventional end points for clinical trials in Crohn's disease and ulcerative colitis have been based on composite indices, such as the Crohn's Disease Activity Index and the Mayo Clinic Score. Although these indices have been shown to reduce the intestinal injury to some extent, satisfactory results have not been obtained in improving the quality of life of patients. Recently, alternative measures of outcome and definitions of response are being developed beyond symptoms...
February 25, 2018: Korean Journal of Gastroenterology, Taehan Sohwagi Hakhoe Chi
Ashish K Singh, Rosanne Y Hertzberger, Ulla G Knaus
Inflammatory bowel disease (IBD) is a multifactorial chronic inflammatory disease of the gastrointestinal tract, characterized by cycles of acute flares, recovery and remission phases. Treatments for accelerating tissue restitution and prolonging remission are scarce, but altering the microbiota composition to promote intestinal homeostasis is considered a safe, economic and promising approach. Although probiotic bacteria have not yet fulfilled fully their promise in clinical trials, understanding the mechanism of how they exert beneficial effects will permit devising improved therapeutic strategies...
February 12, 2018: Redox Biology
K Murray, C Reardon
Inflammatory bowel disease negatively affects the quality of life of millions of patients around the world. Although the precise etiology of the disease remains elusive, aberrant immune system activation is an underlying cause. As such, therapies that selectively inhibit immune cell activation without broad immunosuppression are desired. Inhibition of immune cell activation preventing pro-inflammatory cytokine production through neural stimulation has emerged as one such treatment. These therapeutics are based on the discovery of the cholinergic anti-inflammatory pathway, a reflex arc that induces efferent vagal nerve signaling to reduce immune cell activation and consequently mortality during septic shock...
March 2018: Neurogastroenterology and Motility: the Official Journal of the European Gastrointestinal Motility Society
A B Friedman, S J Brown, P Bampton, M L Barclay, A Chung, F A Macrae, J McKenzie, J Reynolds, P R Gibson, S B Hanauer, M P Sparrow
BACKGROUND: Thiopurine hypermethylation towards 6-methylmercaptopurine (6MMP) instead of 6-thioguanine nucleotides (6TGN) is associated with inefficacy in patients with IBD. Allopurinol reverses such hypermethylation. AIMS: To prospectively determine efficacy of allopurinol-thiopurine combination and to compare 2 doses of allopurinol. DESIGN: In a multicentre, double-blind trial, patients with clinically active or steroid-dependent IBD and thiopurine shunting were randomised to 50 or 100 mg/d allopurinol and 25% of their screening thiopurine dose, which was subsequently optimised, aiming for 6TGN of 260-500 pmol/8x108 RBCs...
February 21, 2018: Alimentary Pharmacology & Therapeutics
Jonathan H Chen, Vikram Deshpande
Primary sclerosing cholangitis (PSC) is a cholangiopathy-usually associated with inflammatory bowel disease-that leads to cirrhosis and liver failure. Based on a multitude of clinical trials, there is general consensus that PSC progression is unchanged by current therapies, including steroids. However, there are scattered reports in the literature of PSC patients responsive to steroids. Recently, several steroid-responsive PSC mimics have been described, most notably immunoglobulin G4-related sclerosing cholangitis...
February 1, 2018: International Journal of Surgical Pathology
Anne-Marie Scholten, Esther Vermeulen, Rosalie A M Dhonukshe-Rutten, Teuni Verhagen, Angeline Visscher, Anouk Olivier, Lilian Timmer, Ben J M Witteman
OBJECTIVE: In non-conventional care, high doses of vitamin B12 supplementation are used for the treatment of fatigue even in case of normal vitamin B12 blood levels. We performed a randomized placebo controlled trial to investigate the effect of surplus oral vitamin B12 supplementation on fatigue in patients with IBS or IBD. METHODS: This randomized double-blind, placebo-controlled trial included 95 out-clinic IBS and IBD patients with deactivating fatigue and normal vitamin B12 blood levels (≥150 pmol/l) aged 18-65 years...
February 2018: Clinical Nutrition ESPEN
S Ben-Horin, B Ungar, U Kopylov, A Lahat, M Yavzori, E Fudim, O Picard, Y Peled, R Eliakim, E Del Tedesco, S Paul, X Roblin
BACKGROUND: Data on combination-biologic treatment in (IBD) are still scant. AIM: To explore outcomes of patients co-exposed to anti-TNF and vedolizumab. METHODS: Patients starting vedolizumab having measurable anti-TNF levels after recently stopping adalimumab/infliximab ('VDZ-aTNF' group), were compared with control vedolizumab patients in a retrospective 1:2 matched case-control study. RESULTS: Seventy-five patients were included (25 VDZ-aTNF, 50 VDZ)...
February 15, 2018: Alimentary Pharmacology & Therapeutics
J L Damman, E A Rodriguez, A H Ali, C W Buness, K L Cox, E J Carey, K D Lindor
BACKGROUND AND AIMS: PSC is an autoimmune biliary inflammatory disorder that is often associated with inflammatory bowel disease (IBD), with 50%-75% of patients with PSC having coexisting IBD, most commonly ulcerative colitis. Currently, no medical therapies have been shown to improve the disease course or slow its progression. However, ongoing research has resulted in a growing interest in the use of antibiotics for treatment of PSC, of which vancomycin is the most studied. In this review, we summarise the current evidence on the use of vancomycin in PSC and comment on future research areas of interest...
February 7, 2018: Alimentary Pharmacology & Therapeutics
Don Husereau, Brian Feagan, Carl Selya-Hammer
Biosimilars are becoming increasingly available internationally as patents expire on the originator biologic drugs they are intended to copy. Although substitution policies seen with generic drugs are being considered as a means to reduce expenditures on biologics, some biosimilars pose particular challenges in that the act of substitution may eventually lead to increased rates of therapeutic failure. As evidence requirements from regulators do not directly address this challenge, switch trials of biosimilars have emerged that may provide further answers...
February 6, 2018: Applied Health Economics and Health Policy
Marjolijn Duijvestein, Robert Battat, Niels Vande Casteele, Geert R D'Haens, William J Sandborn, Reena Khanna, Vipul Jairath, Brian G Feagan
PURPOSE OF REVIEW: This article reviews current treatment options and strategies and provides an update on the status of drug development programs of new therapeutic agents for inflammatory bowel diseases (IBD). RECENT FINDINGS: In the past two decades, tumor necrosis factor antagonist therapy has given clinicians better treatment options. However, not all patients respond to induction therapy with these agents, and of those initially responding, up to 40% ultimately lose response due to suboptimal drug exposure (e...
February 6, 2018: Current Treatment Options in Gastroenterology
Daniël R Hoekman, Judith A Stibbe, Filip J Baert, Philip Caenepeel, Philippe Vergauwe, Martine De Vos, Daniel W Hommes, Marc A Benninga, Severine A Vermeire, Geert R D'Haens
Background and Aims: Long term outcomes of early combined immunosuppression (top-down) compared to conventional management (step-up) in recently diagnosed Crohn's disease (CD) are unknown. We aimed to investigate long-term outcomes of participants of the Step-up/Top-down-trial. Methods: Trial participants' medical records were reviewed retrospectively. For 16 semesters following the 2-year trial, we recorded: clinical activity, medication use, flares, hospitalization, surgery and fistulas...
February 1, 2018: Journal of Crohn's & Colitis
Francisco Wilker Mustafa Gomes Muniz, Keity Taminski, Juliano Cavagni, Roger Keller Celeste, Patrícia Weidlich, Cassiano Kuchenbecker Rösing
OBJECTIVE: This study aimed to systematically review clinical trials about the effect of statins as adjunct to mechanical periodontal therapy, on probing pocket depth, clinical attachment level, and intrabony defects, in comparison to mechanical periodontal therapy alone or in association with placebo. MATERIAL AND METHODS: Three databases were searched for controlled clinical trials that used any locally delivered or systemically statin as a sole adjunctive therapy to mechanical periodontal treatment...
February 2, 2018: Clinical Oral Investigations
Ben Kang, Yoon Lee, Kiwuk Lee, Young Ok Choi, Yon Ho Choe
Background: The relatively high cost and patent expiry of infliximab, an anti-tumor necrosis factor monoclonal antibody used in inflammatory bowel disease (IBD), has led to the development of biosimilar versions of the reference product (RP). This study investigated the long-term efficacy, safety, pharmacokinetics, and immunogenicity of CT-P13 after switching from infliximab RP in pediatric-onset IBD patients. Methods: In this prospective observational study, patients with pediatric-onset IBD receiving maintenance infliximab RP were followed for 1 year after continuing infliximab RP (RP maintenance group) or switching to CT-P13 (CT-P13 switch group)...
January 30, 2018: Inflammatory Bowel Diseases
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