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Clinical trials in ibd

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https://www.readbyqxmd.com/read/28328760/current-practice-for-therapeutic-drug-monitoring-of-biopharmaceuticals-in-inflammatory-bowel-disease
#1
Iris Detrez, Thomas Van Stappen, María Dolores Martín Arranz, Kostas Papamichael, Ann Gils
Since the late nineties, biopharmaceuticals targeting tumor necrosis factor α have revolutionized the treatment of moderately to severely active inflammatory bowel disease. The robust efficacy witnessed in many patients stands in stark contrast with the observation of a proportion of patients who fail to respond or who lose response over time. Therapeutic drug monitoring has been proposed as a means to understand and respond to the variability in clinical response and remission. Various treatment algorithms have been proposed, but optimal use of these measurements in daily practice awaits additional prospective validation trials...
March 22, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28327826/efficacy-of-tacrolimus-for-induction-of-remission-in-patients-with-moderate-to-severe-ulcerative-colitis-a-systematic-review-and-meta-analysis
#2
Juan Lasa, Pablo Olivera
BACKGROUND: There is evidence that shows that calcineurin inhibitors may be useful for the treatment of severe ulcerative colitis. However, evidence regarding the efficacy of tacrolimus for remission induction in this setting is scarce. OBJECTIVE: To develop a systematic review on the existing evidence regarding the clinical efficacy of tacrolimus for the induction of remission in patients with moderate-to-severe ulcerative colitis. METHODS: A literature search was undertaken from 1966 to August 2016 using MEDLINE, Embase, LILACS and the Cochrane Library...
March 16, 2017: Arquivos de Gastroenterologia
https://www.readbyqxmd.com/read/28316250/adalimumab-in-ulcerative-colitis-efficacy-safety-and-optimization-in-the-era-of-treat-to-target
#3
Miles P Sparrow
Active ulcerative colitis is associated with significant morbidity and impairment to quality of life. Adalimumab is a welcome addition to the therapeutic armamentarium for clinicians treating patients with moderate-severe ulcerative colitis refractory to conventional therapies, an indication with few prior treatment options. It offers the convenience of self-injection and is most appropriate for outpatients with moderate disease activity. Areas covered: This review briefly summarizes data from well-designed clinical trials and observational real-life studies that demonstrate the safety and efficacy of adalimumab in UC...
March 20, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28315032/novel-indications-for-fecal-microbial-transplantation-update-and-review-of-the-literature
#4
REVIEW
Nathaniel Aviv Cohen, Nitsan Maharshak
BACKGROUND AND AIMS: Fecal microbial transplantation (FMT) is an established successful treatment modality for recurrent Clostridium difficile infection (CDI). The safety profile and potential therapeutic advantages of FMT for diseases associated with dysbiosis and immune dysfunction have led to many publications, mainly case series, and while many studies and reviews have been published on the use of FMT for inflammatory bowel disease (IBD), its potential use for other disease conditions has not been thoroughly reviewed...
March 17, 2017: Digestive Diseases and Sciences
https://www.readbyqxmd.com/read/28295267/pyoderma-gangrenosum-clinical-characteristics-associated-diseases-and-responses-to-treatment-in-a-retrospective-cohort-study-of-31-patients
#5
Aldana S Vacas, Ana C Torre, María L Bollea-Garlatti, Fernando Warley, Ricardo L Galimberti
OBJECTIVE: The aim of this study was to describe the clinical characteristics of patients with pyoderma gangrenosum (PG) and to evaluate the association between these characteristics, the treatment followed, and the patient responses, relapses, and mortality rates. MATERIAL AND METHODS: This retrospective cohort study identified adults diagnosed with pyoderma gangrenosum over the duration of 10 years. RESULTS: Thirty-one patients were evaluated; 58% were women and 55% were older than 65 years, 87% presented with the ulcerative type, and 77% showed lower limb compromise...
April 2017: International Journal of Dermatology
https://www.readbyqxmd.com/read/28294322/probiotics-are-a-good-choice-in-remission-of-inflammatory-bowel-diseases-a-meta-analysis-and-systematic-review
#6
REVIEW
Mahboube Ganji-Arjenaki, Mahmoud Rafieian-Kopaei
Altered gut bacteria and bacterial metabolic pathways are two important factors in initiation and progression of inflammatory bowel disease (IBD). However, efficacy of probiotics in remission of patients with IBD has not been characterized. This study was performed on the studies that specifically assessed the efficacy of probiotics in attaining clinical response on patients with various types of IBD. The efficacy of variant species of probiotics in different conditions and the influence of study quality in outcomes of randomized controlled trials (RCTs) were also assessed...
March 15, 2017: Journal of Cellular Physiology
https://www.readbyqxmd.com/read/28286192/endoscopic-and-histologic-healing-in-children-with-inflammatory-bowel-diseases-treated-with-thalidomide
#7
Marzia Lazzerini, Vincenzo Villanacci, Maria Chiara Pellegrin, Stefano Martelossi, Giuseppe Magazzù, Salvatore Pellegrino, Maria Cristina Lucanto, Arrigo Barabino, Angela Calvi, Serena Arrigo, Paolo Lionetti, Massimo Fontana, Giovanna Zuin, Giuseppe Maggiore, Matteo Bramuzzo, Massimo Maschio, Marianna Salemme, Stefania Manenti, Lorenzi Luisa, Giuliana Decorti, Marcella Montico, Alessandro Ventura
BACKGROUND & AIMS: Mucosal healing, determined by endoscopic evaluation, is one of the most important prognostic markers for patients with inflammatory bowel diseases. Findings from histologic evaluation, however, could complement findings from endoscopy in assessing mucosal responses to treatment. We analyzed long term results of children treated with thalidomide to determine the association between clinical response and histology and endoscopy findings. METHODS: We collected data from 2 multi-center trials of 70 children with refractory Crohn's disease (CD) or ulcerative colitis (UC) (2-18 years old; ileo-colonic or colonic disease) given thalidomide or placebo (NCT00720538)...
March 7, 2017: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28281165/effectiveness-and-safety-of-ct-p13-biosimilar-infliximab-in-patients-with-inflammatory-bowel-disease-in-real-life-at-6%C3%A2-months
#8
F Argüelles-Arias, M F Guerra Veloz, R Perea Amarillo, A Vilches-Arenas, L Castro Laria, B Maldonado Pérez, D Chaaro, A Benítez Roldán, V Merino, G Ramírez, A Caunedo Álvarez, M Romero Gómez
BACKGROUND: CT-P13 is a biosimilar of Remicade(®), an agent approved in some countries for use in inflammatory bowel disease (IBD). Controlled clinical trials have demonstrated the efficacy and safety of CT-P13 in rheumatic diseases, but not in IBD. AIMS: To assess the effectiveness and safety of CT-P13 in IBD patients in real clinical practice. METHODS: This is a prospective observational study in patients with moderate to severe Crohn's disease or ulcerative colitis treated with CT-P13...
March 9, 2017: Digestive Diseases and Sciences
https://www.readbyqxmd.com/read/28279838/modulation-of-sphingosine-1-phosphate-in-inflammatory-bowel-disease
#9
REVIEW
Laurent Peyrin-Biroulet, Ronald Christopher, Dominic Behan, Cheryl Lassen
Inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn's disease, involve an inappropriate immune reaction in the digestive tract, causing a variety of disabling symptoms. The advent of monoclonal antibodies (anti-tumor necrosis factor, anti-integrin, anti-interleukin -23) has revolutionized IBD management. Nevertheless, these agents, with potential for immunogenicity, are associated with high rates of response loss and disease relapse over time. They are also associated with high production costs...
March 6, 2017: Autoimmunity Reviews
https://www.readbyqxmd.com/read/28276820/cannabinoids-for-treating-inflammatory-bowel-diseases-where-are-we-and-where-do-we-go
#10
Carina Hasenoehrl, Martin Storr, Rudolf Schicho
Fifty years after the discovery of Δ(9)-tetrahydrocannabinol (THC) as the psychoactive component of Cannabis, we are assessing the possibility of translating this herb into clinical treatment of inflammatory bowel diseases (IBDs). Here, a discussion on the problems associated with a potential treatment is given. From first surveys and small clinical studies in patients with IBD we have learned that Cannabis is frequently used to alleviate diarrhea, abdominal pain, and loss of appetite. Single ingredients from Cannabis, such as THC and cannabidiol, commonly described as cannabinoids, are responsible for these effects...
April 2017: Expert Review of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28274849/patient-age-sex-and-inflammatory-bowel-disease-phenotype-associate-with-course-of-primary-sclerosing-cholangitis
#11
Tobias J Weismüller, Palak J Trivedi, Annika Bergquist, Mohamad Imam, Henrike Lenzen, Cyriel Y Ponsioen, Kristian Holm, Daniel Gotthardt, Martti A Färkkilä, Hanns-Ulrich Marschall, Douglas Thorburn, Rinse K Weersma, Johan Fevery, Tobias Mueller, Olivier Chaouillères, Kornelius Schulze, Konstantinos N Lazaridis, Sven Almer, Stephen P Pereira, Cynthia Levy, Andrew Mason, Sigrid Naess, Christopher L Bowlus, Annarosa Floreani, Emina Halilbasic, Kidist K Yimam, Piotr Milkiewicz, Ulrich Beuers, Dep K Huynh, Albert Pares, Christine N Manser, George N Dalekos, Bertus Eksteen, Pietro Invernizzi, Christoph P Berg, Gabi I Kirchner, Christoph Sarrazin, Vincent Zimmer, Luca Fabris, Felix Braun, Marco Marzioni, Brian D Juran, Karouk Said, Christian Rupp, Kalle Jokelainen, Maria Benito de Valle, Francesca Saffioti, Angela Cheung, Michael Trauner, Christoph Schramm, Roger W Chapman, Tom H Karlsen, Erik Schrumpf, Christian P Strassburg, Michael P Manns, Keith D Lindor, Gideon M Hirschfield, Bettina E Hansen, Kirsten M Boberg
BACKGROUND & AIMS: Primary sclerosing cholangitis (PSC) is an orphan hepatobiliary disorder associated with inflammatory bowel disease (IBD). We aimed to estimate the risk of disease progression based on distinct clinical phenotypes in a large, international cohort of patients with PSC. METHODS: We performed a retrospective outcome analysis of patients diagnosed with PSC from 1980 through 2010 at 37 centers in Europe, North America, and Australia. For each patient, we collected data on sex, clinician-reported age at and date of PSC and IBD diagnoses, phenotypes of IBD and PSC, and date and indication of IBD-related surgeries...
March 5, 2017: Gastroenterology
https://www.readbyqxmd.com/read/28255960/jak-stat-signaling-as-a-target-for-inflammatory-and-autoimmune-diseases-current-and-future-prospects
#12
REVIEW
Shubhasree Banerjee, Ann Biehl, Massimo Gadina, Sarfaraz Hasni, Daniella M Schwartz
The Janus kinase/signal transduction and activator of transcription (JAK-STAT) signaling pathway is implicated in the pathogenesis of inflammatory and autoimmune diseases including rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Many cytokines involved in the pathogenesis of autoimmune and inflammatory diseases use JAKs and STATs to transduce intracellular signals. Mutations in JAK and STAT genes cause a number of immunodeficiency syndromes, and polymorphisms in these genes are associated with autoimmune diseases...
March 3, 2017: Drugs
https://www.readbyqxmd.com/read/28239315/single-fecal-microbiota-transplantation-failed-to-change-intestinal-microbiota-and-had-limited-effectiveness-against-ulcerative-colitis-in-japanese-patients
#13
Shinta Mizuno, Kosaku Nanki, Katsuyoshi Matsuoka, Keiichiro Saigusa, Keiko Ono, Mari Arai, Shinya Sugimoto, Hiroki Kiyohara, Moeko Nakashima, Kozue Takeshita, Makoto Naganuma, Wataru Suda, Masahira Hattori, Takanori Kanai
BACKGROUND/AIMS: Recent developments in analytical techniques including next-generation sequencing have clarified the correlation between intestinal microbiota and inflammatory bowel disease. Fecal microbiota transplantation (FMT) for patients with ulcerative colitis (UC) is proposed as a potential approach to resolving their dysbiosis; however, its safety and efficacy have not been confirmed. This single-arm, open-label, non-randomized study aimed to evaluate the safety and efficacy of FMT for Japanese patients with UC as the first registered clinical trial in Japan...
January 2017: Intestinal Research
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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