Natalizumab for the Treatment of Multiple Sclerosis and Crohn's Disease

2005 ◽  
Vol 39 (11) ◽  
pp. 1833-1843 ◽  
Author(s):  
Kendra A Keeley ◽  
Michael P Rivey ◽  
Douglas R Allington
Keyword(s):  
Multiple Sclerosis ◽  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Bowel Disease ◽  
Randomized Clinical Trials ◽  
Case Reports ◽  
Data Extraction ◽  
Data Sources ◽  
Medline Search ◽  
Inflammatory Bowel

OBJECTIVE To review the pharmacology, pharmacokinetics, safety, and pivotal clinical trials for natalizumab in the treatment of multiple sclerosis (MS) and inflammatory bowel disease. DATA SOURCES A PubMed/MEDLINE search was conducted (1966–June 2005), and information was obtained from Iowa Drug Information Services. Additional data sources included meeting abstracts, bibliographies from identified articles, and information from the manufacturer. STUDY SELECTION AND DATA EXTRACTION Studies and review articles examining natalizumab were evaluated. All published, randomized clinical trials evaluating natalizumab in MS and IBD were included in this review. DATA SYNTHESIS Natalizumab is the first drug in a new class of agents called selective adhesion molecule inhibitors. It has shown promising results in MS and inflammatory bowel disease and appears superior compared with current therapies in reducing relapse rates. However, 3 recent, confirmed case reports of progressive multifocal leukoencephalopathy (PML) create concern about natalizumab's use in combination with existing therapies or in undefined patient subgroups. Natalizumab was voluntarily withdrawn from the market in March 2005 while the drug's safety is further evaluated. CONCLUSIONS Although long-term efficacy and safety of natalizumab have not been established, available data indicate that it is a novel drug for patients with MS or inflammatory bowel disease. Analysis of its possible association with PML will determine the risk–benefit evaluation and eventual place in therapy for natalizumab.

scholarly journals Effectiveness and safety of probiotic preparations in clinical treatment of inflammatory bowel disease

2018 ◽  
Vol 72 ◽  
pp. 159-174 ◽  
Author(s):  
Ewa Wasilewska ◽  
Barbara Wroblewska
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Bowel Disease ◽  
Case Reports ◽  
Health Benefit ◽  
Supportive Therapy ◽  
Functional Health ◽  
Specific Patient ◽  
Gut Mucosa ◽  
Inflammatory Bowel

Inflammatory bowel disease (IBD) is characterized by an aggressive immune response to luminal antigens including those of commensal microbiota, which are essential for intestinal homeostasis and appear to play a role in tolerance and immunity. Its disturbances can result in intestinal dysbiosis and the development of disease. The precise role of luminal bacteria in the pathogenesis of IBD has yet to be elucidated; however, considerable evidence implicates changes to bacterial communities associated with the gut mucosa in the disease state. It is also well known that beneficial microbes can confer a functional health benefit to the host. We analysed the effectiveness of probiotics to relieve symptoms in patients suffering from IBD. Using the Medline database and manually searching articles, we reviewed clinical trials performed with probiotics and lactic acid bacteria as supportive or alternative IBD treatments. The article summarizes IBD microenvironment and the efficiency of probiotic preparations in attenuating the symptoms of Crohn’s disease, ulcerative colitis, and pouchitis. The safety of probiotic intake is also analyzed based on existing outcomes of clinical trials and case reports. Strong evidence exists that probiotics are effective as supportive therapy for IBD; however, only a few preparations have well documented efficiency and safety. Clinical studies demonstrated that probiotics were more effective in preventing recurrence of the disease symptoms than in the management of its active stage. Some products may increase the risk of complications in specific patient groups; therefore, the use of probiotics should be considered with caution in the case of severe active IBD, especially with disrupted mucosa.

Prebiotics and Probiotics in Inflammatory Bowel Disease: Where are we now and where are we going?

2020 ◽  
Vol 15 (3) ◽  
pp. 216-233 ◽  
Author(s):  
Maliha Naseer ◽  
Shiva Poola ◽  
Syed Ali ◽  
Sami Samiullah ◽  
Veysel Tahan
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Adverse Effects ◽  
Bowel Disease ◽  
Relapse Prevention ◽  
Remission Induction ◽  
Inflammatory Bowel

The incidence, prevalence, and cost of care associated with diagnosis and management of inflammatory bowel disease are on the rise. The role of gut microbiota in the causation of Crohn's disease and ulcerative colitis has not been established yet. Nevertheless, several animal models and human studies point towards the association. Targeting intestinal dysbiosis for remission induction, maintenance, and relapse prevention is an attractive treatment approach with minimal adverse effects. However, the data is still conflicting. The purpose of this article is to provide the most comprehensive and updated review on the utility of prebiotics and probiotics in the management of active Crohn’s disease and ulcerative colitis/pouchitis and their role in the remission induction, maintenance, and relapse prevention. A thorough literature review was performed on PubMed, Ovid Medline, and EMBASE using the terms “prebiotics AND ulcerative colitis”, “probiotics AND ulcerative colitis”, “prebiotics AND Crohn's disease”, “probiotics AND Crohn's disease”, “probiotics AND acute pouchitis”, “probiotics AND chronic pouchitis” and “prebiotics AND pouchitis”. Observational studies and clinical trials conducted on humans and published in the English language were included. A total of 71 clinical trials evaluating the utility of prebiotics and probiotics in the management of inflammatory bowel disease were reviewed and the findings were summarized. Most of these studies on probiotics evaluated lactobacillus, De Simone Formulation or Escherichia coli Nissle 1917 and there is some evidence supporting these agents for induction and maintenance of remission in ulcerative colitis and prevention of pouchitis relapse with minimal adverse effects. The efficacy of prebiotics such as fructooligosaccharides and Plantago ovata seeds in ulcerative colitis are inconclusive and the data regarding the utility of prebiotics in pouchitis is limited. The results of the clinical trials for remission induction and maintenance in active Crohn's disease or post-operative relapse with probiotics and prebiotics are inadequate and not very convincing. Prebiotics and probiotics are safe, effective and have great therapeutic potential. However, better designed clinical trials in the multicenter setting with a large sample and long duration of intervention are needed to identify the specific strain or combination of probiotics and prebiotics which will be more beneficial and effective in patients with inflammatory bowel disease.

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