W1169 Route of Administration and Placebo Response Rates: Is There Any Correlation? Review of Placebo-Controlled, Randomized Clinical Trials (PC-RCTs) of Biologics in Crohn's Disease

2009 ◽  
Vol 136 (5) ◽  
pp. A-669
Author(s):  
Alla Grigorian ◽  
Houssam E. Mardini
Author(s):  
Bénédicte Caron ◽  
Ferdinando D’Amico ◽  
Silvio Danese ◽  
Laurent Peyrin-Biroulet

Abstract Background and Aims Since the 1980s, many studies have evaluated the efficacy of therapies to improve the outcomes of patients with perianal Crohn’s disease. We performed a systematic review to describe the evolution of endpoints in perianal fistulizing Crohn’s disease. Efficacy outcomes, definitions and measurement tools were assessed. Methods Electronic databases were searched up to November 1, 2020. All published randomized placebo-controlled trials enrolling patients with perianal fistula and Crohn’s disease were eligible for inclusion. Ongoing randomized clinical trials were also described. Results Nineteen randomized controlled trials were included. Clinical efficacy endpoints were reported in all trials. Clinical response was the most frequent primary endpoint [6/19 studies, 31.6%], followed by clinical remission in four studies [21%]. Clinical response was defined as closure of at least 50% of fistulas, while remission was defined as closure of all fistulas. A combined clinical and radiological primary endpoint was used to assess fistula healing in four studies [21%]. The Perianal Disease Activity Index was a primary endpoint in only one study [5.5%]. In addition, eight ongoing controlled trials were identified. Combined clinical and radiological remission was the most frequent primary endpoint in these studies [4/8, 50%]. Conclusion In this systematic review, significant changes in outcomes used in randomized clinical trials of perianal Crohn’s disease were observed. Radiological endpoints are increasingly used in perianal fistulizing Crohn’s disease trials.


2014 ◽  
Vol 12 (12) ◽  
pp. 1981-1990 ◽  
Author(s):  
Alexander C. Ford ◽  
Pavit Luthra ◽  
Stephen B. Hanauer ◽  
Simon P. Travis ◽  
M. Scott Harris ◽  
...  

2020 ◽  
Vol 15 (3) ◽  
pp. 216-233 ◽  
Author(s):  
Maliha Naseer ◽  
Shiva Poola ◽  
Syed Ali ◽  
Sami Samiullah ◽  
Veysel Tahan

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.


Author(s):  
Ahmed Almradi ◽  
Christopher Ma ◽  
Geert R. D'Haens ◽  
William J. Sandborn ◽  
Claire E. Parker ◽  
...  

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