W1134 The Vwf (Voting with Their Feet) Endpoint in Ulcerative Colitis Clinical Trials Reflects Clinical Practice Outcomes

2008 ◽  
Vol 134 (4) ◽  
pp. A-640
Author(s):  
Sujal Rangwalla ◽  
Akbar K. Waljee ◽  
Peter D. Higgins
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Trials ◽  
Clinical Practice

scholarly journals Assessment of Endoscopic Disease Activity in Ulcerative Colitis: Is Simplicity the Ultimate Sophistication?

2021 ◽  
pp. 1-6
Author(s):  
Ala I. Sharara ◽  
Maher Malaeb ◽  
Matthias Lenfant ◽  
Marc Ferrante
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Disease Activity ◽  
Incomplete Response ◽  
Endoscopic Remission ◽  
Endoscopic Score

<b><i>Background:</i></b> Endoscopic remission is an increasingly recognized important therapeutic endpoint in the management of patients with UC. <b><i>Summary:</i></b> The Mayo Endoscopic Score (MES) remains the most common endoscopic index recommended in guidelines and widely used in clinical trials and in clinical practice. The MES is easy, simple, and practical but is suboptimal at providing an accurate depiction of segmental healing and/or at measuring a substantial but incomplete response across the spectrum of endoscopic inflammation. Other endoscopic scores have been proposed but have not received wide recognition or adoption.

scholarly journals Vedolizumab in the treatment of inflammatory bowel diseases: whom and how?

2018 ◽  
pp. 44-49
Author(s):  
A. O. Golovenko ◽  
O. V. Golovenko
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Inflammatory Bowel Diseases ◽  
Safety Profile ◽  
Actual Clinical Practice ◽  
Loss Of Response ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
Available Information

The article is devoted to the use of vedolizumab, an α4β7 integrin antagonist, in the treatment of inflammatory bowel diseases (ulcerative colitis and Crohn’s disease). It presents the results of clinical trials of the drug and the experience of using vedolizumab in actual clinical practice. The latest available information about the drug’s safety profile is provided. The authors considered the practical aspects of therapy, such as determining the indications for treatment, tactics in loss of response, the need for a combination of vedolizumab with immunosuppressors, and the use of the drug in specific categories of patients.

Controlling Hypertension and Stroke Prevention – From Guideline to Clinical Practice

2011 ◽  
Vol 3 (1) ◽  
pp. 30
Author(s):  
Anding Xu ◽  
Zefeng Tan ◽  
◽  
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Stroke Prevention ◽  
Modifiable Risk Factors ◽  
Cerebrovascular Events

Hypertension is the most important of the prevalent and modifiable risk factors for stroke. Based on evidence, blood pressure (BP) lowering is recommended in guidelines for the prevention of stroke. However, there are still some uncertainties in the guidelines for controlling BP and preventing stroke in patients with previous cerebrovascular events, such as the goal BP, who to treat and which class of BP-lowering drugs to use. This article discusses these questions by reviewing guidelines and corresponding clinical trials, with the aim of reducing the gap between guidelines and clinical practice.

Features of the complex treatment of ulcerative colitis in clinical practice

2020 ◽  
pp. 6-11
Author(s):  
Svetlana Svetlana ◽  
Mikhail Klimentov ◽  
Olga Neganova ◽  
Alina Nazmieva ◽  
Anastasiya Kochurova
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Practice ◽  
Statistical Study ◽  
Age Groups ◽  
Length Of Hospital Stay ◽  
Unknown Etiology ◽  
Number Of Patients ◽  
First Republic ◽  
Bowel Diseases ◽  
Inflammatory Bowel

Nowadays there are certain difficulties in the early diagnosis of ulcerative colitis, proceeding with minimal intestinal symptoms. The etiology of the disease remains unclear to this day; there is no exact information about the prevalence of the disease due to the large number of latent forms and the low number of patients seeking medical help. This article presents the results of a retrospective analysis of the incidence of ulcerative colitis in the coloproctology department of the First Republic Clinical Hospital of Izhevsk. The study was conducted to assess the frequency of occurrence and determine the internal picture of ulcerative colitis. To achieve this goal, we selected 34 patients with ulcerative colitis. A statistical study was conducted on the following criteria: gender composition, age groups, forms of the disease, localization, complications, and main complaints. The length of hospital stay often was not more than 20 days. The literature on this pathology was also studied and presented in the form of a theoretical basis, which consisted of the determination and etiology of inflammatory bowel diseases. Due to the unknown etiology, insufficiently studied pathogenesis, difficult differential diagnosis with other intestinal diseases and insufficiently perfect treatment methods, there are a large number of unresolved problems in the field of ulcerative colitis. That is why, in this article we tried to reveal the problem of the features of the course and complex therapy of that disease in clinical practice.

ANTIBODY-DRUG CONJUGATES FOR TARGETED CANCER THERAPY

2019 ◽  
Vol 65 (6) ◽  
pp. 777-784
Author(s):  
David Korman
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Gemtuzumab Ozogamicin ◽  
Brentuximab Vedotin ◽  
Cytostatic Agent ◽  
Cytostatic Agents ◽  
Drug Conjugates ◽  
Natural Substances ◽  
Intracellular Release ◽  
High Antitumor Activity

Monoclonal antibody (MAB) conjugates with cytostatic agents (ADC) are intended for selective delivery of a cytostatic agent to a tumor cell. Three ADC have been approved for clinical use (gemtuzumab ozogamicin, brentuximab vedotin, trastuzumab-DM1); a few dozens of other ADC are undergoing clinical trials. Several derivatives of natural substances (antibiotics and inhibitors of microtubules) having a high antitumor activity are used as cytostatic agents included in ADC. They are inapplicable in clinical practice as self-sustained drugs due to their considerable toxicity. Of great importance for the implementation of the ADC effect is the character of a linker connecting MAB with a cytostatic agent and ensuring selective intracellular release after ADC internalization. The structure, mechanisms of action, and the results of clinical trials of a number of ADC are considered here as an illustration (by way of example). The development of ADC can help introduce new effective cytostatic agents into clinical practice.

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.

scholarly journals Adverse events of special interest in clinical trials of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and psoriasis with 37 066 patient-years of tofacitinib exposure

RMD Open ◽  
2021 ◽  
Vol 7 (2) ◽  
pp. e001595
Author(s):  
Gerd R Burmester ◽  
Peter Nash ◽  
Bruce E Sands ◽  
Kim Papp ◽  
Lori Stockert ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Ulcerative Colitis ◽  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Adverse Events ◽  
Special Interest ◽  
Phase 1 ◽  
Incidence Rates ◽  
Study Data ◽  
System Organ Class

ObjectivesTo analyse adverse events (AEs) of special interest across tofacitinib clinical programmes in rheumatoid arthritis (RA), psoriatic arthritis (PsA), ulcerative colitis (UC) and psoriasis (PsO), and to determine whether the incidence rates (IRs; unique patients with events per 100 patient-years) of these events are consistent across diseases.MethodsThe analysis included data from patients exposed to ≥1 dose of tofacitinib in phase 1, 2, 3 or 3b/4 clinical trials and long-term extension (LTE) studies (38 trials) in RA (23 trials), PsA (3 trials), UC (5 trials) and PsO (7 trials). All studies were completed by or before July 2019, except for one ongoing UC LTE study (data cut-off May 2019). IRs were obtained for AEs of special interest.Results13 567 patients were included in the analysis (RA: n=7964; PsA: n=783; UC: n=1157; PsO: n=3663), representing 37 066 patient-years of exposure. Maximum duration of exposure was 10.5 years (RA). AEs within the ‘infections and infestations’ System Organ Class were the most common in all diseases. Among AEs of special interest, IRs were highest for herpes zoster (non-serious and serious; 3.6, 1.8, 3.5 and 2.4 for RA, PsA, UC and PsO, respectively) and serious infections (2.5, 1.2, 1.7 and 1.3 for RA, PsA, UC and PsO, respectively). Age-adjusted and sex-adjusted mortality ratios (weighted for country) were ≤0.2 across cohorts.ConclusionsThe tofacitinib safety profile in this analysis was generally consistent across diseases and with longer term follow-up compared with previous analyses.

scholarly journals International teleproctoring in neurointerventional surgery and its potential impact on clinical trials in the era of COVID-19: legal and technical considerations

2020 ◽  
pp. neurintsurg-2020-017053
Author(s):  
Emanuele Orru' ◽  
Miklos Marosfoi ◽  
Neil V Patel ◽  
Alexander L Coon ◽  
Christoph Wald ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
High Resolution ◽  
Situational Awareness ◽  
Flow Diverter ◽  
Multiple Sources ◽  
Remote Supervision ◽  
Angiography Suite ◽  
The Us ◽  
Travel Restrictions

BackgroundExisting travel restrictions limit the mobility of proctors, significantly delaying clinical trials and the introduction of new neurointerventional devices. We aim to describe in detail technical and legal considerations regarding international teleproctoring, a tool that could waive the need for in-person supervision during procedures.MethodsInternational teleproctoring was chosen to provide remote supervision during the first three intracranial aneurysm treatments with a new flow diverter (currently subject of a clinical trial) in the US. Real-time, high-resolution transmission software streamed audiovisual data to a proctor located in Canada. The software allowed the transmission of images in a de-identified, HIPAA-compliant manner.ResultsAll three flow diverters were implanted as desired by operator and proctor and without complication. The proctor could swap between images from multiple sources and reported complete spatial and situational awareness, without any significant lag or delay in communication. Procedural times and radiologic dose were similar to those of uncomplicated, routine flow diversion cases at our institution.ConclusionsInternational teleproctoring was successfully implemented in our clinical practice. Its first use provided important insights for establishing this tool in our field. With no clear horizon for lifting the current travel restrictions, teleproctoring has the potential to remove the need for proctor presence in the angiography suite, thereby allowing the field to advance through the continuation of trials and the introduction of new devices in clinical practice. In order for this tool to be used safely and effectively, highly reliable connection and high-resolution equipment is necessary, and multiple legal nuances have to be considered.

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