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Efficacy and safety of prolonged release budesonide granules in mesalazine-refractory ulcerative colitis: A multi-centre Phase IIa study (TOPICAL-1).

Author: DerovaJelena, FellermannKlaus, GreinwaldRoland, JonaitisLaimas, NacakTanju, RáczIstván, SchiefkeIngolf, WehrumSarah

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

Prolonged release budesonide granules were effective for inducing remission in patients with mesalazine-refractory ulcerative colitis. Clinical remission was achieved in 47.5% of patients by Week 8. Budesonide granules were well-tolerated with a favorable safety profile.
Paper Details　
Original Abstract of the Article :
BACKGROUND: In patients with mesalazine-refractory ulcerative colitis, systemic corticosteroids are the treatment of choice. OBJECTIVE: To evaluate the efficacy and safety of prolonged release budesonide granules for the induction of remission in patients with mesalazine-refractory ulcerative colit...See full text at original site
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引用元：
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7724525/

データ提供：米国国立医学図書館（NLM）

Prolonged-Release Budesonide Granules: A Promising Treatment for Mesalazine-Refractory Ulcerative Colitis

Ulcerative colitis, a debilitating inflammatory bowel disease, often requires systemic corticosteroids when conventional treatments like mesalazine fail. This Phase IIa study evaluated the efficacy and safety of prolonged-release budesonide granules in patients with mesalazine-refractory ulcerative colitis. The study found that the treatment led to significant improvements in clinical, endoscopic, and histological measures of disease, suggesting its potential as a viable alternative for this challenging patient population.

A New Hope for Mesalazine-Refractory Ulcerative Colitis

The study found that budesonide granules induced clinical remission in 47.5% of patients with mesalazine-refractory ulcerative colitis. This is a promising result, as it offers hope for patients who have not responded to traditional therapies. The study also demonstrated the treatment's favorable safety profile, further supporting its potential for future development.

Managing Ulcerative Colitis with Budesonide

This study is a ray of hope for patients with mesalazine-refractory ulcerative colitis. The effectiveness and safety of prolonged-release budesonide granules offer a potential alternative to corticosteroids. However, further research is necessary to optimize treatment strategies and confirm these encouraging findings. In the meantime, patients should continue to discuss their treatment options with their physician.

Dr.Camel's Conclusion

This study provides a glimmer of hope for individuals with mesalazine-refractory ulcerative colitis. Prolonged-release budesonide granules show promising results in inducing clinical remission, offering a potential alternative to systemic corticosteroids. While further research is crucial, this study opens the door to new treatment avenues for this debilitating condition.

Date :
  1. Date Completed 2021-07-26
  2. Date Revised 2021-07-26
Further Info :

Pubmed ID

33028169

DOI: Digital Object Identifier

PMC7724525

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Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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