Once versus three times daily dosing of oral budesonide for active Crohn's disease: a double-blind, double-dummy, randomised trial
Language English Country England, Great Britain Media print-electronic
Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial
PubMed
24534142
DOI
10.1016/j.crohns.2014.01.021
PII: S1873-9946(14)00040-3
Knihovny.cz E-resources
- Keywords
- Adherence, Budesonide, Clinical remission, Crohn's disease, Dosing,
- MeSH
- Patient Compliance MeSH
- Administration, Oral MeSH
- Budesonide administration & dosage MeSH
- Crohn Disease drug therapy pathology MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Endoscopy, Gastrointestinal MeSH
- Glucocorticoids administration & dosage MeSH
- Remission Induction MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Follow-Up Studies MeSH
- Prospective Studies MeSH
- Drug Administration Schedule MeSH
- Aged MeSH
- Intestinal Mucosa pathology MeSH
- Treatment Outcome MeSH
- Dose-Response Relationship, Drug MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Budesonide MeSH
- Glucocorticoids MeSH
BACKGROUND: Oral budesonide 9 mg/day represents first-line treatment of mild-to-moderately active ileocolonic Crohn's disease. However, there is no precise recommendation for budesonide dosing due to lack of comparative data. A once-daily (OD) 9 mg dose may improve adherence and thereby efficacy. METHODS: An eight-week, double-blind, double-dummy randomised trial compared budesonide 9 mg OD versus 3mg three-times daily (TID) in patients with mild-to-moderately active ileocolonic Crohn's disease. Primary endpoint was clinical remission defined as CDAI <150 at week 8 (last observation carried forward). RESULTS: The final intent-to-treat population comprised 471 patients (238 [9 mg OD], 233 [3 mg TID]). The confirmatory population for the primary endpoint analysis was the interim per protocol population (n=377; 188 [9 mg OD], 189 [3mg TID]), in which the primary endpoint was statistically non-inferior with budesonide 9 mg OD versus 3 mg TID. Clinical remission was achieved in 71.3% versus 75.1%, a difference of -3.9% (95% CI [-14.6%; 6.4%]; p=0.020 for non-inferiority). The mean (SD) time to remission was 21.9 (13.8) days versus 21.4 (14.6) days with budesonide 9 mg OD versus 3 mg TID, respectively. In a subpopulation of 122 patients with baseline SES-CD ulcer score ≥1, complete mucosal healing occurred in 32.8% (21/64) on 9 mg OD and 41.4% (24/58) on 3mg TID; deep remission (mucosal healing and clinical remission) was observed in 26.6% (17/64) and 32.8% (19/58) of patients, respectively. Treatment-emergent suspected adverse drug reactions were reported in 4.6% of 9 mg OD and 4.7% of 3 mg TID patients. CONCLUSIONS: Budesonide at the recommended dose of 9 mg/day can be administered OD without impaired efficacy and safety compared to 3mg TID dosing in mild-to-moderately active Crohn's disease.
Agaplesion Markus Krankenhaus 1st Dept of Medicine Goethe University 60431 Frankfurt am Main Germany
DEOEC 2 sz Belgyógyászati Klinika 4012 Debrecen Hungary
District Hospital Mladá Boleslav 293 01 Mladá Boleslav 2 Czech Republic
Dr Falk Pharma GmbH Clinical Research and Development Dept 79108 Freiburg Germany
Gastro 1 s r o Gastroenterology Dept 080 01 Prešov Slovakia
Lithuanian University of Health Sciences Dept of Gastroenterology 50009 Kaunas Lithuania
Medical Center Tuculanu 300158 Timisoara Romania
Paula Stradina University Hospital Center of Gastroenterology 1002 Riga Latvia
References provided by Crossref.org
ClinicalTrials.gov
NCT01086553