Budesonide For Maintenance Of Remission Research Articles

Azathioprine or 6-mercaptopurine for maintenance of remission in Crohn's disease.

Azathioprine or 6-mercaptopurine for maintenance of remission in Crohn's disease.

Budesonide for maintenance of remission in Crohn's disease.

Budesonide for maintenance of remission in Crohn's disease.

Budesonide for Maintenance of Remission in Crohnʼs Disease: Update of a Systematic Review and Meta-analysis for the Cochrane Collaboration

Purpose: Budesonide (BUD) has been shown to be effective for induction of remission in Crohn's disease (CD), but concerns have been raised about the efficacy and safety of its long-term use. This systematic review and meta-analysis examined the efficacy and safety of BUD for maintenance of remission in CD. Methods: MEDLINE, EMBASE, other electronic databases, article reference lists, and conference proceedings were searched up to January, 2013 to identify randomized controlled trials on BUD. Those comparing BUD to a control treatment or comparing two doses of BUD were included. The primary outcome was maintenance of remission at one year. Secondary outcomes included mean change in CD activity index (CDAI), adverse events, and study withdrawal. Two independent investigators reviewed studies for eligibility and extracted the data. For the meta-analysis, a random or fixed effects model was chosen based on an assessment of heterogeneity. Results: Twelve studies were identified. Only one additional study was found since the previous review, which compared azathioprine with BUD. BUD 6 mg daily was no more effective than placebo for maintenance of remission at 3 months (RR 1.25, 95% CI 1.00-1.58), 6 months (RR 1.15, 95% CI 0.95-1.39), or 12 months (RR 1.13, 95% CI 0.94-1.35). BUD was neither more effective than azathioprine (RR 0.81, 95% CI 0.61-1.08), nor weaning doses of prednisolone for maintenance of remission at 12 months (RR 0.79; 95% CI 0.55-1.13), but was better than mesalamine (RR 2.51, 95% CI 1.03-6.12). BUD 3 mg daily was more effective than placebo at 3 months (RR 1.31, 95% CI 1.03-1.67). This benefit was not sustained at 6 months (RR 1.10; 95% CI 0.81-1.50), or 12 months (RR 1.04, 95% CI 0.84-1.30). The use of BUD 6 mg resulted in a modest improvement in CDAI scores at 12 months (WMD -23.49; 95% CI -46.65 to -0.32). Adverse events were more frequent in patients treated with 6 mg of BUD, compared with placebo (RR 1.49; 95% CI 1.01-2.19). Abnormal adrenocorticoid stimulation tests were seen more frequently in patients receiving both 6 mg daily (RR 2.88; 95% CI 1.72-4.82) and 3 mg daily (RR 2.73, 95% CI 1.34-5.57), compared with placebo. Patients receiving BUD were less likely to withdraw due to adverse events than those receiving azathioprine (RR 0.42; 95% CI 0.18-0.97). Conclusion: BUD is not more effective than placebo for maintenance of remission in CD. BUD results in a modest drop in CDAI scores; however, these benefits are offset by higher adverse events and more frequent adrenocorticoid suppression in patients receiving BUD. Lack of superiority of BUD compared to azathioprine is a new finding in this update. Disclosure - EK, AR, EIB - none. GGK - speaker for Merck, Schering-Plough, Abbott, and UCB Pharma; participated in advisory board meetings for Abbott, Merck, Schering-Plough, Shire, and UCB Pharma; research support from Abbott and Shire. ARO - advisory board for Janssen Canada, Abbvie Canada, Nestle Canada; research support (clinical trial site) from Janssen, Abbvie, Optimer US, Janssen US, Astra-Zeneca AHS - advisory boards for Merck, Abbott, and Shire; Speakers Bureau for Merck, Abbott, Shire, Aptalis, and Warner Chilcott; research support from Merck and Abbott CHS - advisory boards for Janssen Canada, Abbvie; Speaker for Janssen Canada; research support from Janssen Canada.

Oral budesonide for maintenance of remission of Crohn’s disease: a pooled safety analysis

Budesonide exhibits similar efficacy to systemic glucocorticosteroids (GCSs) in Crohn's disease (CD), but with fewer adverse events (AEs). Aim To evaluate budesonide's safety profile in CD patients, in particular, incidences of clinically important AEs known to be associated with systemic GCSs. Five 1-year, double-blind, placebo-controlled trials evaluating budesonide for mild-to-moderate CD were pooled for analysis. The highest incidence rates of AEs were gastrointestinal- and endocrine systems-related in both groups (budesonide 6 mg/day, n = 208; placebo, n = 209). Incidence rates were similar, except for higher incidence of endocrine disorders in budesonide versus placebo patients (P = 0.0042) caused by a higher overall occurrence of cutaneous GCS symptoms (P = 0.0036) in the budesonide group; differences in individual symptoms were nonsignificant. Percentage of patients with normal adrenal function was significantly lower at 13 weeks (three of five studies), but not at 52 weeks (two studies) in the budesonide versus placebo groups. Occurrence of clinically important or serious AEs associated with systemic GCSs, including sepsis, cataracts, adrenal insufficiency was rare and similar between groups. Budesonide treatment for up to 1 year is well-tolerated in CD patients, with an AE profile similar to placebo and only rare occurrences of clinically important AEs associated with systemic GCSs.

Budesonide for maintenance of remission in Crohnʼs disease: A systematic review and meta-analysis for the Cochrane Collaboration.

Budesonide for maintenance of remission in Crohnʼs disease: A systematic review and meta-analysis for the Cochrane Collaboration.

Budesonide for Maintenance of Remission in Patients with Crohn's Disease in Medically Induced Remission: A Predetermined Pooled Analysis of Four Randomized, Double-Blind, Placebo-Controlled Trials

To evaluate the efficacy and safety of oral budesonide for maintenance of remission in patients with mild to moderately active Crohn's disease (CD) of the ileum and/or ascending colon. Four double-blind, placebo-controlled trials with identical protocols were combined according to a predetermined analysis plan. Three hundred eighty patients with CD in medically induced remission (CD activity index [CDAI]< or =150) were randomized to receive oral budesonide 3 mg, 6 mg, or placebo daily for 12 months. The primary outcome measure was time to relapse (increase in CDAI of 60 points above baseline and >150). The median time to relapse was 268, 170, and 154 days for budesonide 6 mg, budesonide 3 mg, and placebo groups, respectively (p= 0.0072). The frequency of adverse events and glucocorticosteroid side effects were similar in all groups. Budesonide 6 mg/day is effective for prolonging time to relapse and for significantly reducing rates of relapse at 3 and 6 months but not 12 months in patients with CD in medically induced remission.

Crohn's Colitis in Infancy

Crohns disease is an idiopathic chronic inflammatory disorder involving any region of the alimentary tract from the mouth to the anus. Its pathogenesis is not known but immunological disturbance has been suggested by many authors. In Crohns colitis the inflammatory process tends to be eccentric and segmental with normal regions of bowel between inflamed areas ("skip areas"). Colonic involvement alone occurs in 10% (granulomatous colitis). Although there are many similarities between ulcerative colitis and Crohns disease there are also major differences in the clinical course and distribution of the disease in the gastrointestinal tract. The incidence of Crohns disease has been increasing over the past 10 years and it was reported to be 3-4/100 000. It may rarely present in the first year of life. We report a case of Crohns colitis because it is rare at this age and appeared at our hospital in an infant for the first time. (excerpt)

Budesonide for maintenance of remission in Crohn's disease.

The primary objective was to precisely derive an estimate of the efficacy of oral budesonide for the maintenance of remission in Crohn's disease. Medline 1966-September 2000 was searched using the text and key words "oral budesonide", "Crohn's disease", "Crohn disease", and "inflammatory bowel disease". Proceedings from the American Gastroenterology Association conference (1980-1998) were hand searched. Additionally, the Cochrane Controlled Trials Register and the Inflammatory Bowel Disease Review Group Trials Registers were also searched. The manufacturer of oral budesonide was also contacted, as were some of the local trialists involved in the oral budesonide trials. Relevant articles were retrieved, and their reference lists were also reviewed. Randomized controlled trials of oral budesonide in which patients at entry were in remission with a Crohn's Disease Activity Index (CDAI) <= 150, and had disease restricted to the ileum and colon. The primary outcome was the relative risk (RR) of relapse (and 95% confidence interval [CI]) during the 12 months of treatment, as defined by the number of patients who relapsed, and the number of patients who entered the trial. The numbers needed to treat were also derived. Three randomized controlled trials of oral budesonide (controlled ileal release preparation) 6 mg/day, 3mg/day and placebo for a one year period were included in the analysis. Budesonide 6 mg/day was not effective at preventing relapse of Crohn's disease over the 12 months of treatment. The relative risk of relapse was 0.89 (95% CI: 0.71-1.13) comparing budesonide 6 mg/day and placebo. Similar results were also observed in the comparison of budesonide 6 mg/day with budesonide 3 mg/day; the relative risk of relapse was 0.89 (95% CI: 0.70-1.11). The 3 mg/day dose was similarly found to be ineffective at preventing relapse during the 12 months of treatment; the relative risk of relapse was 1.00 (95% CI: 0.80-1.24). The results of the analysis of relative risk of relapse were supported by the analysis of withdrawal due to treatment failure. The relative risks for withdrawal due to treatment failure for budesonide 6 mg/day compared with placebo was 0.85 (95% CI: 0.65-1.10), for budesonide 3 mg/day compared with placebo was 0.94 (95% CI: 0.73-1.20), and for budesonide 6 mg/day compared with budesonide 3 mg/day was 0.89 (95% CI: 0.68-1.17). Oral budesonide therapy at 6 mg/day is not effective in preventing relapses of Crohn's disease.

Oral budesonide as maintenance treatment for Crohn's disease: A placebo-controlled, dose-ranging study. Canadian Inflammatory Bowel Disease Study Group

BACKGROUND & AIMS: Budesonide is a corticosteroid with high topical anti-inflammatory activity and low systemic activity due to rapid hepatic metabolism. The efficacy and safety of an oral controlled- release preparation of budesonide for maintenance of remission was evaluated in patients with ileal or ileocecal Crohn's disease. METHODS: In a double-blind, multicenter trial, 105 patients were randomly assigned to receive placebo or budesonide at doses of 3 or 6 mg daily for 1 year. The primary outcome measure was relapse defined by a Crohn's Disease Activity Index score of > 150 and a minimum increase of 60 points. RESULTS: Patients receiving 6 mg of budesonide had a median time to relapse or discontinuation of therapy of 178 days compared with 124 days in those receiving 3 mg of budesonide and 39 days in those receiving placebo. However, at 1 year, the rate of relapse in the group receiving 6 mg of budesonide was similar to the rates in the 3-mg and placebo groups. Basal plasma cortisol levels and incidence of corticosteroid-associated effects were similar in the three groups. CONCLUSIONS: Oral controlled-release budesonide (6 mg/day) was well tolerated and prolonged remission in Crohn's disease of the ileum and proximal colon, but this effect was not sustained at 1-year follow-up. (Gastroenterology 1996 Jan;110(1):45-51)