A Cochrane review [Abstract] 1 included 12 studies with 1273 subjects. Budesonide 6 mg daily was no more effective than placebo for maintenance of remission at 3 months (RR 1.25, 95% CI 1.00 to 1.58; 6 studies, n=540), 6 months (RR 1.15, 95% CI 0.95 to 1.39; 5 studies, n=420), or 12 months (RR 1.13, 95% CI 0.94 to 1.35; 5 studies, n=420). Budesonide was not more effective than weaning doses of prednisolone for maintenance of remission at 12 months (RR 0.79, 95% CI 0.55 to 1.13; 1 study, n=90), but was better than mesalamine 3 grams per day (RR 2.51, 95% CI 1.03 to 6.12; 1 study, n=57).
At 12 months 55% of budesonide 6 mg patients remained in remission compared to 48% of placebo patients (RR 1.13; 95% CI 0.94 to 1.35; 5 studies, 420 patients). Similarly, there was no significant benefit for budesonide 3 mg compared to placebo at 6 and 12 months. There was no statistically significant difference in continued remission at 12 months between budesonide and weaning doses of prednisolone (RR 0.79; 95% CI 0.55 to 1.13; 1 study, 90 patients). Budesonide 6 mg was better than mesalamine 3 g/day at 12 months (RR 2.51, 95% CI 1.03 to 6.12; 1 study, 57 patients).There was no statistically significant difference in continued remission at 12 months between budesonide and azathioprine (RR 0.81; 95% CI 0.61 to 1.08; 1 study 77 patients). The use of budesonide 6 mg resulted in slight improvements in CDAI scores when assessed at 6 months (WMD -24.3, 95% CI -46.31 to -2.29; 5 studies, n=420) and 12 months (WMD -23.49, 95% CI -46.65 to -0.32; 5 studies, n=420) and mean time to relapse of disease (WMD 59.93 days, 95% CI 19.02 to 100.84; 4 studies, n=171). Mean time to relapse was significantly shorter for patients receiving budesonide than for those receiving azathioprine (MD -58.00, 95% CI -96.68 to -19.32).
Adverse events were not more common in patients treated with budesonide compared to placebo (6 mg: RR 1.51, 95% CI 0.90 to 2.52; 3 mg: RR 1.19, 95% CI 0.63 to 2.24). These events were relatively minor and did not result in increased rates of study withdrawal. Abnormal adrenocorticoid stimulation tests were seen more frequently in patients receiving both 6 mg daily (RR 2.88, 95% CI 1.72 to 4.82; 4 studies, n=296) and 3 mg daily (RR 2.73, 95% CI 1.34 to 5.57; 3 studies, n=164) compared with placebo.
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