When compared to prednisone, budesonide 9 mg/d there were no significant differences found in clinical remission rates[40,41,50,51] although 17-DMAG Phase 2 a meta-analysis revealed the pooled rate difference of response of budesonide vs conventional corticosteroids to be – 8.5%, P = 0.02[52]. Budesonide was associated with fewer steroid side effects overall in three studies[40,41,50] and reduced incidence of moon facies and adrenal impairment in the other[51]. While extended treatment with budesonide has been shown to prolong the time to relapse compared to placebo, the difference was not sustained at one year with 3 mg[53] or 6 mg[54�C56]. Similarly, another study found no difference in relapse rate at any time point over a one year period between patients treated with either 3 mg or 6 mg budesonide and placebo[57].

Neither budesonide 3 nor 6 mg/d was shown to be more effective than placebo in preventing post-operative clinical[58] or endoscopic recurrence[58,59]. Both a Cochrane review and meta-analysis confirmed that budesonide is ineffective at maintaining CD remissions[52,60]. However, in a trial that allowed flexible dosing of budesonide or prednisone over two years to maintain clinical quiescence and examined bone mineral density (BMD) in relation to efficacy and side effects in CD patients, only 37% of budesonide-treated patients withdrew from the study because of failure to improve or worsening disease. However, the average dose of budesonide required to maintain remissions was higher than (6.8 mg/d) doses used in the placebo-controlled trials.

Nevertheless, among patients who were steroid-na?ve prior to entering the study, smaller reductions in BMD were seen in the budesonide group compared to the prednisolone group (mean, -1.04% vs -3.84%; P = 0.0084)[61]. Budesonide at doses below 6 mg/d has Entinostat been demon-strated to be safe for long-term (one year) use. Results from a pooled analysis of five one-year controlled trials using budesonide 6 mg/d showed that while the overall number of adverse events were not different between the budesonide and placebo groups, patients treated with budesonide had more endocrine and ��resistance mechanism�� disorders (infection) (P = 0.0042 and P = 0.042, respectively). The higher incidence of endocrine problems was primarily driven by acne and moon facies, while viral infections accounted for the difference in infection rate. Serious adverse events were reported as rare[62]. In summary, while budesonide is an effective and safe medication for the induction of remission in patients with mild-moderate ileal and proximal colonic disease, optimal dosing schedules to maintain remissions have yet to be established.