Efficacy Glucocorticosteroids selleck chem Erlotinib are effective inductive agents for CD. The first definitive data came from the NCCDS, in which 60% of patients treated with prednisone (0.25-0.75 mg/kg per day) were in remission at 17 wk compared to 30% of placebo-treated patients[3]. Even more impressive were the results from the ECCDS in which 80% of patients treated with methylprednisolone (48 mg) achieved remission at 18 wk compared to less than 40% of placebo patients[4]. More recent randomized controlled studies have compared prednisolone (40 mg) or 6-methylprednisolone (48 mg) to budesonide (9 mg) in the treatment of active CD ileocolitis, with similar rates found for the induction of remission at 66% and 73% for the two systemic steroids[40,41].

Although in one retrospective review, 60% patients treated with alternate-day prednisone treatment (mean dose of 25 mg q.o.d.) maintained ��favorable responses�� for an average of 6.6 years[42], the overwhelming evidence does not support the use of corticosteroids for maintenance of remission. Neither the NCCDS nor ECCDS studies showed benefit of corticosteroids over placebo in maintaining remissions[3,4]. Conventional corticosteroids are not effective at preventing post-operative relapse[43] and a recent Cochrane review of three randomized double-blind placebo controlled studies showed no benefit of corticosteroid therapy in preventing relapses in patients with quiescent CD over 24 mo[44]. NON-SYSTEMIC STEROIDS Budesonide, in delayed or controlled-release formulations that deliver the potent glucocorticoid to the ileum and/or right colon, has low systemic side effects owing to a high (80%-90%) first-pass metabolism[45].

Two randomized controlled studies demonstrated superiority of budesonide in the induction of remission in patients with ileal or ileo-right colonic disease[46]. In the first trial, 258 patients received 15, 9, or 3 mg of budesonide, daily, or placebo, with 43%, 51%, 33% and 20% of patients respectively achieving clinical remission in 8 wk (P < 0.001, P = 0.009 for the higher doses compared to placebo respectively)[47]. In the second study (n = 200), 9 mg/d, 4.5 mg BID twice daily budesonide or placebo yielded remission rates of 48%, 53%, and 33% respectively after 8 wk of treatment. Although differences between the groups were not significant, when data from the two treatment groups were pooled, the budesonide group had a significantly greater decrease in CDAI than the placebo group (P < 0.05)[48]. One study comparing daily 18 mg, 9 mg, and 6 mg Entinostat of budesonide found a dose-dependent effect, with 66%, 55% and 36% achieving remission.