In contrast, the ECCDS did not demonstrate efficacy for sulfasalazine 3 g/d alone, but only in combination with 6-methylprednisolone[4]. Subsequently, newer mesalamine agents have been evaluated in clinical trials for CD. In the largest of these studies selleck products (n = 310), patients with active ileal or ileocolonic CD were randomized to receive Pentasa?, 1, 2 or 4 g/d or placebo. The 4 g/d group experienced a greater decrease in CDAI than the placebo group (72 vs 21 points, P < 0.01), an effect more pronounced in isolated ileal disease, and remission was achieved in 43% vs 18% respectively[5]. Subsequently, two similarly designed trials described in a meta-analysis failed to replicate these findings although there was an overall statistical benefit for the 4 g dose of mesalamine that was of questionable clinical significance[6,7].

Several other trials also have demonstrated benefit for mesalamine in CD, but the quality of the trials was less robust[8,9]. When compared to other agents in controlled trials approximately 40%-55% of patients treated with mesalamine 4 g/d achieve remissions but the efficacy was less than budesonide (9 mg/d) for the induction of remission at both 8 wk (45% vs 65%, P = 0.001) and 16 wk (36% vs 62%, P < 0.001)[10] and comparable to ciprofloxacin 1 g/d[11]. Maintenance after medical remission Sulfasalazine at reduced doses compared to the induction phase provided no benefit compared to placebo in the maintenance phase of the NCCDS and ECCDS, nor in a smaller study[3,4,12].

Gisbert et al have reviewed nine randomized placebo-controlled studies of mesalamine as a maintenance agent, four of which showed a significantly decreased risk of relapse compared to placebo, although there was great heterogeneity in formulation, dosage, duration of treatment, and disease location[13]. Further, a Cochrane review of seven randomized placebo-controlled trials concluded that treatment with 5-ASA agents for at least six months did not confer an advantage over placebo in patients with medically-induced remission[14]. When initiated within three AV-951 months of a medically-induced remission, mesalamine (2 g bid), in contrast to placebo, prevented more relapses over a two year period[15]. In the context of a steroid-induced remission, short-term weaning from steroids may be slightly facilitated with mesalamine 4 g/d, but there was no benefit at one year in relapse rate between patients maintained on mesalamine compared with placebo[16]. Post-operative maintenance The natural history of CD after ileocolonic resection is variable, and may be influenced by such factors as pattern, extent, and duration of disease preoperatively as well as smoking history.