Mesalamine in the treatment of mild to moderate active Crohn's ileitis: Results of a randomized, multicenter trial

Background & Aims: The efficacy of 5-aminosalicylic acid (mesalamine) in th e treatment of flare-ups of Crohn's disease is controversial. In previous s tudies, different locations and pathological behavior of Crohn's disease co uld have obscured the efficacy of these drugs that deliver their substance in different intestinal sites. The present study tested two different mesal amine formulations with 6-methylprednisolone in mild to moderate active Cro hn's ileitis. Methods: Ninety-four patients with Crohn's ileitis (Crohn's D isease Activity Index [CDAI], 180-350) were randomly assigned to receive fo r 12 weeks mesalamine tablets, 4 g (35 patients); mesalamine microgranular preparation, 4 g (28 patients); and 6-methylprednisolone, 40 mg (31 patient s). Mesalamine microgranular preparation was a gelatin capsule containing 4 00 mg of mesalamine microgranules coated with Eudragit S, which has been sh own to deliver the drug in the terminal ileum. Results: Patients taking mes alamine tablets experienced a decrease of CDAI median score value of 113.5 (95% confidence interval [CI], 33-149) compared with 123 (95% CI, 77-155) i n the mesalamine microgranular group and 154 (95% CI, 99-197) in the 6-meth ylprednisolone group (P = 0.07 [NS]). Remission at the final visit occurred in 19 of 31 (61%) patients taking steroids compared with 21 of 35 (60%) pa tients taking mesalamine tablets and 22 of 28 (79%) patients taking microgr anular mesalamine (NS). Five patients on steroids were withdrawn because of side effects, and a case of pancreatitis was related to microgranular mesa lamine. Conclusions: Mesalamine in microgranular formulation seems to be eq ually as effective as a standard dosage of steroids in the treatment of the mild to moderate form of Crohn's ileitis.