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Mesalamine Granules lowers the risk of Relapse and Side Effects in Corticosteroid-Induced Ulcerative Colitis

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What's This?

Use of Mesalamine Granules Results in Low risk of Relapse and Side Effects in Patients Who Achieved Corticosteroid-Induced Ulcerative Colitis Remission

Abstract

Background

Corticosteroids are used in the treatment of ulcerative colitis (UC). Patients who discontinues the treatment or tapers it has remission period. To avoid the corticosteroid remission, alternative treatments limiting steroid exposure and UC relapse would be beneficial. It remains uncertain whether patients with corticosteroid-induced remission experience benefit with mesalamine granules (MG), a locally acting aminosalicylate extended release capsule formulation for maintenance of UC remission in adults.

Aims

To evaluate the efficacy and safety of mesalamine granules (MG) 1.5 grams once daily in the patients with UC in corticosteroid-induced remission.

Methods

The data is collected from patients with previous corticosteroid use to achieve baseline and to analyze the UC remission from two 6-month randomized, double-blind, placebo-controlled trials and a 24-month open-label extension (OLE). Six-month relapse-free rates were assessed using the revised Sutherland Disease Activity Index. UC-related adverse events (AEs) were recorded during the 30 months.

Results

158 steroid-treated patients in UC remission were included (MG, n = 105; placebo, n = 53) and 74/105
MG- treated patients who continued MG in the OLE. A significantly larger percentage of patients remained relapse-free at 6 months with MG (77.1 %) versus placebo (54.7 %; P = 0.006), with a 55 % reduction in relapse risk (hazard ratio [HR] 0.45; 95 % CI 0.25–0.79). There was a similar (49.2 %) reduction in risk of UC-related AEs at 6 months (HR 0.51; 95 % CI 0.31–0.84; P = 0.009) that was sustained during the OLE.

Conclusions

MG 1.5 g once daily administered for maintenance of corticosteroid-induced remission was associated with low risk of relapse and UC-related AEs.

Reference:

Gary R. Lichtenstein et al. 2016. Spingerlink.3

Available at: http://www.ncbi.nlm.nih.gov/pubmed/26563167/

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