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Effect of extended MMX mesalamine therapy for acute, mild-to-moderate Ulcerative Colitis

2008; Oxford University Press; Volume: 15; Issue: 1 Linguagem: Inglês

10.1002/ibd.20580

1536-4844

Michael A. Kamm, Gary R. Lichtenstein, William J. Sandborn, Stefan Schreiber, Kirstin Lees, Karen Barrett, Raymond E. Joseph,

Liver Diseases and Immunity

Many patients with ulcerative colitis (UC) respond to mesalamine therapy within 8 weeks. Those not achieving remission after 8 weeks are often treated with steroids or other immunosuppressive therapies. This study aimed to determine the effect of 8 weeks' high-dose MMX mesalamine extension therapy in patients with active, mild-to-moderate UC who had previously failed to achieve complete remission in 2 phase III, double-blind, placebo-controlled studies of MMX mesalamine (SPD476-301 and -302).Patients with active, mild-to-moderate UC who did not achieve clinical and endoscopic remission after <or=8 weeks' treatment with MMX mesalamine (2.4 or 4.8 g/day), ASACOL (mesalamine) delayed-release tablets 2.4 g/day, or placebo in the phase III studies received MMX mesalamine 4.8 g/day for 8 weeks. The aim was to assess remission at week 8, defined as a total modified UC Disease Activity Index score of <or=1, calculated as: scores of 0 for rectal bleeding and stool frequency, a combined Physician's Global Assessment score and sigmoidoscopy score of or=1 point reduction from baseline in sigmoidoscopy score.Overall, 304 patients who entered this acute extension study were evaluated; 59.5% achieved remission at week 8. Remission rates were similar irrespective of prior treatment in the initial acute phase III studies.Most patients with mild-to-moderate UC who fail to achieve remission with up to 8 weeks' initial mesalamine therapy can achieve clinical and endoscopic remission following a further 8 weeks' treatment with high-dose MMX mesalamine therapy, thereby avoiding step-up therapy.