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Data from two Phase III, multi-center, randomized, double-blind, 6-week, active-controlled studies of similar design (Ascend I&II) were combined and analyzed. The aim of this analysis was to evaluate the efficacy of oral delayed-release Asacol dosed at 2.4 g/day to treat active UC flares in patients with isolated proctitis.
Of the 349 patients who received Asacol 2.4 g/day, 63 had isolated proctitis, 205 had left-sided disease (proctosigmoiditis and left-sided colitis) and 81 had pancolitis. Patients were prohibited from taking rectal therapies and were only treated with Asacol. The results showed that patients with isolated proctitis who took Asacol, dosed at 2.4 g/day for six weeks, experienced significant improvement as early as three weeks, and sustained improvement at six weeks, of UC symptoms. At six weeks 83% of patients had improvement in rectal bleeding, 75% had mucosal healing and 57% had reduced stool frequency.
Seymour Katz, clinical professor of medicine at the New York University School of Medicine, said: "The positive findings from these Asacol studies reassure physicians that Asacol is one treatment that has been proven effective throughout the entire colon, even the most distal portions, and should help guide physicians how to effectively treat their UC patients."
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