Delayed-Release Oral Mesalamine 4.8 g/day (800-mg Tablet) Is Effective for Patients With Moderately Active Ulcerative Colitis

Patient disposition. Patients (n = 772) with moderately active ulcerative colitis were randomized to treatment and dosed with delayed-release mesalamine 2.4 g/day or 4.8 g/day.

(A) Treatment success at week 6. The 4.8 g/day dose was noninferior to delayed-release mesalamine 2.4 g/day for the endpoint of treatment success (overall improvement). Treatment success was defined as either a complete response (remission) or a partial response (improvement) to treatment from baseline at week 6. A complete response was defined as complete resolution or normalization of all of the following: stool frequency, rectal bleeding, and sigmoidoscopy with contact friability test assessment score. A partial response was defined as improvement from baseline in the Physician's Global Assessment score and no worsening in any of the 3 component scores. The complete response rates in the 4.8 g/day and 2.4 g/day groups were 2.6% and 5.0%, respectively. The partial response rates in the 4.8 g/day and 2.4 g/day groups were 67.6% and 60.6%, respectively. (B) Clinical remission at weeks 3 and 6. Significantly more patients who received 4.8 g/day compared to 2.4 g/day achieved clinical remission at week 3 (P = .02) and week 6 (P = .04).

Improvement in individual clinical assessments at week 3. Significantly more patients who received 4.8 g/day compared to 2.4 g/day achieved improvement in stool frequency (P = .002). The 4.8 g/day treatment group showed numerically higher improvement rates than 2.4 g/day for rectal bleeding and Patient's Functional Assessment, but these differences were not statistically significant.

Improvement in individual clinical assessments at week 6. Improvement in stool frequency, rectal bleeding, Patient's Functional Assessment, and Physician's Global Assessment was numerically greater for patients who received 4.8 g/day compared to 2.4 g/day, but these differences were not statistically significant. Approximately 30% of patients in both treatment groups had improvement in sigmoidoscopy with contact friability test.

(A) and (B) Treatment outcome by subgroups at week 6. Treatment success in favor of 4.8 g/day was generally consistent among most subgroups.

Treatment success at week 6 in patients having taken previous ulcerative colitis (UC) therapy. An advantage of 4.8 g/day versus 2.4 g/day was observed with patients previously treated with oral mesalamines (P = .07), rectal therapies (P = .06), corticosteroids (P = .05), or multiple UC medications (P = .01).