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108

RAPID SYMPTOM RESOLUTION WITH DELAYED RELEASE MESALAMINE IN MILDLY AND MODERATELY ACTIVE UC

WJ Sandborn¹, S Katz, D Ramsey, DH Present
¹Mayo Clinic, Rochester, MN, United States

PURPOSE: To evaluate the time to clinical remission in patients with mild and moderate active UC receiving 2.4g/d of Asacol (mesalamine) delayed-release tablets.
METHODS: Data from 2 multi-center, randomized, double-blind, active-controlled, 6-week studies of similar design (ASCEND I&II) were combined and analyzed. The studies included patients with mild (PGA=1) and moderate (PGA=2) active UC. This analysis includes data from the 2.4g/d active control arms of these 2 studies. Clinical remission was defined as resolution (score=0) of both rectal bleeding (RB) and stool frequency (SF). Resolution of RB was defined as the absence of visible blood in stools and resolution of SF was defined as a patient’s return to his/her normal number of stools/day. To be included in this analysis patients had to have symptoms at baseline. Time to initial clinical remission was defined as the first day of 3 consecutive days of complete symptom resolution based on symptoms recorded daily by the patients through an integrated voice response system (IVRS).
RESULTS: A total of 687 patients were randomized in the two studies, of which 349 received 2.4g/d. Based on IVRS data, the median time to clinical remission in patients with mild and moderate active UC was 26 days (95% CI 24, 33). Time to clinical remission by disease severity is shown in the figure below:
In addition, results of the time to complete resolution analysis by individual symptoms and disease severity are shown in the table below:
                  

	Mild and Moderate UC (Median)	Mild UC (Median)	Moderate UC (Median)
RB	15 days (95% CI, 10,18)	4 days (95% CI, 3,5)	21 days (95% CI, 17,28)
SF	21 days (95% CI, 16,24)	10 days (95% CI, 7,15)	26 days (95% CI, 22,38)

Asacol 2.4g/d was well-tolerated, with adverse events consistent with those described in the current prescribing information. In pivotal clinical studies of active UC, the most frequent AEs reported for Asacol were headache, abdominal pain and eructation.
CONCLUSION: In active UC, rapid symptom relief is a key goal of treatment. Asacol 2.4g/d provided rapid symptom relief in patients with mild and moderate active UC.
This research was funded by Procter & Gamble Pharmaceuticals.

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