Modified-Release Mesalazine Effective, Safe, and Useful for Patients With Refractory Ulcerative Colitis: Presented at UEGW

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Title: Modified-Release Mesalazine Effective, Safe, and Useful for Patients With Refractory Ulcerative Colitis: Presented at UEGW
URL: http://www.pslgroup.com/dg/2313E6.htm
Doctor's Guide
October 22, 2008

By Judith Moser, MD

VIENNA, Austria -- October 22, 2008 -- Modified-release mesalazine 4.8 g/day proved equally effective and safe compared to mesalazine 2.4 g/d in the treatment of patients with moderate ulcerative colitis, and could be useful for patients with refractory disease, according to results of a study presented here at the 16th United European Gastroenterology Week (UEGW).

The superiority of oral mesalazine 4.8 g/d over 2.4 g/d in patients with moderately active ulcerative colitis was demonstrated in 2 trials called Assessing the Safety and Clinical Efficacy of a New Dose of 5-ASA (ASCEND I and II). ASCEND III was designed to evaluate the efficacy and safety of a new modified-release oral mesalazine formulation.

The ASCEND III study also aimed at further evaluating the clinical benefit of modified-release mesalazine 4.8 g/d by assessing the noninferiority of the 4.8-g dose to the 2.4-g dose.

"We needed a confirmatory trial," explained William Sandborn, MD, Mayo Clinic, Rochester, Minnesota, who presented the results of ASCEND III at a poster presentation here on October 21.

Patients with moderately active ulcerative colitis received either 2.4 g/d (400-mg tablets; n = 383) or 4.8 g/d (800-mg tablets; n = 389) in a double-blind, randomised fashion.

The primary endpoint of ASCEND III was overall improvement/treatment success defined as improvement according to the physician's global assessment (based on stool frequency, rectal bleeding, sigmoidoscopy, and clinical judgement of disease severity), and no worsening in stool frequency, rectal bleeding, or sigmoidoscopy with contact friability test.

Results demonstrated that "the 4.8-g dose was as effective as the 2.4-g dose, but not significantly so," Dr. Sandborn described. "This trend is consistent with what we saw in patients with moderate disease in the other 2 trials."

Overall improvement at week 6 was 65.5% and 70.2% in the 2.4-g and 4.8-g arms, respectively.

Evidence of an increased therapeutic advantage of 4.8 g was seen in patients with a clinical history of more difficult-to-treat disease. The overall improvement at week 6 was higher with the 4.8-g dose in subgroups of patients who had received previous treatment with oral mesalazine, rectal therapies, steroids, or multiple medications.

The rates of adverse events were identical in both dosage groups (20.6%), and the safety profile of the 4.8-g dose was comparable to that of the 2.4-g dose.

"Not every patient with moderate disease will need a dosage of 4.8 g," Dr. Sandborn noted. "Patients with mild disease should probably be given the 2.4-g dose, as well as patients with moderate disease who are treatment-naïve."

For somewhat more refractory patients, however, Dr. Sandborn recommended the higher dosage. Furthermore, the safety data provide a good basis for increasing the dosage in patients who do not show a sufficient response with the 2.4-g dose.

Funding for this study was provided by Procter and Gamble.

[Presentation title: Modified-Release Oral Mesalazine at 4.8 g/d (800mg Tablet) Is Effective and Well Tolerated in the Treatment of Moderately Active Ulcerative Colitis (UC): Results of the ASCEND III Study. Abstract 794]

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