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Prior Relapse Does not Interfere With MMX Mesalazine-Induced Remission in Ulcerative Colitis: Presented at UEGW

By Jill Stein

PARIS, FRANCE -- October 31, 2007 -- Despite recent multiple relapses, more than half of ulcerative colitis (UC) patients stay in remission for at least 1 year with MMX(TM) mesalazine treatment, according to data reported on October 29 at the 15th United European Gastroenterology Week (UEGW).

Jean-Frederic Colombel, MD, Section Head for Small Intestine, Claude Huriez Hospital, Lille, France, and colleagues conducted a study to examine the effect of relapse history in patients with mild to moderate UC on the efficacy of maintenance therapy with MMX mesalazine.

MMX mesalazine had been demonstrated to be effective for the induction of clinical and endoscopic remission of active, mild-to-moderate UC in 2, 8-week, placebo-controlled, phase 3 studies (SPD476-301 and -302). In a subsequent, long-term study (SPD476-303) that included patients who achieved remission in the 2 earlier studies, MMX mesalazine was shown to be effective for the maintenance of remission.

The current analysis looked at remission rates at the end of long-term study in patients who had developed fewer than 3 or more relapses in the 2 years before enrolling in the parent studies.

Patients in the parent studies received MMX mesalazine 2.4 or 4.8 g/day, or placebo, for 8 weeks. Study 302 also included mesalazine delayed-release tablet 2.4 g/d as an internal reference arm.

Patients not in remission after these studies could opt to enter an 8-week extension phase as part of study 303 and receive further treatment with high-dose (4.8 g/d) MMX mesalazine therapy. Patients who achieved remission following the 8-week extension phase were also eligible to enter the 12-month maintenance phase of study 303.

A total of 459 patients entered the maintenance phase: 225 in the 2.4 g/d QD group and 234 in the 2.4 g/d BID group.

Remission rates were assessed for all patients who entered the maintenance phase and received at least 1 dose of study medication.

Overall, 438 patients had complete relapse records prior to enrolment in the parent studies.

Remission rates were higher in those who had previously experienced fewer than 3 relapses than in those who had previously experienced at least 3 relapses in the 2 years prior to entering the parent study (70.1% vs 59.8% for the 2 groups, respectively).

"While relapse history may identify patients with difficult-to-control UC in whom long-term remission rates may be decreased, roughly 60% of patients who experience 3 or more relapses in the 2 years prior to receiving treatment with MMX mesalazine are likely to be in remission up to 1 year later when receiving MMX mesalazine 2.4 g/d maintenance therapy," Dr. Colombel pointed out.

He added that future research may help further define this population and also help ascertain whether a higher maintenance dose of MMX mesalazine is needed in patients who are prone to relapse.

The study was funded by Shire Pharmaceuticals.

[Presentation Title: MMX Mesalazine Maintains Remission of Mild-to-Moderate Ulcerative Colitis Irrespective of Patients' Previous Relapse History. Abstract G-192]

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