Results of a recent sub analysis of data from the MOTUS study showed that a once-daily 4g dose of mesalazine (Pentasa granules) was non-inferior to the twice-daily 2g dose for such formulation in inducing remission in patients with left-sided active ulcerative colitis. These reults were presented at the Congress of European Crohn’s and Colitis Organisation.

The objective of the MOTUS study was to show non-inferiority of once-daily mesalazine versus twice-daily dosing for the induction of remission in active ulcerative colitis. As many patients with ulcerative colitis experience left-sided disease, the aim of the new sub analysis was to assess specifically the efficacy in patients with left-sided ulcerative colitis.

Patients with active mild-to-moderate ulcerative colitis were randomised to 4g mesalazine once-daily or 2g mesalazine twice-daily. All patients also received mesalazine enema (1g/day) for four weeks. The primary endpoint was clinical and endoscopic remission at week 8 (UC-DAI score =1). Secondary endpoints were clinical remission at weeks 4, 8, 12 (normal stool frequency, no bloody stools, no active disease by physician’s global assessment); mucosal healing at week 8 (UC-DAI endoscopic mucosal appearance score =1). Subgroup analyses of the primary endpoint were carried out by disease location (left-sided disease versus overall study population). Statistical data were based on intent-to-treat (ITT) analyses. If the lower limit of the 95 per cent CI was between -15 per cent and 0 per cent, then the once-daily regimen was declared non-inferior to the twice-daily regimen.

206 patients were enrolled (once-daily n=102, twice-daily n=104). Of the overall population, 83 per cent had left-sided or distal ulcerative colitis and 17 per cent had pancolitis or extensive ulcerative colitis. Patients with left-sided/distal ulcerative colitis comprised 81.4 per cent of the once-daily arm (n=82) and 84.6 per cent of the twice-daily arm (n=86). The primary endpoint of clinical and endoscopic remission at week 8 (UC-DAI score =1) was achieved by 52.9 per cent and 41.5 per cent of patients with left-sided/distal ulcerative colitis in the once-daily arm and the twice-daily arm, respectively (lower 95% CI limit -3.7%). These remission rates are comparable to those of the overall study population (once-daily 52.1%, twice-daily 41.8%). For patients with left-sided/distal ulcerative colitis, non-inferiority was also demonstrated for the secondary endpoints of complete remission (UC-DAI=0; once-daily 28.0%, twice-daily 24.4%, lower 95% CI limit -9.9%) and mucosal healing (endoscopic sub score UC-DAI =1; once-daily 86.6%, twice-daily 68.2%, lower 95% CI limit -5.0%) at week 8.

“These results show that patients with active, left-sided ulcerative colitis may benefit from the convenience of once-daily dosing of mesalazine granules”, said Prof. Bernard Flourié, Lyon Sud Hospital, France.

Pentasa belongs to a class of anti-inflammatory drugs called the aminosalicylates. It is used to treat and control the symptoms of inflammatory bowel disease (IBD) - both ulcerative colitis (UC) and Crohn's disease (CD). Approved indications vary by country.

Ulcerative colitis is a form of inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon. The inflammation can interfere with the normal function of the colon, often causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss and may also strongly affect quality of life.

Mesalazine is approved in many countries for the treatment of mild to moderate ulcerative colitis. Patients with active colitis are commonly prescribed multiple doses daily. However, non-compliance, failure of patients to take the medication as often as prescribed, significantly increases the risk of symptom persistence and recurrence.

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