2013-02-14 12:02:00 -
Results of a recent sub analysis 1 of data from the MOTUS study 2 presented today at the Congress of European Crohn’s and Colitis Organisation 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.
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 4 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% CI was between -15% and 0%, 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% had left-sided or distal ulcerative colitis and 17% had pancolitis or extensive ulcerative colitis. Patients with left-sided/distal ulcerative colitis comprised 81.4% of the once-daily arm (n=82) and 84.6% 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% and 41.5% 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.
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Notes for editors
About Pentasa ® (mesalazine)
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.
About Ulcerative colitis
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. It is believed that as many as 800,000 people in the U.S. and as many as 900,000 people in the EU have ulcerative colitis.
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. 3
About Ferring Pharmaceuticals
Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology and endocrinology. Ferring has its own operating subsidiaries in 50 countries and markets its products in more than 90 countries. To learn more about Ferring or its products please visit www.ferring.com : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww ..
1 Flourié, B., Comparing the efficacy of once-daily or twice-daily mesalazine dosing in the treatment of left-sided ulcerative colitis versus the overall MOTUS study population, ECCO 2013 abstract number P562
2 Flourié, B., Once-Daily versus Twice-daily Mesalazine (PENTASA®) for Active Ulcerative Colitis: Efficacy Results from MOTUS, a Multicentre, Controlled, Randomised, Investigator-Blinded Study, UEGW 2011 abstract number 0P95
3 Kane, S., Am J Med. 2003; 114:39-43
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Ferring PharmaceuticalsPatrick GormanTel: +41 (0) 58 301 00