Similar remission results shown between once-daily 4g dose and twice-daily 2g doses of mesalazine (PENTASA®) in active ulcerative colitis
Stockholm, Sweden – 24 October 2011 –
Results of a new study 1 presented today at the United European Gastroenterology Week (UEGW) congress in Stockholm demonstrate that a single daily 4g dose of mesalazine (PENTASA granules) is non-inferior to the standard, twice-daily 2g dose in inducing remission in patients with active ulcerative colitis.
The objective of the study was to show non-inferiority of once daily mesalazine (PENTASA) versus the standard twice-daily dosing for the induction of remission in active 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). The primary endpoint was met. The study found similar clinical and endoscopic remission rates for the once-daily 4g dose and twice-daily 2g doses (52.1% and 41.8% respectively, p=0.1402). With regard to secondary endpoints, clinical remission at weeks 4, 8 and 12 were similar between the once-daily 4g dose and twice-daily 2g doses at 39.8% versus 27.6% (p=0.07), 45.1% versus 40.8% (p=0.53), 92.4% versus 79.4% (p=0.13); mucosal healing at week 8 by UC-DAI sub-score ≤1: 87.5% versus 71.1% (p=0.007).
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. 2
“We’ve known for some time that once-daily dosing can effectively maintain remission in patients suffering from mild to moderate ulcerative colitis. This new study suggests that the benefits of once-daily dosing can be extended to patients with active ulcerative colitis,” said Prof. Bernard Flourié, Lyon Sud Hospital, France.
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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.
Inflammatory Bowel Disease (IBD) describes a range of chronic diseases of the gastrointestinal system, encompassing Ulcerative Colitis (UC) and Crohn’s Disease (CD). IBD is characterised by intermittent flares with debilitating symptoms (such as diarrhea, abdominal pain and weight loss) that can result both in a significant worsening of the patient’s quality of life as well as causing emotional distress and social isolation. In addition, patients can also suffer from a number of serious complications of the disease and may require life-long treatment and often surgery.
Both CD and UC are ongoing diseases and, although symptoms may disappear with treatment, they tend to come back over time. Thus, patients are at risk of future attacks unless they continue to take their medication to keep them in remission.
During the acute, active phase of IBD doctors may prescribe stronger therapies to control the inflammation, despite their potential harmful effects, if they will help the patient get better. However, side effects from a treatment being used for maintenance therapy are far less acceptable. Since patients will most probably have to take these medications over their entire lifetime, they must be both effective and safe. Mesalazine fulfils these requirements, as well as being convenient for the patient.
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 70 countries.
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- Flourie, B., Once-Daily versus Twice-daily Mesalazine (PENTASA®) for Active Ulcerative Colitis: Efficacy Results from MOTUS, a Multicentre, Controlled, Randomised, Investigator-Blinded Study, UEGW Abstract number 0P95
- Kane, S., Am J Med. 2003; 114:39-43