Data from two Phase III clinical trials support that Asacol, an oral, non-steroidal medication that belongs to the class of agents known as 5-aminosalicylic acids (5-ASAs), is an effective and well-tolerated treatment for patients with all extents of ulcerative colitis (UC), including isolated proctitis.
The results showed that patients with isolated proctitis who took Asacol, dosed at 2.4 g/day for six weeks, experienced significant improvement as early as three weeks, and sustained improvement at six weeks, of UC symptoms. At six weeks 83 percent of patients had improvement in rectal bleeding, 75 percent had mucosal healing and 57 percent had reduced stool frequency.
These data were presented at the Crohn’s & Colitis Foundation of America’s (CCFA) National Research and Clinical Conference/Sixth Annual Advances in the Inflammatory Bowel Diseases (IBD) Meeting.
Treatment of UC patients is impacted by the fact that most patients would choose oral therapy over other routes of delivery, such as rectal therapy. However, approximately 30 percent of UC patients have isolated proctitis, a condition that is thought to be a challenge to treat with oral medication alone.
“A common misperception among physicians is that all oral 5-ASA studies have included proctitis patients; however, this is not the case,” says Dr. Seymour Katz, Clinical Professor of Medicine at the New York University School of Medicine. “The positive findings from these Asacol studies reassure physicians that Asacol is one treatment that has been proven effective throughout the entire colon, even the most distal portions, and should help guide physicians how to effectively treat their UC patients.”
Ulcerative Colitis (UC) involves inflammation of the lining of the colon and rectum. It varies in clinical severity with patients having mild, moderate or severe disease. Treatment depends on the extent and severity of disease. UC causes flares followed by periods of remission. During a flare, in which the rectum or colon become inflamed, people experience symptoms such as diarrhea, rectal bleeding, abdominal cramping and an urgent need to go to the bathroom. Flares can vary in duration and intensity. While UC is a lifelong condition, medication may help control flares. UC affects people of all ages, but is often diagnosed during early adulthood. The causes of this condition are unknown, but may involve heredity, infection or the immune system.
Source: Procter & Gamble Pharmaceuticals, Inc., USA