Takeda drug impresses in ulcerative colitis study
NEW YORK (Reuters) - More than 40 percent of patients with moderate to severe ulcerative colitis achieved clinical remission from the debilitating condition after a year of taking an experimental drug developed by Japan's Takeda Pharmaceutical Co, according to data from a pivotal late-stage trial.
The drug, vedolizumab, showed advantages in rates of remission, clinical response and bowel healing compared with a placebo, researchers said.
Of the patients taking part in the year-long study, 45 percent of those who received vedolizumab every four weeks and 42 percent who got the drug every eight weeks were deemed to be in clinical remission at the end of the year.
That compares with 16 percent for those who received a placebo.
In a subset of patients who were not also taking a steroid for the condition, the remission rate was 45 percent for those who got the Takeda drug every four weeks compared with 14 percent in the placebo group.
"The maintenance study data are really spectacular," said Dr. Brian Feagan, the trial's lead investigator who presented the data on Tuesday at the Digestive Disease Week meeting in San Diego.
"I think this is a pretty exciting result and has big implications for patient care ultimately," added Feagan, of the University of Western Ontario, who said he believes the data to be strong enough for the drug to gain approval.
Clinical remission was defined as a score of two points or less on a 12-point scale of disease activity. A score of six to 12 indicates moderate-to-severe disease.
Ulcerative colitis is a chronic condition that affects roughly 700,000 Americans, and often strikes younger, active people. Common symptoms include diarrhea, rectal bleeding, incontinence, abdominal pain, fever, fatigue and weight loss.
Vedolizumab, which is given intravenously, targets a protein present in a small percentage of white blood cells that have been shown to play a role in controlling inflammation.
Other ulcerative colitis drugs, while highly effective, suppress the immune system and have been associated with infections and other serious complications, such as tuberculosis.
"It would be nice to have a drug that didn't do that," Feagan said. "There was no increased risk of serious infection or any infection over placebo. It's pretty striking actually."
In addition to remission rates, researchers looked at the rate of durable clinical response and bowel improvement, or mucosal healing, at one year.
The mucosal healing rate was 52 percent for vedolizumab once every eight weeks and 56 percent for every four-week therapy, compared with 20 percent for placebo.
Patients in the study began with a six-week induction phase in which they got an initial 400-milligram dose of the drug to start and another 400 mg dose at week two before moving into the maintenance phase for the next 46 weeks.
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