Maintenance therapy for Crohn's disease features the use of immunosuppressive drugs, which are associated with an increased risk of infection.
Identification of safe, and effective maintenance strategies is a priority.
|The rate of relapse in the Epanova Program in Crohn's Study 1 was 32% with omega-3|
|Journal of the American Medical Association|
Dr Brian Feagan and colleagues from Canada determined whether the oral administration of omega-3 free fatty acids is more effective than placebo for prevention of relapse of Crohn's disease.
The research team conducted 2 randomized, double-blind, placebo-controlled studies between 2003 and 2007 at 98 centers in Canada, Europe, Israel, and the United States.
The trials included the Epanova Program in Crohn's Study 1 and EPIC-2 .
Data from 363 and 375 patients with quiescent Crohn's disease were evaluated in Epanova Program in Crohn's Study 1, and Epanova Program in Crohn's Study-2, respectively.
Patients with a Crohn's Disease Activity Index score of less than 150 were randomly assigned to receive either 4 g/d of omega-3 free fatty acids or placebo for up to 58 weeks.
No other treatments for Crohn disease were permitted.
Clinical relapse was defined by a Crohn's Disease Activity Index score of 150 points or greater.
An increase of more than 70 points from the baseline value, or initiation of treatment for active Crohn disease were also considered as clinical relapse.
For Epanova Program in Crohn's Study 1, 188 patients received omega-3 free fatty acids, and 186 patients received placebo.
Corresponding numbers for Epanova Program in Crohn's Study -2 were 189 and 190 patients, respectively.
The rate of relapse at 1 year in Epanova Program in Crohn's Study 1 was 32% in patients who received omega-3 free fatty acids, and 36% in those who received placebo.
The team found that corresponding values for Epanova Program in Crohn's Study -2 were 48% and 49%, respectively.
Serious adverse events were uncommon, and mostly related to Crohn's disease.
Dr Feagans' team concluded, "In these trials, treatment with omega-3 free fatty acids was not effective for the prevention of relapse in Crohn disease."