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The EPIC Randomized Controlled Trials

Brian G. Feagan, MD; William J. Sandborn, MD; Ulrich Mittmann, MD; Simon Bar-Meir, MD; Geert D’Haens, MD, PhD; Marc Bradette, MD; Albert Cohen, MD; Chrystian Dallaire, MD; Terry P. Ponich, MD; John W. D. McDonald, MD, PhD; Xavier Hébuterne, MD, PhD; Pierre Paré, MD; Pavel Klvana, MD; Yaron Niv, MD; Sandro Ardizzone, MD; Olga Alexeeva, MD; Alaa Rostom, MD; Gediminas Kiudelis, MD; Johannes Spleiss, MSc; Denise Gilgen, PhD; Margaret K. Vandervoort, MSc; Cindy J. Wong, MSc; Guang Yong Zou, PhD; Allan Donner, PhD; Paul Rutgeerts, MD, PhD

JAMA. 2008;299(14):1690-1697.

Context  Maintenance therapy for Crohn 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.

Objective  To determine whether the oral administration of omega-3 free fatty acids is more effective than placebo for prevention of relapse of Crohn disease.

Design, Setting, and Patients  Two randomized, double-blind, placebo-controlled studies (Epanova Program in Crohn's Study 1 [EPIC-1] and EPIC-2) conducted between January 2003 and February 2007 at 98 centers in Canada, Europe, Israel, and the United States. Data from 363 and 375 patients with quiescent Crohn disease were evaluated in EPIC-1 and EPIC-2, respectively.

Interventions  Patients with a Crohn's Disease Activity Index (CDAI) 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.

Main Outcome Measure  Clinical relapse, as defined by a CDAI score of 150 points or greater and an increase of more than 70 points from the baseline value, or initiation of treatment for active Crohn disease.

Results  For EPIC-1, 188 patients were assigned to receive omega-3 free fatty acids and 186 patients to receive placebo. Corresponding numbers for EPIC-2 were 189 and 190 patients, respectively. The rate of relapse at 1 year in EPIC-1 was 31.6% in patients who received omega-3 free fatty acids and 35.7% in those who received placebo (hazard ratio, 0.82; 95% confidence interval, 0.51-1.19; P = .30). Corresponding values for EPIC-2 were 47.8% and 48.8% (hazard ratio, 0.90; 95% confidence interval, 0.67-1.21; P = .48). Serious adverse events were uncommon and mostly related to Crohn disease.

Conclusion  In these trials, treatment with omega-3 free fatty acids was not effective for the prevention of relapse in Crohn disease.

Trial Registration  clinicaltrials.gov Identifiers: EPIC-1: NCT00613197, EPIC-2: NCT00074542

Author Affiliations: Robarts Clinical Trials, Robarts Research Institute (Drs Feagan, Zou, and Donner and Mss Vandervoort and Wong) and Department of Epidemiology and Biostatistics (Drs Feagan, Zou, and Donner), University of Western Ontario, London, Ontario, Canada; Mayo Clinic, Rochester, Minnesota (Dr Sandborn); MP Consulting, Basel, Switzerland (Dr Mittmann); Sheba Medical Center, Tel Hashomer, Israel (Dr Bar-Meir); Imelda General Hospital, Imeldalaan Bonheiden, Belgium (Dr D’Haens); Pavillon Hôtel-Dieu de Québec, Québec City, Québec, Canada (Dr Bradette); Jewish General Hospital, Montreal, Québec, Canada (Dr Cohen); Pavillon Saint-François d’Assise, Québec City (Dr Dallaire); London Health Sciences Centre, London, Ontario, Canada (Drs Ponich and McDonald); Centre Hospitalier Universitaire, University of Nice Sophia Antipolis, Nice, France (Dr Hébuterne); Hôpital Saint-Sacrement, Québec City (Dr Paré); University Hospital, Ostrava, Czech Republic (Dr Klvana); Rabin Medical Center, Petah Tiqva, Israel (Dr Niv); Ospedale Luigi Sacco, Milan, Italy (Dr Ardizzone); Regional Clinical Hospital, Nizhny Novgorod, Russia (Dr Alexeeva); University of Calgary, Calgary, Alberta, Canada (Dr Rostom); Kaunas Medical University, Kaunas, Lithuania (Dr Kiudelis); Tillotts Pharma AG, Ziefen, Switzerland (Mr Spleiss and Dr Gilgen); and University Hospital Gasthuisberg, Herestraat, Leuven, Belgium (Dr Rutgeerts).

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