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* = Presenting author

P567 The long-term efficacy of concomitant enteral nutritional therapy during maintenance infliximab in patients with Crohn's disease: a prospective observational trial

T. Yamamoto*, M. Nakahigashi, T. Shimoyama, K. Matsumoto

Yokkaichi Hazu Medical Centre, Inflammatory Bowel Disease Centre, Yokkaichi, Japan

Background

Several controlled studies have reported that enteral nutrition (EN) with elemental diet (ED) was effective for maintenance of clinical remission in patients with quiescent Crohn's disease (CD). However, most studies on EN have been done before the era of biological therapy and therefore, the long-term efficacy of EN on clinical outcomes during biological maintenance therapy in CD patients has not yet been investigated. This prospective study was undertaken to assess the long-term efficacy of EN on the maintenance rate of clinical remission in patients with quiescent CD receiving infliximab maintenance therapy.

Methods

Eighty patients who achieved clinical remission with infliximab induction therapy received infliximab as maintenance therapy (5 mg/kg, every 8 weeks). Forty-two patients who were known to show good compliance with EN were assigned to an EN-group, and 38 with poor compliance were assigned to a non-EN group. Patients in the EN group received concomitant EN with ED at 1200-1500 mL/day (1200-1500 kcal/day) by using an infusion pump during night time and a low fat diet (20-30 g/day) during daytime, while patients in the non-EN group received neither nutritional therapy nor food restriction. All 80 patients were followed for 3 years. CD activity index (CDAI) was assessed every 8 weeks and CDAI < 150 was defined as clinical remission.

Results

During the 3 years observation time, the mean CDAI was not significantly different between the two groups. During the study period, 20 patients in the EN group ceased EN therapy because they had maintained complete remission. Seventeen (85%) of the 20 patients who ceased EN therapy maintained clinical remission during the study period. On an intention-to-treat basis, 24 patients (57%) in the EN group and 21 patients (55%) in the non-EN group remained in clinical remission during the 3 years observation (not significant). The cumulative proportion of patients in clinical remission was not significantly different between the two groups.

Conclusion

In this long-term study, concomitant EN during infliximab maintenance therapy did not appear to significantly increase the maintenance rate of clinical remission.