Relapse-Free Course in Nearly Half of Crohn's Disease Patients With Infliximab and Plant-Based Diet as First-Line Therapy: A Single-Group Trial.

Introduction Incorporation of a plant-based diet was effective in both induction and short-term relapse prevention in Crohn's disease. Ten-year long-term relapse-free rates in Crohn's disease are around 10% to 23%. Objective We investigated whether infliximab and plant-based diet as first-line therapy enhance the long-term relapse-free rate in patients with Crohn's disease. Methods This single-group, prospective study was performed in tertiary hospitals in Japan. Remission was induced in 24 consecutive newly diagnosed adult patients with Crohn's disease during hospitalization via 3 standard infliximab infusions together with a plant-based diet. Patients were instructed to continue the diet after discharge. Scheduled maintenance infliximab infusion was not used. The primary endpoint was relapse, which was defined as the appearance of symptoms resulting in the alteration of therapeutic modality. The secondary endpoints were C-reactive protein level, plant-based diet score, and surgery. Results The median follow-up period was 8.6 years. Thirteen cases were relapse-free. The relapse-free rate evaluated by Kaplan-Meier survival analysis at 1, 2, 3, and 4 years was 79%, 66%, 57%, and 52%, respectively. There was no further reduction afterward up to 10 years. The relapse-free rate with normal C-reactive protein levels at 1 to 2 and 3 to 10 years was 57% and 52%, respectively. The plant-based diet score at 20 months and 5 years was significantly higher relative to baseline ( < 0.0001). Surgical rates at 5 and 10 years were 12% and 19%, respectively. Conclusions Infliximab and plant-based diet as first-line therapy created an unprecedented relapse-free course in nearly half of patients with Crohn's disease.