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

Abstract

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 (p < 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.

Figure 1:

Enrollment of inpatients with active Crohn’s disease (CD) for first-line therapy with infliximab and a plant-based diet (IPF). One newly diagnosed patient with CD who underwent intestinal surgery before medical therapy was excluded from this study.

Figure 2:

Life table estimate of relapse-free, relapse-free with normal C-reactive protein, and surgery-free cases in the follow-up period after infliximab and plant-based diet as first-line (IPF) therapy for active Crohn’s disease. Black Line = relapse-free, red line = relapse-free with normal C-reactive protein, green line = surgery-free.

Figure 3:

Change over time in plant-based diet score (PBDS) (mean ± SD). PBDS+ (green dotted line) at baseline, in short-term, and in long-term was 21.4 (8.9), 33.0 (5.1), and 29.9 (7.3), respectively. PBDS– (red dotted line) for those was 13.2 (5.1), 2.4 (2.6), and 5.7 (6.9), respectively. PBDS (black line) for those was 8.2 (8.3), 30.6 (6.3), and 24.2 (12.2), respectively (Table 2). SD = standard deviation.

Figure 4:

Graphic clinical course in Crohn’s disease (CD). Solberg et al. presented 4 graphic clinical courses of CD: Curve 1 (decrease in the severity of bowel symptoms), curve 2 (increase in the severity of bowel symptoms), curve 3 (chronic continuous bowel symptoms), and curve 4 (chronic relapsing bowel symptoms) (with permission from Elsevier). In the present study, a relapse-free course was attained in nearly half of the patients with CD treated with infliximab and a plant-based diet as first-line (IPF) therapy.