High Remission Rate with Infliximab and Plant-Based Diet as First-Line (IPF) Therapy for Severe Ulcerative Colitis: Single-Group Trial

Abstract

Introduction: About one-third of patients with severe ulcerative colitis (UC) do not respond to corticosteroid therapy and receive rescue therapy with infliximab or cyclosporine. Up to 20% of such patients fail to respond to rescue therapy and undergo colectomy.

Objective: We investigated the outcomes of infliximab and a plant-based diet (PBD) as first-line therapy for severe UC.

Methods: Patients with severe UC defined by the Truelove and Witts criteria were admitted and given standard induction therapy with infliximab (5.0 mg/kg-7.5 mg/kg) at 0, 2, and 6 weeks. Additionally, they received a PBD. The primary endpoint was remission or colectomy in the induction phase and 1 year after discharge. Secondary endpoints were changes in inflammatory markers in the induction phase and the PBD score at baseline and follow-up. A higher PBD score indicates greater adherence to a PBD.

Results: Infliximab and PBD as first-line therapy was administered in 17 cases. The remission rate was 76% (13/17), and the colectomy rate was 6% (1/17) in the induction phase. C-reactive protein values and the erythrocyte sedimentation rate significantly decreased at week 6 from 9.42 mg/dL to 0.33 mg/dL and from 59 to 17 mm/h, respectively (p < 0.0001). At 1-year follow-up, the cumulative relapse rate was 25%, and there were no additional colectomy cases. Mean PBD scores of 27.7 at 1 year and 23.8 at 4 years were significantly higher than baseline scores of 8.3 and 9.9, respectively (p < 0.0001 and p = 0.0391).

Conclusion: This new first-line therapy for severe UC demonstrated a higher remission rate and lower colectomy rate than with the current modality.

Figure 1.

Enrollment of inpatients with severe ulcerative colitis for infliximab and plant-based diet as first-line (IPF) therapy.

Figure 2.

Change in C-reactive protein (CRP) concentration (left) and erythrocyte sedimentation rate (ESR; right) before and after infliximab and plant-based diet as first-line (IPF) therapy in 13 patients with severe ulcerative colitis who achieved clinical remission. Solid bar denotes mean, and error bar shows standard deviation. Arrows with a number in parentheses indicate 3 infliximab infusions at weeks 0, 2, and 6. CRP concentrations and ESRs are presented in Table 3. CRP concentrations and ESRs after IPF therapy were significantly decreased compared with before therapy (analysis of variance, p < 0.0001).

Figure 3.

Cumulative relapse rates during follow-up after discharge for treatment of severe ulcerative colitis (n = 14).