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Induction with Infliximab and a Plant-Based Diet as First-Line (IPF) Therapy for Crohn Disease: A Single-Group Trial.

The Permanente journal
May 5, 2017
Mitsuro Chiba et al. (10 authors)
Journal ArticleHuman Study
Study Details

Study Goal

The researchers aimed to determine the remission rate of infliximab combined with a plant-based diet as first-line therapy for Crohn disease (CD).

Results Summary

The study found high remission rates (96% intention-to-treat, 100% per-protocol), significant reductions in CDAI scores and CRP levels, and mucosal healing in 46% of cases. The combination therapy was effective in inducing remission in most patients.

Population

Adults and children with newly diagnosed or relapsing CD who were naïve to biologics.

Effective Dosage

Infliximab (5 mg/kg at 0, 2, and 6 weeks) plus a lacto-ovo-semivegetarian diet.

Duration

6 weeks

Interactions

None mentioned

Extracted Claims (6)
InterventionDirectionEndpointPopulationDosageImpactClaim #
infliximab combined with a plant-based diet as first-line (IPF) therapy
increase
remission
patients with CD who are naïve to biologics regardless of age or whether they have a new diagnosis or relapse
-
can induce remission
#1
infliximab combined with a plant-based diet as first-line (IPF) therapy
increase
remission
adults with a new diagnosis, children with a new diagnosis, and relapsing adults with CD who were naïve to treatment with biologics
96% (44/46)
remission rates
#2
infliximab combined with a plant-based diet as first-line (IPF) therapy
increase
remission
adults with a new diagnosis, children with a new diagnosis, and relapsing adults with CD who were naïve to treatment with biologics
100% (44/44)
remission rates
#3
infliximab combined with a plant-based diet as first-line (IPF) therapy
decrease
Crohn Disease Activity Index (CDAI) score
adults with a new diagnosis, children with a new diagnosis, and relapsing adults with CD who were naïve to treatment with biologics
from 314 to 63 at week 6
decreased
#4
infliximab combined with a plant-based diet as first-line (IPF) therapy
decrease
C-reactive protein (CRP) concentration
adults with a new diagnosis, children with a new diagnosis, and relapsing adults with CD who were naïve to treatment with biologics
from 5.3 mg/dL to 0.2
decreased
#5
infliximab combined with a plant-based diet as first-line (IPF) therapy
increase
mucosal healing
adults with a new diagnosis, children with a new diagnosis, and relapsing adults with CD who were naïve to treatment with biologics
46% (19/41)
was achieved
#6
Abstract

BACKGROUND: Approximately 30% of patients with Crohn disease (CD) are unresponsive to biologics. No previous study has focused on a plant-based diet in an induction phase of CD treatment. OBJECTIVE: To investigate the remission rate of infliximab combined with a plant-based diet as first-line (IPF) therapy for CD. METHODS: This was a prospective single-group trial conducted at tertiary hospitals. Subjects included consecutive adults with a new diagnosis (n = 26), children with a new diagnosis (n = 11), and relapsing adults (n = 9) with CD who were naïve to treatment with biologics. Patients were admitted and administered a standard induction therapy with infliximab (5 mg/kg; 3 infusions at 0, 2, and 6 weeks). Additionally, they received a lacto-ovo-semivegetarian diet. The primary end point was remission, defined as the disappearance of active CD symptoms at week 6. Secondary end points were Crohn Disease Activity Index (CDAI) score, C-reactive protein (CRP) concentration, and mucosal healing. RESULTS: Two adults with a new diagnosis were withdrawn from the treatment protocol because of intestinal obstruction. The remission rates by the intention-to-treat and per-protocol analyses were 96% (44/46) and 100% (44/44), respectively. Mean CDAI score (314) on admission decreased to 63 at week 6 (p < 0.0001). Mean CRP level on admission (5.3 mg/dL) decreased to 0.2 (p < 0.0001). Mucosal healing was achieved in 46% (19/41) of cases. CONCLUSION: IPF therapy can induce remission in most patients with CD who are naïve to biologics regardless of age or whether they have a new diagnosis or relapse.

Medical Subject Headings (MeSH)
AdolescentAdultAgedAntibodies, MonoclonalCrohn DiseaseDiet, VegetarianFemaleHumansInfliximabMaleMiddle AgedProspective StudiesYoung Adult
Study Links
Quality Scores
SafetyNot Assessed
Efficacy85/10
Quality75/10
Citation Metrics
Total Citations33
Citations/Year4.1
Relative Citation Ratio1.51
NIH Percentile65.4%
Research Impact Scores
APT Score0.75
Weight Score1.98
Normalized Score0.69
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