Subclinical Persistent Inflammation as Risk Factor for Crohn's Disease Progression: Findings From a Prospective Real-World Study of 2 Years

Data de publicação: Data Ahead of Print:

Autores da FMUP

  • Fernando José Magro Dias

    Autor

  • Claudia Camila Rodrigues Pereira Dias

    Autor

Participantes de fora da FMUP

  • Magalhaes, D
  • Patita, M
  • Arroja, B
  • Lago, P
  • Rosa, I
  • de Sousa, HT
  • Ministro, P
  • Mocanu, I
  • Vieira, A
  • Castela, J
  • Moleiro, J
  • Roseira, J
  • Cancela, E
  • Sousa, P
  • Portela, F
  • Correia, L
  • Santiago, M
  • Dias, S
  • Alves, C
  • Afonso, J
  • Danese, S
  • Peyrin-Biroulet, L
  • GEDII

Unidades de investigação

Abstract

BACKGROUND AND AIMS: Subclinical intestinal inflammation is common in Crohn's disease (CD). We aimed to explore its impact in the disease progression of infliximab-treated patients and the usefulness of fecal calprotectin (FC) and C-reactive protein (CRP) as surrogate minimally invasive biomarkers. METHODS: The registry-based, prospective, observational, multicenter DIRECT (study to investigate the correlation of fecal calprotectin with serum Drug levels and development of an antI-dRug antibodiEs among adult patients with inflammatory bowel disease reCeiving anti-TNF-alfa treatment or vedoluzimab treatment) study followed infliximab-treated CD patients for 2 years in a tertiary care setting. Persistent inflammation definition was based on FC (>150 mu g/g, >250 mu g/ g, or >350 mu g/g) or serum CRP (>3 mu g/mL) concentrations over 2 consecutive or at least 3 visits. Patients were categorized according to a composite outcome reflecting disease progression that incorporated surgery; hospitalizations; new fistulae, abscess, or stricture; and treatment escalation. RESULTS: Of 322 DIRECT study patients, 180 asymptomatic, infliximab treated on maintenance regimen were included in the analysis. Patients developing the composite endpoint (n = 96) presented higher median levels of FC (205 [interquartile range, 98-515] mu g/g; P = .045) but not of CRP (2.50 [interquartile range, 0.80-6.00] mu g/mL; P = .895). Biomarker-defined persistent subclinical inflammation prevalence ranged from 24% to 81%. Considering FC >250 mu g/g in 2 consecutive visits, prevalence was 50%, odds of achieving the endpoint were increased 3-fold (odds ratio, 2.996 [95% confidence interval, 1.557-5.776]), and time-to-outcome occurrence was significantly lower among subjects with persistent inflammation (median time: 11 months). Both clinical-related and treatment-related components were significantly associated with persistent inflammation. Definitions based on CRP >3 mu g/mL, FC >150 mu g/g, FC >350 mu g/g, double biomarkers (FC >250 mu g/g and/or CRP >3 mu g/mL), or more visits did not improve predictive ability. CONCLUSIONS: Persistent inflammation, defined simply and readily by FC >250 mu g/g over 2 consecutive visits, was associated with a significantly higher risk and shorter time to occurrence of a composite outcome reflecting disease progression in asymptomatic infliximab-treated CD patients.

Dados da publicação

ISSN/ISSNe:
1542-7714, 1542-3565

Clinical Gastroenterology and Hepatology  W.B. Saunders Ltd

Tipo:
Article
Páginas:
2059-20737
Link para outro recurso:
www.scopus.com

Citações Recebidas na Web of Science: 4

Citações Recebidas na Scopus: 9

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Keywords

  • Inflammatory Bowel Disease; Anti-TNF-alpha; C-Reactive Protein; Fecal Calprotectin

Financiamento

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