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

Autores da FMUP
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
- Tipo:
- Article
- Páginas:
- 2059-20737
- PubMed:
- 34896644
- Link para outro recurso:
- www.scopus.com
Clinical Gastroenterology and Hepatology W.B. Saunders Ltd
Citações Recebidas na Web of Science: 4
Citações Recebidas na Scopus: 9
Documentos
- Não há documentos
Filiações
Keywords
- Inflammatory Bowel Disease; Anti-TNF-alpha; C-Reactive Protein; Fecal Calprotectin
Financiamento
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