November 8, 2022
To what extent does subclinical inflammation predict Crohn’s disease outcomes?
Monitoring fecal calprotectin in patients with Crohn’s disease in clinical remission can predict disease progression and identify patients for further investigation and/or intervention.
Magro F, Magalhães D, Patita M, et al. Subclinical Persistent Inflammation as Risk Factor for Crohn’s Disease Progression: Findings From a Prospective Real-World Study of 2 Years. Clin Gastroenterol Hepatol. 2022;20(9):2059–73.e7; https://www.cghjournal.org/article/fulltext
In this registry-based, prospective, observational study, researchers at eight centers in Portugal followed 180 infliximab-treated adults with Crohn’s disease for two years. Patients underwent testing for fecal calprotectin (FC) and serum C-reactive protein (CRP) every 4, 6, or 8 weeks. All were asymptomatic at baseline and had received at least 14 weeks of infliximab treatment prior to study outset.
The authors examined various definitions of subclinical inflammation according to combinations and cut-off points of FC and CRP. They also documented a composite measure of disease progression based on surgery, hospitalization, new fistulae, abscess, or stricture, or required treatment escalation during the two-year study period.
Over the course of the study, 96 patients experienced disease progression as defined by this composite endpoint and biomarker-defined persistent subclinical inflammation prevalence ranged from 24% to 81%, depending on the thresholds and combinations used.
The most accurate biomarker-based predictor of disease progression was FC >250 μg/g over two consecutive visits, which half of all patients experienced. Patients meeting this criterion had three-fold higher odds of experiencing disease progression during the two-year study, compared to those who did not meet this definition of persistent subclinical inflammation (Odds Ratio, 2.996; 95% Confidence Interval, 1.557–5.776). The time-to-disease progression was a median of 11 months in this group and this definition of persistent subclinical inflammation had a positive predictive value of 65% and a negative predictive value of 59%.
Upper gastrointestinal disease involvement predicted disease progression, while administration of monotherapy or combination therapy and infliximab serum levels were not associated with disease outcome during the study period.
Study Design: Registry-based, prospective observational
Funding: The Portuguese Group of Studies in Inflammatory Bowel Disease
Allocation: Not applicable
Level of Evidence: 1b