Development and Internal Validation of a Model Using Fecal Calprotectin in Combination with Infliximab Trough Levels to Predict Clinical Relapse in Crohn's Disease

The best noninvasive method predicting clinical relapse remains undetermined in infliximab (IFX)-treated patients with Crohn's disease. All patients with CD on IFX maintenance treatment and in clinical remission for at least 16 weeks, between 2011 and 2014, were enrolled in a prospective single...

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Published in:Inflammatory bowel diseases 2017-01, Vol.23 (1), p.126-132
Main Authors: Roblin, Xavier, Duru, Gerard, Williet, Nicolas, Del Tedesco, Emilie, Cuilleron, Murielle, Jarlot, Camille, Phelip, Jean Marc, Boschetti, Gilles, Flourié, Bernard, Nancey, Stephane, Peyrin-Biroulet, Laurent, Paul, Stephane
Format: Article
Language:English
Subjects:
Adult
Azathioprine - administration & dosage
C-Reactive Protein - analysis
Crohn Disease - diagnosis
Crohn Disease - drug therapy
Crohn Disease - metabolism
Feces - chemistry
Female
Gastrointestinal Agents - administration & dosage
Gastrointestinal Agents - blood
Humans
Infliximab - administration & dosage
Infliximab - blood
Leukocyte L1 Antigen Complex - analysis
Logistic Models
Maintenance Chemotherapy - methods
Male
Middle Aged
Predictive Value of Tests
Prospective Studies
Recurrence
Severity of Illness Index
Treatment Outcome
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Summary:The best noninvasive method predicting clinical relapse remains undetermined in infliximab (IFX)-treated patients with Crohn's disease. All patients with CD on IFX maintenance treatment and in clinical remission for at least 16 weeks, between 2011 and 2014, were enrolled in a prospective single-center study. The Crohn's Disease Activity Index (CDAI), fecal calprotectin, C-reactive protein levels, antibodies (ATI), and trough level (TLI) of IFX were measured at every IFX infusion. The best thresholds of TLI (2 versus 3 μg/mL) and calprotectin (50 versus 250 μg/g stools) were identified across four logistic regression models. One hundred nineteen patients (mean age: 34 ± 12 yrs, mean disease duration: 7.8 yrs) were included. Mean follow-up was 20.4 months, and 17% of the patients were on IFX and azathioprine at inclusion. During follow-up, 37 patients (31.1%) relapsed, 78% within the first 6 months. The clinical characteristics of the relapsed and nonrelapsed patients were similar. After logistic regression, fecal calprotectin >250 μg/g stools (OR: 4.09; 95% CI, 1.01-16.21; P = 0.049) and TLI
ISSN:1078-0998
1536-4844
DOI:10.1097/MIB.0000000000000986