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Although the efficacy of TNF antagonist Invlissi monoantigen in the treatment of inflammatory bowel disease (IBD) is more recognized, there are still some serious adverse events, especially infections and malignant tumors.
recent studies have shown an increased risk of serious infection after Crohn's disease patients (CDs) receive inflexi monotherapy, and there is a suspected correlation between inflexissi monoantigen exposure and this risk.
levels of the drug valley concentration (TLI) of inflissi monoantigen are considered to be the most critical factors affecting infection in patients.
but some literature suggests that the overall cumulative exposure is related to infection.
, the study aims to explore the factors associated with infection in patients treated with infriffic monotherapy, including pharmacodynamic characteristics.
researchers collected clinical data on 209 IBD patients (159 crohn's disease) who received Inflixi monoantigen maintenance therapy in France between November 2016 and April 2017; 54 cases received a combined drug treatment).
exposure to inflixi monoantigen is estimated based on the area between the curves (AUC) of the drug concentration in the pharmacodynamic model.
total individual exposure over a six-month basis based on the AAUC's total.
results showed an average concentration of 5.46 mg / L and a cumulative AAUC average of 3938±1427 mg.d / L.
a total of 215 infections were collected from 640 infusion visits, and 123 patients (59%) were infected at least once.
after multivariable analysis, the factors associated with infection independence include smoking (advantage ratio of .OR, 2.05; P s.046), IBD recurrence (OR, 2.71; P s.006) and the cumulative AUC high (3234 mg.d/L) (OR, 2.02; P .02).
AAUC is higher in patients who have been infected (P - .04) and is associated with the number of infections (P - .04).
low concentration of inflixi monoantigen was not associated with infection.
, the researchers confirmed through this study that nearly two-thirds of patients treated with inflixi monotherapy had an infection.
risk of infection was associated with an increased cumulative exposure to the drug, but not to the level of inflixi monodrive.