Risk factors of adverse events associated with infliximab treatment for inflammatory bowel disease.

LIU Ai-ling; LYU Hong; LI Yue; YANG Hong; QIAN Jia-ming

doi:10.19538/j.nk2018030111

Abstract：Objective To explore the risk factors of adverse events in patients with inflammatory bowel disease treated with infliximab(IFX). Methods From March 2009 to September 2017, demographic and clinical data of 95 IBD patients (65 CD and 30 UC)who received IFX treatment (≥3 infusions) were retrospectively analyzed. Based on presence or absence of adverse events, the enrolled patients were divided into adverse effect group and non-adverse effect group. Wilcoxon rank sum test was used for comparison of measurement data between groups. Chi-square test was performed for the rate comparison. Multivariate analysis was made with Logistic regression. Results (1)The rate of male to female in 95 patients was 3:1. The average age of onset was (24. 4±9. 7)years old. The age of receiving the first treatment with IFX was (31. 2±11. 1)years. The mean disease duration prior to IFX was (6. 9±5. 8) years. The median duration of IFX therapy was 7. 3 months. (2) In the 95 patients, 24(25. 2％) patients had at least one adverse event, and 6 patients had at least two adverse events. There were 10(10.5％) allergic reactions, 16(16. 8％)infections, 2(2. 1％)leukopenia and 2(2. 1％)liver dysfunction. The median length from adverse event to the first IFX infusion was 5. 2 months. (3) IFX was discontinued in 7(29. 2％) out of 24 patients with adverse events. All patients had been treated effectively, and none died. (4) The level of hsCRP >9 mg/L at baseline (OR 5. 119, 95％ Cl 1. 737～15. 089, P=0.003), non-structuring type (OR 4. 914, 95％ Cl 1. 007～23. 970, P=0.049) and severe disease activity (OR 0.067, 95％ Cl 0.007～0.678, P=0.022) were risk factors of adverse reactions. Conclution IFX is relatively safe for IBD. The level of hsCRP >9 mg/L at baseline, non-stricturing type and severe disease are associated with a higher risk of adverse reactions.