Analysis of adverse effects of infliximab treatment in 486 patients with Crohn′s disease

Objective To assess the safety of infliximab(IFX) treatment in patients with Crohn′s disease(CD). Methods From January 2009 to May 2018, at inflammatory bowel disease (IBD) center of Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 486 CD patients received the treatment of IFX were enrolled and their clinical data were collected. Univariate and multivariate regression of binary logistic were performed for statistical analysis. Results The median follow-up duration was 31.1 months (12.0 months to 40.0 months). The median duration of IFX therapy was 13.0 months (7.0 months to 21.0 months). Among 486 patients, 98 (20.16%) patients reported adverse effects, and 12 (2.47%) patients discontinued the therapy because of adverse effects. Acute infusion reaction was the most common adverse effect in CD patients who received IFX treatment accounting for 41.84%(41/98)of all the adverse effects, and the incidence was 8.44%. Thirty-nine patients had mild and moderate infusion reaction, and all improved after symptomatic treatment (eight patients discontinued IFX therapy because of recurrent infusion reaction). Two patients developed severe infusion reaction as allergic shock, and both relieved after emergency rescue. Four patients developed late-phase allergic reactions. Among 486 patients, 39 (8.02%) patients had infections, including infections of Clostridium difficile, cytomegalovirus, herpeszoster virus, Mycobacterium tuberculosis, and other opportunistic pathogens. There was no cases of infection related death. Thirty-six patients continued with IFX treatment after infection controlled. Among 486 patients, 14(2.88%) patients had severe infection, and all the cases improved after anti-infection treatment. Twenty-seven CD patients with hepatitis B virus (HBV) infection received anti-viral treatments, no active HBV infection was observed. Colon adenocarcinoma was found in one patient under colonoscopy at 22 months after discontinuation of IFX therapy. There were six patients with the history of benign tumors, and no evidence of recurrence, progress or malignancy during treatment. In terms of other rare adverse effects in 486 patients, there were eight (1.64%) patients with liver function injury, two (0.41%) patients with anemia, one (0.21%) patient with peripheral neuropathy, and four (0.82%) patients with skin lesion. Prolonged duration of IFX therapy, without combination of immune-suppressors and with increased baseline body mass index (BMI) were the risk factors of acute infusion reactions. Prolonged duration of IFX therapy and with low baseline albumin level were the risk factors of infections. Conclusions IFX is generally safe as the treatment for CD patients, and its adverse effects can be clinically controlled. Screening before therapy and monitoring during therapy may reduce the risks of adverse effects. Key words: Crohn disease; Infection; Neoplasms; Infliximab; Adverse effects; Infusion reaction