Risk of Autoimmune Hepatitis Among Patients with Inflammatory Bowel Disease Treated with Infliximab: A Retrospective Cohort Study Using a National Database.

BACKGROUND AND AIMS: Infliximab and adalimumab are widely used anti-tumor necrosis factor agents for inflammatory bowel disease, both with reported cases of drug-induced autoimmune hepatitis. However, comparative data on the risk of autoimmune hepatitis with infliximab versus adalimumab are limited. We aimed to compare the risk of autoimmune hepatitis among patients with inflammatory bowel disease treated with infliximab versus adalimumab.

METHODS

We conducted a retrospective active-comparator, new-user cohort study using the TriNetX US collaborative network. Adults with Crohn's disease or ulcerative colitis who initiated infliximab or adalimumab were included. Patients with prior autoimmune hepatitis, prior exposure to the alternate anti-tumor necrosis factor agent, selected autoimmune comorbidities, or other biologic exposure were excluded. The primary outcome was new autoimmune hepatitis occurring at least 3 months after treatment initiation. Propensity score matching was performed to balance baseline covariates. A sensitivity analysis was also conducted including autoimmune comorbidities in the matching model.

RESULTS

After propensity score matching, 15,298 patients remained in each group. Autoimmune hepatitis occurred in 33 patients (0.216%) treated with infliximab and 13 patients (0.085%) treated with adalimumab. Infliximab was associated with a higher risk of autoimmune hepatitis (risk ratio 2.53; 95% confidence interval (CI) 1.336-4.818; P = 0.0032). Time-to-event analysis showed similar findings (hazard ratio 2.602; 95% CI 1.369-4.945). In the sensitivity analysis, infliximab remained associated with a higher risk of autoimmune hepatitis.

CONCLUSIONS

In this large national cohort of patients with inflammatory bowel disease, infliximab was associated with a higher observed risk of autoimmune hepatitis compared with adalimumab.