Infliximab as a rescue treatment in difficult-to-treat autoimmune hepatitis.

Background & Aims: Autoimmune hepatitis is a chronic inflammatory liver disease that leads to liver cirrhosis and corresponding complications, if left untreated. Current standard treatment with azathioprine and prednisolone induces remission in the vast majority of patients. However, for those patients not responding to standard treatment or not tolerating these drugs, few alternatives can be used and their effectiveness might be limited. We sought to analyze the safety and efficacy of off-label treatment with infliximab in a cohort of eleven patients with difficult-to-treat autoimmune hepatitis.

Methods: Patients with difficult-to-treat autoimmune hepatitis who could not be brought into remission with standard treatment, either due to drug intolerance or to insufficient drug impact, were treated off-label with infliximab for a minimum of six months. Patient files were reviewed retrospectively.

Results: Treatment with infliximab led to reduction of inflammation, evidenced by a decrease in transaminases (mean AST prior treatment 475 U/L ± 466, mean AST during treatment 43 U/L ± 32) as well as in immunoglobulins (pretreatment mean IgG 24.8 mg/dl ± 10.1, mean IgG during treatment 17.38 mg/dl ± 6). Infectious complications occurred in seven out of eleven patients and close monitoring was necessary.

Conclusions: Infliximab may be considered as rescue therapy in patients with difficult-to-treat autoimmune hepatitis, albeit treatment may be associated with infectious complications.