[Suspected cases of severe side effects after infliximab (Remicade) in Germany]

Abstract

Background: Remicade is a chimeric, human-murine, monoclonal antibody. Remicade was approved in the EU in August 1999 for the treatment of active refractory Crohn's disease, and for treating fistulas in subjects with refractory Crohn's disease, and in December 2000 for preventing disease progression in subjects with methotrexate-resistant rheumatoid arthritis. In May 2003, infliximab was approved in the EU for the treatment of ankylosing spondylitis in patients with severe symptoms and elevated serologic parameters of inflammation, who have been refractory to standard treatment.

Results: On the basis of the so-called spontaneous capture, the Paul Ehrlich Institute was notified of 44 adverse drug reactions leading to the death of the patient after the application of infliximab in Germany. 18 of these patients had rheumatoid arthritis, eight Crohn's disease, 13 graft-versus-host disease, and five other diseases. 24 of those patients had sepsis or serious infections. According to the manufacturer, 20,000 patients have been treated in Germany with infliximab.

Discussion and conclusion: We discuss, in this article, the question of causal relation with the medication and make recommendations for the safe use of infliximab.