United States of America. The Food and Drug Administration has licensed a new biotechnology product - a monoclonal antibody called infliximab (Remicade: Centocor) - to treat patients with moderate to severe Crohn’s disease, a chronic, incurable inflammatory bowel disease that causes diarrhoea, cramps and abdominal pain, and in some cases fistulae leading from the intestine to the skin. Because short-term use has benefited patients with a serious disease, the product received accelerated approval.

Infliximab is the first approved treatment for Crohn’s disease. It is a genetically engineered antibody against a protein, tumour necrosis factor alfa, that promotes inflammation in the body. The antibody is manufactured using cells containing human and mouse antibody genes.

The most common adverse effects were related to the intravenous infusion itself and included rash, low blood pressure, chills, and chest pain. These symptoms were generally temporary. Other common adverse effects included infections, some serious, that responded to antibiotic treatment. In addition, patients occasionally developed antibodies which could have been associated in rare cases with symptoms similar to those seen in patients with systemic lupus erythematosus. These symptoms were also transient.

References: FDA Talk Paper T98-23 dated 24 August 1998.