Posted on: 10 July 2009, source: MedPage Today
The death of a young patient participating in a gene-therapy trial for a rheumatoid arthritis drug was most likely the result of another arthritis drug, adalimumab (Humira), and not the novel gene therapy agent, a new study found. "The death of this young patient who was receiving multiple forms of TNF inhibitors highlights the risk of opportunistic infections in patients receiving such agents, and the importance of having a well-designed monitoring plan when a patient in a study becomes ill," Karen M. Frank, MD, of the University of Chicago Medical Center, and colleagues wrote in the July 9 issue of New England Journal of Medicine.
The patient, a 35-year-old woman with a 15-year history of rheumatoid arthritis, first presented three days after receiving a second injection on July 2, 2007, of the active gene-therapy agent, tgAAC94, a tumor necrosis factor alpha (TNF-α) antagonist. She was suffering from a range of symptoms that including fever, chills, abdominal pain, and vomiting.