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Investigation of the Cause of Death in a Gene-Therapy Trial
Oleh:
Frank, Karen M.
;
Hogarth, D. Kyle
;
Miller, Jonathan L.
;
Mandal, Saptarshi
Jenis:
Article from Journal - ilmiah internasional
Dalam koleksi:
The New England Journal of Medicine (keterangan: ada di Proquest) vol. 361 no. 02 (Jul. 2009)
,
page 161-169.
Topik:
Gene-Therapy Trial
Ketersediaan
Perpustakaan FK
Nomor Panggil:
N08.K.2009.04
Non-tandon:
1 (dapat dipinjam: 0)
Tandon:
tidak ada
Lihat Detail Induk
Isi artikel
We present a case of disseminated histoplasmosis, complicated by retroperitoneal bleeding and leading to death, in a patient who was receiving systemic immunosuppressive therapy for rheumatoid arthritis and who was enrolled in a gene-therapy trial. This trial was designed to evaluate intraarticular delivery of a tumor necrosis factor {alpha} (TNF-{alpha}) antagonist, through an adeno-associated virus (AAV) type 2 delivery system, for inflammatory arthritis. The patient's receipt of concurrent anti–TNF-{alpha} therapy and other immunosuppressive therapy while she was living in an area where histoplasmosis was endemic was thought to be the most likely explanation for the infection; the evidence presented suggests that this fatal infection was unlikely to have been related to exposure to the agent administered in the gene-therapy trial. This case reinforces the importance of considering infectious complications, such as those from endemic mycoses, in patients receiving treatment with a TNF-{alpha} antagonist and the importance of having a well-designed monitoring plan when subjects in a research study become ill.
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