This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Psoriasis is a chronic and severe autoimmune skin disease with an incidence of approximately 1-3% in the general population. There is currently no cure for psoriasis. Tumor necrosis factor occurs naturally in humans and has been shown to be associated with anti-tumor activity. It is also known to be involved in the body's inflammatory responses and may be responsible for acute and chronic inflammatory diseases such as severe life-threatening adult lung failure, rheumatoid arthritis and inflammatory bowel disease. Physicians anticipate using cell-adhesion molecule (CAM) antagonists, which affect T-cell function, in the treatment of cutaneous psoriasis and using TNF inhibitors, which affect TNF in the inflammatory cascade, in the treatment of both psoriasis and psoriatic arthritis (PsA). The discovery that TNF inhibition has a beneficial effect on both the articular lesions of PsA and psoriatic skin lesions may lead to further investigation of new drugs that are effective in subjects with psoriasis. There is a protein (TBP-1) made naturally by the body with the ability to bind with TNF-alpha, that plays an important role in the immune system and inflammation. Human soluble recombinant-human TBP-1 (onercept) is almost the same as the body's own natural TBP-1 except that it is produced artificially outside the body through genetic engineering. Onercept effectively binds TNF-alpha , thus interfering with its action. Soluble TNF-binding proteins act by competing with the cell surface receptors for TNF-alpha and TNF-beta molecules. Many of the biological effects of TNF are blocked by TBPs. The presence of TBF-binding proteins in biological fluids is detected by their ability to compete with the binding of TNF-alpha and TNF-beta to specific cell receptors, and is measured by their ability to inhibit TNF-alpha and TNF-beta cell lytic activity. Onercept is an investigational medication, not yet approved by the Food and Drug Administration (FDA), of Serono, Inc., the sponsor of this study. The purpose of this research study is to find out how safe and effective onercept is when taken by subjects who have moderate to severe plaque psoriasis (with or without psoriatic arthritis).
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