Systemic Lupus Erythematosus - Treatment for Severe SLE

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Danazol. Researchers are also investigating the use of danazol (Danocrine), a male hormone. One study reported long-term remission of thrombocytopenia when it was used with the corticosteroid prednisone. As with DHEA, side effects include male characteristics such as acne and hair growth.

Plasmapheresis

Plasmapheresis is a process in which the fluid part of the blood, called plasma, is removed from blood cells. The procedure involves first taking blood from the patient. The plasma, which contains the inflammatory antibodies and other immunologically active substances, is discarded and replaced with other fluids. The blood is then returned. Plasmapheresis is not useful for routine management of patients but may have some benefits for patients who do not respond to standard treatments or in specific cases, such as lupus patients with hemolytic anemia.

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Investigational Treatments

Monoclonal Antibodies (MAbs). A MAb is a laboratory-made protein that targets specific immune cells, such as B cells. B cell over-activation has been identified as a key component of the lupus disease process.

• Epratuzumab is being investigated for treatment of moderate to severe lupus. The FDA granted the drug Fast Track status (a designation that speeds up the approval process for promising drugs that address an unmet need). Phase III trials began in 2005.
• Belimumab (Lymphostat-B) has also received Fast Track status. Phase II trial data has shown promising results, and the drug is entering Phase III trials.
• Rituximab (Rituxan), a lymphoma cancer and rheumatoid arthritis drug, has shown good results in reducing B cells and improving lupus symptoms. It is currently in Phase II/III trials. However, in December 2006 the FDA warned of several cases of progressive multifocal leukoencephalopathy (PML) in patients with lupus who took this drug. PML is a life-threatening brain infection. Some patients developed PML as late as 12 months after their last dose of rituximab. Two patients with lupus died from PML.