Systemic Lupus Erythematosus - Treatment for Severe SLE

Hormone Treatments

Dehydroepiandrosterone (DHEA). Dehydroepiandrosterone (DHEA) is a natural steroid hormone that is produced by the adrenal glands and converted into estrogen and androgen. Some evidence suggests that DHEA deficiencies may play a role in SLE. Although DHEA is sold as a dietary supplement, and has been proclaimed as a cure for a wide variety of ailments, there is little scientific evidence to support most of these claims. In addition, because natural supplements are unregulated, there is no guarantee of quality control..

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However, the synthetic equivalent of DHEA, prasterone, is being investigated as a potential treatment for SLE and several clinical trials have indicated promising, although mixed, results. In a 2004 randomized, double-blind, placebo-controlled trial of women with active lupus, prasterone significantly improved or stabilized lupus symptoms and reduced disease flare-ups. Women who received prasterone also experienced reductions in total cholesterol and triglyceride levels. A 2005 trial of women with SLE found that prasterone prevented bone loss and increased spinal and hip BMD, but additional trials have failed to confirm the benefit. Women in both trials were also taking other SLE drug treatments, such as prednisone. Prasterone is still in the drug development stage and it is not clear when, or if, it will be commercially available.

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 firsttaking 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.

InvestigativeTreatments

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

Epratuzamab is being investigated for treatment of moderate to severe SLE. 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 trialsbegan in 2005.
Lymphostat-B has also received Fast Track status. Phase II trial data showed mixed results, but the drug will enter Phase III trials.
Rituximab, a lymphoma cancer drug, is currently in Phase I/II trials to evaluate the safety of higher doses. Initial results in several small trials indicate significant B-cell reduction with symptom improvement lasting at least one year.