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New Lupus Drug may have Passed Key Test

After over 50 years of waiting for a new lupus treatment, researchers may have developed can reduce the symptoms of the life-threatening autoimmune disorder that afflicts as many as 1.5 million Americans.

Lupus is a chronic inflammatory disease in which the body’s immune system attacks its own tissues and organs. About 90% of patients are women, usually in their 30s and 40s when it first strikes. Typical symptoms can include fatigue, fever, joint pain, stiffness and swelling, rashes, skin lesions, mouth sores, hair loss and chest pain. The disease can attack many internal organs, leading eventually to death.

In unpublished results released by the Human Genome Sciences company said that the experimental drug Benlysta significantly reduced lupus symptoms in a randomized trial of 865 patients, reducing their need for steroids and improving quality of life.

The new trial was conducted in 865 patients at 90 sites in 13 countries, primarily abroad. Patients all had active lupus, although none had a severe form requiring hospitalization, and received normal care for the disease. The participants were randomly placed into three groups, two receiving different amounts of the drug and the third receiving a placebo. Patients were given an infusion of the drug at the beginning of the trial, at two weeks, at four weeks, and then every four weeks after that. They were followed for 52 weeks.

About 58% of patients who received the highest dose of Benlysta showed a significant improvement on an index used to assess impact, compared with 46% of those receiving the placebo. More of the patients receiving the drug were able to reduce their prednisone intake, and most reported a better quality of life, although specific numbers were not provided.

About 6% of both patients receiving the drug and those on the placebo suffered side effects, including headache, joint pain and infections.

Experts cautioned that the results have not been peer-reviewed or published in a journal; the significance of this study is unknown at this time. Human Genome Sciences said the results will be published after a second study is completed.

Only three drugs are approved for treating lupus — aspirin, the steroid prednisone and the antimalarial drug Plaquenil (hydroxychloroquine) — and all were approved over 50 years ago during the Eisenhower administration. All can have severe side effects, including stomach bleeding for aspirin; weight gain, bruising, high blood pressure and diabetes for prednisone; and vision problems and muscle weakness for Plaquenil.

Benlysta is a monoclonal antibody known generically as belimumab. It is an immune protein produced artificially, which then binds to and blocks the activity of a protein called B-lymphocyte stimulator. Human Genome Sciences discovered the protein. Elevated levels of B-lymphocyte stimulator are believed to contribute to the production of antibodies that attack the patient’s own organs.

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