FDA approves Benlysta to treat lupus

The U.S. Food and Drug Administration today approved Benlysta (belimumab) to treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs.

Benlysta is delivered directly into a vein (intravenous infusion) and is the first inhibitor designed to target B-lymphocyte stimulator (BLyS) protein, which may reduce the number of abnormal B cells thought to be a problem in lupus.

Prior to Benlysta, FDA last approved drugs to treat lupus, Plaquenil (hydroxychloroquine) and corticosteroids, in 1955. Aspirin was approved to treat lupus in 1948.

Lupus is a serious, potentially fatal, autoimmune disease that attacks healthy tissues. It disproportionately affects women, and usually develops between ages 15 and 44. The disease affects many parts of the body including the joints, the skin, kidneys, lungs, heart, and the brain. When common lupus symptoms appear (flare) they can present as swelling in the joints or joint pain, light sensitivity, fever, chest pain, hair loss, and fatigue.

Estimates vary on the number of lupus sufferers in the United States ranging from approximately 300,000 to 1.5 million people. People of all races can have the disease; however, African American women have a 3 times higher incidence (number of new cases) than Caucasian women.

“Benlysta, when used with existing therapies, may be an important new treatment approach for health care professionals and patients looking to help manage symptoms associated with this disease,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

Two clinical studies involving 1,684 patients with lupus demonstrated the safety and effectiveness of Benlysta. The studies diagnosed patients with active lupus and randomized them to receive Benlysta plus standard therapy, or an inactive infused solution (placebo) plus standard therapy. The studies excluded patients who had received prior B-cell targeted therapy or intravenous cyclophosphamide, and those who had active lupus involving the kidneys or central nervous system.

Patients treated with Benlysta and standard therapies experienced less disease activity than those who received a placebo and standard of care medicines. Results suggested, but did not definitively establish, that some patients had a reduced likelihood of severe flares, and some reduced their steroid doses.

African American patients and patients of African heritage participating in the two studies did not appear to respond to treatment with Benlysta. The studies lacked sufficient numbers to establish a definite conclusion. To address this concern, the sponsor has agreed to conduct an additional study of people with those backgrounds to further evaluate the safety and effectiveness of Benlysta for this subgroup of lupus patients.

Those receiving Benlysta during clinical studies reported more deaths and serious infections compared with placebo. The drug should not be administered with live vaccines. The manufacturer is required to provide a Medication Guide to inform patients of the risks associated with Benlysta.

The most common side effects in the studies included nausea, diarrhea, and fever (pyrexia). Patients also commonly experienced infusion reactions, so pre-treatment with an antihistamine should be considered.

Human Genome Sciences Inc., based in Rockville, Md., developed Benlysta and will co-market the drug in the United States with GlaxoSmithKline of Philadelphia.

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Green Tea May Delay Onset of Type 1 Diabetes

A powerful antioxidant in green tea may prevent or delay the onset of type 1 diabetes, Medical College of Georgia researchers say.

Researchers were testing EGCG, green tea's predominant antioxidant, in a laboratory mouse with type 1 diabetes and primary Sjogren's syndrome, which damages moisture-producing glands, causing dry mouth and eyes.

"Our study focused on Sjogren's syndrome, so learning that EGCG also can prevent and delay insulin-dependent type 1 diabetes was a big surprise," says Dr. Stephen Hsu, molecular/cell biologist in the School of Dentistry.

They found it also worked well in their original disease focus.

In the mouse, EGCG reduced the severity and delayed onset of salivary gland damage associated with Sjogren's syndrome, which has no known cure.

"EGCG modulates several important genes, so it suppresses the abnormality at the molecular level in the salivary gland. It also significantly lowered the serum autoantibodies, reducing the severity of Sjogren's syndrome-like symptoms," Dr. Hsu says. Autoantibodies are antibodies the body makes against itself.

Both type 1 diabetes and Sjogren's syndrome are autoimmune diseases, which cause the body to attack itself. Autoimmune disorders are the third most common group of diseases in the United States and affect about 8 percent of the population, says Dr. Hsu. Sjogren's syndrome can occur alone or secondary to another autoimmune disease, such as lupus, rheumatoid arthritis or type 1 diabetes.

The study, published in the Oct. 24 issue of Life Sciences, supports earlier research showing EGCG's impact on helping prevent autoimmune disease.

Researchers treated a control group of mice with water and a test group with a purified form of EGCG dissolved in the drinking water. At 16 weeks, the EGCG-fed mice were 6.1 times more likely to be diabetes-free than the water-fed group, and 4.2 times more likely at 22 weeks.

"Previous studies used another animal model that developed type 1 diabetes only after an injected chemical killed the insulin-producing cells. That may not accurately resemble disease development in humans, because type 1 diabetes is a genetic disease," says Dr. Hsu, the study's corresponding author.

"Our study is significant because we used a mouse model with the genetic defects that cause symptoms similar to human type 1 diabetes and Sjogren's syndrome, so the immune cells attack the pancreas and salivary glands until they are no longer functional."

Another related finding was that even when salivary cells were under attack, they seemed to be rapidly reproducing in the control group. The proliferation was suppressed in the EGCG-fed group.

"It's kind of counterintuitive – why would there be proliferation of the glandular cells occurring when the present cells are not secreting saliva?" says Dr. Kevin Gillespie, first author of the study he conducted for his master's research project at MCG.

The proliferation phenomenon also can be observed in psoriasis, an autoimmune disease affecting the skin and joints, says Dr. Hsu. "Normal skin cells turn over every 30 days or so, but skin cells with psoriasis turn over every two or three days." Dr. Hsu's group previously found that green tea polyphenols, including EGCG, inhibited rapid proliferation in an animal model for human psoriasis.

"We never thought proliferation was going on to this extent in the salivary gland, but we now believe it is tightly associated with Sjogren's syndrome," he says.

The next step is to observe Sjogren's syndrome in human salivary gland samples to determine whether the study findings hold up in humans.

"If the abnormal expression of these genes is the same in humans as in the animal model, then the second stage will be intervention and treatment with a pure form of EGCG," says Dr. Hsu.

"The benefit of using green tea in preventing or slowing these autoimmune diseases is that it's natural and not known to harm the body," says Dr. Gillespie, periodontics chief resident at Fort Gordon's Tingay Dental Clinic. "EGCG doesn't have the negative side-effects that can be associated with steroids or other medications that could otherwise be prescribed."

By Paula Hinely
Medical College of Georgia

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FDA Approves Treatment for Rare Neurologic Disease

The U.S. Food and Drug Administration today announced that it has approved an immune globulin product called Gamunex for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder characterized by progressive weakness and impaired sensory function in the legs and arms.

The FDA designated Gamunex as an orphan drug to treat CIDP. The orphan drug designation provides manufacturers with financial incentives to develop treatments for rare diseases, those affecting fewer than 200,000 people in the United States.

"This approval is part of the FDA's effort to address unmet medical needs in patients who are suffering from rare and serious diseases," said Jesse L. Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation and Research.

CIDP, which affects about 25,000 people in the United States, is caused by an immune system attack on the body's peripheral nervous system. The effects of CIDP—progressive muscle weakness, loss of deep tendon reflexes, tingling, and numbness—are caused by damage to the strong, fatty material that covers and protects the nerve fibers, called the myelin sheath.

Immune globulin (antibody) products are obtained from pooled human blood plasma, which contains antibodies that fight infections. These products are often given to patients with compromised immune systems, who are at increased risk for certain infectious disease. They are also used to adjust the immune response in certain autoimmune diseases.

Researchers think it is likely that Gamunex helps improve muscle function in patients with CIDP by modulating the immune system's response to the inflammation that damages the myelin sheaths, but the exact mechanism is not known.

The FDA based its approval of Gamunex on clinical trials that showed Gamunex was effective at improving certain motor functions for up to 48 weeks after the initial treatment. Researchers used the Inflammatory Neuropathy Cause and Treatment scale (INCAT) to measure a patient's ability to perform tasks such as walking and motor tasks for the hands.

The trials showed improved CIDP patient INCAT scores for muscle function after receiving Gamunex every three weeks for a 24-week period. Twenty-eight of 59 patients treated with Gamunex had improved INCAT scores compared to 13 of 58 patients treated with placebo.

In addition, patients with improved INCAT scores participated in a follow-up trial for an additional 24 weeks. Eighty-six percent of the patients who continued to receive Gamunex maintained their improved INCAT scores compared to 61 percent of the patients who received placebo during the follow-up trial.

Adverse reactions were similar to those of other immune globulin products and included headache, fever, increased blood pressure, rash, joint pain, chills, back pain, nausea, and lightheadedness.

Gamunex is manufactured by Talecris Biotherapeutics Inc. of Research Triangle Park, N.C.