On LI, some abuzz about new lupus drug

Controlling symptoms of lupus has long vexed doctors and patients, but approval this week of a promising new drug has them "buzzing" with excitement.

The drug, which is not a cure, is called Benlysta. It controls lupus, a disorder that predominantly strikes women under the age of 45, by targeting rogue components of the immune system.

"Everybody is buzzing about this because it is so historic, and it's a first," said Dr. Cynthia Aranow, co-director of clinical research at the Feinstein Institute for Medical Research in Manhasset.

Aranow and colleagues began testing the drug three years ago.

Lupus is a mystifying condition known as an autoimmune disease, which means it's a disorder in which the body attacks itself, damaging the skin, heart, brain, kidneys and joints.

Kathleen Nolan, 43, who was diagnosed with lupus in 1996, participated in Feinstein's portion of the Benlysta trial for several years.

The intravenous medication, she said, has made a dramatic difference. Before joining the trial, Nolan would feel overwhelmed by severe fatigue.

"It has really improved my quality of life," she said. "I am glad it has been approved, so I can continue with it."

Dr. Betty Diamond, chief of Feinstein's Center for Autoimmune and Musculoskeletal Diseases, said Benlysta will be used in combination with standard medications.

Patients, however, can now taper off their use of Prednisone, a steroid that can produce damaging side effects, she said. Other standard medications include anti-malarial drugs and the cancer medication methotrexate.

Benlysta is effective, Diamond said, because it acts on the immune system's population of cells known as B-lymphocytes, which produce antibodies that attack the organs and skin.

A product of Human Genome Sciences and GlaxoSmithKline, Benlysta is neither perfect nor cheap.

At a cost of about $35,000 a year, research presented to the U.S. Food and Drug Administration for approval shows it works in only 44 percent of patients.

The medication does not appear to have much effect in people with severe disease or African-Americans who tend to have more aggressive forms of lupus, and are three times more likely to be diagnosed with the disorder than whites.

With FDA approval Wednesday, Benlysta became the first new drug to treat lupus in a half-century.

UNDERSTANDING LUPUS

The disease is formally known as systemic lupus, because multiple organs are attacked.

-- Patients can suffer heart attacks, kidney failures, arthritis and strokes. Debilitating fatigue is a hallmark of the disease.

-- The cause is unknown, and there is no cure.

-- A "butterfly" rash that runs cheek to cheek is a common symptom.

-- African-Americans and Hispanics tend to be more severely affected.

SOURCE: NEWSDAY RESEARCH