Factbox: Autoimmune disease lupus wins new treatment

The first new treatment in a half-century for the autoimmune disease lupus won U.S. approval on Wednesday. The drug, Benlysta from Human Genome Sciences Inc, is given once a month by intravenous infusion.

Below are some facts about lupus, current treatments and other drugs in development.

LUPUS

Lupus is a potentially fatal disease that makes the immune system attack the body's own tissue and organs. It most often affects women and usually develops between ages 15 and 44.

It causes a range of symptoms that wax and wane including arthritis, kidney damage, chest pain, hair loss, fatigue and a butterfly-shaped rash across the cheeks and nose. The organ damage can be fatal.

NEW TREATMENT

The new drug, Benlysta, won approval for certain lupus patients already receiving standard therapy. In a company-funded study, 43 percent of patients given a high Benlysta dose with standard therapies felt relief and no disease worsening in various organs after one year of treatment. That compared with nearly 34 percent with a placebo and standard care.

Doctors hail Benlysta as an advance but note it will not work for everyone and more treatments are needed. Some experts have described Benlysta's effects as mild.

The Food and Drug Administration noted Benlysta did not appear to help black patients in clinical studies but there were not enough of them to draw a firm conclusion. The agency is requiring a post-approval study to further assess results in black patients.

Black women have a three times higher incidence of lupus than white women, the FDA said.

The most common side effects in Benlysta studies included nausea, diarrhea and fever.

More deaths and serious infections were reported with Benlysta compared with a placebo. Studies showed 0.9 percent of patients died after taking the highest Benlysta dose, compared with 0.4 percent in the placebo group.

OTHER OPTIONS

Older drugs work for some patients but can carry harsh side effects such as severe bone loss from steroids. Many are not approved for lupus. Nonsteroidal anti-inflammatory drugs, steroids and immunnosuppressants often are prescribed.

ON THE HORIZON

Human Genome is developing a new version of Benlysta that could be given by injection rather than intravenously.

Another drug, epratuzumab from UCB and Immunomedics Inc, is in late-stage studies. Earlier research is ongoing for other potential therapies.