The first new drug to treat Lupus Erythematosus in more than 50 years was approved this month by the U.S. Food and Drug Association (FDA).  Lupus is a chronic, inflammatory, multi-system disorder of the immune system, which causes fibrous tissue and inflammation of internal organs, skin rashes and joint pain.  A facial rash that resembles a wolf bite often accompanies lupus and is what gave the disorder it’s name, lupus meaning “wolf” and erythematosus meaning “redness.”

The new drug, Belimumab (Benlysta), is an injectable drug that was designed to relieve flare-ups and pain.  Benlysta was created — after 15 years of development — by Human Genome Sciences Inc. and GlaxoSmithKline PLC.  The drug is a monoclonal antibody that targets the B-lymphocyte stimulator protein (BLyS).  According to the FDA, this is the first drug designed to target a protein that may reduce the number of abnormal B cells believed to be at the root of lupus.

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

The last drugs to be approved by the FDA for lupus was Plaquenil (hydroxychloroquine), a malaria drug, and corticosteroids in 1955.  Before that, aspirin was approved as a treatment.

Benlysta was approved by the FDA after an advisory committee of independent experts voted 13-to-2 in November to recommend its approval.  At that time, there was some reservations about the effectiveness of the drug.  Most of the drug’s benefit came from relieving muscle inflammation, not organ problems.

A clinical study showed that Benlysta, after one-year of monitoring response rates, was more effective than placebo.  In the study, to be credited with a response, patients had to have at least a four-point improvement in SELENA-SLEDAI score, have no increase in Physician Global Assessment scores of 0.3 points or more, and have no new flares meeting the British Isles Lupus Assessment (BILAG) 1A-2B standard.  That being said, a relatively small proportion of patients met the study’s criteria for a response after one year (43% with the drug vs. 32% with the placebo).

More clinical trials need to be conducted with Benlysta because thus far the drug has been shown to be less effective in African Americans — who are twice as likely as Caucasians to be diagnosed with lupus.  Studies to date were not extensive enough to make any conclusions about whether the drug will be ineffective for all African Americans or not.  Also, the new drug was not effective for any trial patients with the deadliest form of lupus.

Benlysta, even though only modestly effective, should provide encouragement that after more than 50 years of no new approved drugs, there is still a future for drug advancement for lupus.  The drug “will send out the message that it’s possible to conduct a successful clinical trial in lupus and that’s tremendously important to keep the pharmaceutical industry interested in this disease,” Dr. Betty Diamond, a researcher at the Feinstein Institute in New York said.

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