New Treatment For Lupus..First in 50 years

FDA approves Benlysta to treat lupus

First new lupus drug approved in 56 years

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.

BENLYSTA TRIAL (belimumad) for treating lupus

First new drug for lupus in over 5o years

Additional Findings from the BENLYSTA™ (belimumab) BLISS-76 Phase III Clinical Trial Announced

April 21, 2010

The Alliance for Lupus Research (ALR) is pleased to bring you an update on the clinical trial results recently announced following an analysis of the secondary endpoints of the BLISS-76 study conducted by Human Genome Sciences (HGS) and GlaxoSmithKline (GSK).  The BLISS-76 study is the second of two Phase III trials of BENLYSTA™ (belimumab), an investigational lupus drug. 

The new analysis, which looked at data at 76-weeks from the initiation of the study, further showcased that BENLYSTA plus standard of care resulted in higher response rates compared with placebo plus standard of care.  However, this secondary endpoint did not reach statistical significance.  The new data also showcased that BENLYSTA continued to be well-tolerated, and adverse event rates remained comparable between BENLYSTA and placebo treatment groups.

“The complexity of the immune system alterations in patients with lupus will continue to present challenges for scientists who are studying disease mechanisms and for clinical development programs testing new drug candidates,” said Dr. Peggy Crow, Chair of the Scientific Advisory Board of the ALR.  “BENLYSTA has well-documented effects on some of the immunologic parameters associated with disease activity, but the drug’s impact on clinical disease will likely be variable from one patient to another.”

BENLYSTA already met its primary efficacy endpoint at 52-weeks in both BLISS-76, as well as in the first of the two pivotal Phase III trials, BLISS-52.  These findings were previously announced in the second half of last year.  Based on the study findings at 52-weeks, consistent with the study protocol, HGS and GSK are expected to submit marketing applications for regulatory approval in the United States, Europe and other regions in the second quarter of this year.  The full presentation of the BLISS-76 trial, including results at 52-weeks and 76-weeks, are expected to be presented at medical meetings later this year.

 

“The ALR is pleased with the companies’ continued commitment to the BENLYSTA development program,” explains Ken Farber, Acting Executive Director of the ALR.  “The findings at 76-weeks from the trial provide a closer look at the benefits of this potential new therapeutic option for people with lupus.  Our hope is that this clinical trial, as well as other lupus research underway, will ultimately help doctors in developing new strategies for treating this debilitating disease.”

The ALR will continue to report on new research and milestones surrounding BENLYSTA, as well as other therapeutic lupus research underway.

Advancing Lupus Research for More Than 10 Years

Over the past 10 years, the ALR has advanced pioneering lupus investigations and has achieved great progress in lupus research, including supporting some of the important basic and translational research on the molecule targeted by BENLYSTA, BLyS, also called B cell-activating factor (BAFF).  The ALR has funded more than five million dollars in B-cell research.

The ALR is committed to supporting important research that will ultimately lead to a detailed understanding of lupus, as well as hopefully a cure.  The ALR is the world’s largest charitable funder of lupus research.  One hundred percent of all donations to the organization support innovative medical research programs focused on preventing, treating and curing systemic lupus erythematosus or lupus, as the Board of Directors funds all administrative and fundraising expenses.