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.

Monday, November 1, 2010

NYT Lupus Article and chronic illness

New York Times article on Lupus Research

This is an interesting article on lupus with many links to other informative articles and data. I will have to make one correction though. It is widely accepted within the lupus community that there are more than 1.5 million lupus patients in the United States. Some experts believe the number is more like 2.5 million (1 in 170 people) and they say 5 million world wide diagnosed. Because people of color have 3 times the prevalence (Blacks, Native Americans, Asians, Hispanics) and 90% of lupus patients are women; it is likely not all are being diagnosed, treated or included in research studies. Remember a few years back it was discovered that many breast cancer studies were being performed on men? Same goes for past lupus studies. Maybe because men are more likely to take the risk of being study participants or that most researchers in the past were men. Not sure. I do know that ACCURATE numbers are not truly known. The other reason people do not get diagnosed is because it is such a difficult disease to pin down. Some people have told me they had symptoms for 10-20 years before they found out that what they were experiencing was lupus. Almost all lupus patients have arthritis so it can be misdiagnosed as Arthritis alone.The flares can come and go and lab tests can be off especially if it take 6 months to see a specialist. The flare could be gone and lupus in an inactive state by the time a patient is tested. Then there is the fear of losing insurance. Some people with lupus will not allow Dr.'s to test them because they do not want to lose their jobs or insurance. It happened to me years ago so I can understand cause for alarm.Loss of income is a huge factor as well. Who wants to hire someone who will be on and off sick indefinitely? Thank goodness for Americans with Disabilities Act!

In order to make it OK for all lupus patients to be diagnosed and treated we need more public awareness and PR like the ingenious Susan G. komen campaign http://ww5.komen.org/(you see the pink ribbon everywhere and many movie stars and musicians supporting the cause) and more funds to research the disease. Chronic disease, which includes Systemic Lupus, are the leading causes of disability and death in the US as most lupus patients have arthritis, heart involvement, increased obesity levels mainly due to steroid treatments and kidney disease. Bottom line for me is that we need to make aware the seriousness of lupus and the prevalence of the disease in order to save lives.

According to the CDC:

Chronic Diseases are the Leading Causes of Death and Disability in the U.S.

7 out of 10 deaths among Americans each year are from chronic diseases. Heart disease, cancer and stroke account for more than 50% of all deaths each year.¹
In 2005, 133 million Americans – almost 1 out of every 2 adults – had at least one chronic illness.²
Obesity has become a major health concern. 1 in every 3 adults is obese³ and almost 1 in 5 youth between the ages of 6 and 19 is obese (BMI ≥ 95th percentile of the CDC growth chart).⁴
About one-fourth of people with chronic conditions have one or more daily activity limitations.⁵
Arthritis is the most common cause of disability, with nearly 19 million Americans reporting activity limitations.⁶
Diabetes continues to be the leading cause of kidney failure, nontraumatic lower-extremity amputations, and blindness among adults, aged 20-74.⁷