RESEARCH
UPDATES : November 2009
A WEBINAR with Dr. Joan Merrill on BENLYSTA
For the general public and those living with lupus click on the link above.
The Lupus Foundation of America (LFA) invites those living with lupus and interested in learning more about the results of the BENLYSTA studies to join us for a special Webinar on Monday, November 30, 2009 at 7 p.m. EST. LFA’s Medical Director, Dr. Joan Merrill, will review the results of the BENLYSTA studies and answer questions.
For the media information on the Webchat with Dr. Merrill.
NEW RESULTS ON BENLYSTA
Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) today announced positive results from BLISS-76, the second of two large-scale phase III clinical trials of BENLYSTA™ (belimumab) for treating systemic lupus. Both trials succeeded in meeting their primary endpoints, which should make BENLYSTA eligible for approval by the U.S. Food and Drug Administration (FDA). Both trials demonstrate that treatment with BENLYSTA plus standard of care was superior to that of placebo (inactive agent) plus standard of care. BENLYSTA significantly reduced disease activity. If approved by the FDA, BENLYSTA would be the first drug ever developed and approved specifically for the treatment of lupus.
Sandra C. Raymond, President and Chief Executive Officer of the Lupus Foundation of America (LFA) issued the following statement. "We are truly excited to receive this groundbreaking news! Individuals with lupus and their families have waited more than 50 years to hear that it is possible to develop therapies that control the disease. We believe that this is a significant first step in developing
the full arsenal of therapies and personalized treatment lupus requires.”
BENLYSTA is going to have a huge effect on the 3,000+ people and their families that the Lupus Foundation of America, NJ Chapter supports. The LFANJ will be closely following further developments of this drug.
Click Webinar and be transported to the page for this informative discussion on lupus and BENLYSTA.
For the press release from the Lupus Foundation of America, Inc. Promise of A New Treatment
First Potential Lupus-Specific Treatment in Sight
BENLYSTA™ Successful in First of Two Pivotal Clinical Trials today, Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) announced positive results from a year-long clinical trial of BENLYSTA for treating lupus. When the 52-week study concluded, the lupus patients who were treated with BENLYSTA had improvement in overall disease activity without clinically significant flare-ups in one or more isolated organs when compared to patients who received the placebo (inactive agent). The patients receiving BENLYSTA also were able to reduce their intake of steroid medications. The study is the largest ever to be completed for lupus and the first Phase III (late stage) trial of a new biologic immune therapy for lupus to succeed in meeting its primary endpoint and most of its secondary endpoints.
Sandra C. Raymond, President and Chief Executive Officer of the
Lupus Foundation of America (LFA) issued the following statement.
"For people with lupus and their loved ones, this is an historic day! With no new drugs for more than 50 years, since the Eisenhower Administration, the news today indicates that it is possible to develop new, safe, and effective therapies for lupus. We are greatly encouraged by the positive top-line data which shows that HGS’ 52-week BENLYSTA study met its primary endpoint. These results provide hope that this complex chronic autoimmune disease can be brought under control and that, eventually, a cure can be found for the estimated 1.5 million Americans and more than 5 million people worldwide living with lupus.
"We look forward to hearing the results, this fall, of a longer-term Phase III clinical study of BENLYSTA. The data from both studies will be evaluated by the U.S. Food and Drug Administration (FDA). Should the FDA ultimately approve BENLYSTA, it would become the first drug successfully developed to specifically treat lupus since the disease was discovered more than a century ago.
"Lupus is a complex disease and not every therapy will be appropriate for all patients. Each person with lupus is unique and it is likely that successful management of lupus will require a number of therapies, perhaps used in combination with each other. The LFA and its Medical-Scientific Advisory Council urge the federal government and industry to greatly step up their research efforts on lupus so that physicians have a complete arsenal of therapies at their disposal to provide the individualized treatment that lupus requires.
"We are grateful to Human Genome Sciences and GlaxoSmithKline for their pioneering efforts to develop a new, safe, effective and tolerable treatment for lupus, to the physicians who have passionately committed to researching this disease, to the companies who continue to invest in finding new treatments, and to the thousands of people with lupus who have volunteered and participated in clinical studies over the years so discoveries such as this one could be possible.
"Meanwhile, the LFA will continue to implement its initiative entitled, A New 21st Century Approach to Lupus Healthcare, to ensure the ongoing advancement of the science and medicine of lupus to meet the multi-dimensional needs of people with lupus."
For more information download the article:
Questions and Answers for Benelysta
or go to the article for Benlysta on our homepage.
LUPUS FOUNDATION OF AMERICA, NEW JERSEY CHAPTER, INC.
To find out more about LFA, New Jersey Chapter, Inc.'s currently funded research programs please email info@lupusnj.org.
To find out about current studies on lupus that are taking place near you visit www.clinicaltrials.gov and click on search for clinical trials and type
lupus AND New Jersey (or whatever state you live in).
The LFA Research Program
The Lupus Foundation of America would like to alert you about a clinical trial that is taking place in your area.
The MEDI 545 Phase II Study (MI-CP179) will evaluate the safety and tolerability of an investigational new drug for people with moderately to severely active lupus. Study participants must be at least 18 years old and have a positive ANA test. In addition, participants must not be pregnant or planning to become pregnant. For more information about this study, you can visit www.clinicaltrials.gov and enter the study identification number: NCT00657189.
As you may know, approximately 1.5 million Americans have some form of lupus. Ninety percent of people with lupus are women and 80% develop it between the ages of 15 and 45. It is two to three times more common among African-Americans, Hispanics, Asians and Native Americans. Unfortunately, medications for lupus are limited and no new medication has been approved by the FDA in the last 50 years.
We are sharing this information with you as a valuable public service, not an endorsement of these or any particular clinical trials. Choosing to take part in a clinical trial is an important, personal decision. You may want to consult with your doctor, family or close friends before considering enrollment. You may also visit the LFA Center for Clinical Trials Education (CCTE) at www.lupus.org/clinicaltrials/ to learn more about participating in clinical trials and to find resources. Using the CCTE, you may also ask questions about clinical trials or share your experience.
Lupus Foundation of America's National Research Program is dedicated to bringing down the barriers that have obstructed basic biomedical, clinical, epidemiological, behavioral, and translational research for decades.
The LFA is committed to accelerating the pace of medical discovery in lupus with the clear goal of making clinical research more feasible. The LFA has been aggressively pursuing strategies to greatly increase federal, state, and industry support for a robust medical research effort on lupus, and will continue to lead the way in facilitating extensive collaborations between the United States Congress, the National Institutes of Health, and our nation's leading pharmaceutical and biotechnology companies.
LFA's Lupus Research Report e-newsletter
January 2009
2008 Was a Year of Progress and Hope for a Better Quality of Life for 1.5 Million Americans Affected by Lupus
The Lupus Foundation of America is pleased to report continuing progress was achieved in
2008 in efforts to combat lupus, a chronic autoimmune disease which affects an estimated 1.5 million
Americans and at least five million people worldwide. Teams of researchers announced important findings which provided clues to the underlying genetic origins of lupus, several companies released clinical data on studies of potential new treatments, and Congress reaffirmed its commitment to provide
greatly expanded federal support for lupus research and education programs.
Read the LFA's 2008 list of ten important advances in lupus research and education >>
LFA Congratulates Dr. Joseph Ahearn for Receiving DoD Grant for Research on Lupus Biomarkers
The LFA congratulates Joseph M. Ahearn, M.D., Associate Professor of Medicine and Co-Director of the Lupus Center of Excellence . at the University of Pittsburgh, for being selected to receive a research grant from the U.S. Department of Defense’s (DoD) Congressionally Directed Peer Reviewed Medical Research Program (PRMRP). The DoD award will fund the Lupus Center of Excellence’s ongoing studies on lupus biomarkers.
Read more >>
A Potential New Treatment for Severe Discoid Lupus
Discoid lupus is a form of lupus that affects the skin (cutaneous lupus). In most cases the discoid lupus rash appears on the face, neck, or scalp, though it can also show up on other areas of the skin. Severe discoid lupus may result in scarring. The treatments that are used most often for severe discoid lupus are strong immunosuppressants that may have significant side effects, especially when used over long
periods of time. Efalizumab (trade name, Raptiva™) works by interfering with the function of overactive immune cells that are causing disease activity. The researchers in this study wanted to see if Raptiva could be effective in treating discoid lupus.
Read more >>
Chronic Lesions Versus Active Lesions in Lupus Nephritis
For many years doctors have classified lupus nephritis (LN) by the extent of inflammation and where it occurs in the kidney. Under the original classification system developed in 1974 by the World Health Organization (WHO), there were six categories, or classes, of lupus nephritis, reflecting different ways in which inflammation could affect the kidney tissue. In 2003, changes to these WHO classifications were proposed. The researchers wanted to see if the new classifications could be used to predict how LN would progress and whether it would respond to treatment.
Read more >>
Antiphospholipid Antibodies: It May Matter Which Ones You Have
One-third of people with lupus test positive for antiphospholipid antibodies (aPLs). The aPLs are a group of antibodies that interact with proteins that regulate blood clotting and blood vessel stability. Antiphospholipid antibodies can interfere with the normal function of blood
vessels in various ways, which in turn can lead to complications such as immediate blood clots in arteries or veins, miscarriages, or more long-term damage to blood vessels, including hardening of the arteries (atherosclerosis) and later onset of heart disease and strokes.
Read more >>
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