RESEARCH
UPDATES : June 2010
Lupus Foundation of America Says Results of Latest Study of CellCept®
Provide Encouragement and Hope for People with Lupus Nephritis
(June 3, 2010 – Washington, DC) The Lupus Foundation of America today praised the results of a new long-term study for the treatment of lupus nephritis (lupus-related kidney disease) which demonstrated superiority of CellCept® (mycophenolate mofetil or MMF) to azathioprine (standard care) as a long-term treatment for lupus nephritis. The Phase III study results released by Vifor Pharma and Roche convincingly reached the primary endpoint of delaying treatment failure in patients with lupus nephritis who had successfully responded to induction therapy.
Responding to the release of data of the Aspreva Lupus Maintenance Study (ALMS), Sandra C. Raymond, President and CEO of the Lupus Foundation of America issued the following statement:
The results of this study provide more good news for the estimated 1.5 million Americans and the more than five million people worldwide who are living with lupus. Previous studies have provided convincing evidence that CellCept is better tolerated, and, more importantly to patients and their doctors, is associated with few serious or life-threatening infections and hospitalizations. It has been more than 51 years since the last drug was approved for lupus. We are greatly encouraged that people with lupus nephritis and their physicians will have additional options available to treat this potentially life-threatening and disabling complication of lupus.
The results of study are significant because as many as forty percent of people with lupus will experience lupus kidney disease. The results of this study offer hope for an improved quality of life for these individuals. We look forward to reviewing data from the study when the company presents more details at the upcoming Ninth International Congress on Lupus, June 24-27 in Vancouver, Canada.
The Lupus Foundation of America is the nation’s foremost national voluntary health organization dedicated to finding the causes of and cure for lupus and providing support, services and hope to all people affected by lupus. The LFA conducts programs of research, education and advocacy through a national network of chapters, branches, and support groups. For more information about lupus, visit the LFA website at www.lupusnj.org or call 800-322-5816 to receive a free information packet about lupus. Read Press Release from Vifor Pharma .
March/April 2010
Have you been diagnosed with lupus?
Or had lupus for a number of years?
Dr. Laura Maggio is conducting a research study in writing and lupus. The study is being conducted thru Springfield College and people with lupus are invited to partcipate in this important work.
" We are conducting a study that will help us learn about ways to help people better cope with lupus."
Partcipation on this study with involve three brief (20 minute) writing period and completing a short health survey in the beginning, and after one, and three months the total amount of time rquired will be 1 1/2 hours.
This will all be completed via email and will not require you to leave your home. Your results will remain confidential and will not affect your medical care. We hope the results of this study will help us to learn about way to help people better cope with lupus.
If interested please contact Dr. Laura Maggio at Imaggio@spfldcol.edu
January 2010
LFA's Lupus Research Report e-newsletter
Immunosuppressants Render Flu Vaccination Less Effective in People With Lupus
The immune system fights off the flu in different ways. One way is by making antibodies (immune proteins) that recognize the flu virus and attack it. Another way is by activating certain white blood cells to fight the virus; this is called "cell-mediated immunity." Since cell-mediated responses to the influenza vaccine also influence how well the vaccine will work, it is important to understand how lupus may affect the body’s cell-mediated response to the vaccine. Read more >>
A Second Flu Shot Might Be More Effective in Some People With Lupus
One of the ways that the immune system fights off the flu is by making antibodies (immune proteins) that can recognize the flu virus and attack it. The immune system can also make little chemicals called "cytokines" that signal to the white blood cells to make more of these antibodies when there is a virus in the bloodstream. The flu shot is made with dead virus that can help a patient make protecting antibodies but won’t cause the full flu infection to start up. In this way, individuals can be protected in advance before they are exposed to the flu that is "going around" in their community. Some lupus patients make fewer antibodies to the flu shot than most people, and there is some concern that medications for lupus can reduce the response to the flu shot since they can suppress the immune system in other ways. If there was a way to increase these responses, then the flu shot might be more effective for people with lupus. Read more >>
Potential New Indicators of Lupus Being Studied in Children
Since the 1970s, researchers have known that lupus patients are at risk for hardening of the arteries (“atherosclerosis”). Some of this risk may be from the increased inflammation that lupus patients have in the bloodstream over many years, but some of it is from the same reasons that hold true for everybody: especially high blood pressure, high blood glucose (sugar), or low levels of "good cholesterol." Read more >>
People Who Have Both Lupus and Antiphospholipid Syndrome Might Have Higher Risk of Thyroid Disease
The thyroid is a gland in the neck which helps the body keep order over how food and nutrients are handled and how fast people grow, gain or lose weight, how the heart beats, or how blood pressure and cholesterol levels in the blood respond to these changes. A protein called "thyroid peroxidase" helps to modify other proteins that the thyroid produces that perform all of these functions. Some people make antibodies (immune proteins) against their own thyroid peroxidase (these are called "anti-TPO"). People with anti-TPO sometimes have an underactive thyroid; this causes weight gain, fatigue, and a tendency to feel cold when other people around you do not. Read more >>
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The Lupus Research Report, a free enewsletter from the Lupus Foundation of America, provides reviews of recently published papers from significant medical journals translated into understandable language, information about advances in lupus research and clinical studies, and other relevant news for individuals with an interest in lupus. The commentary aims to put research findings into perspective, explain the limits to the conclusions that can be drawn, and examine the possibilities for future research directions. This is an exciting time in lupus research, so it is important for everyone in the lupus community to be fully informed about ongoing studies and developments and what they might mean.
Joan T. Merrill, M.D., Editor
Head, Clinical Pharmacology, Oklahoma Medical Research Foundation
Medical Director, Lupus Foundation of America, Inc.
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.