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Lupus Organizations
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http://www.lupusresearch.org/
LRI champions only new science — the truly innovative research that will prevent, treat, and cure lupus. In this mission it unites leading scientists and physicians, patients, and their families. http://www.lupusresearchinstitute.org/index.php
The Lupus Foundation of Colorado Web site is created to provide you with the latest and most up to date information about Lupus. Whether you are newly diagnosed with Lupus, a longtime family member or friend, or a member of the medical community, this Web site will provide you with a better understanding of Lupus and tools to manage Lupus more effectively. Our programs and supportive services are designed to increase awareness and improve the quality of life for people living with Lupus through education, community outreach services, and support of research that will lead to effective treatment and cure for the disease. http://www.lupuscolorado.org/
http://www.lupus.org/newsite/index.html
http://www.couldihavelupus.gov
http://www.lupusresearch.org/
LRI champions only new science — the truly innovative research that will prevent, treat, and cure lupus. In this mission it unites leading scientists and physicians, patients, and their families. http://www.lupusresearchinstitute.org/index.php
The Lupus Foundation of Colorado Web site is created to provide you with the latest and most up to date information about Lupus. Whether you are newly diagnosed with Lupus, a longtime family member or friend, or a member of the medical community, this Web site will provide you with a better understanding of Lupus and tools to manage Lupus more effectively. Our programs and supportive services are designed to increase awareness and improve the quality of life for people living with Lupus through education, community outreach services, and support of research that will lead to effective treatment and cure for the disease. http://www.lupuscolorado.org/
http://www.lupus.org/newsite/index.html
http://www.couldihavelupus.gov
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Major Report to Congress
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Secretary of Health and Human Services Documents Need for National Lupus Health Education Program for Health Care Providers
New report resulting from Lupus Research Institute’s congressional advocacy describes state of lupus research, impact of disease, and barriers to care
A major report on lupus from the Secretary of Health and Human Services to the U.S. Congress this week reviews the state of the disease and documents the need for a comprehensive national provider health education program to help eliminate the barriers of racial disparities in the early medical diagnosis and treatment of lupus.
The report was the result of advocacy by the Lupus Research Institute’s National Coalition of state and local lupus organizations. The LRI National Coalition (LRI) vigorously petitioned for congressional funding for a new National Lupus Health Education Program for physicians and healthcare providers, successfully working to secure federal funding of $2.6 million to date to advance needed professional education about lupus.
The new education program is led by the Office of Minority Health in the federal Department of Health and Human Services in partnership with the U.S. Surgeon General and the Office of Women’s Health and implemented through the American College of Rheumatology (ACR).
The Secretary’s report highlights the effect of disparities on lupus patients, stating that “many still die prematurely from lupus because of complications of the disease, late diagnosis and co-occurring chronic conditions.”
It also documents the need for health education efforts, noting that “until researchers discover a cure or new ways of identifying at-risk individuals as well as diagnosing and treating lupus, educating health care professionals about the importance of early diagnosis and teaching patients how to manage and cope with lupus providesthe best opportunity for improving quality of life for patients and for controlling morbidity and mortality.”
“We are delighted that a wide spectrum of federal agencies and leading medical, research, and health organizations across the country will now collaborate on this crucial health education program,” said LRI President Margaret G. Dowd. “The program rollout began with a kick-off meeting last week in Atlanta hosted by the ACR.”
The LRI National Coalition is committed to ongoing advocacy leadership in advancing additional federal funding for this crucial national lupus education program, she added.
“This National Lupus Health Education Program is a hallmark event in a 10-year effort by LRI National Coalition members to bring attention to the issues of racial disparity and support to the needs of people with lupus, particularly those in underserved communities,” said Dowd.
About Lupus
Systemic lupus erythematosus (S.L.E.), commonly called lupus, is a chronic and potentially fatal autoimmune disorder and one of the nation’s least recognized major diseases. In lupus, the body's immune system forms antibodies that can attack virtually any healthy organ or tissue, from the kidneys to the brain, heart, lungs, skin, joints and blood.
About 90 percent of those diagnosed with lupus are women. African-American women are about three times more likely to develop lupus, and it is also more common in Hispanic, Asian and American Indian women. Lupus is a leading cause of cardiovascular disease, kidney disease, and stroke among young women. No new treatments for lupus have been approved in 50 years.
The Lupus Research Institute: Pioneering discovery to prevent, treat, and cure lupus.
Lupus Research Institute (LRI) is the world’s leading private supporter of innovative research in lupus. The LRI champions scientific creativity and risk-taking in the hunt for solutions to this complex and dangerous autoimmune disease. Founded by families and shaped by scientists, the LRI mandates sound science and rigorous peer review to uncover and support only the highest-ranked novel research. It is the only lupus organization to receive an A+ rating by the American Institute of Philanthropy, directly channeling 94 cents of every dollar donated right back to the programs supporting brilliant and determined lupus researchers. The LRI’s bold and proven research strategy consistently achieves the insights, breakthroughs, and solid results that are changing the course of lupus research and bringing new hope to people with lupus nationwide and around the world.
The LRI’s advocacy arm is its National Coalition, a powerful network of state and local lupus organizations united to prevent, treat and cure lupus by advocating for lupus on Capitol Hill. The Coalition unites lupus groups from both coasts and the nation’s major urban centers—New York, Chicago, Los Angeles, San Francisco, and Washington, D.C.
Secretary of Health and Human Services Documents Need for National Lupus Health Education Program for Health Care Providers
New report resulting from Lupus Research Institute’s congressional advocacy describes state of lupus research, impact of disease, and barriers to care
A major report on lupus from the Secretary of Health and Human Services to the U.S. Congress this week reviews the state of the disease and documents the need for a comprehensive national provider health education program to help eliminate the barriers of racial disparities in the early medical diagnosis and treatment of lupus.
The report was the result of advocacy by the Lupus Research Institute’s National Coalition of state and local lupus organizations. The LRI National Coalition (LRI) vigorously petitioned for congressional funding for a new National Lupus Health Education Program for physicians and healthcare providers, successfully working to secure federal funding of $2.6 million to date to advance needed professional education about lupus.
The new education program is led by the Office of Minority Health in the federal Department of Health and Human Services in partnership with the U.S. Surgeon General and the Office of Women’s Health and implemented through the American College of Rheumatology (ACR).
The Secretary’s report highlights the effect of disparities on lupus patients, stating that “many still die prematurely from lupus because of complications of the disease, late diagnosis and co-occurring chronic conditions.”
It also documents the need for health education efforts, noting that “until researchers discover a cure or new ways of identifying at-risk individuals as well as diagnosing and treating lupus, educating health care professionals about the importance of early diagnosis and teaching patients how to manage and cope with lupus providesthe best opportunity for improving quality of life for patients and for controlling morbidity and mortality.”
“We are delighted that a wide spectrum of federal agencies and leading medical, research, and health organizations across the country will now collaborate on this crucial health education program,” said LRI President Margaret G. Dowd. “The program rollout began with a kick-off meeting last week in Atlanta hosted by the ACR.”
The LRI National Coalition is committed to ongoing advocacy leadership in advancing additional federal funding for this crucial national lupus education program, she added.
“This National Lupus Health Education Program is a hallmark event in a 10-year effort by LRI National Coalition members to bring attention to the issues of racial disparity and support to the needs of people with lupus, particularly those in underserved communities,” said Dowd.
About Lupus
Systemic lupus erythematosus (S.L.E.), commonly called lupus, is a chronic and potentially fatal autoimmune disorder and one of the nation’s least recognized major diseases. In lupus, the body's immune system forms antibodies that can attack virtually any healthy organ or tissue, from the kidneys to the brain, heart, lungs, skin, joints and blood.
About 90 percent of those diagnosed with lupus are women. African-American women are about three times more likely to develop lupus, and it is also more common in Hispanic, Asian and American Indian women. Lupus is a leading cause of cardiovascular disease, kidney disease, and stroke among young women. No new treatments for lupus have been approved in 50 years.
The Lupus Research Institute: Pioneering discovery to prevent, treat, and cure lupus.
Lupus Research Institute (LRI) is the world’s leading private supporter of innovative research in lupus. The LRI champions scientific creativity and risk-taking in the hunt for solutions to this complex and dangerous autoimmune disease. Founded by families and shaped by scientists, the LRI mandates sound science and rigorous peer review to uncover and support only the highest-ranked novel research. It is the only lupus organization to receive an A+ rating by the American Institute of Philanthropy, directly channeling 94 cents of every dollar donated right back to the programs supporting brilliant and determined lupus researchers. The LRI’s bold and proven research strategy consistently achieves the insights, breakthroughs, and solid results that are changing the course of lupus research and bringing new hope to people with lupus nationwide and around the world.
The LRI’s advocacy arm is its National Coalition, a powerful network of state and local lupus organizations united to prevent, treat and cure lupus by advocating for lupus on Capitol Hill. The Coalition unites lupus groups from both coasts and the nation’s major urban centers—New York, Chicago, Los Angeles, San Francisco, and Washington, D.C.
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Historic Research Breakthrough
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From the Lupus Research Institute November 2009 Newsletter
Benlysta™ trial results in an historic research breakthrough and victory for people with lupus
Second successful phase III trial points to the first new lupus treatment in over 50 years.
The Lupus Research Institute (LRI) and its National Coalition of state and local lupus organizations congratulate Human Genome Sciences (HGS) and GlaxoSmithKline for achieving an historical landmark – the second positive phase 3 clinical trial of Benlysta (belimumab), the first successfully tested new drug developed specifically for people with systemic lupus.
“This is a pivotal moment in lupus research,” said Margaret G. Dowd, president of the LRI, an organization that pioneers discovery in lupus. “It demonstrates the power of innovative science to drive discovery and achieve solid clinical results in the complex autoimmune disease of lupus. Benlysta represents new hope for the 1.5 million Americans with lupus and millions more worldwide who have suffered without a safe and effective treatment for more than 50 years.”
“This is spectacular news for the world-wide lupus community,” said Tammy O. Utset, MD, MPH, an associate professor of medicine at the University of Chicago. “These trials demonstrate that SLE can be studied successfully in a clinical trial setting and should encourage further interest in drug development for lupus, an area of great unmet need. Further, these two large, well-designed trials will allow Benlysta, the first biological agent for the treatment of SLE, to be submitted to the FDA for potential approval.”
The trial was the second double-blind, placebo-controlled, multi-center study of Benlysta. Known as BLISS-76, the trial enrolled and randomized 826 patients at 133 clinical sites in 19 countries, primarily in North America and Europe.
“Combining the results of this study with the previous successful BLISS-52 study will yield a very large dataset that will allow a better understanding of lupus, the instruments to measure lupus activity, and the responses to treatment,” explained Richard Furie, MD, chief of the division of rheumatology and allergy-clinical rheumatology at North Shore-LIJ Health System in New York. “And most important, the two positive trials will allow Human Genome Sciences and GlaxoSmithKline to file for drug approval with regulatory agencies around the world.”
“The Benlysta trials are the first well-designed and conducted, comprehensive studies that assessed several measurements of disease,” said Daniel J. Wallace, MD, clinical professor of medicine at the David Geffen School of Medicine at UCLA. “These trials are a breakthrough for utilizing a methodology that enables researchers to demonstrate disease improvement, and represent a solid path forward for people with lupus.”
“As the organization uniquely dedicated to funding bold approaches to novel research in lupus, the Lupus Research Institute commends HGS and GSK for their commitment and courage in pursuing innovative science, state of the art technology, and smart trial design which has put Benlysta on the road to become the first new drug for lupus that can potentially win FDA approval and start to roll out to physicians and patients,” said Dowd.
The LRI funds innovative and creative research to discover new scientific solutions for lupus, and assists in recruiting patients to participate in trials to bring safe and effective treatments to market for people with lupus.
“We thank the hundreds of people with lupus who enrolled and took part in these important trials,” Dowd said.
To learn more about lupus clinical trials, visit LupusTrials.org.
From the Lupus Research Institute November 2009 Newsletter
Benlysta™ trial results in an historic research breakthrough and victory for people with lupus
Second successful phase III trial points to the first new lupus treatment in over 50 years.
The Lupus Research Institute (LRI) and its National Coalition of state and local lupus organizations congratulate Human Genome Sciences (HGS) and GlaxoSmithKline for achieving an historical landmark – the second positive phase 3 clinical trial of Benlysta (belimumab), the first successfully tested new drug developed specifically for people with systemic lupus.
“This is a pivotal moment in lupus research,” said Margaret G. Dowd, president of the LRI, an organization that pioneers discovery in lupus. “It demonstrates the power of innovative science to drive discovery and achieve solid clinical results in the complex autoimmune disease of lupus. Benlysta represents new hope for the 1.5 million Americans with lupus and millions more worldwide who have suffered without a safe and effective treatment for more than 50 years.”
“This is spectacular news for the world-wide lupus community,” said Tammy O. Utset, MD, MPH, an associate professor of medicine at the University of Chicago. “These trials demonstrate that SLE can be studied successfully in a clinical trial setting and should encourage further interest in drug development for lupus, an area of great unmet need. Further, these two large, well-designed trials will allow Benlysta, the first biological agent for the treatment of SLE, to be submitted to the FDA for potential approval.”
The trial was the second double-blind, placebo-controlled, multi-center study of Benlysta. Known as BLISS-76, the trial enrolled and randomized 826 patients at 133 clinical sites in 19 countries, primarily in North America and Europe.
“Combining the results of this study with the previous successful BLISS-52 study will yield a very large dataset that will allow a better understanding of lupus, the instruments to measure lupus activity, and the responses to treatment,” explained Richard Furie, MD, chief of the division of rheumatology and allergy-clinical rheumatology at North Shore-LIJ Health System in New York. “And most important, the two positive trials will allow Human Genome Sciences and GlaxoSmithKline to file for drug approval with regulatory agencies around the world.”
“The Benlysta trials are the first well-designed and conducted, comprehensive studies that assessed several measurements of disease,” said Daniel J. Wallace, MD, clinical professor of medicine at the David Geffen School of Medicine at UCLA. “These trials are a breakthrough for utilizing a methodology that enables researchers to demonstrate disease improvement, and represent a solid path forward for people with lupus.”
“As the organization uniquely dedicated to funding bold approaches to novel research in lupus, the Lupus Research Institute commends HGS and GSK for their commitment and courage in pursuing innovative science, state of the art technology, and smart trial design which has put Benlysta on the road to become the first new drug for lupus that can potentially win FDA approval and start to roll out to physicians and patients,” said Dowd.
The LRI funds innovative and creative research to discover new scientific solutions for lupus, and assists in recruiting patients to participate in trials to bring safe and effective treatments to market for people with lupus.
“We thank the hundreds of people with lupus who enrolled and took part in these important trials,” Dowd said.
To learn more about lupus clinical trials, visit LupusTrials.org.
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More Good News for Lupus
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Human Genome Sciences and GlaxoSmithKline Report Details of First Positive Phase 3 Clinical Trial for Lupus
Drug company Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) today reported details of the first of their two crucial Phase 3 trials of belimumab (Benlysta™) in people with systemic lupus erythematosus at the American College of Rheumatology’s (ACR) annual scientific meeting in Philadelphia.
“There is a lot of encouraging information in here for the 1.5 million Americans with lupus,” said Lupus Research Institute (LRI) President Margaret G. Dowd at the meeting.
HGS first reported on the clinical trial (BLISS-52) results this summer. If findings from the longer “BLISS-76” trial due in November are positive as well, the company can apply to the Food and Drug Administration (FDA) for drug approval in 2010—possibly the first drug approval for lupus in more than 50 years.
Specifics on effectiveness and safety
"The BLISS-52 Phase 3 results presented at ACR demonstrated that the efficacy of treatment with belimumab plus standard of care was superior to that of placebo [dummy drug] plus standard of care," explained David C. Stump, MD, executive vice president of research and development at HGS in a statement. "These data were statistically significant and were strongly supported across multiple measures of clinical effect and multiple time-points.”
The company shared these and other trial details on belimumab’s ability to significantly reduce lupus disease activity and the rate of lupus flares, as well as to lower the rate of flares and significantly delay the length of time to the first flare.
“Belimumab’s apparent capacity to lower the use of the dreaded corticosteroid, prednisone, is also notable,” said Dowd, who has heard from the thousands of LRI members that lessening the dosage of this often lifesaving but complication-ridden medicine is a priority. In the trial, a greater percentage of participants taking belimumab were able to reduce their prednisone use than those taking the placebo.
LRI Program Director Catherine Anastasia noted that the significant reductions in fatigue with belimumab would also come as particularly welcome news. “The fatigue of lupus can be draining and debilitating. A route out of the exhaustion would make a big difference in quality of life for so many.”
The company additionally reported that people taking belimumab generally tolerated the drug well.
Key trial design
“This is the first drug shown to be effective in ameliorating the signs and symptoms of lupus in decades,” said Daniel J. Wallace, MD, clinical professor of medicine at the David Geffen School of Medicine at UCLA. “It represents a breakthrough for finally utilizing a methodology that enables researchers to demonstrate disease improvement. This will benefit lupus patients and their doctors.”
BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in people with lupus.
Dowd and other LRI representatives are among the thousands of attendees—physicians, health professionals, and scientists—at the Philadelphia meeting designed to advance rheumatology through programs of education, research, advocacy and practice support.
The new details of the trial are available here.
Human Genome Sciences and GlaxoSmithKline Report Details of First Positive Phase 3 Clinical Trial for Lupus
Drug company Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) today reported details of the first of their two crucial Phase 3 trials of belimumab (Benlysta™) in people with systemic lupus erythematosus at the American College of Rheumatology’s (ACR) annual scientific meeting in Philadelphia.
“There is a lot of encouraging information in here for the 1.5 million Americans with lupus,” said Lupus Research Institute (LRI) President Margaret G. Dowd at the meeting.
HGS first reported on the clinical trial (BLISS-52) results this summer. If findings from the longer “BLISS-76” trial due in November are positive as well, the company can apply to the Food and Drug Administration (FDA) for drug approval in 2010—possibly the first drug approval for lupus in more than 50 years.
Specifics on effectiveness and safety
"The BLISS-52 Phase 3 results presented at ACR demonstrated that the efficacy of treatment with belimumab plus standard of care was superior to that of placebo [dummy drug] plus standard of care," explained David C. Stump, MD, executive vice president of research and development at HGS in a statement. "These data were statistically significant and were strongly supported across multiple measures of clinical effect and multiple time-points.”
The company shared these and other trial details on belimumab’s ability to significantly reduce lupus disease activity and the rate of lupus flares, as well as to lower the rate of flares and significantly delay the length of time to the first flare.
“Belimumab’s apparent capacity to lower the use of the dreaded corticosteroid, prednisone, is also notable,” said Dowd, who has heard from the thousands of LRI members that lessening the dosage of this often lifesaving but complication-ridden medicine is a priority. In the trial, a greater percentage of participants taking belimumab were able to reduce their prednisone use than those taking the placebo.
LRI Program Director Catherine Anastasia noted that the significant reductions in fatigue with belimumab would also come as particularly welcome news. “The fatigue of lupus can be draining and debilitating. A route out of the exhaustion would make a big difference in quality of life for so many.”
The company additionally reported that people taking belimumab generally tolerated the drug well.
Key trial design
“This is the first drug shown to be effective in ameliorating the signs and symptoms of lupus in decades,” said Daniel J. Wallace, MD, clinical professor of medicine at the David Geffen School of Medicine at UCLA. “It represents a breakthrough for finally utilizing a methodology that enables researchers to demonstrate disease improvement. This will benefit lupus patients and their doctors.”
BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in people with lupus.
Dowd and other LRI representatives are among the thousands of attendees—physicians, health professionals, and scientists—at the Philadelphia meeting designed to advance rheumatology through programs of education, research, advocacy and practice support.
The new details of the trial are available here.
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Combined Federal Campaign (CFC)
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The Lupus Research Institute is now an official charity of the "Combined Federal Campaign (CFC)"
If you, or someone you know, works for the federal government, the military, or the U.S. Postal Service, designate the LRI as a charity of choice for CFC donations!
Fuel discoveries with every paycheck.
For the first time ever, the Lupus Research Institute is an official charity of the “Combined Federal Campaign (CFC).” Every Fall, all federal and U.S. Postal employees participate in the Combined Federal Campaign and allocate a portion of their pay checks to a selection of pre-approved charities.
This means that you, or anyone else you know who works for the federal government, military or U.S. Postal Service, can designate $10, $20, $50, or another portion of your biweekly paycheck as a donation to innovative lupus research at the Lupus Research Institute.
Designate your CFC contribution to the Lupus Research Institute by using our CFC code number - #48891.
The Lupus Research Institute is now an official charity of the "Combined Federal Campaign (CFC)"
If you, or someone you know, works for the federal government, the military, or the U.S. Postal Service, designate the LRI as a charity of choice for CFC donations!
Fuel discoveries with every paycheck.
For the first time ever, the Lupus Research Institute is an official charity of the “Combined Federal Campaign (CFC).” Every Fall, all federal and U.S. Postal employees participate in the Combined Federal Campaign and allocate a portion of their pay checks to a selection of pre-approved charities.
This means that you, or anyone else you know who works for the federal government, military or U.S. Postal Service, can designate $10, $20, $50, or another portion of your biweekly paycheck as a donation to innovative lupus research at the Lupus Research Institute.
Designate your CFC contribution to the Lupus Research Institute by using our CFC code number - #48891.
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Experimental Drug Epratuzumab
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Lupus Research Institute Encouraged by Phase 2 Trial Results of Experimental Drug Epratuzumab
The Lupus Research Institute (LRI) and its National Coalition of state and local organizations congratulate Immunomedics and UCB on the successful results of the Phase 2b clinical trial of epratuzumab for people with systemic lupus.
“It is heartening to see success in lupus trials and to see innovative companies investing in new research to combat this devastating disease,” said LRI President, Margaret G. Dowd. “Lupus is full of surprises and this is a welcome outcome. Each successful trial brings us closer to a cure and we look forward to the results of the next trial phase.”
In the mid-stage trial, there was a favorable difference in reduction of lupus symptoms between the placebo group and at least one treatment group detected early (12 weeks) after the start of treatment at different dosage levels.
“We all hope that this therapy moves to the next phase of clinical development and that it continues to show promise,” said Betty Diamond, MD, chief of the Autoimmune Disease Center at the Feinstein Institute for Medical Research at North Shore-LIJ Health System upon hearing the results. “We celebrate continued interest in clinical trials in lupus.”
Although its exact mechanism of action is unknown, epratuzumab likely works to reduce lupus symptoms by acting as an inhibitor to CD22, a cell surface receptor that when blocked has an indirect effect of inhibiting the activity of the immune system’s B cells, explained Daniel J. Wallace, MD, clinical professor of medicine at the David Geffen School of Medicine at UCLA and founder of LRI Coalition member Lupus LA.
A previous trial had shown steroid-sparing properties, fewer disease flares, and improvements in patient quality of life,” added Wallace, who was one of the study’s principal investigators. “Now these promising results provide new hope for the millions of people struggling with this difficult disease.”
“Because there is still so much about this complex and surprising disease that we don’t understand,” said Dowd, “it's critical to explore multiple research areas and to stay open to the best new ideas. We need to encourage scientists to think creatively, take risks and bring new ideas, new questions and new sets of eyes to bear on the complexities of lupus and autoimmmunity.”
“Finding a cure will require corporations, government, and private funders, like the LRI, to pioneer new approaches in lupus research,” she said.
Lupus Research Institute Encouraged by Phase 2 Trial Results of Experimental Drug Epratuzumab
The Lupus Research Institute (LRI) and its National Coalition of state and local organizations congratulate Immunomedics and UCB on the successful results of the Phase 2b clinical trial of epratuzumab for people with systemic lupus.
“It is heartening to see success in lupus trials and to see innovative companies investing in new research to combat this devastating disease,” said LRI President, Margaret G. Dowd. “Lupus is full of surprises and this is a welcome outcome. Each successful trial brings us closer to a cure and we look forward to the results of the next trial phase.”
In the mid-stage trial, there was a favorable difference in reduction of lupus symptoms between the placebo group and at least one treatment group detected early (12 weeks) after the start of treatment at different dosage levels.
“We all hope that this therapy moves to the next phase of clinical development and that it continues to show promise,” said Betty Diamond, MD, chief of the Autoimmune Disease Center at the Feinstein Institute for Medical Research at North Shore-LIJ Health System upon hearing the results. “We celebrate continued interest in clinical trials in lupus.”
Although its exact mechanism of action is unknown, epratuzumab likely works to reduce lupus symptoms by acting as an inhibitor to CD22, a cell surface receptor that when blocked has an indirect effect of inhibiting the activity of the immune system’s B cells, explained Daniel J. Wallace, MD, clinical professor of medicine at the David Geffen School of Medicine at UCLA and founder of LRI Coalition member Lupus LA.
A previous trial had shown steroid-sparing properties, fewer disease flares, and improvements in patient quality of life,” added Wallace, who was one of the study’s principal investigators. “Now these promising results provide new hope for the millions of people struggling with this difficult disease.”
“Because there is still so much about this complex and surprising disease that we don’t understand,” said Dowd, “it's critical to explore multiple research areas and to stay open to the best new ideas. We need to encourage scientists to think creatively, take risks and bring new ideas, new questions and new sets of eyes to bear on the complexities of lupus and autoimmmunity.”
“Finding a cure will require corporations, government, and private funders, like the LRI, to pioneer new approaches in lupus research,” she said.
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Benlysta™ Trial Results
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Lupus Research Institute Highly Encouraged by Benlysta™ Trial Results
First Phase 3 Lupus Drug Trial in Decades to Show Effectiveness
The Lupus Research Institute (LRI) and its National Coalition of state and local organizations congratulate Human Genome Sciences (HGS) and GlaxoSmithKline on the highly promising results of this landmark clinical trial of Benlysta™ (belimumab) for people with systemic lupus.
“We are very hopeful that we now are strongly on our way to the first new treatment for lupus in 50 years,” said LRI President, Margaret G. Dowd. “We look forward to the impact that a new drug for lupus will have on the lives of the 1.5 million Americans, and millions more worldwide, who suffer from this devastating autoimmune illness.”
“This is a major advance for patients, families, and physicians—the entire lupus community!” said Richard Furie, MD, chief of the division of rheumatology and allergy-clinical rheumatology at North Shore-LIJ Health System in New York. “There is no doubt that a drug approval will foster further drug development and additional discoveries.”
In the double-blind, placebo-controlled, multi-center trial, known as BLISS-52, both dose levels of Benlysta™ plus standard of care were more effective than a placebo plus standard of care in people with serologically active systemic lupus. A total of 867 participants at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe, were enrolled in the trial.
“This is the first drug shown to be effective in ameliorating the signs and symptoms of lupus in decades,” said Daniel J. Wallace, MD, clinical professor of medicine at the David Geffen School of Medicine at UCLA. “It represents a breakthrough for finally utilizing a methodology that enables researchers to demonstrate disease improvement. This will benefit lupus patients and their doctors.”
Results of a second Phase 3 trial of Benlysta™, known as BLISS-76, are expected later this year. That trial has enrolled 826 participants at 133 clinical sites in 19 countries, primarily in North America and Europe.
BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in people with lupus.
First of its kind
“Benlysta™ is the first ‘targeted biological agent’ developed specifically for systemic lupus that has the potential to obtain FDA approval…with the positive results of this 52-week trial and pending the results of the 76-week trial,” said Tammy O. Utset, MD, MPH, an associate professor of medicine at the University of Chicago.
“HGS took a very ambitious development approach—huge international concurrent trials which represent a large investment in systemic lupus therapy," Utset added.
“The lupus community commends HGS and GlaxoSmithKline for their commitment and perseverance in finally bringing this potential new lupus treatment to trial,” said Dowd. “And we thank the hundreds of people with lupus who enrolled and took part in this important trial. Participation like theirs is critical to finding answers to this illness.”
The LRI builds the research pipeline and assists in recruiting patients to participate in trials to bring safe and effective treatments to market for people with lupus.
To learn more about lupus clinical trials, log on to www.LupusTrials.org.
Lupus Research Institute Highly Encouraged by Benlysta™ Trial Results
First Phase 3 Lupus Drug Trial in Decades to Show Effectiveness
The Lupus Research Institute (LRI) and its National Coalition of state and local organizations congratulate Human Genome Sciences (HGS) and GlaxoSmithKline on the highly promising results of this landmark clinical trial of Benlysta™ (belimumab) for people with systemic lupus.
“We are very hopeful that we now are strongly on our way to the first new treatment for lupus in 50 years,” said LRI President, Margaret G. Dowd. “We look forward to the impact that a new drug for lupus will have on the lives of the 1.5 million Americans, and millions more worldwide, who suffer from this devastating autoimmune illness.”
“This is a major advance for patients, families, and physicians—the entire lupus community!” said Richard Furie, MD, chief of the division of rheumatology and allergy-clinical rheumatology at North Shore-LIJ Health System in New York. “There is no doubt that a drug approval will foster further drug development and additional discoveries.”
In the double-blind, placebo-controlled, multi-center trial, known as BLISS-52, both dose levels of Benlysta™ plus standard of care were more effective than a placebo plus standard of care in people with serologically active systemic lupus. A total of 867 participants at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe, were enrolled in the trial.
“This is the first drug shown to be effective in ameliorating the signs and symptoms of lupus in decades,” said Daniel J. Wallace, MD, clinical professor of medicine at the David Geffen School of Medicine at UCLA. “It represents a breakthrough for finally utilizing a methodology that enables researchers to demonstrate disease improvement. This will benefit lupus patients and their doctors.”
Results of a second Phase 3 trial of Benlysta™, known as BLISS-76, are expected later this year. That trial has enrolled 826 participants at 133 clinical sites in 19 countries, primarily in North America and Europe.
BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in people with lupus.
First of its kind
“Benlysta™ is the first ‘targeted biological agent’ developed specifically for systemic lupus that has the potential to obtain FDA approval…with the positive results of this 52-week trial and pending the results of the 76-week trial,” said Tammy O. Utset, MD, MPH, an associate professor of medicine at the University of Chicago.
“HGS took a very ambitious development approach—huge international concurrent trials which represent a large investment in systemic lupus therapy," Utset added.
“The lupus community commends HGS and GlaxoSmithKline for their commitment and perseverance in finally bringing this potential new lupus treatment to trial,” said Dowd. “And we thank the hundreds of people with lupus who enrolled and took part in this important trial. Participation like theirs is critical to finding answers to this illness.”
The LRI builds the research pipeline and assists in recruiting patients to participate in trials to bring safe and effective treatments to market for people with lupus.
To learn more about lupus clinical trials, log on to www.LupusTrials.org.
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National Lupus Health Education Program
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On-Going Congressional Support for National Lupus Health Education Program
The U.S. House of Representatives today approved its Fiscal Year 2010 appropriations bill for health programs and included $1 million for a second year of funding to continue the national lupus health education program for physicians and healthcare providers.
The education program is being led by the Office of Minority Health in the federal Department of Health and Human Services in partnership with the U.S. Surgeon General and the Office of Women’s Health.
“We are very pleased that the House of Representatives is continuing its strong commitment to lupus education among healthcare providers,” said Margaret G. Dowd, president of the Lupus Research Institute (LRI). “Lupus is most prevalent in underserved communities. This program will help to eliminate the barrier of racial disparity in the diagnosis and treatment of lupus.”
“The entire lupus community, including the families and friends of everyone with lupus, is deeply indebted to the House Appropriations Committee for its on-going concern about the need for early diagnosis of lupus,” continued Dowd.
“We thank all those in our LRI National Coalition of state and local lupus organizations who invested their time and energy into the effort to continue funding of the clinical education programs on lupus.”
A Decade of Change for Communities in Need
Member groups of the LRI National Coalition began their outreach in to underserved communities 10 years ago with the creation of the first neighborhood Lupus Cooperative in East Harlem, which was founded by S.L.E. Lupus Foundation of New York in 1999. Cooperatives have since been opened in the Bedford Stuyvesant neighborhood of Brooklyn and the South Bronx, both areas with large African-American and Hispanic populations.
Over the years, the LRI National Coalition has created visibility for the needs of underserved populations through awareness building and advocacy and education programs on the national, state, and local levels.
Highlights have included:
• “Invisible No More” forum on race and lupus at the Congressional Black Caucus Annual Legislative Conference in 2004.
• Educational panel on heart disease and lupus presented at the Congressional Black Caucus Annual Legislative Conference in 2005.
• Spanish language public awareness campaign to alert Hispanic women to the dangers of lupus in 2005.
• Congressional briefing on racial disparities in lupus in 2006.
• Five-city series on the increased risk of heart disease in people with lupus, particularly young women and African-American women. Presented in 2007 in conjunction with the Association of Black Cardiologists. The series was held in New York City, San Francisco, Chicago, Los Angeles, and Detroit.
On-Going Congressional Support for National Lupus Health Education Program
The U.S. House of Representatives today approved its Fiscal Year 2010 appropriations bill for health programs and included $1 million for a second year of funding to continue the national lupus health education program for physicians and healthcare providers.
The education program is being led by the Office of Minority Health in the federal Department of Health and Human Services in partnership with the U.S. Surgeon General and the Office of Women’s Health.
“We are very pleased that the House of Representatives is continuing its strong commitment to lupus education among healthcare providers,” said Margaret G. Dowd, president of the Lupus Research Institute (LRI). “Lupus is most prevalent in underserved communities. This program will help to eliminate the barrier of racial disparity in the diagnosis and treatment of lupus.”
“The entire lupus community, including the families and friends of everyone with lupus, is deeply indebted to the House Appropriations Committee for its on-going concern about the need for early diagnosis of lupus,” continued Dowd.
“We thank all those in our LRI National Coalition of state and local lupus organizations who invested their time and energy into the effort to continue funding of the clinical education programs on lupus.”
A Decade of Change for Communities in Need
Member groups of the LRI National Coalition began their outreach in to underserved communities 10 years ago with the creation of the first neighborhood Lupus Cooperative in East Harlem, which was founded by S.L.E. Lupus Foundation of New York in 1999. Cooperatives have since been opened in the Bedford Stuyvesant neighborhood of Brooklyn and the South Bronx, both areas with large African-American and Hispanic populations.
Over the years, the LRI National Coalition has created visibility for the needs of underserved populations through awareness building and advocacy and education programs on the national, state, and local levels.
Highlights have included:
• “Invisible No More” forum on race and lupus at the Congressional Black Caucus Annual Legislative Conference in 2004.
• Educational panel on heart disease and lupus presented at the Congressional Black Caucus Annual Legislative Conference in 2005.
• Spanish language public awareness campaign to alert Hispanic women to the dangers of lupus in 2005.
• Congressional briefing on racial disparities in lupus in 2006.
• Five-city series on the increased risk of heart disease in people with lupus, particularly young women and African-American women. Presented in 2007 in conjunction with the Association of Black Cardiologists. The series was held in New York City, San Francisco, Chicago, Los Angeles, and Detroit.
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