Lupus Foundation of America Says Results of Latest Study of CellCept Provide Encouragement and Hope for People with Lupus Nephritis

WASHINGTON–(Business Wire)–
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 and were in
remission.

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.lupus.org or call 800-558-0121 to receive a free
information packet about lupus.

Lupus Foundation of America
Duane Peters, 202-349-1145
peters@lupus.org

Copyright Business Wire 2010

Cognitive behavior therapy may rapidly relieve severe IBS symptoms

Washington, May 13 (ANI): Cognitive behavior therapy may rapidly relieve severe symptoms of irritable bowel syndrome (IBS), according to a new study.

The study has been published in Clinical Gastroenterology and Hepatology, the official journal of the American Gastroenterological Association (AGA) Institute.

“Patients who quickly achieve treatment gains – for example, IBS symptom relief – may be spared the cost and inconvenience of follow-up care of little therapeutic value. This scenario may lead to the development of self-guided treatments based on multimedia technology, such as Web, DVD and smartphone, and free up trained clinicians to focus on more severely affected patients,” said Jeffrey M. Lackner, PsyD, of the University at Buffalo, SUNY, and lead author of the study. “Conversely, patients who do not respond within a set number of sessions early on could be immediately identified and triaged or ”stepped up” to potentially more powerful treatment(s) rather than bearing the cost, demoralization and frustration that comes with treatment failure.”

In the study, doctors investigated whether patients who achieved rapid, substantial and sustained symptom improvements relatively early in treatment (by week four) – called “rapid responders” – maintain treatment gains, compared with non-rapid responders.

A total of 71 patients were randomly assigned to undergo 10 weekly, one-hour sessions of cognitive behavior therapy or four, one-hour cognitive behavior therapy sessions over 10 weeks. Rapid responders were classified as patients who reported adequate relief of pain, adequate relief of bowel symptoms and a decrease in total IBS severity scores of greater than or equal to 50 by week four.

Of patients undergoing cognitive behavior therapy, 30 percent were rapid responders, of whom 90 percent to 95 percent maintained gains at the immediate and three-month follow-up examinations. Although the rapid responders reported more severe IBS symptoms at baseline, they achieved more substantial, sustained IBS symptom reduction than non-rapid responders. Both dosages of cognitive behavior therapy had comparable rates of rapid responders.

“We don”t believe the rapidity of response is simply because rapid responders had less severe IBS when they began treatment. In fact, rapid responders had more severe IBS symptoms and quality of life impairment than other patients. Nor did we find evidence to support the notion that patients responded more rapidly just because they were less distressed,” added Dr. Lackner. “Further research is needed to clarify whether rapid responders maintain treatment response longer term and, if so, what drives the durability of treatment response.” (ANI)

‘Aspirin resistance’ behind lack of clinical aspirin benefit on heart attacks

Washington, May 5 (ANI): A researcher at Florida Atlantic University had earlier shown that aspirin prevents a first heart attack.

Based on the landmark, physicians Health Study (PHS), Dr. Charles H. Hennekens, Sir Richard Doll Research Professor in the Charles E. Schmidt College of Biomedical Science, proposed that individuals who develop a heart attack on aspirin do so, at least in part, because they are not taking the drug or they are taking non-steroidal anti-inflammatory drugs (NSAIDs) which inhibit the clinical benefit of aspirin.

Previous studies had suggested that the lack of clinical benefit was due to “aspirin resistance.”

Subjects in the PHS were 22,071 apparently healthy U.S. male physicians, aged 40-84 at entry, without prior history of cardiovascular disease, cancer or other major illnesses.

Participants assigned to aspirin who were non-compliant (did not take the 180 study pills per year) had no significant reduction in risk of myocardial infarction. Furthermore, participants assigned to aspirin who self-selected the use of NSAIDs had no significant reduction in risk of myocardial infarction.

All of these observations contribute to the formulation of the researchers’ hypothesis that non-adherence or NSAIDs use explains the lack of clinical benefit of aspirin on first myocardial infarction which has been attributed to “aspirin resistance.”

Their observations also imply that the interrelationship between laboratory measurements used to indicate inadequate anti-platelet responses to aspirin and “treatment failure” requires evaluation in randomized trials designed to test this hypothesis.

“Aspirin non-response is a clinical reality, but “aspirin resistance” remains a theoretical possibility which requires further research,” said Hennekens.

The study has been published in the May issue of the American Heart Journal. (ANI)

Cognitive behavior therapy may rapidly relieve severe IBS symptoms

Washington, Apr 27 (ANI): Cognitive behavior therapy may rapidly relieve severe symptoms of irritable bowel syndrome (IBS), according to a new study.

The study has been published in Clinical Gastroenterology and Hepatology, the official journal of the American Gastroenterological Association (AGA) Institute.

“Patients who quickly achieve treatment gains — for example, IBS symptom relief — may be spared the cost and inconvenience of follow-up care of little therapeutic value. This scenario may lead to the development of self-guided treatments based on multimedia technology, such as Web, DVD and smartphone, and free up trained clinicians to focus on more severely affected patients,” said Jeffrey M. Lackner, PsyD, of the University at Buffalo, SUNY, and lead author of the study. “Conversely, patients who do not respond within a set number of sessions early on could be immediately identified and triaged or ”stepped up” to potentially more powerful treatment(s) rather than bearing the cost, demoralization and frustration that comes with treatment failure.”

In the study, doctors investigated whether patients who achieved rapid, substantial and sustained symptom improvements relatively early in treatment (by week four) — called “rapid responders” — maintain treatment gains, compared with non-rapid responders.

A total of 71 patients were randomly assigned to undergo 10 weekly, one-hour sessions of cognitive behavior therapy or four, one-hour cognitive behavior therapy sessions over 10 weeks. Rapid responders were classified as patients who reported adequate relief of pain, adequate relief of bowel symptoms and a decrease in total IBS severity scores of greater than or equal to 50 by week four.

Of patients undergoing cognitive behavior therapy, 30 percent were rapid responders, of whom 90 percent to 95 percent maintained gains at the immediate and three-month follow-up examinations. Although the rapid responders reported more severe IBS symptoms at baseline, they achieved more substantial, sustained IBS symptom reduction than non-rapid responders. Both dosages of cognitive behavior therapy had comparable rates of rapid responders.

“We don”t believe the rapidity of response is simply because rapid responders had less severe IBS when they began treatment. In fact, rapid responders had more severe IBS symptoms and quality of life impairment than other patients. Nor did we find evidence to support the notion that patients responded more rapidly just because they were less distressed,” added Dr. Lackner. “Further research is needed to clarify whether rapid responders maintain treatment response longer term and, if so, what drives the durability of treatment response.” (ANI)