Platelet E-News: December 27, 2011

This e-newsletter is a monthly publication of the Platelet Disorder Support Association. The information in this newsletter is for educational purposes only. For advice on your unique medical condition, please consult a health care professional.

Contents:

ITP and Platelet Disorders Research and Treatments

Hospitals, Insurance, and Medical Care

General Health and Medicine

--------------------------------------------------------------------------------------------------------

ITP and Platelet Disorders Research and Treatments

FDA Eases Rules for Nplate and Promacta

As part of the approval process for Nplate (romiplostim) and Promacta (eltrombopag) the FDA mandated safety-monitoring (REMS) programs requiring targeted education and registration for patients, physicians, and pharmacists. The FDA has recently examined the safety data collected in the years since these treatments became available and concluded that the REMS program criteria could be relaxed. They eliminated the education and registration requirements, reducing the time and paperwork for everyone involved and potentially increasing access to these treatments.

Press Release. "FDA announces changes to risk strategy requirements for 2 drugs to treat low platelet counts: Includes labeling revisions for both drugs." December 6, 2011.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements


Platelets Big News at ASH Meeting

The 2011 American Society of Hematology (ASH) meeting, held December 10 -13, 2011 in San Diego, featured many sessions on all aspects of hematology, including some that could directly impact the PDSA audience. Below are a few highlights. PDSA will have in-depth coverage of the meeting in the next issues of The Platelet News (http://www.pdsa.org/products-a-publications/newsletters.html)


Platelets Fascinate Researchers and Audience

"'Platelet Pandemonium," the December 10 headline of the ASH News Daily, drew attention to two sessions, 3 hours of information, about platelet drugs, platelet disorders, and the role of platelets in fighting disease.

Attendees at the scientific session, "Platelets in Disease and Inflammation" (http://ash.confex.com/ash/2011/webprogram/Session3116.html) learned that platelets in obese people or those with infections release more inflammatory proteins than platelets of healthy, normal weight people, platelet microparticles promote joint inflammation in people with rheumatoid arthritis, and platelets contain about 100 times more TGF-b1(a protein that regulates many body functions) than other cells.

The "Platelet Drugs and Disorders" program (http://asheducationbook.hematologylibrary.org/content/current) emphasized the importance of considering an inherited platelet disorder if thrombocytopenia or disproportionate bleeding is chronic or doesn't respond to treatments. Attendees also learned about screening for other diseases such as Hepatitis C, HIV, and H. pylori when diagnosing people with low platelet counts. The third speaker emphasized that many drugs, supplements, and even some food can affect the ability of platelets to form clots.


TPO Agents: Continued Interest, More Data

In a single-arm, open-label, international Phase 3 study, about 91% of patients given Nplate (romiplostim) doubled their platelet count to greater than or equal to 50,000. The side effects reported in this study were similar to those reported in other studies, most often headache, joint pain, and fatigue. In addition to the international trial, eight other ASH abstracts described Nplate research results.

Amgen Press Release
http://www.amgen.com/media/media_pr_detail.jsp?releaseID=1639328

Data is now available on patients who are continuing to take Promacta (eltrombopag), some for more than four years. Of the people in the extended study, 88% achieved a platelet count of greater than or equal to 50,000 at least once and, for most, bleeding symptoms were markedly reduced. The most frequent adverse events were headaches, inflammation of the nasal cavity, and upper respiratory infections.

Abstract 3296. "Safety and Efficacy of Extended Treatment with Eltrombopag in Adults with Chronic Immune Thrombocytopenia (ITP) From June 2006 to February 2011."
http://ash.confex.com/ash/2011/webprogram/Paper41738.html (click on 'agree' to see abstract)

For more information on TPO treatments see:
http://www.pdsa.org/treatments/conventional/platelet-growth-factors.html


New ITP Treatments in Research Pipeline

Rozrolimupab (SYM001), a polyclonal antibody, targeting the Rh factor on red blood cells (similar to anti-D,) was shown safe and effective in a Phase 2 clinical trial. On the best dose, 9 of the 13 ITP patients responded by day 7, with the response lasting about 14 days. Of the 61 patients in the trial, 18% experienced a headache, the most common side effect, and four patients had serious adverse events.

Symphogen Press Release
http://www.symphogen.com/web/guest/newsarchive/readmore?p_p_id=56_INSTANCE_ZUuU&articleId=134719

Veltuzumab, a humanized anti-CD20 antibody (similar in action to rituximab), was tested in 39 ITP patients to determine the safety and efficacy at various doses. In preliminary results, 67% of trial participants had some response and 18% had a complete response. Immunomedics expects to complete enrollment of patients in their veltuzumab trial in 2012.

Immunomedics Press Release
http://www.immunomedics.com/pdfs/news/2011/pr12122011.pdf

Note: Want to know more ASH information? You can search the meeting programs and read the abstracts at http://ash.confex.com/ash/2011/webprogram/start.html (click on 'agree' to see program information)


Hospitals, Insurance, and Medical Care

Uninsured Americans Rate Remains Near 50 Million

About 16.3 percent or 50 million Americans did not have health insurance in 2010, 13 million more than in 2000 and slightly more than in 2009. Compared to 2009, the percent of people covered by private or employer-based insurance declined, while the number of people covered by Medicaid and Medicare increased. The nation's poverty rate reached 15.1 percent in 2010 compared to 14.3 percent in 2009, demonstrating the importance of government health programs as a safety-net, according to health officials.

Tucker C. "Census: Rate of uninsured Americans holding steady: Overall number continues to increase." The Nation's Health. November/December 2011. vol. 41 no. 9 1-20.
http://thenationshealth.aphapublications.org/content/41/9/1.2.full

Potential Medicare Cuts Jeopardize Service

Doctors are faced with a 27% cut in Medicare fees unless Congress acts before January 1, potentially jeopardizing access to services for Medicare recipients. While both political parties want to solve the problem, they disagree on the method to fund the $22 billion needed to eliminate the cut for one year. Since the Medicare funding law was passed in the 1990s, the additional costs have been added to the budget deficit, but now Congress needs to find the money elsewhere.

Alonso-Zaldivar R. "Medicare back on the brink over cuts to doctors." Associated Press. November 28, 2011.
http://news.yahoo.com/medicare-back-brink-over-cuts-doctors-082541512.html


General Health and Medicine

"Tis better to give…" Research Shows

Some regions of the brain are important in maintaining good health because they help control stress. Now, a new study shows that a simple act of giving can change the brain's stress response. In a study measuring the neural effect of supportive touch, 20 women were asked to either touch the arms of their boyfriends or refrain from contact when their boyfriends were given electric shocks. The brain scans of the female participants showed an increase in the response of regions of the brain that register rewards and control the stress response when they were able to touch their boyfriends' arms but not when they had to refrain from giving that kind of support. Naomi Eisenberger, the lead author of the study, suggests that the same positive phenomenon would be found when supporting loved ones through other stressful events.

Wolpert S. ''Tis better to give than to receive?:UCLA life scientists find that giving support offers health benefits -- to the giver." UCLA Press Release. November 09, 2011 http://newsroom.ucla.edu/portal/ucla/tis-better-to-give-than-to-receive-217764.aspx

Tristen K. "Neural Correlates of Giving Support to a Loved One." Psychosomatic Medicine November 9, 2011.
http://www.psychosomaticmedicine.org/content/early/2011/11/09/PSY.0b013e3182359335.abstract

 

Fever Helps Fight Infection

A mild fever can help certain types of white blood cells (CD8+ cytotoxic T-cells) destroy virus and tumor cells by increasing the number of these cells and also by changing the cells' membrane to make them more effective in fighting disease. " …Although very high body temperatures are dangerous and should be controlled, this study shows that we may need to reconsider how and when we treat most mild fevers," says John Wherry, Ph.D., Deputy Editor of the Journal of Leukocyte Biology.

"Fever Plays Key Role in Fighting Infection." Worldhealth.net. November 24, 2011.
http://www.worldhealth.net/news/fever-plays-key-role-fighting-infection/

Mace TA. "Differentiation of CD8+ T cells into effector cells is enhanced by physiological range hyperthermia." J Leukoc Biol'. November 2011 90:951-962.
http://www.jleukbio.org/content/90/5/951.abstract?sid=3ead874e-6913-473e-b3e4-f963a6efbf93

 

--------------------------------------------------------------------------------------------------------

This e-newsletter is published by the Platelet Disorder Support Association, 133 Rollins Avenue, Suite 5, Rockville, MD 20852, phone 1-87-Platelet, fax: 301-770-6638, web: http://www.pdsa.org, e-mail: pdsa@pdsa.org

back to top

BBB Cleveland logo GuideStar Seal NORD Member Badge 2018THSNA logo