Dedicated to Claudia who is Living in Peace

 
Dedicated to Claudia who is Living in Peace
FDA approves Benlysta to treat lupus today 10 March 2011. First new lupus drug approved in 56 years. The U.S. Food and Drug Administration approved Benlysta (belimumab) to treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs. Benlysta is delivered directly into a vein (intravenous infusion) and is the first inhibitor designed to target B-lymphocyte stimulator (BLyS) protein, which may reduce the number of abnormal B cells thought to be a problem in lupus. Prior to Benlysta, FDA last approved drugs to treat lupus, Plaquenil (hydroxychloroquine) and corticosteroids, in 1955. Aspirin was approved to treat lupus in 1948. Lupus is a serious, potentially fatal, autoimmune disease that attacks healthy tissues. It disproportionately affects women, and usually develops between ages 15 and 44. The disease affects many parts of the body including the joints, the skin, kidneys, lungs, heart, and the brain. When common lupus symptoms appear (flare) they can present as swelling in the joints or joint pain, light sensitivity, fever, chest pain, hair loss, and fatigue. Estimates vary on the number of lupus sufferers in the United States ranging from approximately 300,000 to 1.5 million people. People of all races can have the disease; however, African American women have a 3 times higher incidence (number of new cases) than Caucasian women. “Benlysta, when used with existing therapies, may be an important new treatment approach for health care professionals and patients looking to help manage symptoms associated with this disease,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. Two clinical studies involving 1,684 patients with lupus demonstrated the safety and effectiveness of Benlysta. The studies diagnosed patients with active lupus and randomized them to receive Benlysta plus standard therapy, or an inactive infused solution (placebo) plus standard therapy. The studies excluded patients who had received prior B-cell targeted therapy or intravenous cyclophosphamide, and those who had active lupus involving the kidneys or central nervous system. Patients treated with Benlysta and standard therapies experienced less disease activity than those who received a placebo and standard of care medicines. Results suggested, but did not definitively establish, that some patients had a reduced likelihood of severe flares, and some reduced their steroid doses. African American patients and patients of African heritage participating in the two studies did not appear to respond to treatment with Benlysta. The studies lacked sufficient numbers to establish a definite conclusion. To address this concern, the sponsor has agreed to conduct an additional study of people with those backgrounds to further evaluate the safety and effectiveness of Benlysta for this subgroup of lupus patients. Those receiving Benlysta during clinical studies reported more deaths and serious infections compared with placebo. The drug should not be administered with live vaccines. The manufacturer is required to provide a Medication Guide to inform patients of the risks associated with Benlysta. The most common side effects in the studies included nausea, diarrhea, and fever (pyrexia). Patients also commonly experienced infusion reactions, so pre-treatment with an antihistamine should be considered. Human Genome Sciences Inc., based in Rockville, Md., developed Benlysta and will co-market the drug in the United States with GlaxoSmithKline of Philadelphia.
Balises:
 
Moiwahine
Créé par: Moiwahine

Noter cette image:

  • Actuellement 4.9/5 étoiles.
  • 1
  • 2
  • 3
  • 4
  • 5

18 Votes.


Partager ce Blingee

  • Facebook Facebook
  • Myspace Myspace
  • Skyrock Skyrock
  • Tumblr Tumblr
  • Pinterest Pinterest
  • Partager ce Blingee plus...

Lien court vers cette page:

 

Stamps Blingee utilisés

12 graphiques ont été utilisés pour créer cette image "living in peace".
purple background with rain and lightening
Frame
SERCE HEART LOVE valentine  WHITE
Background tlo  transparent
gothic dancer
Living In Peace
Purple  vintage compass..©Ƹ̵̡Ӝ̵̨̄Ʒ...hïρρÿсhïсќ33
○•Animatred Purple Lilies○•
rainbow ©dK
RAMCIA  FRAME GLITTER BORDER
CLAUDIA
Kekuhoumana PINK
 
 

Commentaires

LillySwanC

LillySwanC dit:

Il y a 4766 jours
WOW (crying)
cherrysherrygk

cherrysherrygk dit:

Il y a 4766 jours
Yes thank you for the information & This Beautiful Blingee...I Did Hear About It On The News...see she is moving mountains from above...:) 5*...<3
suzanne-angel

suzanne-angel dit:

Il y a 4766 jours
Amen Claudia you did not fight for nothing you made it possible ! to believe and never give up !
glorious blingee  
Nanoue53

Nanoue53 dit:

Il y a 4766 jours
quite interesting info and awesome blingee! 
alwaysanangel69

alwaysanangel69 dit:

Il y a 4767 jours
♥♥♥♥♥Great Job♥♥♥♥♥
Kaleiwahea

Kaleiwahea dit:

Il y a 4767 jours
heavenly
Nanoue53

Nanoue53 dit:

Il y a 4769 jours
awesome dear!
Pau79

Pau79 dit:

Il y a 4769 jours
precioso trabajo ^^

Veux-tu ajouter un commentaire?

Viens t'inscrire à Blingee (pour un compte gratuit),
Connexion (si tu es déjà membre).

Nos partenaires:
FxGuru: Special Effects for Mobile Video