uaauu Long time!

So much happened lately. New job, new home, new roomate,new weight, new drams,new confidence,new fate. Im happy , tired, complete I would say. Living the fulest.

My treatment is doing great, I feel wonderfull. Still a little scared at times. very optmistic. Things a re looking good! Still in search of what to do, what kind of bussiness I wnat to have. If I should go or stay. Those are questions on my mind

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New Drug for Lupus!



F.D.A. Approves Drug for Lupus, an Innovation After 50 Years

By ANDREW POLLACK
Published: March 9, 2011

The first new drug to treat lupus in more than half a century won approval from the Food and Drug Administration on Wednesday, offering a new option for people with lupus, an often-debilitating immune system disease.

The drug, Benlysta, is also the first product approved for its developer, Human Genome Sciences, which has accumulated losses of more than $2 billion since its founding in 1992. GlaxoSmithKlinewill help market the drug.

Lupus has been a particularly challenging disease for the pharmaceutical industry. At least seven drugs in the last several years have suffered setbacks in clinical trials. Doctors and patient advocates said that having a drug finally make it to market would encourage other pharmaceutical companies to pursue treatments for the disease.

“It’s important to the field to have an approved product,” said Dr. David S. Pisetsky, a professor of medicine at Duke and a scientific adviser to the Lupus Research Institute, which finances efforts to develop treatments.

Aspirin was approved for the disease in 1948, and two other drugs gained approval in 1955 — corticosteroids and Plaquenil, originally a malaria drug. However, there are several other drugs that doctors use off-label that experts say appear to have some effectiveness.

Benlysta’s approval was expected because an advisory committee to the F.D.A. had endorsed the drug in November by a 13-to-2 vote, despite the reservations of many committee members that the drug was only marginally effective.

In the trial that took place partly in North America, about 43.2 percent of patients receiving Benlysta experienced a reduction in symptoms after one year compared with 33.8 percent of those on a placebo. Over all, the F.D.A. estimated, about 11 patients must be treated with Benlysta for one to benefit.

The drug is not recommended for patients whose disease is severely damaging their kidneys or central nervous systems because it was not tested on those patients.

Moreover, African-Americans, who have a far higher incidence of lupus than white people, did not appear to respond to the drug. In a news release on Wednesday, the F.D.A. said there were too few African-Americans in the trials to draw a definitive conclusion. Therefore, Human Genome Sciences has agreed to do another trial to assess the safety and effectiveness of the drug in people of African descent.

Still, some patients benefited and there were signs, though not consistent, that some patients were able to reduce doses of steroids, which cause weight gain, bone-weakening and other side effects.

Saudia Sinclair of the Bronx, who has been taking Benlysta since participating in an early clinical trial in 2003, said the drug had cleared up her skin lesions, partly relieved her fatigue and allowed her to stop taking steroids. “It was the reason I was able to get through college and grad school, and I’m now working as a social worker,” she said.

In a trial, there were more deaths and serious infections among those who received the drug compared with those on a placebo. However, this finding did not concern experts on the F.D.A. advisory committee. Side effects of Benlysta included nausea and diarrhea.

The companies said the price of Benlysta would be about $35,000 a year.

Many analysts expect worldwide sales to eventually exceed $2 billion a year. But initial sales are expected to be slow because insurers might balk at paying for the drug, at least until patients try less expensive alternatives.

One study estimated that about 300,000 Americans, many of them young women, have systemic lupus erythematosus, the most common form of the disease and the one for which Benlysta was approved.

The disease occurs when the immune system attacks the body’s own cells. Symptoms vary widely but include fatigue, pain, rashes, and damage to the kidneys, heart, lung and brain.

Benlysta, which is given as an intravenous infusion every 28 days, is a monoclonal antibody that curbs the immune system by inhibiting a protein in the body called B lymphocyte stimulator. Human Genome discovered that protein by sifting through its database of human genes. That makes Benlysta, also known as belimumab, one of the first drugs to emerge from the genomics revolution.

A version of this article appeared in print on March 10, 2011, on page B1 of the New York edition.
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Moonface

Moon face a condition that is characterized by a moon shaped face.

It is one of the side effects from my meds. I’m not complaining at all, I choose the big face over my headaches. However I have to confess during this time I avoid pictures and I have a vacation coming up in two weeks! I’m already on a low salt diet to avoid it but I’ll try to be more rigorous for the next 2 weeks . Hopefully it will help.

PS: I was in the movie theater watching 3D movie (Justin Bieber)

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My first sewing class

My mother bought a sewing machine at a small store in Milford Ct , and with it we got 3 free sewing classes. Since mom knows how to do it I decided to take the classes. It was so much fun! hopefully I ll be able to sew some clothes, one day ! Chances are yes!

It was very special to me because brought me stories from my past. My mom , aunts and grandmother knew how to sew. My mother told me how my grandmother (vo Maria ) used to sew pants for man in exchange of their work in the farm in order to help my grandfather plant . She was a bussiness woman already! Very smart with her little education. My mom also told me she had memories playing in my grandma sewing machine, how she used to pedal it. Nice hearing these stories.

Anyways I hope learn more on the subject, and recommend!

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Discovery:My illness is the secret of my happiness

illness secret for my happiness  Continue reading

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Last Doctor’s visit

So, I saw my doctor yesterday. My symptoms are still under control! We are keeping prednisone 30 mg for the next 4 weeks, plus keep adding MTX on Saturdays. He will see me again in 4 weeks. He said we are tapering prednisone very slowly this time around. I feel so confident about my doctor, he is so kind and he cares, I can see in his eyes. it is a good feeling. I didn’t always feel that way, but now I do. I had trust issues myself. I was in a sick state of mind where i thought everyone was hiding something from me, i felt abandoned by GOD, so how to trust anyone? I told him after 2 years it was my happiest medical visit. I finally feel my hopes up again. I wished i could share this feelings with some of you who are in a depressed state of mind as I was few months ago. I just want to reassure you it will go away.

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Brand New!

I feel great today. It is snowing , not as bad as the last few snow storms, but I didn’t go to work. YES! I said work. I couple of months ago I thought I would never be able to work again in my life, but here I’am working. I got this temporary position at a place in NY. I  would like to register that I’m free of symptoms, currently at 40mg prednisone and 7.5 mg methotrexate once a week, scheduled to see my doctor soon. The only side effect I have from the medicine right now is insomnia and I feel restless, my mind works a thousand miles an hour. New thoughts every minute. But I’m loving it!

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