It has been over 50 years since a new drug for Lupus was approved by the Food & Drug Administration (FDA), but Maryland-based biotechnology company Human Genome Sciences (HGSI) announced on Monday, November 2, 2009, that its experimental lupus treatment passed another key milestone toward FDA approval.
Challenges in developing new Lupus treatments have frustrated both patients and pharmaceutical companies as one drug after another has either suffered setbacks in the FDA approval process or resulted in outright clinical trial failures.
HGSI announced that in the latest round of studies, the experimental drug known as Benlysta given in higher doses to lupus patients resulted in patient improvement after a year. Unfortunately, a lower dose of the treatment did not meet that target.
The manufacturer’s next step is to submit the clinical trial data, including evidence of its demonstrated safety and effectiveness, to the FDA. HGSI worked in close collaboration with the FDA in designing its clinical trials around specific endpoints that the agency indicated would demonstrate its effectiveness. Benlysta met those endpoints in both trials and, if approved, could be commercially available by the end of 2010.
The Los Angeles Times recently reported:
Benlysta, known generically as belimumab, is an artificially generated monoclonal antibody that inhibits the biological activity of a naturally occurring protein called B-lymphocyte stimulator or BLyS. BLyS is required for the creation of plasma B cells that produce the antibodies that attack organs. . . .
The second trial, whose results were announced today by the company, involved 816 patients at 19 centers, primarily in North America and Europe. Researchers found that 43.2% of those taking the highest dose of Benlysta in addition to standard therapy had a significant reduction in symptoms with no worsening of the disease in organs. That compares with 33.8% of those taking a placebo in addition to standard care. Most of the patients, though, were not able to reduce their steroid use, but that was not a primary endpoint of the trial and failure to achieve it is not likely to prevent approval of the drug.
Please click on the link to view the LA Times report on Benlysta.
While this is great news for the nearly 5 million people suffering from lupus, the treatment is not without its drawbacks. Like most monoclonal antibodies, the Benlysta will not be available in an oral or other self-administered formulation. Patients will need to go to their doctor, hospital outpatient department, or infusion center for treatment (intravenous infusion) once a month. It is also likely to come with a high price tag. While HGSI has not yet announced any decision on pricing, monoclonal antibodies currently on the market cost thousands of dollars per dose; a breakthrough product such as Benlysta is unlikely to be any cheaper.
Filed under Lupus - medical developments by on Nov 12th, 2009. Comment. 
The ’09 Richmond Walk for Lupus did far more than educate people about the disease. It also raised more than $58,375 in donations, surpassing the goal of $50,000. The walk, sponsored by the Lupus Foundation of America, was held Oct. 31.
The ’09 Richmond Walk for Lupus did far more than educate people about the disease. It also raised more than $58,375 in donations, surpassing the goal of $50,000. The walk, sponsored by the Lupus Foundation of America, was held Oct. 31.
Although it was raining, Lupus patients, as well as hundreds of others, walked in order to raise money for Lupus. Walkers and volunteers never lost focus and remained persistent in reaching their goal. Take Tamara Williams, for example, who became the “top fundraiser” at the Richmond walk. She collected almost $3,150.
Their determination paid off in a major way because the day after the lupus awareness walk at Richmond International Raceway, participants received an e-mail with groundbreaking news – about a new drug for treating lupus. The drug is called Benlysta, and if its endorsed by the U.S. Federal Drug Administration, it would be the first drug ever developed and approved specifically for the treatment of lupus.
Currently, the Human Genome Sciences and GlaxoSmithKline are conducting clinical trials with Benlysta and have found that it reduces disease activity.
Filed under Lupus in the news by on Nov 5th, 2009. Comment.
It turns out that people who have been diagnosed with Lupus are at greater risk of having a severe case of the H1N1 (swine flu) virus.
Also, per a recent report by the Lupus Foundation of America, people with lupus are typically at increased risk for infections, particularly if they are taking medicines that suppress the immune system. Therefore, it is important to be vigilant about following the general information and precautions.
If you have lupus and experience a sudden onset of flu-like symptoms, immediately contact your doctor. An anti-viral medication can be dispensed to you. If you do think you may have swine flu, you should be particularly cautious to prevent sickness by washing your hands regularly and remaining a comfortable distance from others while communicating to prevent the spread of the flu.
If you are pursuing a Lupus Disability claim, I’m sure the last thing you need to deal with is something like the swine flu! I have not yet heard any horror stories about claimants missing their Social Security hearing due coming down with swine flu…let’s just hope if that happens the Judge will have a little sympathy!
FYI: People with lupus who have a confirmed diagnosis of the Swine Flu can receive treatment with appropriate anti-virals, such as Tamiflu or Relenza. To date, there have not been any major drug interactions between typical lupus medications and to anti-virals effective in treating the Swine Flu.
Filed under Lupus - medical developments by on Oct 26th, 2009. Comment.
A new study links insecticide use with an increased instance of autoimmune diseases, such as lupus, in women. This study raises many questions about the many environmental factors that can cause or compound ailments such as lupus.
The study involved more than 75,000 women. Those that had used insecticides six or more times a year had an almost two-and-a-half times increased risk of developing an autoimmune illness, such as lupus, than women who did not use insecticides. The risk of developing autoimmune illnesses, such as lupus, also doubled in women who used bug sprays in the home for twenty or more years. Interestingly, the bug sprays used in the home seemed more lethal and persistent, because the chemicals used in these sprays do not break down as readily in the home environment.
The study found some mitigating factors. For instance, hiring a gardener or other company to spray the insecticides minimized the risk of developing autoimmune illnesses, but not if they were used long-term.
The study indicates that with insecticides, the longer the exposure, the greater the risk of developing an autoimmune illness. Therefore, it is not too late to minimize your exposure to insecticides and bug sprays, even if you have been a regular user of them in the past.
If you are suffering from lupus, it is important to review your exposure to insecticides and bug sprays and to immediately limit or stop your exposure. This study might also create pause and force you to consider what other chemicals you are regularly exposed to. As with any social security disability case, it is important that you as a claimant give the impression that you have taken steps to minimize your condition and certainly to avoid its worsening.
If you have worked as a sprayer for a farm or in any other professional capacity that involved regular and prolonged exposure to these chemicals, you may consider discussing this study as part of your hearing. It may help establish that your case is severe and why you cannot perform your past relevant work.
Filed under Lupus - medical developments by on Oct 26th, 2009. Comment.
A recent study determined that for individuals with lupus, depression increased their already elevated risk for cardiovascular disease. Per the study, depressed lupus patients exhibited an almost four-fold greater risk of early stage cardiovascular disease than those lupus patients not suffering from depression. This is yet another study that explores the relationship between depression and chronic diseases, and it raises questions about whether depression can precipitate further health problems.
The study is being reviewed as helpful because depression is seen as a disease capable of modification; once diagnosed, it can be readily treated and limit the likelihood of cardiovascular disease and potentially other diseases that might be precipitated by depression. This most recent study is apparently the second to identify a link between depression and cardiovascular disease among lupus patients.
This study, like many others that examine depression and its links to other chronic diseases, demonstrates even more clearly how one chronic disease can seemingly cause another to occur. Depression may or may not be the link—but at least in this instance, it does appear to make a patient more susceptible to at least some diseases. If you have been diagnosed with lupus, it is important to be self-aware. Do you feel symptoms of depression? Are you even familiar with what those symptoms are? Please visit Mayo Clinic’s page discussing depression symptoms if you think you may have symptoms.
Depression, once diagnosed and identified, can be treated readily. Seek out help from friends and family. Contact your doctor to inquire about different treatments. By treating your depression you may be doing much more than just alleviating your feelings of sadness and helplessness. You may actually be preventing a further complication of your condition. If you have lupus, you may be preventing heart disease.
Filed under Lupus - medical developments by on Oct 26th, 2009. Comment.
Hello and welcome to Lupus-Disability.com, your all-in-one resource site for information relating to pursuing a Social Security Disability claim based on Lupus.
October is Lupus Awareness Month, so we figure there is no better time to start blogging about Lupus and Social Security Disability!
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Additionally, please fill out the form on the right if you are interested in pursuing a Social Security Disability claim based on Lupus. Either Jonathan Ginsberg or another Social Security Disability attorney in your area will get back to you about how to best pursue your claim.
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Filed under Lupus Resources by on Oct 1st, 2009. Comment.
