Resources, Lupus Info
Resources Available to Lupus Patients:
MIZUNO MOVES: Join me in Mizuno Moves, exercises designed for those with chronic conditions to get toned. Muscle strength is increased so that mobility can be regained. Exercises include 17 short segments of light free-weights alternating with low impact aerobics. The free-weight segments involve joint-friendly and muscle-friendly moves, and the aerobic segments include simple step work. All exercises are modifiable to include chair work up to a more intense workout. Work at your own pace. We begin and end with stretching, and perform core work before the cool-down stretch. Appropriate for all ages and fitness levels. Persons of every walk of life are welcome. Get strong in a group environment where we are all working together towards the same goal. Sign up by contacting Regan at: 303 723 0765 303 723 0765 or rmizuno@comcast.net.
LUPUS-SMART DIET: Learn how to reduce the inflammation in your body and the pain that can be associated with inflammation. This diet helped me, and following it allowed me to regain energy so that I could start exercising. Learn about this diet at: http://beatlupus.com/smart-nutrition.
ARTICLES:
1) Lupus Patient Perspective of Benlysta copyright Regan Mizuno, Harmonics Engineering Services, LLC 2009, all rights reserved
A new drug for systemic lupus is potentially on the horizon. This is groundbreaking news. The drug is called Benlysta and has been codeveloped and tested by Human Genome Sciences (HGS) and GlaxoSmithKline (GSK). If approved by the FDA, it would be the only drug ever specifically designed for lupus. I realize this does not sound plausible, and here’s the explanation. Curiously, the drugs that we currently use for the treatment of lupus were initially designed to treat other diseases, and the discovery that these drugs could be used to treat lupus was accidentally stumbled upon. Current methods of treatment of systemic lupus include cytotoxic drugs such as Cytoxan (a chemotherapy used for breast cancer) and immune suppressants (prednisone). Should Benlystaearn the ever-important approval from the FDA, Benlysta would also be the first new drug in 50 years to be approved for usein lupus. A successful 52 week trialhas given lupus patients hope. Pending another round of successful testing in a 76-week trial(the 52-week trial results will be presented in November, 2009), a new treatment option may be available.
This is terribly exciting. Obviously, lupus patients like me are very interested in this potentially helpful drug. And I personally would like to know Benlysta’s efficacy during the trials as well as its mechanism of action. To learn the answer to some of these questions, I sought the opinion of Dr. David Roth, Director of Clinical Development for Immunology for GSK. I was delighted to learn that Dr. Roth’s specialty is nephrology, as I myself had been treated for kidney disease caused by lupus. My treatment was a regimen of Cytoxan for 2.5 years. Dr. Roth has been working closely on the development of Benlysta and the trials.
Systemic lupus erythematosus (SLE), or lupus, is a chronic and sometimes fatal autoimmune disorder. Lupus is not well known, even though it is more prevalent than AIDS and Multiple Sclerosis combined and affects more than 1.5 million Americans. Lupus affects primarily women of childbearing age, and thesewomen are predominantly women of color. Lupus is a leading causeofpremature cardiovascular disease, kidney disease, and stroke among young women, says the Lupus Research Institute.
My first question to Dr. Roth was a hypothesis. I asked: if there exists a universal, basic mode of operation in lupus, in all its forms, might all lupus patients, no matter what their disease manifestations are, potentially benefit from a successful, universal lupus drug?
Dr. Roth began his answer by saying that lupus, in general, is a disease of autoimmunity, where one’s own body produces antibodies against one’s self, called “autoreactive antibodies”, or “auto-antibodies”. Auto-antibodies attack healthy tissue, including the heart, lungs, kidneys, brain, blood, and skin.
He proceeded to explain: in normalhumanfunctioning, the body produces B lymphocyte cells. (I did some quick research of my own, and learned that B lymphocytes are white blood cells manufactured in the bone marrow, and they identify antigens). B Lymphocytes then produce antibodies that attack antigens. Antigens are commonly thought of as foreign objects such as viruses or bacteria that enter our body; however, antigens are actually contained on the surface and inside the viruses and bacteria. In general, antigens are substances capable of inducing a specific immune response. Antigens are often indeed foreign proteins (or parts of them) that enter the body via an infection. However, sometimes the body’s own proteins, expressed in an inappropriate manner (and this will be further explained below), are treated like antigens by the immune system. This information was taken from the DalhousieUniversityFaculty of Medicine “Immunology Bookcase” as published on: http://pim.medicine.dal.ca/atg.htm and is further explained below by Dr. Roth.
Doctor Roth continued: B lymphocytes’ primary function is the production of antibodies. B lymphocytes also react to our own bodies (by producing auto-antibodies). Now, a certain amount of autoreaction is normal. Normally, the B lymphocytes produce a normal amount of auto-antibodies, and then the B lymphocytes die off (and therefore stop producing auto-antibodies).
There is also a protein in our bodies called BLyS, which stands for “B lymphocyte stimulator”. BLyS is necessary for normalfunctioningof the human body, because BLySis important to the survival and stimulation of our B Lymphocytes. Basically, the BlyS protein boosts our B lymphocytes in the following two ways: BLyS is one of the proteins that makes it more likely that B Lymphocytes that produce autoantibodies will survive (remember, they’re supposed to die off). Secondly, BLyS makes those autoreactive B lymphocytes that survive more active. A normal amount of BLyS is good. However, when BLyS is present in high amounts, it stimulates an overabundance of B lymphocytes, which in turn causes the production of an overabundance of long-livingauto-antibodies. In other words, in high amounts, BLyS allows autoreactivecells to overcome their natural tendency to die off. That is basic to autoimmune disease and lupus.
The mechanism of action of Benlysta is to block BLyS. Therefore, Dr. Roth hopes that by inhibiting BLyS, all forms of lupus will be improved.
However, he stressed that it is necessary to see such improvement happen within the clinical trials to be able to make that statement definitively.
Therefore, in summary, and in my lay-person terms, in a systemic lupus patient, too much BLyS leads to the production of too many auto-antibodies. And, too much BLyS leads to longer-living auto-antibodies. It’s like fleas – a small amount of fleas may be tolerable, but an abundance of fleas is a not a good thing, and, fleas, especially in large numbers, are not easy to get rid of. Theoretically, by blocking BLyS in systemic lupus patients, the destructive overproduction of auto-antibodies (which attack our organs – and attacked my kidneys) will be stopped, and symptoms will subside.
So, that’s the theoreticalbit of it. Let’s move on to the details of the trial.
The 52 week trial, called BLISS-52, showed success. That is, it met its primary endpoint. The primary endpoint was a patient response defined by an improvement in the SELENA SLEDAI score of 4 points or greater, no clinically significant BILAG worsening, and no clinically significant worsening in Physician’s Global Assessment.
The SELENA SLEDAI is a disease activity scale that indicates a clinically important reduction in SLE disease activity. The BILAG measures severity of flares as they affect organs, and the Physician’s Global Assessment defines worsening as an increase of 0.30 points or more from the patient’s baseline.
Being that I was affected severely by lupus, I wanted to know if the drug might be applicable to me, and patients like me, who have suffered organ involvement.
I asked Dr. Roth if he hoped for “severe” SLE prevention. Dr. Roth explained that the patients in the study were moderately ill to severely ill. The study that was completed and being analyzed was not specificallya lupus nephritis trial per se, but the trialdid include patients with lupus nephritis. Lupus nephritis patients are also included in the North American and European BLISS-76 trial. The trials were not specific to lupus nephritis patients. However, there is hope that the drug can benefit lupus nephritis patients.
Dr. Roth continued by saying there has always been a big focus on better lupus nephritis treatment. I was glad to hear this, because in my opinion, my treatment of Cytoxan (wherein the goal was to suppress the immune system) was archaic. Barbaric, even. The hope is that Benlystawill prove beneficialtomoderately ill patients as well as severely ill patients. Right now HGS does not have the data to be able to make any kind of claim. However, if enough promise was shown in the improvement of certain subsets of patients (those with heart involvement, those with kidney involvement, for example), specific studies of thosetypes of patients will be incited. HGS will therefore analyze the BLISS-52 trial results to see if they can detect patterns within such subsets of patients.
If HGS and GSK do indeed achieve two positive trials in general lupus, specific trials may then be designed. Personally, that is what I hope for. I’d like to see a study done on patients like me, as well as cardiac patients, so I can feel a sense of assurance such that if and when I get attacked again, I can have a mechanism to turn to that is far more favorable to chemotherapy.
Dr. Roth stated that the trial was very consistent.
“Consistent in what way?“ I asked. Dr. Roth described lupus as a variable disease – that even within a single patient, there are relapses and remission periods (tell me about it). From what I have learned and seen, lupus is an individual disease. Everybody’s lupus is different. No two patients are alike. Dr. Roth continued to say that when judging efficacy of trial drugs by looking at one patient and then another patient, it can be difficult to see improvement. However, when looking at different ways that lupus manifests itself (different organs, different patterns of worsening, fatigue, etc.) and different ways of measuring lupus activity, each with its own pros and cons (SELENA SLEDAI, BILAG, flares) and putting all these together into a total picture lets you see whether these different ways of looking at lupus are giving you the same picture. And looking at all these patterns as a whole, it seems that the results of the trial are consistent in the way the patients fared.
It should be noted that meeting this endpoint is significant, as it is a higher hurdle to overcome than, say, an improvement in labs. As we lupus patients know, lupus is a clinical disease. Personally, I can have a “bad” lab result and feel OK. My doctor becomes far more concerned when I have normal labs but feel terrible. So there is something to this physician’s global assessment, that’s for sure.
In addition to measuring each patient’s SELENA SLEDAI, BILAG, and Physician’s Global Assessment, the patients’ labs were also checked. HGS/GSK checked double-stranded DNA, ANA, complements, albumin, protein in the urine, and more.
Heart patients were used in the trialalso, if they were stable. (If they had just had cardiovascular (CV) involvement, they were allowed to be in trialif they were stable. If they had had a history of CV, or had current CV involvement that did not make them unstable, they were allowed to be in the trial). And if they’d had an active CV involvement but were on stable treatment, they could be in the study. So, the trial did include “stable but serious” heart patients and nephritis patients. I found this very interesting, and brave alallpeople involved, especially the patients, to test this drug to the nines. People with end stage kidney disease(where the kidneys are no longer functioning) were not allowed in the study. But if they’d had active nephritis that was on stable treatment, they were allowed in the trial.
The analysis has not yet been done to determine if this particular subset of patients also benefitted from the Benlysta. However, again, should both trials provide improvements in general lupus, a subset analysis on heart and nephritis patients may be conducted.
Bottom line, says Dr. Roth, is that as hopeful as this study is, it is only the first study. We really need to see consistent data in the second study. At that point, we’d be moving forward.
Everybody, stay tuned! And in the meantime, here are some links to both HGS and GSK for more information:
Copyright © 2009, Harmonics Engineering Services, LLC, all rights reserved
2) Michael Jackson had Lupus copyright Regan Mizuno, Harmonics Engineering LLC, 2009, all rights reserved
Holy Smokes. You know, I did not know that Michael Jackson had Lupus. A friend of mine, Dr. Christine Dumas, recently pointed me to a press release by Dr. Deepak Chopra, who announced on June 27 that Michael had Lupus.
I was shocked to learn this. And it’s funny – just one evening before learning this information, (and after hearing some reported details of Michael’s passing), my mother was surmising that perhaps Michael Jackson had Lupus. I considered that. He did, after all, have hair loss, he apparently suffered from fatigue and extreme pain, and it seemed as though his body and his organs simply gave out. “Nah”, I thought. It can’t be – he would have said, we would have known, etc.
And then I came to find out that is exactly what he had.
Knowing this, I now have to wonder, why didn’t he come out and say he had it? Well, it turns out he never really hid the fact he had Lupus. I read a 2003 article about his presence at a Lupus LA fundraiser, and that the media had disclosed his Lupus several years ago in many different publications.
But it never made headline news. Was the world not ready to hear it? Did we not understand (or care to understand) Lupus? Did people brush it off or simply feel disbelief? Did we simply not know of the nature or gravity of Lupus?
I think all these scenarios were present. Before I was diagnosed, I really didn’t know much about Lupus either. And after I was diagnosed, I was in denial. Yikes!
Deepak Chopra had said, in the referenced PEOPLE magazine article: [http://www.people.com/people/package/article/0,,20287787_20288162,00.html], “I know it (Lupus) was something that bothered him a lot.” That’s an understatement in terms of how I personally have previously felt about having Lupus. And I too kept the fact to myself for years.
I know I’m not the only one to who neglected to speak up.
Perhaps for these quiet reasons, combined with the fact that Lupus is very difficult to understand (not only for health professionals but also for lay-persons like me), Lupus has, until recently, remained in the shadows.
THE GOOD NEWS is that Lupus is gaining national attention. Websites like this one ensure Lupus is getting the attention it deserves. And I’d like to play my part in that by being a face for Lupus. Hi! I’m real! (Please see an upcoming article about my relationship with Lupus – what involvement I have with it, and how I have been treated).
The thing that really excites me is the research that is changing the landscape of Lupus’ presence in our world today. For example, the Lupus Research Institute (LRI) has announced on its website [http://www.lupusresearchinstitute.org/research] that LRI scientists have made breakthroughs in:
-Genes that increase susceptibility to Lupus
-How Lupus damages organs—kidneys, heart, brain, skin
-Pathways that enable misguided antibodies to attack
-Molecules that determine control of the immune system
-Targets for new treatments
-Biomarkers for diagnosing, monitoring and treating Lupus.
And of the LRI’s $26 million invested so far, millions more have been secured at the National Institutes of Health and other agencies to expand on the research.
Yippee! As a patient and advocate, this makes me very optimistic about my future.
And Michael Jackson, may he rest in peace, has impacted me, as I’m sure he has impacted other Lupus patients, and the world, by increasing knowledge about Lupus.
Copyright © 2009, Harmonics Engineering Services, LLC, all rights reserved
EXCELLENT LUPUS LINKS:
Empowher: http://www.empowher.com/users/regan
Lupus Research Institute: http://www.lupusresearchinstitute.org/
Lupus Foundation of America: http://www.lupus.org/newsite/index.html
Lupus Foundation of Northern California: http://www.lfnc.org/
Lupus LA: http://www.lupusla.org/
Lupus Canada: http://www.lupuscanada.org/
Lupus and Kidney Disease: http://www.lupus.org/webmodules/webarticlesnet/templates/new_aboutdiagnosis.aspx?articleid=100&zoneid=15
Lupus Foundation of Colorado: http://www.lupuscolorado.org/
GlaxoSmithKline: www.gsk.com
Human Genome Sciences: www.hgsi.com
Kelowna’s Walk a Block for Lupus video, featuring my Mom and Dad!: http://www.youtube.com/watch?v=H78zpwfNlrA
REGAN’S UPCOMING BOOK:
Methods to Beat Pain and Fatigue: I’ve created successful treatment methods to virtually eliminate pain and increase energy. Please stay tuned for my book, Lupus Lifestyle.
Diet: I developed a very specific, yet easy to follow, common-sense approach to wellness. Using food to stabilize the molecular reactions in my body, my pain plummeted and my energy increased dramatically. It has changed my life. These life-changers of course enabled me to exercise, which has also served to increase my energy. It is a complete circle, and I hope you will benefit from these methods as I did. These methods will also be included in my book, Lupus Lifestyle.
Exercise: The book will also contain an exercise DVD showing easy-to-do exercises that range in intensity from floor-inspired exercises to weight lifting and low-impact, high-energy aerobic exercise.
∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞∞
Beat Pain and Fatigue:
I have created unbelievably effective methods that have helped me recover from the fatigue and joint pain that came with my severe organ involvement (kidney) and a two-and-a-half year treatment of chemotherapy. Now, these crucial survival tools help me maintain an energetic, physically fit, pain-free existence and remain on an even-keel. A must-read for everybody with lupus! And nothing “woo-oo” or “out-there” is involved. It’s all common sense, diet and some supplement as well as exerciseand mentaland spiritual strategies. And they are strategies that can be modified to your own liking to work for you. They are specific, but not regimented enough such that they can’t be tweaked to seriously work for you. For your situation and your person. Trust me. You’ll be glad you did. Here they will reside, pretty unique ideas that are combined in a comprehensive package that when followed, result in an improved energy level and quality of life. Here they are, tied up in a shiny red bow. Stay posted for the new updates. Regan
∞RED BOW∞ : © Regan Mizuno
I found a way to exercise gently despite pain. The pain soon went away, partially because the exercise benefitted my body, and partially because I lost weight. Then I was able to do different exercise - exercise that was more fun and more challenging yet still involved no impact on the joints, (no impact on the knees), which resulted in continued increase in strength. With that, my energy really started to climb, my weight went down further, I was able to breathe and sing and walk up stairs more easily, and I felt stronger. Physically and mentally. Now that was the true beginning of the success story, the happy ending, total recovery. I will include these methods here and in my book. Please stay tuned.
Information About Lupus:
Lupus is a potentially life-threatening disease that can affect the organs (heart, kidneys, lungs, brain, skin) and joints. It is an auto-immune disease and involves a large amount of inflammation. It causes debilitating fatigue, hair loss, brain fog, blood disorders and other hard to manage symptoms. There is currently no known cure, but some companies are making promising head-way. In the meantime, please refer to the following links below for more information about lupus:
The national awareness month for Lupus is October.
The first month-long observance occurred in 1986 when President Reagan signed Public Law 99-365, designating October 1986 as Lupus Awareness Month.
For more information visit:
Lupus Research Institute: http://www.lupusresearchinstitute.org/