New Lupus First Ever Drug on the Horizon for FDA Approval!- post cont! August 11, 2009 6:08 AM
. What side effects have been found with BENLYSTA?
In earlier Phase II studies, BENLYSTA has shown no increase in overall or serious side effects or infections. More information will be available on this issue as the data continues to be analyzed along with the results for the BLISS-76 clinical study which are expected to be released in November.
10. Are there other treatments being researched for lupus?
There are several promising treatments in the near-term pipeline. More companies are involved in lupus research and there are more potential new therapies being investigated than ever before.
11. Why has it taken so long to find a treatment for lupus?
Lupus is a complex disease. It can affect multiple organ systems and symptoms can range in severity from one day to the next. And it can affect each person differently with varying responses to treatment. The complexity presents challenges in evaluating potential new therapies. With each research study, regardless of the outcome, there are new discoveries that help pave the way for new therapies.
More information will be available about this drug as it enters the FDA approval
Here are the URL's where you can find more information out about Benlysta!
I hope this brings hope to all that suffer with Lupus, the caregivers, the spouses and families as it has to myself, my husband and my family!
I will keep you posted! Rhia
New Lupus First Ever Drug on the Horizon for FDA Approval! August 11, 2009 6:06 AM
I have been following this new medication and its clinical trials. It is in the last phase and will be submitted to the FDA this coming Fall for approval. They are hoping to be able to start giving it to patients by the end of 2010! I hope sooner. Here is the article I received, and a couple of URL's about this latest innovation in medicine. Nothing like it has ever existed and Lupus has never had "its own medication". All of the current medications are used for other autoimmune illnesses and they find they work somewhat on Lupus patients in some ways also.
Talk about exciting news for Lupus sufferers! I am definitely ready!
Here is the article - from my North Texas Chapter of Lupus Foundation!
Dear Lupus Supporter,
This is a historic day for all people living with lupus. It has been 40 years since man landed on the moon, but July 20, 2009 will be remembered as the day when a breakthrough in lupus may have occurred.
Human Genome Sciences (HG and GlaxoSmithKline announced that their drug, BENLYSTA, which was developed specifically to treat lupus, was successful in reaching the primary endpoint and most of the secondary endpoints in the first of two pivotal Phase III trials. The 52-week study was innovative in its design. Carefully selected patient participants coupled with a new patient responder index were key factors in the successful result. The drug was generally well tolerated.
The trial is the largest double-blinded, randomized Phase III trial ever completed in lupus. The FDA has required the company to complete two such trials and the data from the second trial will be announced in November. Should this trial confirm the results of the 52-week study, HGS and its partner, GlaxoSmithKline, will submit an application to the FDA for approval to market BENLYSTA.
Following are FAQ's for your review:
Frequently Asked Questions
1. What is BENLYSTA?
BENLYSTA is a human monoclonal antibody that is being investigated as a potential new treatment for lupus. A monoclonal antibody is a type of protein made in the laboratory that is developed to find and attach to only one type of substance in the body.
2. How does BENLYSTA work?
BENLYSTA is a human monoclonal antibody that specifically recognizes and blocks the biological activity of B-lymphocyte stimulator, or BLyS® (pronounced bliss), a naturally occurring protein which was discovered by scientists at Human Genome Sciences (HG. Elevated levels of BLyS prolong the survival of B cells which can contribute to the production of autoantibodies - antibodies that target the body's own tissues. Previous studies have shown that BENLYSTA can reduce autoantibody levels and help control autoimmune disease activity.
3. Who developed BENLYSTA?
BENLYSTA is being co-developed by Human Genome Sciences (HG and GlaxoSmithKline (GSK).
4. What clinical research has been conducted on BENLYSTA?
HGS released Phase II clinical trial results for BENLYSTA in June 2006. The results demonstrated that it significantly reduced disease activity versus a placebo in patients with clinically active lupus, and appeared generally safe and well-tolerated.
In July 2009, HGS announced positive top-line results from the Phase III clinical trial, BLISS-52, which will continue to be analyzed. Results from the Phase III BLISS-76 clinical trial are expected to be released in November 2009. The design of the two trials is similar, but the duration of therapy in the two trials is different, 52 weeks for BLISS-52, and 76 weeks for BLISS-76.The BLISS-52 study was conducted primarily in Asia, South America, and Eastern Europe, and BLISS-76 is being conducted mostly in North America and Europe.
5. What are the results of the BLISS-52, Phase III BENLYSTA study?
The study demonstrated thatlupus patients who were treated with BENLYSTA had improvement in overall disease activity without clinically significant flare-ups in one or more isolated organs when compared to patients who received the placebo (inactive agent). The patients receiving BENLYSTA also were able to reduce their intake of steroid medications. The study is the largest ever to be completed for lupus and the first Phase III (late stage) trial of a new biologic immune therapy for lupus to succeed in meeting its primary endpoint and most of its secondary endpoints.
6. If BENLYSTA is approved by the FDA, what does it mean for people with lupus?
While clinical trials are still ongoing, assuming success, BENLYSTA could represent a breakthrough in the treatment of lupus. If approved, BENLYSTA could be the first drug approved to treat lupus in more than 50 years AND would bethe first drug developed specifically for lupus since the disease was discovered more than a century ago!
7. What makes BENLYSTA different from other lupus treatments?
BENLYSTA could be the FIRST FDA-approvedmedication specifically designed for the treatment of lupus. Current medications are borrowed from other diseases and conditions and some are used off-label, which means they were never approved by the FDA for lupus. These drugs include high doses of steroids, antimalarial medications, immunosupressive drugs, and organ-rejection drugs - many which have serious and devastating side effects.
8. When will the drug be available for patients?
More information on this issue will be available after the results of BLISS-76, a longer-term Phase III clinical study, are released this fall. The results from the BLISS-52 study and the BLISS-72 study will be submitted to the U.S. Food and Drug Administration (FDA) for review. The review process can take anywhere from six months to several years to complete. ONLY after receiving FDA approval will the drug be available to patients.
This post was modified from its original form on 11 Aug, 6:07
Chronic Pain, Chronic Illness, Doctors, Frustrations (kind of OT) June 23, 2009 9:36 AM
cont from above...
We both left totally puzzled, as to why the results could be that dramatically off. I researched the home meters and they are very accurate, especially the new ones. They can be a tiny percentage different, but for the most part, the meter readings at home, should be fairly close to those at the doctors office.
Now don't get me wrong, I don't wish I have diabetes. BUT!, let's say those tests are wrong, and I just drop it. Then I am a walking time bomb for potential other health issues, and especially with the Lupus that could cause me further problems.
Or, someone else could be thinking they do have diabetes, if test results happen to be mixed up, and they don't have it.
Okay, this one is kind of off topic, but it is something I feel we need to think about... not just blood work, but other tests, such as MRI's, CT's, Xrays and much more. All of those things are great if the machinery is working correctly, if the people reading those tests are correct, and even how the test is performed, or how your doctor reads those results. I always get a copy of anything they do... blood work, CT's, MRI's even surgical reports. I have them give me a copy. I feel we should be able to have access to our records if we want to.
Please read my next post... questions and ideas for our group members.
Chronic Pain, Chronic Illness, Doctors, Frustrations June 23, 2009 9:27 AM
Hello to All,
I realize we are all in a state of being a bit too busy with the Summer months. As I had mentioned in an email and on my other group, I am in the process of writing a book. It will be based on all of the realms I have "traveled" through with Chronic Pain and Chronic Illness. The American Pain Foundation is one resource for everyone that has Chronic Pain, or that is a caretaker, relative, or spouse that has Chronic Pain.
We still have a very long way to go when it comes to how the body perceives pain, why some of us have an extremely high tolerance to pain, while others have a very low threshold when it comes to being in pain. Research of course shows that the mind and the body work in unison when it comes to pain. Certain areas of our brains are where our pain receptors work. Whether it is an acute pain, like you burn your finger on a hot iron, for example. The pain is immediate, warning us of "danger". The other types of pain, from surgery, from illness, or something chronic, like joint damage, migraines, long term types of illness and so forth totally work differently within the brain and then into the physical body. I do know that anyone that has never experienced a chronic type of pain, really quite can comprehend just how badly it effects those like myself and many on a daily basis. There are so many emotions surrounding Chronic Pain. For me, after I have a migraine for instance, I almost am in a panic, because I know, usually without much warning I will have another one. I have had them since I was 17, and unless some miracle happens, I shall always be at the mercy of severe headaches that put me down until it is gone. Now, due to the complications of Lupus, my migraines are much worse as far as pain and length that I have them. So, if you have other chronic or even acute illnesses, the chronic pain you deal with can change due to other problems.
What bothers me most for each of us is the public stigma attached with any Chronic Pain Patient. Just a few years back, there was not such a thing as a "Pain Management Specialist". In fact, other than surgeons, OB doctors, Kidney specialists, orthopedic surgeons, and Cancer doctors for the main part, we did not have all of these doctors who decide to become "highly specialized" in one type of illness. That in itself has changed the face of our medical situation. Now, rather than our own family doctor delivering your child, taking out your appendix, setting a broken bone, along with regular checkups, infections and so forth, every little thing you have go wrong health wise, you see another "specialist". I think honestly our entire medical system has specialized itself to a dying breed of Family Practitioners. If you think back in your lifetime, even back to early childhood, most of us had one doctor we saw. He or She gave us our immunizations, took care of ear infections, colds, flu, even taking tonsils out (unless they did send you to a surgeon). They prescribed medications we needed, did any type of blood work or testing sometimes right there at their office, and we much more likely to know and contact us when something was amiss. I just read an article today, plus did my own research online, due to some blood work I had done, and I feel it was either not read correctly, done correctly, or there could be a possibility it is not even my own lab results but someone else, rather than my own. I will elaborate on that one later, but stats say that due to the huge labs doctors use now, the waiting time for instance that blood in the tubes wait before being processes, the automated machines that do lots of the testing, rather than the lab techs themselves, all can absolutely contribute to you not getting an accurate reading from blood/lab work. A for instance for me, my doctor did a glucose tolerance test last week on me. My blood sugar levels have been off (high) 5 times over the past 5 or 6 months. It appeared I was pre-diabetic for sure, and possibly had diabetes due to my physical issues and so forth. So, yesterday, I went back to my doctor due to having an infection, and needing another round of antibiotics. I mentioned that after the test last week, I came home, checked my glucose on my meter and it showed high. High enough to be considered diabetic. So, I figured the test they had performed would confirm that, and I would be at the least monitoring my blood daily, and probably exercising more, watching my diet a little more... etc.
Well, the results happened to be back from the lab (they took the blood in my doctors office, but they sent the blood to a lab in Dallas, which is huge and where many of the doctors from all around this region send theirs also.
My doctor informs me that my blood work was "normal". Well, of course red flags went up for me right away. How could their results be so entirely off from my own reading? It just did not make any sense. I do not and did not want to sound paranoid or accuse the doctors office of being wrong, but honestly Jim and I felt that something is amiss. Either the blood was not handled properly, (I read read glucose readings in drawn blood will sometimes be very wrong (low) if the lab work is NOT done before 5 hours of being drawn.) Well, I know they took my blood early last Thurs. morning, and that lab comes down in the late afternoons to gather everything, then has to go back to Dallas to process, which probably means it could have been 24 hours before mine was processed. Plus, I also read labs are far more inaccurate than we are led to believe. Human error, mixups with others blood other than the correct patients, error on the part of some of the lab machines, and so forth in a study done shows that up to 30% of lab work can be wrong. That also included doctors not reading the lab work correctly. (rest on next post)
Itís usually not easy to cope with chronic pain. Participation in a chronic pain support group can help ease feelings of isolation and depression that may arise ñ feelings which may not be addressed by pain medication. In DailyStrength's chronic pain support group, the tips, advice and feedback from other people around the world can help on many levels. You can chat with those new to the condition, and with those who've met the challenges of chronic pain for many years. If your chronic pain results from other conditions, you may also want to check out DailyStrengthís various pain-related support groups. In addition, you can review treatments, keep a wellness journal, and set goals for yourself, which your DailyStrength friends will encourage you to reach successfully.
If you are new to chronic pain and seeking more information, these resources may be helpful. Feel free to share and discuss what you learn in DailyStrength's Chronic Pain Forum.
Support Group Purpose: As a Mental Health Counselor with Fibromyalgia, I am thrilled to lead this online support group. We will focus on various topics surrounding chronic pain due to living and dealing with a chronic illness. See Website for more info.
Support Group Meeting Location: ONLINE
Meeting Day(s): 4th Tues. of each month.
Start time: 7:00pm Pacific Standard Time
End time: 8:00pm Pacific Standard Time
Membership cost/donations: NONE/FREE
Activities: This group will have 4 professional speakers each year. Our group will also plan an in-person meeting/activity 1-2 times each year.