"While anti-CD20+ treatment for relapsing-remitting disease looked like a home run, these data in primary progressive disease are not nearly as impressive," David Hafler, MD, of Yale University in New Haven, Conn., who was not involved in the study, told MedPage Today.
Dennis Bourdette, MD, of Oregon Health & Science University in Portland, said the 24% reduction in confirmed progression "is not great."
"This is a younger group with shorter duration than in previous trials in PPMS," Bourdette told MedPage Today. "It is also not representative of most PPMS patients that neurologists are seeing today."
linkNot impressive results, in a younger healthier population of patients doesn't seem like something to get excited about, expecially with dangerous and deadly side effects. But that doesn't stop the hyperbole.
In a press release full of bravado ---"Wrapping up multiple sclerosis at UCSF"-- link Dr. Hauser humble brags about his discovery.
“My hope is that, with these wonderful results against relapsing MS and finally a treatment that works at least partially for PPMS, there will be new octane in academia and industry to make even more meaningful advances,” says Hauser. “MS is no longer a black box. There is so much more that can be accomplished, and we need to build upon this important success.”
Hauser's wording could not be more ironic----as there will most likely be an FDA black box warning for ocrelizumab, due to the risk of deadly infections, malignancies, and patient deaths.
Dr. Thrower predicted that the FDA may approve ocrelizumab with a black box warning for progressive multifocal leukoencephalopathy (PML)
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But Montalban noted that there were numerically more malignancies among those in the drug group. There were 11 cancers among those on ocrelizumab compared with only two in the placebo group, something that deserves further monitoring, he said. There was also a numerical imbalance in deaths, with four in the drug group and one in the placebo group.
But Montalban noted that there were numerically more malignancies among those in the drug group. There were 11 cancers among those on ocrelizumab compared with only two in the placebo group, something that deserves further monitoring, he said. There was also a numerical imbalance in deaths, with four in the drug group and one in the placebo group.
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Ocrelizumab is a CD20 monoclonal antibody, which was originally developed as a lymphoma treatment. It targets and binds mature B lymphocytes and suppresses them. It is a humanized version of the chimeric Rituxan, (which was a the end of its patent and had to be altered and re-patented for MS, to continue making money.) So, the idea that this is a new discovery could not be further from the truth.
In fact, ocrelizumab has been around for many years, and trials of this drug in rheumatoid arthritis and lupus were halted, after serious infections and deaths were reported at 52 and 48 weeks.
There were 6 deaths associated with serious infections in the RA phase III trial.
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There were 5 deaths associated with serious infections in the Lupus phase III trial.
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The financial press didn't think ocrelizumab would ever get this far. The Wall Street Journal commented on the dangers of the drug back in 2010, when Roche ended its RA drug trial.
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There were 5 deaths associated with serious infections in the Lupus phase III trial.
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The financial press didn't think ocrelizumab would ever get this far. The Wall Street Journal commented on the dangers of the drug back in 2010, when Roche ended its RA drug trial.
"Roche said Tuesday that ocrelizumab's phase II trials in treating patients with relapsing remitting multiple sclerosis are continuing. But some analysts doubt the drug will come to market as the recent safety issues are likely to put the U.S. Food and Drug Administration on alert.
The recent trial failures have curbed the drug's sales potential and some analysts now expect that if ocrelizumab's multiple sclerosis indication passes all regulatory hurdles, it will generate less than $1 billion in annual sales."
Another problem is that autoreactive B cells return after treatment termination, as this study of rituxan in type 1 diabetes illustrated. Autoreactive B cells would create a rebound or relapse after the immune system is reconstituted, similar to what we see with Tysabri immune reconstitution inflammatory syndrome (IRIS), which occurs after termination of treatment.
We conclude that anti-B cell therapy may provide a temporary dampening of autoimmune processes through B cell depletion. However, repletion with autoreactive B cells may explain the relapse that occurs in many autoimmune patients after anti-B cell therapy.
If MS researchers truly want to make breakthrough discoveries, they will have to expand past the EAE mouse model and their narrative of an out of control immune system. They could begin by looking at the newly discovered lymphatic vessels of the CNS, cerebral endothelial cell permeability, fibrinogen, microbleeds in the MS brain, neurodegeneration and hypoperfusion. If plasmic particles, like viruses, are indeed entering the MS brain through a permeable blood brain barrier, than blocking B cells may not be the best idea. Time will tell.
So much for "wrapping up" MS.....in a billion dollar black box.
Joan
Thank you always from UK for doing so much work and research into MS truths Joan .
ReplyDeleteHi Thank you for all the info and research Joan. since every drug has it's own side effects and may or may not help as well as CCSVI , I am totally confused on what to do , currently after having MS for over 35 years being on two different drugs for 12 years and now going without any drugs for 7 years, and only doing YMCA and swank diet but struggling to move everyday .
ReplyDeleteI was thinking of going for another ccsvi + stent , I know that may or may not help since stent could be a cause for blockage too. But I was thinking that could be a closure on ccsvi perhaps then I can concentrate on this is how life going to be and just deal with it and it's not going to get any better. at least for next 5 years or so.
Hi Vahid--I'm sorry your MS is giving you worsening issues. You're doing well using exercise and Swank. Make sure your vitamin D levels are good. It's tough during the winter. Cold air and lack of sunshine can make blood flow slower and nitric oxide less available. Hang in there. Additional venous treatments may or may not be helpful--it really depends on your unique situation. I hope you find more answers and that there will be better options for you in the future. Take care.
Deletevahid, i'm a believer in ccsvi and in stem cell replacement. have you looked into dr. burt of chicago? i have ms but was too old for the research study he's starting. my friend however did get into the study.
Deleteoh, and vahid, have you tried LDN low dose naltrexone to help with symptom relief? i've used it...many of my friends with ms use it and get good results. along with a paleo diet and mega vitamin d, ldn might help.
DeleteFlorence Guy wrote this to me which is true words. Disclosures from Gavin Giovannoni (below), one of the authors of the study. He goes on social media and is in the press promoting Ocrelizumab. The pharmaceutical industry funded this research then hired individuals with numerous conflicts of interests to do it. I'm a little skeptical. Ok, ok I'm more than a little skeptical, I think motivated reasoning guides them. They want to promote the drug. They don't want to get or give an accurate picture of reality.
ReplyDeleteThank you for this review. I think you have something here
ReplyDeleteAFTER looking for articles about CD20 protein, hearing both versions, being a Young Ms patient myself And reading this article..this may be Joan, the best and most comprehensive information can we email because as others have said i think youre on t something here too especiallly about the blood brain barrier
ReplyDeleteHi Julissa--thank you for your comment. I'm glad you found this information helpful. I don't really do e-mail conversations regarding this blog----but if you have specific questions about the research covered here, you can always leave them in the comments, and I do my best to reply in a timely manner. I always remind readers that I'm not a doctor---I just have a curiosity for this research. Be well.
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