Saturday, January 28, 2012

Rituximab and Ocrelizumab in Rheumatoid Arthritis and MS

One of the treatment stories was one we heard before in 2010 ISNI meeting in Sitges (SPAIN), the one about Rituximab and MS. Apart from the commercial history of Idec, Biogen, Genentech and so on, the important thing is that it all ended up in an phase II clinical trial. A revolutionary clinical trial.

It was revolutionary because it challenged the “MS-is-(for-sure)-a-T-cell-mediated-disease” dogma showing that a B cell therapy was able to achieve unbelivable results in MS. But most importantly it was revolutionary because it got a striking 91% reduction in new enhancing lessions compared to placebo and, despite being a phase II trial, achieved a 50% reduction in relapse rates compared to placebo in less than a year. These are Natalizumab-level results, but with a quite safer profile than Natalizumab. At least, the experience with other diseases yields a progressive multifocal leukoencephalopathy (PML) rate much lower to that of Natalizumab. Just 6 reumathoid arthritis (in which Rituximab is used routinely) patients have suffered PML over more than 120000 patients treated despite RA patients having used much more frequently concomitant immunessuppresants than MS patients do usually.

The results achieved in the study deserved a NEJM paper and, for sure, a phase III trial. But that won’t happen. At least not in the short term.

It turns out that Rituximab patent expires in the US in 2015. This means that, by the time the phase III is over, the patent will be over too. So, no profit then in doing such an investment. To surpass this inconvenience Genentech invented a new drug, antiCD20 as well, but humanized (Rituximab is chimeric), called Ocrelizumab, and started the whole process again. Then, obviously, we got a phase II trial with ocrelizumab in MS. Results have not been published yet but have been presented at 2010 ECTRIMS meeting and show,as expected, an almost equal efficacy profile to that of rituximab. But a patient died on the ocrelizumab arm from an unexpected “systemic inflammatory syndrome”. That could be chance and still hope larger studies to be assured… but it was not chance. Several rheumatoid arthritis trials with ocrelizumab have been terminated because “the overall benefit to risk profile of ocrelizumab was not favorable in RA” what it really means that 7 patients died unexpectedly in the high ocrelizumab dose arms of the trials.
(via ProHealth) 

1 comment:

  1. Spam removed: Healthy Organic Coffee with Ganoderma Lucidum from Organo Gold

    ReplyDelete

Comments are most welcome! But please:

- No SPAM whatsoever, no supplements, no pharmaceuticals, no herbs or any other advertisements

- Absolutely no quack-doctors pushing their quack-BS websites (and if you are a quack, I will call you out)

- Be critical if you want to, but try to be coherent

Comments are moderated, because I am tired of Gerwyn-V99-The-Idiot and his moronic sockpuppets, and tired of the story of the two dogs, but I will try to publish everything else.

If you are not Gerwyn (and want to tell me something other than the story of the two dogs), then relax and write something! :-)

Labels

5-AZA A. Melvin Ramsay Acne Advocacy Alan Light Alternative medicine is an untested danger Ampligen Andrew Wakefield Anecdote Anthony Komaroff Antibiotics Antibodies Anxiety Aphthous Ulcers Apnea Asthma Autism Autoimmune Disease Behçet’s Ben Katz Bertrand Russell Biology Blood sugar Bruce Carruthers Caffeine Calcium Cancer Capitalism Cardiology Carmen Scheibenbogen CBT/GET CDC Celiac Disease Cereal Grains CFIDS Chagas Charité Charles Lapp Christopher Snell Chronix Clinician Coconut Milk Cognition Common Sense and Confirmation Bias Conversion Disorder Coxiella Burnetii Coxsackie Criteria Crohn's Cushing's Syndrome Cytokine Daniel Peterson Darwinism David Bell Depression Diabetes Diagnostic Differential Disease Diseases of Affluence DNA DNA Sequencing Dog DSM5 EBV EEG Eggs Elaine DeFreitas Elimination Diet Enterovirus Epstein-Barr ERV Etiology Evolution Exercise Challenge Faecal Transplant Fame and Fraud and Medical Science Fatigue Fatty Acids Fibromyalgia Francis Ruscetti Fructose Gene Expression Genetics Giardia Gordon Broderick Gulf War Illness Gut Microbiome Harvey Alter Health Care System Hemispherx Hemolytic Uremic Syndrome Herpesviridae High Blood Pressure Historic Outbreaks HIV HPV Hyperlipid Ian Hickie Ian Lipkin Immune System Infection Intermittent Fasting It's the environment stupid Jacob Teitelbaum Jamie Deckoff-Jones Jo Nijs John Chia John Coffin John Maddox José Montoya Judy Mikovits Karl Popper Kathleen Light Kenny De Meirleir Lactose Lamb Laszlo Mechtler LCMV Lecture Leonard Jason Leukemia Life Liver Loren Cordain Low Carb Low-Dose Naltrexone (LDN) Luc Montagnier Lucinda Bateman Ludicrous Notions Lumpers and Splitters Lyme Mady Hornig Mark Hasslett Martin Lerner Mary Schweitzer MCS ME/CFS Medical Industry Medicine is not based on anecdotes Michael Maes Migraine Milk and Dairy Mitochondria MMR Money and Fame and Fraud MRI Multiple Chemical Sensitivity Multiple Sclerosis Mutton My Symptoms n-1 Nancy Klimas Narcolepsy Neurodermitis Neuroscience NK-Cell Nocebo NSAID Nutrition Obesity On Nutrition Pain Paleo Parathyroid Pathogen Paul Cheney PCR Pharmaceutical Industry Picornavirus Placebo Polio Post Exertional Malaise POTS/OI/NMH PTSD PUFA Q Fever Quote Rare Disease Research Retrovirus Rheumatoid Arthritis Rituximab RNA Robert Gallo Robert Lustig Robert Silverman Robert Suhadolnik Rosario Trifiletti Sarah Myhill Sarcasm Science Sequencing Seth Roberts Shrinks vs. Medicine Shyh-Ching Lo Simon Wessely Sinusitis Sjögren's Somnolence Sonya Marshall-Gradisnik Speculation Stanislaw Burzynski Statins Stefan Duschek Study Sucrose Sugar Supplements Symptoms T1DM T2DM There is no such thing as Chronic Lyme There is no such thing as HGRV Thyroid Tinitus To Do Toni Bernhard Tourette's Treatment Tuberculosis Vaccine Video Vincent Lombardi Vincent Racaniello Virus Vitamin B Vitamin D VP62 When Evidence Based Medicine Isn't Whooping Cough Wolfgang Lutz WPI XMRV You fail science forever