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Source: Multiple Sclerosis:   Aug 06, 2020  1 year ago
Multiple Sclerosis: Novartis’s New Drug Ofatumumab Shows Ability To Prevent Multiple Sclerosis Relapses In Phase 3 Trial
Multiple Sclerosis: Novartis’s New Drug Ofatumumab Shows Ability To Prevent Multiple Sclerosis Relapses In Phase 3 Trial
Source: Multiple Sclerosis:   Aug 06, 2020  1 year ago
Multiple Sclerosis:  A recently completed phase 3, multicenter clinical trial has found that an immune-modulating drug can silence inflammatory disease activity in a large majority of patients with relapsing multiple sclerosis (RMS), the most common form of the illness, in which symptoms wax and wane.


 
Multiple Sclerosis or MS is an autoimmune disease in which the body's immune system attacks and destroys the insulating sheaths that normally help speed signaling in nerve pathways within the brain and throughout the body. MS affects about one million people in the United States, striking nerves of the brain and spinal cord in the prime of life, eventually crippling many patients.
 
A study published in The New England Journal of Medicine, in which more than 900 patients received an injectable drug called ofatumumab for a median duration of 1.6 years. https://www.nejm.org/doi/full/10.1056/NEJMoa1917246
 
The research findings showed that ofatumumab produced a significant reduction in new inflammation, as well as fewer clinical relapses and progression events. In the second year of treatment, nearly nine out of 10 patients on ofatumumab showed no sign of disease activity.
 
The Novartis sponsored ASCLEPIOS I and ASCLEPIOS II trials, conducted at 385 sites in 37 countries, compared ofatumumab to teriflunomide, a daily pill commonly prescribed for MS, and found that ofatumumab treatment resulted in half the relapse rate, and significantly fewer instances of worsening disability or new inflammatory lesions in the brain.
 
The initial effective MS treatments became available only two decades ago, but the new study is the latest to demonstrate the much greater effectiveness of a new type of treatment that specifically targets B cells of the immune system to stifle MS. Novartis is now seeking approval to market ofatumumab in the United States and globally to treat RMS.

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Dr Stephen Hauser, MD, a UCSF physician-scientist and director of the UCSF Weill Institute for Neurosciences, for decades, has been a prominent advocate for targeting B cells to treat Multiple Sclerosis. Hauser was a leading advisor on the design of the phase 3 ASCLEPIOS clinical trial protocol, and is corresponding author of the new NEJM study.
 
Dr Hauser served a similar role in an earlier phase 3 study of the first B-cell targeted MS treatment, a Genentech drug called ocrelizumab (brand name Ocrevus). In 2017, Ocrelizumab became the first treatment to be approved for primary progressive MS (PPMS), a less common form in which the disease continually progresses without relapses. About 10 percent of MS cases are diagnosed as PPMS, and ocrelizumab was found to reduce progression of clinical disability by about 25 percent.
 
The drug Ocrelizumab is delivered by infusion every six months, while ofatumumab can be injected under the skin once monthly by patients using an auto-injection pen. Both drugs are antibodies, but they target different sites on the same molecule, called CD20, which is found almost exclusively on B cells.
 
It has been observed that treatment temporarily depletes inflammatory B cell populations from the bloodstream. Ofatumumab is a fully human antibody, but ocrelizumab is partly derived from mouse, and the two drugs work to remove B cells in somewhat different ways.
 
Dr Hauser said, "Both of these B-cell therapies are astoundingly effective for relapsing MS and offer good options for patients," Hauser said. "Given the effectiveness we saw in this study with near-complete elimination of inflammation and scarring in myelin-rich areas of the brain, along with the minimal side effects, the use of either of these therapies is most attractive as first-line treatment for most MS patients."
 
The pharmaceutical development of both drugs for MS was based on work beginning early in Hauser's career in which he demonstrated that B cells play a key role in MS. Two decades ago, that research helped persuade Genentech to test rituximab, an anti-CD20 antibody used to treat non-Hodgkin's lymphoma, in a clinical trial with MS patients. That study was the first to demonstrate the efficacy of this treatment strategy for MS.
 
Further to demonstrating the importance of basic research for understanding the function of the immune system in autoimmune disease, the new NEJM study also highlights the value of clinical research in generating insight into disease, Hauser says. For example, new drugs that have helped control relapsing inflammatory episodes in RMS patients are revealing more underlying biological similarities between relapsing and non-relapsing forms of the disease than previously understood. Even in the absence of the active inflammatory episodes that cause relapses, immune cells that target and destroy neuronal insulation continue to survive in the brain, and neurons continue to degenerate and die.
 
From what has been learned so far, and encouraged by the partial success of ocrelizumab in treating progression, Dr  Hauser and UCSF colleagues aim to explore whether even stronger, but still safe, dosages of anti-CD20 medications given at the time of diagnosis might permanently stop progression of MS and the degeneration of neurons, effectively providing a cure. In addition to anti-CD20 therapies, a variety of other approaches are also now being explored to eliminate culprit B cells in MS even more effectively.
 
Medical researchers are discovering that even some early MS drugs have a previously unrecognized ability to deplete B cells as well as T cells of the immune system, which was their intended target before the field shifted its focus to B cells.
 
Dr Hauser further added, "While there is not yet a cure, a generation ago MS patients typically became cane- or crutch-dependent within 15 or 20 years, but now they often are spared from significant disability. The improvement in MS treatment, especially with drugs that specifically target B cells, is one of the great success stories of medicine."
 
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