A life-changing treatment for the devastating autoimmune multiple sclerosis (MS) could be in sight after the signs of the disease have completely disappeared in nine out of ten patients treated with an experimental drug.
Over 900 volunteers with a common form of recurrent MS received onatumumab, an immune system medication, for an average of about a year and a half.
Patients had fewer relapses during the first year of treatment and their blood counts showed far fewer signs of inflammation.
By the second year of treatment, almost 90 percent had no symptoms at all.
MS is not technically fatal, but there is no cure and for many people, the flare-ups worsen over time and can become debilitating.
The recently published results from the University of California San Francisco study on Novartis' drug suggest that the relief from debilitating pain in MS could be less than a year away if the Food and Drug Administration (FDA) the company's application for approval is accepted.
A new drug called Ofatumumab targets immune B cells that are thought to trigger attacks on nerve coatings that weaken autoimmune multiple sclerosis. In the second year of treatment with the new drug, 90% of the patients had no relapses
Worldwide, more than 2.3 million people live with MS, including almost one million in the United States.
Up until the past 20 years, there was nothing to stop the disease from progressing.
Now there are a handful of treatments that can help reduce the number and severity of relapses, but many still need a stick, walker, or other help to go within 15 years of diagnosis.
The immune system of people with MS gets messed up and attacks the protective covering of the nerves called the myelin sheath.
Like the plastic, the wire insulates the wires so that nothing interrupts the flow of electrical signals through them. Myelin ensures smooth, uninterrupted communication between the body and brain via nerves in the brain and spinal cord.
Attacks on this protective cover disturb these signals and lead to pain and reduced mobility.
The irregular activity of the immune system also appears to cause inflammation, which further aggravates the pain and nerve pain of MS.
Attacks from misdirected immune cells damage the nerves and leave scar tissue or lesions.
These lesions are a hallmark of the disease.
MS has three primary types: relapse, primary progressive and secondary progressive.
WHAT IS MULTIPLE Sclerosis?
Multiple sclerosis (known as MS) is a condition in which the immune system attacks the body and causes nerve damage to the brain and spinal cord.
It is an incurable, lifelong condition. Symptoms can be mild in some and more extreme in others, causing severe disabilities.
MS affects 2.3 million people worldwide – including around one million in the US and 100,000 in the UK.
It is more than twice as common in women as in men. A person is usually diagnosed in their 20s and 30s.
The disease is more often diagnosed in people of European descent.
The cause is not clear. Genes may be associated with it, but it is not inherited directly. Smoking and low vitamin D levels are also associated with MS.
Symptoms include fatigue, difficulty walking, vision problems, bladder problems, numbness or tingling, muscle stiffness and cramps, problems with balance and coordination, and problems with thinking, learning and planning.
The majority of sufferers have episodes of symptoms that go away and come back, while some have symptoms that gradually worsen over time.
The symptoms can be treated with medication and therapy.
The condition shortens the average life expectancy by about five to ten years.
People with primary progressive MS (PPMS) do not relapse, but only get worse when their symptoms first appear. It affects only 15 percent of all people diagnosed with MS and progresses at different speeds in different patients.
Relapse-remitting MS (RRMS) is by far the most common and affects 85 percent of all people diagnosed. This form comes and goes, with flares or "attacks" that subside.
Some people's attacks are getting worse, while others remain roughly the same over time.
Some people with RRMS eventually develop a Secondary Progressive MS (SPMS) that eventually stops transferring and only progresses.
Ofatumumab was developed to treat RRMS, the most common form.
It targets B cells, immune cells that scientists believe are involved in the attacks on myelin in several ways.
Ofatumumab changed the behavior of B cells and appeared in the newly published phase 3 study to largely or completely stop MS activity.
The study was led by UCSF, but was carried out at 385 locations in 37 countries worldwide. The new drug was compared to teriflunomide, an approved drug that is commonly prescribed for MS patients.
Ofatumumab far exceeded teriflunomide, a daily pill.
The new drug, which patients can administer with an auto-injection pen once a month, halved the number of relapses that patients had compared to the pill.
Patients were kept on their respective regimes for an average of 1.6 years. In the second year, the nine out of ten of the more than 900 patients with ofatumumab appeared to have no disease progression.
They also had fewer brain lesions and less inflammation.
& # 39; Given the efficacy we saw in this study in nearly completely eliminating inflammation and scars in myelin-rich areas of the brain, and minimal side effects, the most attractive first-line treatment option for first choice is most MS patients, ”said the corresponding study author Dr. Stephen Hauser, a UCSF neuroscientist who has been working on MS treatments for decades.
Novartis is applying for FDA approval for its new drug, according to the study, published in the New England Journal of Medicine on Wednesday.
"While there is still no cure, MS patients a year ago typically became addicted to sugarcane or crutches within 15 or 20 years, but now they are often spared significant disabilities," said Dr. Houses.
"Improving MS treatment, especially with drugs that target B cells, is one of the great success stories in medicine."
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