Researchers from Mount Sinai School of Medicine will present several studies at the American Academy of Neurology (AAN) Annual Meeting, including a potential new drug for the treatment of multiple sclerosis (MS) and surprising trends showing a reduction in the disease's severity. The meeting will take place April 10-17 in Toronto.
Mount Sinai researchers took part in a Phase II study of teriflunomide, an investigational oral medication for relapsing-remitting multiple sclerosis (RRMS), the most common form of the disease. The study analyzed teriflunomide added to ongoing treatment with glatiramer acetate, a currently prescribed medication, and determined that teriflunomide was safe and effective as part of combination therapy.
Researchers evaluated 123 patients with RRMS over 24 weeks. Patients were given teriflunomide in doses of seven mg/day or 14 mg/day, while a control group received a placebo. Study participants were evaluated through physical examination, laboratory data, electrocardiogram, pancreatic ultrasound, and MRI.
Teriflunomide had a positive safety profile, with only seven treatment emergent adverse events (TEAE) leading to treatment discontinuation. MRI studies revealed that teriflunomide also proved to be effective at reducing the size and volume of lesions on the brain.
"While our study was designed to evaluate the safety of teriflunomide, we determined that in addition to being safe it was also effective in reducing the size and number of lesions in people with RRMS," said Aaron Miller, MD, Professor of Neurology, and Medical Director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai School of Medicine. "Further data are required to evaluate efficacy of this combination therapy, but the results are promising."
Fred Lublin, MD, Saunders Family Professor of Neurology and the Director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis, and Dr. Miller are investigators on a study reviewing the efficacy of the Multiple Sclerosis Severity Score (MSSS), the measuring tool physicians use to determine increase of disability and the time needed to reach it, or the duration of the disease. The study was conducted with the New York State Multiple Sclerosis Consortium and compared disease severity in MS in the era of disease-modifying therapies (DMTs) to disease severity before DMTs were available. The study consisted of 6,238 MS patients, 57 percent of whom were on DMTs.
Results showed a significant decrease in MSSS per year of enrollment, meaning that in newer enrollees, disability and disease progression was less. Patients with relapsing-remitting multiple sclerosis showed the most significant change, especially those with more severe forms of the disease. A similar trend was noted in patients with progressive MS as well.
"There is a definitive shift to lower MS severity," said Dr. Lublin. "A number of factors may influence the decrease, including the effect of disease-modifying therapies or selection bias. Still, this is an exciting development that we will evaluate further."
A second study involving the Multiple Sclerosis Severity Score analyzed whether it was an effective tool for measuring long-term disease outcomes. People with MS are often concerned about the ultimate course of their illness, and physicians typically advise their patients that the disease is ever-changing and that there is no way to predict its course. Researchers evaluated initial MSSS and tracked subsequent outcomes in 122 patients followed by a single physician, Dr. Miller.
Dr. Miller and his team determined that after 12 years nearly 80 percent of the patients were within one point or better of their initial MSSS score, indicating that MSSS is a good measurement for long-term multiple sclerosis outcomes.
"Ours is the first study to review changes in MSSS from initial consultation to 12 or more years later," Dr. Miller continued. "While more research is needed, these data indicate that MSSS may be an effective way to better predict the course of the disease."
Dr. Miller will also participate in a live 90-minute webinar on Wednesday, April 14, 2010, hosted by the National Multiple Sclerosis Society and the American Academy of Neurology (AAN). Dr. Miller and the other panelists will discuss chronic cerebrospinal venous insufficiency (CCSVI), a controversial theory in MS treatment, and what it could mean to the future of people living with multiple sclerosis. The forum is open to journalists and the general public.
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