Mount Sinai researchers present critical MS data at American Academy of Neurology meeting

In a study titled "Evaluation of Progressive Relapsing MS Patients in the PROMISE Trial," Fred Lublin, MD, Saunders Family Professor of Neurology and the Director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at The Mount Sinai Medical Center and Michelle Fabian, MD, Neurology Fellow at Mount Sinai School of Medicine, conducted a subanalysis of the PROMISE trial. The clinical trial is a multinational, multicenter, double-blind, placebo-controlled trial evaluating the effects of glatiramer acetate treatment over three years in patients with primary progressive multiple sclerosis (PPMS). PPMS is characterized by steady disease progression, rather than attacks or exacerbations followed by remissions, which people with relapsing-remitting MS experience.

"We were able to analyze data from a well-controlled clinical trial to determine the frequency and clinical consequences of the occurrence of relapses in MS patients who initially have a progressive course," said Dr. Lublin. "Our data indicate that baseline characteristics and disease progression in PRMS differ from those in PPMS. As such, clinicians should consider evaluating the PRMS subgroup differently from those with PPMS in assessing prognosis and clinical course."

The research team evaluated differences in baseline characteristics and disease progression between patients with PPMS and patients with another subtype called progressive relapsing multiple sclerosis (PRMS) to help determine whether disease prognosis and treatment course should be evaluated differently in these subgroups. People with PRMS have steady disease progression, but also experience exacerbations, or relapses.

Using the data from the PROMISE trial, researchers found that 42 of the 943 PPMS patients in the PROMISE trial had documented relapses over the 53 months of the study, which indicates they could be categorized as PRMS. At the end of the study, the PRMS patients had a larger change in the Expanded Disability Status Scale, a method of quantifying disability in multiple sclerosis (0.92 vs. 0.59) than the PPMS patients, and increased risk for sustained disability progression. These results indicate that there is a definable subgroup that will inevitably convert to PRMS, and that disease progression is more rapid in this group. The data will be presented Thursday, April 14, 2011, at 2:00 PM HST.

Provided by The Mount Sinai Hospital