New options for early treatment of multiple sclerosis.

It is now possible to diagnose patients with multiple sclerosis earlier than previously due to the integration of MRI parameters into the diagnostic criteria. This provides a window of opportunity to treat patients with disease-modifying treatments before clinically-manifest tissue destruction and disability has emerged. There are a number of reasons to believe that such early treatment will be particularly beneficial. For example, immunopathological studies have shown that the irreversible axonal damage that underlies accumulation of disability occurs very early in the course of the disease. In addition, natural history studies demonstrate that frequent relapses and accumulation of a high T2 lesion load in the first years following diagnosis are predictive of long-term disability outcome. Treating patients early, after a clinically isolated neurological syndrome suggestive of multiple sclerosis, appears to have a greater impact on relapse frequency than when treatment is initiated later in the disease course. The latest data comes from the PreCISe study, a placebo-controlled randomised study of glatiramer acetate in patients with a clinically isolated syndrome. The study showed that this treatment significantly reduced the risk of conversion to clinically definite multiple sclerosis, with the quartile time for conversion being prolonged by more than one year in the glatiramer acetate cohort compared to placebo-treated patients. The safety and tolerability of glatiramer acetate in this relatively healthy and independent patient population was acceptable and consistent with its known safety profile in patients with relapsing remitting multiple sclerosis. An application for an extension of the approved indication of glatiramer acetate to the treatment of patients with a first clinical event suggestive of multiple sclerosis has been filed with the regulatory authorities.

RCT Entities:   Population Interventions Outcomes