New oral drug curbs MS disease activity

NEW YORK (Reuters Health) - In people with multiple sclerosis, or MS, treatment with a new immune-modulating drug called laquinimod can significantly reduce disease activity seen on brain MRI scans, a multinational team reports in The Lancet medical journal.

Currently approved drugs that target the inflammation associated with MS are all given by injection, point out Dr. Giancarlo Comi, from the University Vita-Salute in Milan, Italy, and colleagues. By contrast, laquinimod can be taken more conveniently, by mouth.

In a mid-stage clinical trial involving 306 patients with relapsing-remitting MS, Comi's team investigated the effects of two laquinimod doses -- 0.3 and 0.6 milligrams daily -- compared to an inactive placebo.

Treatment with the higher dose of laquinimod reduced the cumulative number of active brain lesions documented over 36 weeks by 40 percent compared with placebo. The lower dose of the drug did not have a significant effect.

Both doses of the drug were well tolerated and although some elevations in liver enzymes were noted, they were typically temporary.

However, Dr. B. Mark Keegan and Dr. Brian G. Weinshenker, from the Mayo Clinic in Rochester, Minnesota, emphasize in a related editorial that, while laquinimod may be an effective treatment for relapse-remitting multiple sclerosis, "safety is paramount."

The editorialists point out that a related drug, linomide, was abandoned after it was linked to heart attacks and severe inflammation. Moreover, these serious consequences were not apparent until after final-stage clinical studies had begun. Thus, it is imperative to continue to establish the safety of laquinimod.

SOURCE: Lancet, June 21, 2008.