Consider The Evidence: Med/Peds Journal Roundup

March 4, 2006

Trio of Tysabri papers while drug awaits fate

Filed under: immunology, multiple sclerosis, NEJM — medblog @ 5:16 pm

NEJM 3/2 – When the Multiple Sclerosis drug Tysabri (Natalizumab) went to market, it quickly became a favorite among many neurologists for treatment resistant MS. Just when many MS sufferers got their hopes up about this first selective immunomodulator for the disease, the drug was pulled from the market due to two cases of PML reported by manufacturer Biogen Idec. Now, the The Journal presents three articles addressing the safety and efficacy of the drug.

Polman et al. demonstrate a reduction in relapse as well as progression in a placebo-controlled trial out to two years.
Rudick et al show a benefit in combination with interferon beta-1a when compared to use alone.
The third paper is a review of adverse events data including over 3000 patients taking natalizumab which shows no further cases of PML and concluded that the incidence is about 1 in 1000 patients treated for an average of 17.9 months.

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