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Assessment: The use of natalizumab (Tysabri) for the treatment of multiple sclerosis (an evidence-based review)

Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology

From the University of California at San Francisco (D.S.G.); Northwestern University School of Medicine (B.A.C.), Chicago, IL; St. Michaels Hospital (P.O.), Toronto, Ontario, Canada; University Hospitals Basel (L.K.), Switzerland; and Lutheran Medical Office (J.C.S.), Fort Wayne, IN.

Address correspondence and reprint requests to the American Academy of Neurology, 1080 Montreal Ave., St. Paul, MN 55116. guidelines{at}aan.com

The clinical and radiologic impact of natalizumab (Tysabri) as therapy for multiple sclerosis (MS) is assessed. On the basis of Class I evidence, natalizumab has been demonstrated to reduce measures of disease activity and to improve measures of disease severity in patients with relapsing-remitting (RR) MS (Level A). The relative efficacy of natalizumab compared to current disease-modifying therapies cannot be defined accurately (Level U). Similarly, the value of natalizumab in the treatment of secondary progressive (SP) MS is unknown (Level U). The value of combination therapy using natalizumab and interferon in the treatment of RRMS is also unknown (Level U). There is an increased risk of developing progressive multifocal leukoencephalopathy (PML) in natalizumab-treated patients (Level A for combination therapy, Level C for monotherapy) and possibly an increased risk of other opportunistic infections (Level C). The PML risk in a pooled clinical trial cohort has been estimated to be 1 person for every 1,000 patients treated for an average of 17.9 months, although this figure could change in either direction with more experience with the drug.

Abbreviations: CAM = cellular adhesion molecule; EDSS = Expanded Disability Status Scale; FDA = Food and Drug Administration; Gd = gadolinium; MAD = mucosal addressin; MS = multiple sclerosis; PML = progressive multifocal leukoencephalopathy; RCT = randomized controlled trial; RR = relapsing-remitting; SP = secondary progressive; WBC = white blood cell.

Supplemental data at www.neurology.org

Approved by the Therapeutics and Technology Assessment Subcommittee on November 1, 2007; by the Practice Committee on November 11, 2007; and by the American Academy of Neurology Board of Directors on May 13, 2008.

Therapeutics and Technology Assessment Subcommittee members, AAN classification of evidence, Classification of recommendations, Conflict of Interest Statement, and Mission Statement of the Therapeutics and Technology Assessment Subcommittee are available as supplemental data on the Neurology® Web site at www.neurology.org.

Disclosure: Author disclosures are provided at the end of the article.

Received November 15, 2007. Accepted in final form May 13, 2008.