[S11.005] Natalizumab in Patients with Relapsing Multiple Sclerosis: Updated Utilization and Safety Results Including TOUCH and TYGRIS

Carmen Bozic, Glyn Belcher, Richard Kim, Wellesley, MA, Robert Hyde, Zug, Switzerland, Frances Lynn, Mariska Kooijmans-Coutinho, Michael Panzara, Wellesley, MA

OBJECTIVE: To report the most recent data on natalizumab utilization and safety in patients with relapsing multiple sclerosis (MS). BACKGROUND: Natalizumab (TYSABRI), an 4-integrin antagonist, provides significant efficacy for the treatment of relapsing MS; natalizumab monotherapy significantly reduced the annualized relapse rate by 68% and the risk of sustained disability progression by 42%54% compared with placebo in a pivotal phase 3 study. The TYSABRI Outreach: Unified Commitment to Health (TOUCH) Prescribing Program and the TYSABRI Global ObseRvation Program In Safety (TYGRIS) are part of a global risk management program that is further evaluating the safety of natalizumab. DESIGN/METHODS: TOUCH is a mandatory prescribing program for all patients, physicians, and infusion centers in the United States that ensures appropriate and informed use of natalizumab. The purpose of TOUCH is to monitor patients for signs and symptoms of progressive multifocal leukoencephalopathy (PML) and to assess the incidence of serious opportunistic infections associated with natalizumab. TYGRIS is a voluntary global observational study that evaluates the long-term safety of natalizumab in the clinical practice setting. It is the largest long-term safety study of any MS therapy ever conducted. Information collected includes medical/MS history; prior natalizumab use; prior immunomodulatory, antineoplastic, or immunosuppressive agent use; and all serious adverse events. Postmarketing safety data from countries that do not participate in TOUCH or TYGRIS are also collected. RESULTS: As of the end of September 2008, approximately 48,000 patients have been exposed to natalizumab in clinical study and postmarketing settings combined, and more than 35,500 patients were receiving natalizumab. The most current exposure and safety data will be presented. CONCLUSIONS/RELEVANCE: The benefit-risk profile of natalizumab remains favorable for patients with relapsing MS. Supported by: Biogen Idec, Inc. and Elan Pharmaceuticals, Inc.
Category - MS and Related Diseases - Clinical Science

Tuesday, April 28, 2009 4:45 PM

Scientific Sessions: Multiple Sclerosis: Clinical Therapeutics and Interventions (3:45 PM-5:00 PM)