Natalizumab: a country-based surveillance program

6533b824fe1ef96bd1281643

RESEARCH PRODUCT

Natalizumab: a country-based surveillance program

Carlo Piccinni Nello Martini Clara Milanese Gianluigi Mancardi Filippo Drago Maria Pia Amato Marisa De Rosa Gioacchino Tedeschi A. Covezzoli Giovanni Savettieri Leandro Provinciali Roberto D’alessandro Nicola Vanacore Nicola Montanaro Antonio Addis Maria Rosaria Tola Patrizia Popoli Laura Periotto Pasqualino Rossi

subject

Adult Male medicine.medical_specialty Neurology Databases Factual Drug-Related Side Effects and Adverse Reactions National Health Programs Drug Resistance Dermatology Disease Antibodies Monoclonal Humanized Natalizumab Internal medicine Outcome Assessment Health Care Multiple Sclerosi Pharmacovigilance Product Surveillance Postmarketing medicine Adverse Drug Reaction Reporting Systems Humans Immunologic Factors MULTIPLE SCLEROSIS NATALIZUMAB Clinical Trials as Topic business.industry Multiple sclerosis Antibodies Monoclonal Mean age General Medicine medicine.disease Psychiatry and Mental health Italy REGISTRY PHARMACOVIGILANCE Physical therapy Female Settore MED/26 - Neurologia Neurology (clinical)Neurosurgery business Previously treated Follow-Up Studies medicine.drug

description

Natalizumab is a humanized monoclonal antibody with a selective adhesion-molecule inhibitor effect, and a demonstrated efficacy in decreasing the frequency of relapses and progression of disability in relapsing-remitting multiple sclerosis (RR MS). After the approval of FDA and EMEA in MS cases unresponsive to immunomodulating therapy or in severe MS patients also not previously treated with interferons, and considering the concern on the possible side effects, an accurate program of surveillance was organized in our country by a combined effort of AIFA, Cineca, Department of Pharmacology of University of Bologna, and a group of neurologists appointed by the National Society of Neurology (SIN). After 15 months from the authorization of natalizumab therapy in MS, as of 31 March 2008, 908 cases have been treated with natalizumab and enrolled in this pharmaco-vigilance study. The mean age is 35 years, while the duration of disease is longer and disability is higher than that reported in the registrative study. Side effects are at the moment mild and similar to those previously described. At follow-up, the majority of treated cases are stable or ameliorated. The treatment was discontinued in 6% of patients.

year	journal	country	edition	language
2008-01-01

10.1007/s10072-008-0948-8 http://hdl.handle.net/11585/105652