TY - JOUR
T1 - Three years of experience:the Italian registry and safety data update.
AU - Savettieri, Giovanni
AU - Mancardi, null
AU - Laroni, null
AU - Piccinni, Carlo
AU - Periotto, Laura
AU - De Rosa, Marisa
AU - Iommelli, Rosamaria
AU - Drago, null
AU - Popoli, Patrizia
AU - Tomino, null
AU - Tomino, null
AU - Covezzoli, Anna
AU - Provinciali, null
AU - Tomino, null
AU - Montanaro, Nicola
AU - Vanacore, Nicola
AU - Milanese, Clara
AU - Popoli, null
AU - Pozzilli, null
AU - Savettieri, Giovanni
AU - Bertolotto, Antonio
AU - Marrosu, null
AU - Tola, null
AU - Grimaldi, Luigi M.E.
AU - Provinciali, null
AU - Tedeschi, Gioacchino
AU - D'Alessandro, Roberto
AU - Amato, Maria Pia
AU - Comi, null
AU - Rossi, null
PY - 2011
Y1 - 2011
N2 - At the end of 2006, a pharmacovigilance program on natalizumab was settled by the Italian Pharmaceutical Agency, and on January 2007, multiple sclerosis patients poorly responding to the immunomodulating therapies or with an aggressive clinical form of disease from onset initiated to be registered and to receive the medication. On February 2010, almost 3,000 cases have been treated with natalizumab. The drop-out rate is 10%.Almost 800 cases received cycles of natalizumab for more than 18 months. One case of PML was reported and other adverse events are similar to those described in phase III studies. The majority of cases remained stable, while in 25% of cases, an improvement of disability was documented.
AB - At the end of 2006, a pharmacovigilance program on natalizumab was settled by the Italian Pharmaceutical Agency, and on January 2007, multiple sclerosis patients poorly responding to the immunomodulating therapies or with an aggressive clinical form of disease from onset initiated to be registered and to receive the medication. On February 2010, almost 3,000 cases have been treated with natalizumab. The drop-out rate is 10%.Almost 800 cases received cycles of natalizumab for more than 18 months. One case of PML was reported and other adverse events are similar to those described in phase III studies. The majority of cases remained stable, while in 25% of cases, an improvement of disability was documented.
KW - Multiple sclerosis
KW - Natalizumab
KW - Pharmacovigilance
KW - Surveillance program
KW - Multiple sclerosis
KW - Natalizumab
KW - Pharmacovigilance
KW - Surveillance program
UR - http://hdl.handle.net/10447/55523
M3 - Article
SN - 1590-1874
VL - 31
SP - 295
EP - 297
JO - Neurological Sciences
JF - Neurological Sciences
ER -