Three years of experience: the Italian registry and safety data update.
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.
Mancardi
G L
GL
Dipartimento di Neuroscienze, Oftalmologia e Genetica, Università degli Studi di Genova, Genova, Italy. glmancardi@neurologia.unige.it
Tedeschi
G
G
Amato
M P
MP
D'Alessandro
R
R
Drago
F
F
Milanese
C
C
Popoli
P
P
Rossi
P
P
Savettieri
G
G
Tola
M R
MR
Comi
G
G
Pozzilli
C
C
Bertolotto
A
A
Marrosu
M G
MG
Grimaldi
L M E
LM
Laroni
A
A
Vanacore
N
N
Covezzoli
A
A
De Rosa
M
M
Piccinni
C
C
Montanaro
N
N
Periotto
L
L
Iommelli
R
R
Tomino
C
C
Provinciali
L
L
D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000453:epidemiology; D000069442:Natalizumab; D011358:Product Surveillance, Postmarketing / Q000639:trends*; D012042:Registries / Q000706:statistics & numerical data
D061067:Antibodies, Monoclonal, Humanized; D000069442:Natalizumab