PMID- 20556456
OWN - NLM
STAT- MEDLINE
DCOM- 20111212
LR  - 20211020
IS  - 1590-3478 (Electronic)
IS  - 1590-1874 (Linking)
VI  - 31 Suppl 3
DP  - 2011 Jan
TI  - Swedish natalizumab (Tysabri) multiple sclerosis surveillance study.
PG  - 289-93
LID - 10.1007/s10072-010-0345-y [doi]
AB  - A post-marketing surveillance program was implemented to monitor the safety and 
      open label efficacy of natalizumab since its launch in Sweden August 2006. 
      Patients are registered in the Swedish multiple sclerosis (MS)-registry that has 
      a nationwide coverage using a standardized follow-up that includes EDSS, MSSS, 
      SDMT, MSIS-29, and recording of adverse events (AEs). As of 31 January, 2010, 
      1,115 patients had been included, of which 363 were treated >/= 24 months. Dropout 
      rate was 10%, mainly due to planned pregnancy. Serious AEs were rare, but 
      included three cases of progressive multifocal leukoencephalopathy (PML), none of 
      which had received previous immunosuppressive therapy. All analyzed clinical 
      outcome parameters showed significant improvements compared to baseline for 
      patients exceeding 24 months of treatment. Our results demonstrate good general 
      tolerability and sustained efficacy of natalizumab for patients with severe MS, 
      though the risk of PML remains a concern.
FAU - Piehl, Fredrik
AU  - Piehl F
AD  - Department of Clinical Neuroscience, Karolinska Institutet, 171 76, Stockholm, 
      Sweden. fredrik.piehl@ki.se
FAU - Holmen, C
AU  - Holmen C
FAU - Hillert, J
AU  - Hillert J
FAU - Olsson, T
AU  - Olsson T
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - Italy
TA  - Neurol Sci
JT  - Neurological sciences : official journal of the Italian Neurological Society and 
      of the Italian Society of Clinical Neurophysiology
JID - 100959175
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Natalizumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/adverse effects/*therapeutic use
MH  - Cardiovascular Diseases/epidemiology/immunology/therapy
MH  - Female
MH  - Humans
MH  - Male
MH  - Multiple Sclerosis/epidemiology/*immunology/*therapy
MH  - Natalizumab
MH  - Product Surveillance, Postmarketing/*trends
MH  - Registries
MH  - Respiration Disorders/epidemiology/immunology/therapy
MH  - Sweden/epidemiology
EDAT- 2010/06/18 06:00
MHDA- 2011/12/14 06:00
CRDT- 2010/06/18 06:00
PHST- 2010/06/18 06:00 [entrez]
PHST- 2010/06/18 06:00 [pubmed]
PHST- 2011/12/14 06:00 [medline]
AID - 10.1007/s10072-010-0345-y [doi]
PST - ppublish
SO  - Neurol Sci. 2011 Jan;31 Suppl 3:289-93. doi: 10.1007/s10072-010-0345-y.