Natalizumab treatment for multiple sclerosis: recommendations for patient
selection and monitoring.
- Kappos
L, Bates
D, Hartung
HP, Havrdova
E, Miller
D, Polman
CH, Ravnborg
M, Hauser
SL, Rudick
RA, Weiner
HL, O'Connor
PW, King
J, Radue
EW, Yousry
T, Major
EO, Clifford
DB.
University Hospital, Basel, Switzerland.
lkappos@uhbs.ch
Natalizumab is a new treatment option for patients with active
relapsing-remitting multiple sclerosis. In phase III studies, natalizumab was
highly effective and well tolerated; however, three cases of progressive
multifocal leucoencephalopathy (PML) were identified (estimated incidence of one
per 1000; 95% CI 0.2-2.8; mean treatment period 17.9 months).
In this Review we
summarise the current information on PML, the three confirmed cases of PML, and
the results of an extensive safety assessment of all patients treated with
natalizumab. On the basis of these reviews, we make recommendations for
appropriate selection of candidates for natalizumab and pretreatment
assessments. In addition, a three-step diagnostic and management algorithm was
developed to monitor natalizumab-treated patients with multiple sclerosis for
PML and other opportunistic infections.
The algorithm includes strategies for
clinical, MRI, and laboratory assessments. Maintaining clinical vigilance allows
for early suspension of natalizumab in potential cases of PML, thereby
increasing the opportunity for immune reconstitution, which may improve
prognosis if PML is confirmed.
PMID: 17434098 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17434098&itool=pubmed_DocSum
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