Pulse monthly steroids during an elective interruption of natalizumab: a post-marketing study.
Eur J Neurol
; 19(5): 783-7, 2012 May.
Article
in En
| MEDLINE
| ID: mdl-22054236
ABSTRACT
BACKGROUND AND PURPOSE:
Temporary discontinuation of natalizumab is sometimes considered as the observed risk of progressive multifocal leukoencephalopathy (PML) in patients with multiple sclerosis (MS). However, interruption of natalizumab may result in a re-start of disease activity.METHODS:
In this prospective post-marketing study, 23 patients with MS treated with natalizumab elected a trial of treatment interruption (90-150 days) because of safety concerns on the risk of developing PML. To reduce the risk of disease activity return, patients received monthly intravenous (i.v.) steroid pulses before natalizumab re-start.RESULTS:
Despite the steroid coverage, seven patients (30.4%) had an active scan during the natalizumab interruption period; of these, four also had a concomitant clinical exacerbation.CONCLUSIONS:
Our findings suggest that i.v. steroids are not currently recommendable as drug coverage during a scheduled treatment interruption period.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Product Surveillance, Postmarketing
/
Antibodies, Monoclonal, Humanized
/
Immunologic Factors
/
Multiple Sclerosis
Type of study:
Observational_studies
/
Risk_factors_studies
Limits:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Eur J Neurol
Journal subject:
NEUROLOGIA
Year:
2012
Type:
Article
Affiliation country:
Italy