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Mitoxantrone prior to interferon beta-1b in aggressive relapsing multiple sclerosis: a 3-year randomised trial.
MedLine Citation:
PMID:  21436229     Owner:  NLM     Status:  Publisher    
Objectives The long-term impact of interferon-beta-1b (IFN) might be improved by short-term immunosuppression with mitoxantrone (MITOX) in aggressive relapsing-remitting multiple sclerosis (ARMS) patients. Methods In this 3-year clinical and MRI study, 109 ARMS patients (two or more relapses in the previous 12&emsp14;months and one or more gadolinium (Gd)-enhancing MRI lesion) were randomised into two groups: 54 patients received MITOX monthly (12&emsp14;mg/m(2); maximum 20&emsp14;mg) combined with 1&emsp14;g of methylprednisolone (MP) for 6&emsp14;months followed by IFN for the last 27&emsp14;months, and 55 patients received IFN for 3&emsp14;years combined with 1&emsp14;g of MP monthly for the first 6&emsp14;months. The primary endpoint was the time to worsen by at least one Expanded Disability Status Scale point confirmed at 3&emsp14;months. Results The time to worsen by at least one Expanded Disability Status Scale point confirmed at 3&emsp14;months was delayed by 18&emsp14;months in the MITOX group compared with the IFN group (p<0.012). The 3-year risk of worsening disability was reduced by 65% in the MITOX group relative to the IFN group (11.8% vs 33.6%). MITOX patients had a reduced relapse rate by 61.7%, a reduced number of Gd-enhancing lesions at month 9 and a slower accumulation of new T2 lesions at each time point. Conclusions Although there were limitations in this investigator-academic-driven study, the data do suggest that mitoxantrone induction therapy prior to INF beta-1b may have a role in aggressive disease.
G Edan; G Comi; E Le Page; E Leray; M A Rocca; M Filippi;
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-3-24
Journal Detail:
Title:  Journal of neurology, neurosurgery, and psychiatry     Volume:  -     ISSN:  1468-330X     ISO Abbreviation:  -     Publication Date:  2011 Mar 
Date Detail:
Created Date:  2011-3-25     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  2985191R     Medline TA:  J Neurol Neurosurg Psychiatry     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Department of Neurology, University Hôpital Pontchaillou, Centre Hospitalier Universitaire, Service de Neurologie, Rennes, France.
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