title: Mitoxantrone prior to interferon beta-1b in aggressive relapsing multiple sclerosis: a 3-year randomised trial.
abstract: OBJECTIVE
  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 months and one or more gadolinium (Gd)-enhancing MRI lesion) were randomised into two groups: 54 patients received MITOX monthly (12 mg/m(2); maximum 20 mg) combined with 1 g of methylprednisolone (MP) for 6 months followed by IFN for the last 27 months, and 55 patients received IFN for 3 years combined with 1 g of MP monthly for the first 6 months. The primary endpoint was the time to worsen by at least one Expanded Disability Status Scale point confirmed at 3 months.
  
  
  RESULTS
  The time to worsen by at least one Expanded Disability Status Scale point confirmed at 3 months was delayed by 18 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.
authors: Department of Neurology, University Hôpital Pontchaillou, Centre Hospitalier Universitaire, Service de Neurologie, Rennes, France. gilles.edan@chu-rennes.fr
authors: G
authors: G
authors: Edan
authors: G
authors: G
authors: Comi
authors: E
authors: E
authors: Le Page
authors: E
authors: E
authors: Leray
authors: M A
authors: MA
authors: Rocca
authors: M
authors: M
authors: Filippi
mesh_terms: D000328:Adult; D001921:Brain / Q000187:drug effects / Q000473:pathology; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005682:Gadolinium; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000008:administration & dosage / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage / Q000627:therapeutic use; D008942:Mitoxantrone / Q000008:administration & dosage / Q000627:therapeutic use*; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000473:pathology; D059906:Neuroimaging / Q000379:methods; D012720:Severity of Illness Index
chemical_list: D007155:Immunologic Factors; D007166:Immunosuppressive Agents; D000068576:Interferon beta-1b; D016899:Interferon-beta; D005682:Gadolinium; D008942:Mitoxantrone; D008775:Methylprednisolone