Mitoxantrone prior to interferon beta-1b in aggressive relapsing multiple sclerosis: a 3-year randomised trial

Gilles Edan 1 G. Comi 2 E. Le Page 3 Emmanuelle Leray 4, 5 M. Rocca 2 M. Filippi
1 Service de Neurologie [Rennes]
2 CRMBM - Centre de résonance magnétique biologique et médicale
3 CIC - Centre d'Investigation Clinique [Rennes]
4 Comportement et noyaux gris centraux = Behavior and Basal Ganglia [Rennes]
5 EHESP - École des Hautes Études en Santé Publique [EHESP]
Abstract : 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 months and one or more gadolinium (Gd)-enhancing MRI lesion) were randomised into two groups: 54 patients received MITOX monthly (12 mg/m2; 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 investigatoreacademic-driven study, the data do suggest that mitoxantrone induction therapy prior to INF beta-1b may have a role in aggressive disease.
Keywords : Multiple Sclerosis Mitoxantrone Secondary progressive
Document type :
Journal articles
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https://hal.ehesp.fr/hal-02437119
Contributor : Scd Ehesp <>
Submitted on : Monday, January 13, 2020 - 3:28:44 PM
Last modification on : Monday, January 20, 2020 - 8:56:02 AM

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Gilles Edan, G. Comi, E. Le Page, Emmanuelle Leray, M. Rocca, et al.. Mitoxantrone prior to interferon beta-1b in aggressive relapsing multiple sclerosis: a 3-year randomised trial. Journal of Neurology, Neurosurgery and Psychiatry, BMJ Publishing Group, 2011, 82 (12), pp.1344-1350. ⟨10.1136/jnnp.2010.229724⟩. ⟨hal-02437119⟩

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