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Mitoxantrone slowed progression of disability and reduced relapses in multiple sclerosis

Key Words: mitoxantrone • multiple sclerosis

The first 150 words of the full text of this article appear below.

Design
Randomised (allocation concealed^*), blinded (patients and outcome assessors),^* placebo controlled trial with 24 months of follow up.

Setting
17 centres in Belgium, Germany, Hungary, and Poland.

Patients
194 patients 18–55 years of age who had worsening relapsing-remitting or secondary progressive MS. Additional inclusion criteria included Kurtzke Expanded Disability Status Scale (EDSS) score 3.0–6.0 and worsening by 1 EDSS point during the 18 months before enrolment. 188 patients (97%) (mean age 40 y, 52% women) completed follow up.

Intervention
Patients were allocated to mitoxantrone, 12 mg/m² (n=63), 5 mg/m² (n=66), or placebo (n=65) administered intravenously every 3 months for 24 months. By design, only patients in the mitoxantrone 12 mg and placebo groups were included in the primary analysis.

Main outcome measures
The primary outcome was a composite of 5 clinical measures, including change from baseline EDSS at 24 months, change from baseline ambulation index at 24 months, number of relapses treated with corticosteroids, time to . . . [Full text of this article]

T Jock Murray, MD

Dalhousie University
Halifax, Nova Scotia, Canada