I'm having a bit of a brain fog today, which might explain why I can't see any clear conclusion from these figures. 52 of the participants followed up with other disease modifying drugs, so wouldn't it be pertinent to be able to compare results with people who took those same drugs without Mitoxantrone?
Emmanuelle Le Page 1*, Emmanuelle Leray 1, Grégory Taurin 1, Marc Coustans 1, Jacques Chaperon 2, Sean Patrick Morrissey 2 and Gilles Edan 2
1 CHU Pontchaillou , RENNES, France
2 CHU Pontchaillou, RENNES, France
* To whom correspondence should be addressed. E-mail: firstname.lastname@example.org
Accepted 16 August 2007
Background: Mitoxantrone was approved by the French health authority (AFSAPPS) in October 2003 to treat patients with aggressive multiple sclerosis (MS).
Objective: To report long-term effectiveness and safety of Mitoxantrone as induction therapy in Aggressive Relapsing Remitting MS patients and to assess treatment response factors.
Material and methods: 100 consecutive aggressive relapsing-remitting MS patients received Mitoxantrone 20 mg monthly combined with methylprednisolone 1g for 6 months. Relapses, EDSS and drug safety were assessed every 6 months up to at least 5 years. Within 6 months after induction, 73 patients received a maintenance therapy (Mitoxantrone every 3 months: 21; Interferon beta: 25; Azathioprine: 15; Methotrexate: 7; Glatiramer acetate: 5).
Results: During the 12 months following Mitoxantrone start, the Annual Relapse Rate (ARR) was reduced by 91%, 78% of patients remained relapse-free, MRI activity was reduced by 89%, the mean EDSS decreased by 1.2 points (p<10-6) and 64% of patients improved by 1 point EDSS or more. At a longer term, the ARR reduction was sustained (0.29-0.42 up to 5 years), the median time to the first relapse was 2.8 years and disability remained improved up-to 5 years. Younger age and lower EDSS at Mitoxantrone start were predictive of better treatment response. Three patients presented an asymptomatic decrease of the left ventricular ejection fraction under 50% (1 reversible). One patient was diagnosed with acute myeloid leukaemia (remission 5 years after diagnosis).
Conclusion: Mitoxantrone monthly for 6 months as induction therapy followed by a maintenance treatment showed sustained clinical benefit up to 5 years with acceptable adverse events profile in patients with aggressive relapsing-remitting MS.