Results of Mitoxantrone study

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Results of Mitoxantrone study

Postby TwistedHelix » Tue Sep 25, 2007 7:20 am

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: emmanuelle.lepage@chu-rennes.fr.
Accepted 16 August 2007


Abstract
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.
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RE: Results of Mitoxantrone study

Postby NHE » Tue Sep 25, 2007 11:01 pm

Without reading the full paper, it appears from the abstract that the authors may have lumped all of the follow-up treatments together. If, and it's a big if, this is the case, then the study may have been poorly designed. However, one would need to read the full paper to be certain. The vastly different numbers of patients on the different follow-up treatments is also a concern with me regarding the study's design. In addition, since only 78% of the patients remained relapse free, there are 22% which did not. This suggests that one or more of the follow-up treatments may not have been as good as the others. It would be really interesting to know which patients were not relapse free.

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Postby Jean » Thu Sep 27, 2007 5:16 pm

This study took place close to where I live (same city, in fact), and I think it was designed to assess the efficiency of a "shock therapy" on agressive MS. The researchers who designed the study believe that a "quick correction" of immune system by harming it early in MS process is more efficient than supressing it later. That's the same idea beahind Rebif or Betaseron after CIS, or HDC for agressive MS. This idea is quite popular among french researchers.
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