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Mitoxantrone as induction treatment in aggressive relapsing remitting Multiple Sclerosis: treatment response factors in a 5-year follow-up observational study of 100 consecutive patients
  1. Le Page Emmanuelle, E. (emmanuelle.lepage{at}chu-rennes.fr)
  1. CHU Pontchaillou , RENNES, France
    1. Leray Emmanuelle, E. (manuetguillaume{at}free.fr)
    1. CHU Pontchaillou , RENNES, France
      1. Taurin Grégory, G. (taurin.greg{at}wanadoo.fr)
      1. CHU Pontchaillou , RENNES, Grenada
        1. Coustans Marc M. (m.coustans{at}ch-cornouaille.fr)
        1. CHU Pontchaillou , RENNES, Gibraltar
          1. Chaperon Jacques, J. (jacques.chaperon{at}univ-rennes1.fr)
          1. CHU Pontchaillou, RENNES, France
            1. Morrissey Sean, S.P. (sean.morrissey{at}chu-rennes.fr)
            1. CHU Pontchaillou, RENNES, France
              1. Edan Gilles, G. (gilles.edan{at}chu-rennes.fr)
              1. CHU Pontchaillou, RENNES, France

                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 leukemia (remission 5 years after diagnostic).

                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.

                • Aggressive Relapsing remitting
                • Drug safety
                • Immunosuppression
                • Mitoxantrone
                • Multiple sclerosis

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