Comparative study of mitoxantrone efficacy profile in patients with relapsing-remitting and secondary progressive multiple sclerosis

Federica Esposito, Marta Radaelli, Vittorio Martinelli, Maria Pia Sormani, Filippo Martinelli Boneschi, Lucia Moiola, Maria Assunta Rocca, Mariaemma Rodegher, Giancarlo Comi

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Abstract

Background: Mitoxantrone (MTX) is an immunosuppressive drug approved for multiple sclerosis (MS) treatment. Objective: The aim of this study is to evaluate and to compare the clinical and neuroradiological responses to MTX in relapsing-remitting (RR) and secondary progressive (SP) MS patients. Methods: We conducted a retrospective, non-randomized, open-label, observational study to evaluate the clinical and neuroradiological response to the drug in 79 patients with RR MS and 210 patients with SP MS. Results: A statistically significant reduction (p <0.001) in the number of relapses was observed during MTX treatment and in the year after in both RR and SP MS patients. On the contrary, an opposite behavior in terms of disease progression was found in RR compared with SP MS patients, resulting in a statistically significant improvement of the Expanded Disability Status Scale score during the MTX treatment (p <0.001) and in the year after (p <0.001) for RR MS patients compared with a continuous, although mild, worsening of the disability in SP MS patients (p <0.001). Finally, a significant reduction (p <0.001) of new Gd-enhanced lesions in both RR and SP MS patients was observed in a subgroup of 224 individuals who underwent a brain MRI evaluation before and after MTX treatment. Conclusions: MTX should be considered as an effective therapeutic option in RR MS patients with evidence of relevant disease activity, but the potential life-threatening adverse events and the overall benefit-risk ratio must be carefully evaluated at individual patient level.

Original languageEnglish
Pages (from-to)1490-1499
Number of pages10
JournalMultiple Sclerosis Journal
Volume16
Issue number12
DOIs
Publication statusPublished - Dec 2010

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Chronic Progressive Multiple Sclerosis
Mitoxantrone
Relapsing-Remitting Multiple Sclerosis
Therapeutics
Immunosuppressive Agents
Pharmaceutical Preparations
Multiple Sclerosis
Observational Studies
Disease Progression
Odds Ratio

Keywords

  • multiple sclerosis
  • relapsing-remitting
  • secondary progressive

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

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title = "Comparative study of mitoxantrone efficacy profile in patients with relapsing-remitting and secondary progressive multiple sclerosis",
abstract = "Background: Mitoxantrone (MTX) is an immunosuppressive drug approved for multiple sclerosis (MS) treatment. Objective: The aim of this study is to evaluate and to compare the clinical and neuroradiological responses to MTX in relapsing-remitting (RR) and secondary progressive (SP) MS patients. Methods: We conducted a retrospective, non-randomized, open-label, observational study to evaluate the clinical and neuroradiological response to the drug in 79 patients with RR MS and 210 patients with SP MS. Results: A statistically significant reduction (p <0.001) in the number of relapses was observed during MTX treatment and in the year after in both RR and SP MS patients. On the contrary, an opposite behavior in terms of disease progression was found in RR compared with SP MS patients, resulting in a statistically significant improvement of the Expanded Disability Status Scale score during the MTX treatment (p <0.001) and in the year after (p <0.001) for RR MS patients compared with a continuous, although mild, worsening of the disability in SP MS patients (p <0.001). Finally, a significant reduction (p <0.001) of new Gd-enhanced lesions in both RR and SP MS patients was observed in a subgroup of 224 individuals who underwent a brain MRI evaluation before and after MTX treatment. Conclusions: MTX should be considered as an effective therapeutic option in RR MS patients with evidence of relevant disease activity, but the potential life-threatening adverse events and the overall benefit-risk ratio must be carefully evaluated at individual patient level.",
keywords = "multiple sclerosis, relapsing-remitting, secondary progressive",
author = "Federica Esposito and Marta Radaelli and Vittorio Martinelli and Sormani, {Maria Pia} and {Martinelli Boneschi}, Filippo and Lucia Moiola and Rocca, {Maria Assunta} and Mariaemma Rodegher and Giancarlo Comi",
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T1 - Comparative study of mitoxantrone efficacy profile in patients with relapsing-remitting and secondary progressive multiple sclerosis

AU - Esposito, Federica

AU - Radaelli, Marta

AU - Martinelli, Vittorio

AU - Sormani, Maria Pia

AU - Martinelli Boneschi, Filippo

AU - Moiola, Lucia

AU - Rocca, Maria Assunta

AU - Rodegher, Mariaemma

AU - Comi, Giancarlo

PY - 2010/12

Y1 - 2010/12

N2 - Background: Mitoxantrone (MTX) is an immunosuppressive drug approved for multiple sclerosis (MS) treatment. Objective: The aim of this study is to evaluate and to compare the clinical and neuroradiological responses to MTX in relapsing-remitting (RR) and secondary progressive (SP) MS patients. Methods: We conducted a retrospective, non-randomized, open-label, observational study to evaluate the clinical and neuroradiological response to the drug in 79 patients with RR MS and 210 patients with SP MS. Results: A statistically significant reduction (p <0.001) in the number of relapses was observed during MTX treatment and in the year after in both RR and SP MS patients. On the contrary, an opposite behavior in terms of disease progression was found in RR compared with SP MS patients, resulting in a statistically significant improvement of the Expanded Disability Status Scale score during the MTX treatment (p <0.001) and in the year after (p <0.001) for RR MS patients compared with a continuous, although mild, worsening of the disability in SP MS patients (p <0.001). Finally, a significant reduction (p <0.001) of new Gd-enhanced lesions in both RR and SP MS patients was observed in a subgroup of 224 individuals who underwent a brain MRI evaluation before and after MTX treatment. Conclusions: MTX should be considered as an effective therapeutic option in RR MS patients with evidence of relevant disease activity, but the potential life-threatening adverse events and the overall benefit-risk ratio must be carefully evaluated at individual patient level.

AB - Background: Mitoxantrone (MTX) is an immunosuppressive drug approved for multiple sclerosis (MS) treatment. Objective: The aim of this study is to evaluate and to compare the clinical and neuroradiological responses to MTX in relapsing-remitting (RR) and secondary progressive (SP) MS patients. Methods: We conducted a retrospective, non-randomized, open-label, observational study to evaluate the clinical and neuroradiological response to the drug in 79 patients with RR MS and 210 patients with SP MS. Results: A statistically significant reduction (p <0.001) in the number of relapses was observed during MTX treatment and in the year after in both RR and SP MS patients. On the contrary, an opposite behavior in terms of disease progression was found in RR compared with SP MS patients, resulting in a statistically significant improvement of the Expanded Disability Status Scale score during the MTX treatment (p <0.001) and in the year after (p <0.001) for RR MS patients compared with a continuous, although mild, worsening of the disability in SP MS patients (p <0.001). Finally, a significant reduction (p <0.001) of new Gd-enhanced lesions in both RR and SP MS patients was observed in a subgroup of 224 individuals who underwent a brain MRI evaluation before and after MTX treatment. Conclusions: MTX should be considered as an effective therapeutic option in RR MS patients with evidence of relevant disease activity, but the potential life-threatening adverse events and the overall benefit-risk ratio must be carefully evaluated at individual patient level.

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