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Kombinierte Mitoxantron-/Methylprednisolon-Behandlung bei primär und sekundär chronisch progredienter Multipler Sklerose

Eine Anwendungsbeobachtung bei 65 Patienten

The effect of combined mitoxantrone and methylprednisolone therapy in primary and secondary progressive multiple sclerosis

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Zusammenfassung

Die “Mitoxantron-in-Multiple-Sclerosis- (MIMS-)Studie” und die deutschsprachige MS-Therapie-Konsensusgruppe stützt die Anwendung von Mitoxantron bei Patienten mit sekundär chronisch progredienter (SP) MS. Für Patienten mit primär chronisch progredienter (PP) MS gibt es bisher keine sichere Evidenz für die Wirksamkeit von Mitoxantron. Das Ziel dieser Anwendungsbeobachtung war es daher, die Wirksamkeit einer Mitoxantron-Therapie [plus Methylprednisolon (MP)] bei Patienten mit PP-MS im Vergleich zu SP-MS zu prüfen. 65 Patienten (20 Patienten mit PP-MS und 45 mit SP-MS) wurden bislang in die Studie eingeschlossen. Das Behandlungsprotokoll sieht insgesamt 10 Zyklen einer kombinierten Mitoxantron- und MP-Therapie vor. Die Abstände zwischen den einzelnen Zyklen wurden systematisch von initial 3 Monaten auf 12 Monate verlängert, so dass die gesamte Behandlungsdauer 57 Monate umfasste. Die Ergebnisse der Zwischenauswertung nach 5 Jahren zeigen, dass die kombinierte Mitoxantron- und Kortikosteroidtherapie zu einer signifikanten Reduktion der Krankheitsprogression im Vergleich zum spontanen Verlauf sowohl bei Patienten mit SP- als auch mit PP-MS führt. Die Beurteilung der Langzeitwirkung und -sicherheit von Mitoxantron in höherer kumulativer Dosis erfordert jedoch weitere Untersuchungen.

Summary

Mitoxantrone (mitox) has been shown to be effective for secondary progressive (SP) and relapsing-remitting multiple sclerosis (MS). The aim of this open trial was to evaluate the effects of combined mitox and methylprednisolone (MP) therapy on patients with primary progressive (PP)-MS or with SP-MS. We present here the results of an interim analysis done after the study had lasted 5 years. Sixty-five patients (20 with PP-MS and 45 with SP-MS) have been included so far. The treatment involved ten cycles of combined mitox and MP. The intervals between the individual cycles were systematically prolonged from 3 months initially to 12 months, so the complete treatment took a total of 57 months. Conclusion This interim analysis indicates that mitox combined with MP beneficially reduces the progression of disability in patients with PP-MS and SP-MS. Therefore, this therapy regimen can also be considered a feasible option for PP-MS.

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Zingler, V.C., Strupp, M., Jahn, K. et al. Kombinierte Mitoxantron-/Methylprednisolon-Behandlung bei primär und sekundär chronisch progredienter Multipler Sklerose. Nervenarzt 76, 740–747 (2005). https://doi.org/10.1007/s00115-005-1885-x

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