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Effect of mitoxantrone on MRI in progressive MS

Results of the MIMS trial

H. Krapf, MD^*, S. P. Morrissey, MD^*, O. Zenker, MD, T. Zwingers, MA, R. Gonsette, MD, H. -P. Hartung, MD and the MIMS Study Group

From the Department of Neuroradiology (Dr. Krapf), Eberhard-Karls-University, Tübingen; Department of Neurology (Drs. Morrissey and Hartung), Bayerische Julius-Maximilians University, Würzburg; Wyeth Pharma GmbH (Drs. Morrissey and Zenker), Münster; Estimate GmbH (T. Zwingers), Augsburg, Germany; National Center for Multiple Sclerosis (Dr. Gonsette), Melsbroek, Belgium; and Department of Neurology (Dr. Hartung), Heinrich-Heine-University, Düsseldorf, Germany.

Address correspondence and reprint requests to Dr. Hilmar Krapf, Department of Neuroradiology, University of Tübingen, Hoppe-Seyler-Str.3, D- 72076 Tübingen, Germany; e-mail: hilmar.krapf{at}dgn.de

Objective: To evaluate the effects of mitoxantrone (Mx) in progressive multiple sclerosis (MS) on MRI.

Methods: A total of 194 patients with worsening relapsing-remitting or secondary progressive MS were treated with Mx 12 mg/m² (n = 34), Mx 5 mg/m² (n = 40), or placebo (n = 36) at 3-month intervals IV over a 2-year period. In preselected MRI centers unenhanced and Gd-enhanced MRI scans were performed at month (M) 0, 12, and 24 in a non-randomized subset of 110 patients and non-selected for MRI criteria. The primary MRI outcome measure was the total number of MRI scans with positive Gd enhancement per group.

Results: Twelve mg/m² Mx failed to reach a significant difference from placebo as measured by the primary MRI outcome at month 12 (p = 0.431) and 24 (p = 0.065). Secondary MRI outcome measures: 5 mg/m² Mx influenced favorably the number of Gd-enhancing lesions only at month 24 (p = 0.004), but not at month 12 (p = 0.095). Twelve mg/m² Mx reduced the number of T2-weighted lesions at month 24 (p = 0.027) and showed a positive trend at month 12 (p = 0.069), but not 5 mg/m² Mx. The number of active MR lesions showed a strong trend toward reduction in the 12 mg/m² Mx group only at month 24 (p = 0.054). All comparisons are vs placebo, and unadjusted for baseline incidence.

Conclusions: In the MIMS trial 12 mg/m² Mx does not reduce the number of MRI scans with positive Gd enhancement at month 12 and 24 vs placebo. Results of secondary MRI outcome measures are suggestive of a positive impact of 12 and 5 mg/m² Mx on some of the Gd enhanced and unenhanced MRI measures as expected from other Mx MRI studies in the past.

Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the September 13 issue to find the title link for this article.

*Both authors contributed to this article equally.

Mitoxantrone in Multiple Sclerosis (MIMS) Study Group members are listed in the Appendix.

The MIMS study was supported by Wyeth-Lederle.

Disclosure: R. Gonsette, MD, H.-P. Hartung, MD, and S.P. Morrissey, MD, have received honoraria from Wyeth-Lederle and Immunex Corporations for educational presentations (less than four and participation in a meeting at the Food and Drug Administration, Bethesda, MD). O.Z. was an employee of Lederle/Germany until 2000, and S.P. Morrissey, MD, was employed by Wyeth GmbH Germany from 2003 to 2005. O. Zenker, MD, and T. Zwingers, MA, report no conflicts of interest.

Received February 20, 2004. Accepted in final form May 23, 2005.

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