Induction Therapy with Mitoxantrone Reduces Relapses in Multiple Sclerosis

DENVER, CO -- April 17, 2002 -- Used in induction therapy, mitoxantrone dramatically decreases disease activity in multiple sclerosis (MS) patients for at least four years, according to a study presented at the Annual Meeting of the American Academy of Neurology (AAN) in Denver, Colorado.

Mitoxantrone is a chemical routinely used to fight breast cancer, leukemia and malignant lymphoma.

Frequently used against cancers, induction therapy is designed to wipe out abnormal cells and allow for the re-growth of normal cells.

Mitoxantrone for the treatment of MS has recently been approved by the U.S. Food and Drug Administration. It has been used to treat MS in France for more than a decade. Researchers from CHU Pontchaillou of Rennes, France, have demonstrated that mitoxantrone induction therapy for relapsing-remitting MS (RRMS) patients has produced dramatic results in disease activity.

Over the past ten years, 100 worsening RRMS patients were given initial mitoxantrone induction therapy for six months, with mitoxantrone combined with methylprednisolone administered intravenously on a monthly schedule. The annual relapse rate decreased significantly from 3.20 during the 12 months preceding mitoxantrone onset to 0.30 during the first year following induction onset, corresponding to a reduction of nearly 90 percent that was maintained for more than five years. The percentage of relapse-free patients was 76 percent at one year of follow-up, and was maintained at 64 percent, 45 percent, and 43 percent at years two, three and four, respectively, with a median time to the first relapse of 2.8 years.

"The clinical benefit and reduction of disease activity supports our belief that mitoxantrone, as administered in this study, may be an effective induction treatment before initiating other long-term disease modifying therapies for worsening relapsing-remitting MS patients," commented study author Emmanuelle Le Page, MD.

SOURCE: American Academy of Neurology


Neurology 2002 Sep 24;59(6):954-5  
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Therapy-related acute myeloblastic leukemia after mitoxantrone treatment in a patient with MS.

Brassat D, Recher C, Waubant E, Le Page E, Rigal-Huguet F, Laurent G, Edan G, Clanet M.

Departments of Neurology (Drs. Brassat and Clanet) and Haematology (Drs. Recher, Rigal-Huguet and Laurent) Hopital Purpan, Toulouse University Medical Center, Toulouse.

The authors report a patient with severe secondary progressive MS who responded to mitoxantrone but developed a fatal acute myeloblastic leukemia 15 months after completion of mitoxantrone therapy. Therapy-related acute leukemia (TRAL) in relation with mitoxantrone is rare; this patient was the first case among a cohort of 802 French MS patients treated with mitoxantrone. Nevertheless, this case stresses the need to further evaluate the long-term risk of TRAL in patients with MS who receive mitoxantrone.

PMID: 12297591 [PubMed - in process]



A study of therapy-related acute leukaemia after mitoxantrone therapy for multiple sclerosis
Multiple Sclerosis,  1 October 2002, vol. 8, no. 5,   pp. 441-445(5)
Ghalie R.[1]; Mauch E.[2]; Edan G.[3]; Hartung H.[4]; Gonsette R.[5]; Eisenmann S.[2]; Le Page E.[3]; Butine M.[1]; Goodkin D.[1]
[1] Immunex Corporation, 51 University Street, Seattle, Washington 98101, USA [2] The Clinic for Neurological Diseases, Ditenbroon 7, Schwendi D-88477, Germany [3] Clinique Neurologique, HŰpital Pontchaillou, Rennes 35033, France [4] Neurologische Klinik-Universitšt Graz, Auenbruggerplatz 22, Graz A-8036, Austria [5] Centre National de la Sclerose en Plaques, Van Heylenstraat 16, Melsbroek B-1820, Belgium
To evaluate the incidence of therapy-related acute leukaemia (t-AL) after single-agent mitoxantrone (MITO) treatment, we reviewed medical records of patients in three studies of single-agent MITO therapy for multiple sclerosis (MS) and existing literature on MITO therapy in MS, leukaemia, and solid tumors. Of 1378 MITO recipients in the three MS studies (mean cumulative dose of 60 mg/m2 and mean follow-up of 36 months), one patient had t-AL, an observed incidence proportion of 0.07% [95% confidence interval (CI)=0.00 - 0.40%]. There were no cases of t-AL in published reports of nine additional studies of single-agent MITO therapy for MS. There was one published case report of acute promyelocytic leukaemia detected five years after initiating MITO therapy for MS. The observed incidence proportion of t-AL is very low in patients who received MITO as single-agent therapy for MS. Although these observations provide preliminary reassurance, extended follow-up of these patients and those who receive higher cumulative doses of MITO is required to define the long-term risk of t-AL after MITO therapy for MS.
Document Type: Research article ISSN: 1352-4585

SICI (online): 1352-4585(20021001)8:5L.441;1-



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