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• W1569133904 abstract "OBJECTIVE: to assess immunosuppressive properties of pixantrone (PIX), its activity on Gd+ lesions and its safety profile BACKGROUND: Mitoxantrone (MX) is very effective as an induction phase to control relapses and disability progression in aggressive MS. However, the use of MX is associated with potential cardiotoxicity. Pixantrone (PIX) is structurally similar to MX excepted the lack of two hydroxy groups. Both compounds have similar immunosuppressive properties in EAE, but PIX is definitely less cardiotoxic. DESIGN/METHODS: 18 patients with aggressive MS received 4 iv injections of PIX base 120 mg/m² every 3 weeks. Neurological examination, hematology, lymphocyte subsets and biochemistry were performed at day 1, weeks 3,6,9 and months 3,6,9,12. Echocardiography was performed before each infusion and at months 3,6,12. MRI was performed at baseline and at months 6 and 12. RESULTS: like MX, PIX mainly affects B lymphocytes that were reduced by 95% at month 3 and by 47% at month 12.A transient decrease by 33% was observed for T lymphocytes. At month 12, compared with baseline, annual relapse rate was reduced (0.22±0.42 vs 1.67±1.46) and EDSS was stabilized (3.58±0.76 vs3.92±0.89). ). At month 3, the mean number of Gd+ lesions was reduced by 88% (0.38±0.96 vs 3.23±3.59) and by 86% at month 12 (0.46±0.75 vs 3.23±3.59). No serious adverse events were noted.A neutropenia by 53% was observed after each infusion but neutrophils were restored to 100% one month after the last infusion. The mean left ventricular ejection fraction (LVEF) remained stable (baseline:64.22±6.48 %, month 12: 62.20±6.64 %). One patient had an early, asymptomatic, rapidly reversible decrease < 50% in LVEF (PIX5.5% of patients vs MX 22%). A second patient had a transient LVEF <50 % grade 3 at month 6. CONCLUSIONS: PIX is as effective as MX but less cardiotoxic and could be an alternative in aggressive MS Study Supported by: Fondation Charcot Stichting Disclosure: Dr. Gonsette has nothing to disclose. Dr. Edan has received personal compensation for activities with Bayer Pharmaceuticals Corp., Biogen Idec, Teva Neuroscience, Novartis, and LFB. Dr. Debouverie has received personal compensation for activities with Biogen Idec, Bayer Schering, Merck Serono, Novartis, Sanofi-Aventis Pharmaceuticals Inc., and Teva Neuroscience. Dr. Sindic has received personal compensation for activities with Biogen Idec, Novartis, Sanofi-Genzyme, Teva Neuroscience, Bayer Schering and Merck Serono. Dr. Sindic has received research support from Bayer Schering. Dr. Ferre has nothing to disclose." @default.
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• W1569133904 date "2014-04-08" @default.
• W1569133904 modified "2023-10-13" @default.
• W1569133904 title "A Phase I/II Study of Pixantrone in Patients with an Agressive Relapsing-Remitting or SecondaryProgressive Multiple Sclerosis (PIXAMS) (P3.170)" @default.
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