Pixantrone: a B-cell-depleting immunosuppressant for multiple sclerosis patients with active disease.
(2016) Multiple sclerosis (Houndmills, Basingstoke, England) — Vol. 22, n° 6, p. 817-821 (2016)
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- Abstract
- Mitoxantrone has been approved for patients with worsening relapsing-remitting (RR) or secondary progressive multiple sclerosis (SPMS), but its long-term use is limited by its cardiotoxicity. Pixantrone (PIX) is an analog of mitoxantrone. The aim of this open-label, multicenter, noncomparative Phase I/II trial was to explore the immunosuppressive effect of PIX, its impact on clinical disease activity and cerebral gadolinium-enhanced (Gd(+)) lesions, and its safety. Eighteen patients with active RRMS and SPMS (⩾ 1 cerebral Gd(+) lesion) despite approved immunomodulatory therapy received four intravenous PIX injections every 21 days. A neurological examination, hematology, lymphocyte subsets, and biochemistry were performed at Day 1, Weeks 3, 6 and 9, and Months 3, 6, 9 and 12. Echocardiography was performed before each infusion, at Months 3, 6 and 12. Cerebral MRI was performed at baseline, and at Months 6 and 12. CD19+ cells were reduced by 95% at Month 3 and by 47% at Month 12. Gd+ lesions were reduced by 86% at Month 12 (p = 0.01). The annual relapse rate was reduced by 87% (p < 10(-4)). Two patients experienced a transient reduction in left ventricular fraction. These preliminary data indicate the efficacy of PIX in active RRMS and SPMS.
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Gonsette, R., Debouverie, M., Sindic, C., Ferré, J.-C., & Edan, G. (2016). Pixantrone: a B-cell-depleting immunosuppressant for multiple sclerosis patients with active disease. Multiple sclerosis (Houndmills, Basingstoke, England), 22(6), 817-821. https://doi.org/10.1177/1352458515601902 (Original work published 2016)