Gonsette R, Debouverie M, Sindic C, Ferré JC, Edan G.
Mult Scler. 2015 Aug 18. pii: 1352458515601902 Pixantrone: a B-cell-depleting immunosuppressant for multiple sclerosis patients with active disease. [Epub ahead of print]
OBJECTIVES: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.
METHODS: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.
RESULTS: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.
CONCLUSION: These preliminary data indicate the efficacy of PIX in active RRMS and SPMS.
via BartsMS Blog