Pixantrone: a B-cell-depleting immunosuppressant for multiple sclerosis patients with active disease

Abstract : Background: 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. 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 \textless 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
Type de document :
Article dans une revue
MULTIPLE SCLEROSIS JOURNAL, 2016, 22 (6), pp.817-821. 〈10.1177/1352458515601902〉
Liste complète des métadonnées

https://hal-univ-rennes1.archives-ouvertes.fr/hal-01324700
Contributeur : Laurent Jonchère <>
Soumis le : mercredi 1 juin 2016 - 13:23:41
Dernière modification le : jeudi 14 février 2019 - 13:09:38

Identifiants

Citation

Richard Gonsette, Marc Debouverie, Christian Sindic, Jean-Christophe Ferré, Gilles Edan. Pixantrone: a B-cell-depleting immunosuppressant for multiple sclerosis patients with active disease. MULTIPLE SCLEROSIS JOURNAL, 2016, 22 (6), pp.817-821. 〈10.1177/1352458515601902〉. 〈hal-01324700〉

Partager

Métriques

Consultations de la notice

515