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Old 10-13-2015, 05:19 PM
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Default STUDY: Safety profile of HSCT following natalizumab therapy in aggressive forms of MS

Safety profile of autologous haematopoietic stem cell transplantation following natalizumab therapy in aggressive forms of multiple sclerosis

A. Mariottini1, C. Innocenti2, A.M. Repice1, A. Fani2, L. Massacesi1, R. Saccardi2
1Neurology Dept., 2Heamatology Dept., AOU Careggi, Hospital-University of Florence, Florence, Italy

Introduction: Natalizumab (NTZ) is a widely accepted therapy for patients affected by aggressive Multiple Sclerosis (MS) but its withdrawal is frequently associated to disease reactivation. A number of treatment strategies have been tested to prevent this event, without adequate efficacy and safety profiles. Autologous haematopoietic stem cell transplantation (aHSCT) is a treatment for rapidly progressive MS that has never been evaluated following NTZ therapy and therefore data about safety are lacking, hence we analyse a series of 13 patients who underwent aHSCT following NTZ therapy.

Materials and methods: Patients with inflammatory highly active MS that required interruption of NTZ or other DMT and that underwent aHSCT after a minimum washout period of 8 months were included. The frequency of adverse events after aHSCT was compared in the two groups. aHSCT procedure: Peripheral Blood Stem Cells (PBSC) were mobilized by Cyclophosphamide 4 g/sqm + G-CSF and stored in liquid nitrogen. Patients were conditioned with BEAM plus rabbit ATG. All patients underwent to standardized hematologic and neurological follow-up.

Results: 13 MS patients (11RR, 2SP) previously treated with NTZ and 13 control patients treated with DMT (10RR, 3SP) were included. The median washout period from NTZ was 14 months (6-45), the median number of NTZ administrations was 23(2-43) and the median time of follow up was 11 months (3-61). The baseline clinical characteristics were similar in the two groups. In the NTZ group a higher incidence of mayor infections requiring hospitalization occurred (Fisher´s exact test p value < 0.05) within the six months after transplant. The incidence of infections was not related to any of the other variable considered. There wasn't any statistically significant differences in number of CMV and EBV viral reactivations. Clinical-radiological examination did not show any sign of reactivation of the disease.

Discussion: The higher incidence of mayor infective events occurring in the six months after transplant in NTZ group suggests that the safety profile of aHSCT after NTZ is acceptable but a stringent neurological and hematological follow-up is needed.
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Old 10-15-2015, 02:22 PM
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FYI, I had Tysabri before HSCT, but only one infusion. I relapsed, took steroids, and the docs said no more Ty before the transplant. Probably worked out for the best....
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