Extending the Interval of Natalizumab Dosing: Is Efficacy Preserved?
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ORIGINAL ARTICLE
Extending the Interval of Natalizumab Dosing: Is Efficacy Preserved? Marinella Clerico 1 & Stefania Federica De Mercanti 1 & Alessio Signori 2 & Marco Iudicello 1 & Cinzia Cordioli 3 & Elisabetta Signoriello 4 & Giacomo Lus 4 & Simona Bonavita 5 & Luigi Lavorgna 5 & Giorgia Teresa Maniscalco 6 & Erica Curti 7 & Lorena Lorefice 8 & Eleonora Cocco 8 & Viviana Nociti 9 & Massimiliano Mirabella 9 & Damiano Baroncini 10 & Giorgia Mataluni 11 & Doriana Landi 11 & Martina Petruzzo 12 & Roberta Lanzillo 12 & Ilaria Gandoglia 13 & Alice Laroni 14 & Rita Frangiamore 15 & Arianna Sartori 16 & Paola Cavalla 17 & Gianfranco Costantini 17 & Maria Pia Sormani 2 & Ruggero Capra 3
# The American Society for Experimental NeuroTherapeutics, Inc. 2019
Abstract Extending the natalizumab interval after the 24th administration could reduce the risk of progressive multifocal leukoencephalopathy (PML). The objective is to evaluate the noninferiority of the efficacy of an extended interval dosing (EID) compared with the standard interval dosing (SID) of natalizumab. It is an observational, multicenter (14 Italian centers), retrospective cohort study, starting from the 24th natalizumab infusion to the loss of follow-up or 2 years after baseline. Patients were grouped in 2 categories according to the mean number of weeks between doses: < 5 weeks, SID; ≥ 5 weeks, EID. Three hundred and sixty patients were enrolled. Median dose interval (MDI) following 24th infusion was 4.7 weeks, with a bimodal distribution (modes at 4 and 6 weeks). Two hundred and sixteen patients were in the SID group (MDI = 4.3 weeks) and 144 in the EID group (MDI 6.2 weeks). Annualized relapse rate was 0.060 (95% CI = 0.033–0.087) in the SID group and 0.039 (95% CI = 0.017–0.063) in the EID group. The non-inferiority of EID versus SID was satisfied. In conclusion, there is no evidence of a reduced efficacy of natalizumab in an EID setting. This observation confirms previous results and together with the emerging evidence of a reduced risk of PML associated to an EID, supports the need of a randomized study to assess the need to change the standard of the natalizumab dosing schedule. Key Words Multiple sclerosis . natalizumab . extended dose . progressive multifocal leukoencephalopathy . efficacy
Introduction Natalizumab (Tysabri; Biogen-Idec, Cambridge, MA, USA) is a humanized monoclonal antibody directed against the α4 subunit of α4β1 and α4β7 integrins, localized on the surface of circulating mononuclear cells, inhibiting the binding to
Stefania Federica De Mercanti and Alessio Signori share cosecond authorship. Ruggero Capra and Maria Pia Sormani share cosenior authorship. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s13311-019-00776-7) contains supplementary material, which is available to authorized users. * Stefania Federica De Mercanti [email protected] Extended author information available on the last page of the article
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