TY - JOUR
T1 - Extending the Interval of Natalizumab Dosing
T2 - Is Efficacy Preserved?
AU - Clerico, Marinella
AU - De Mercanti, Stefania Federica
AU - Signori, Alessio
AU - Iudicello, Marco
AU - Cordioli, Cinzia
AU - Signoriello, Elisabetta
AU - Lus, Giacomo
AU - Bonavita, Simona
AU - Lavorgna, Luigi
AU - Maniscalco, Giorgia Teresa
AU - Curti, Erica
AU - Lorefice, Lorena
AU - Cocco, Eleonora
AU - Nociti, Viviana
AU - Mirabella, Massimiliano
AU - Baroncini, Damiano
AU - Mataluni, Giorgia
AU - Landi, Doriana
AU - Petruzzo, Martina
AU - Lanzillo, Roberta
AU - Gandoglia, Ilaria
AU - Laroni, Alice
AU - Frangiamore, Rita
AU - Sartori, Arianna
AU - Cavalla, Paola
AU - Costantini, Gianfranco
AU - Sormani, Maria Pia
AU - Capra, Ruggero
PY - 2019/1/1
Y1 - 2019/1/1
N2 - 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.
AB - 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.
KW - efficacy
KW - extended dose
KW - Multiple sclerosis
KW - natalizumab
KW - progressive multifocal leukoencephalopathy
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U2 - 10.1007/s13311-019-00776-7
DO - 10.1007/s13311-019-00776-7
M3 - Article
AN - SCOPUS:85071446493
SN - 1933-7213
JO - Neurotherapeutics
JF - Neurotherapeutics
ER -