1. MRI activity and extended interval of Natalizumab dosing regimen: a multicentre Italian study
- Author
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Doriana Landi, Gianmarco Abbadessa, Gianfranco Costantini, Giacomo Lus, Stefania Federica De Mercanti, Cinzia Cordioli, Simona Bonavita, Giorgia Mataluni, Massimiliano Mirabella, Maria Pia Sormani, Ilaria Gandoglia, Giorgia Teresa Maniscalco, Martina Petruzzo, Rita Frangiamore, Eleonora Cocco, Erica Curti, Damiano Baroncini, Ruggero Capra, Elisabetta Signoriello, Paola Cavalla, Luigi Lavorgna, Lorena Lorefice, Alice Laroni, Marinella Clerico, Viviana Nociti, Alessio Signori, Arianna Sartori, Roberta Lanzillo, De Mercanti, Stefania Federica, Signori, Alessio, Cordioli, Cinzia, Signoriello, Elisabetta, Lus, Giacomo, Bonavita, Simona, Abbadessa, Gianmarco, Lavorgna, Luigi, Maniscalco, Giorgia Teresa, Curti, Erica, Lorefice, Lorena, Cocco, Eleonora, Nociti, Viviana, Mirabella, Massimiliano, Baroncini, Damiano, Mataluni, Giorgia, Landi, Doriana, Petruzzo, Martina, Lanzillo, Roberta, Gandoglia, Ilaria, Laroni, Alice, Frangiamore, Rita, Sartori, Arianna, Cavalla, Paola, Costantini, Gianfranco, Capra, Ruggero, Sormani, Maria Pia, Clerico, Marinella, De Mercanti, S. F., Signori, A., Cordioli, C., Signoriello, E., Lus, G., Bonavita, S., Abbadessa, G., Lavorgna, L., Maniscalco, G. T., Curti, E., Lorefice, L., Cocco, E., Nociti, V., Mirabella, M., Baroncini, D., Mataluni, G., Landi, D., Petruzzo, M., Lanzillo, R., Gandoglia, I., Laroni, A., Frangiamore, R., Sartori, A., Cavalla, P., Costantini, G., Capra, R., Sormani, M. P., and Clerico, M.
- Subjects
medicine.medical_specialty ,Efficacy ,Progressive Multifocal ,Relapsing-Remitting ,Settore MED/26 ,law.invention ,Multiple sclerosis ,03 medical and health sciences ,Magnetic resonance imaging ,Immunologic Factor ,Multiple Sclerosis, Relapsing-Remitting ,0302 clinical medicine ,Natalizumab ,Randomized controlled trial ,Leukoencephalopathy ,Retrospective Studie ,law ,Internal medicine ,Multiple Sclerosi ,Humans ,Immunologic Factors ,Medicine ,030212 general & internal medicine ,Dosing ,Retrospective Studies ,Extended dose ,medicine.diagnostic_test ,business.industry ,Progressive multifocal leukoencephalopathy ,Leukoencephalopathy, Progressive Multifocal ,Retrospective cohort study ,medicine.disease ,Settore MED/26 - NEUROLOGIA ,Regimen ,Italy ,Neurology ,Magnetic Resonance Imaging ,Multiple Sclerosis ,Neurology (clinical) ,business ,030217 neurology & neurosurgery ,Human ,medicine.drug - Abstract
Background: To minimize the risk of Progressive Multifocal Leukoencephalopathy and rebound in JCV-positive multiple sclerosis (MS) patients after 24 natalizumab doses, it has been proposed to extend the administrations interval. The objective is to evaluate the EID efficacy on MRI activity compared with the standard interval dosing (SID). Methods: Observational, multicentre, retrospective cohort study, starting from the 24th natalizumab infusion to the loss of follow-up or 2 years after baseline. Three hundred and sixteen patients were enrolled. The median dose interval (MDI) following the 24th infusion was 5 weeks, with a bimodal distribution (modes at 4 and 6 weeks). Patients were grouped into 2 categories according to the mean number of weeks between doses: < 5 weeks, SID; ≥ 5 weeks, EID. Results: One hundred and eighty-seven patients were in the SID group (MDI = 4.5 weeks) and 129 in the EID group (MDI 6.1 weeks). The risk to develop active lesions on MRI is similar in SID and EID groups during the 6 and 12 months after the 24th natalizumab infusion, respectively 4.27% (95% CI:0.84–7.70) vs 4.71% (95% CI:0.16–9.25%) [p = 0.89] and 8.50% (95% CI:4.05–12.95) vs 6.55% (95% CI:2.11–11.00%) [p = 0.56]. The EID regimen does not appear to increase the occurrence of MRI activity during follow-up. Conclusion: There is no evidence of the reduced efficacy of natalizumab in an EID setting regarding the MRI activity. This observation supports the need for a bigger randomized study to assess the need to change the standard of the natalizumab dosing schedule, to better manage JCV-positive patients.
- Published
- 2021