Lessons learned after 20 years of real-world experience with natalizumab

Multiple Sclerosis and Related Disorders - Tập 80 - Trang 105048 - 2023
Bhupendra O. Khatri1, Tayo Olapo1, Sara Beals1, Emily Lindman1, Toni Perea1, Pamela Van Zealand1, Ryan R Metzger2
1The Regional MS Center, Center for Neurological Disorders SC, Ascension St. Francis Hospital, 3237 S. 16th Street, Milwaukee, WI 53215, United States
2RM Biosciences Inc, Sandy, UT, United States

Tài liệu tham khảo

Avila R., Adams B., Stevenson J., et al. PML incidence rates in US patients treated with natalizumab: Update from the TOUCH®program. Presented at: Americas Committee For Treatment and Research in Multiple Sclerosis Forum; 2022; West Palm Beach, FL, USA. Biogen, 2023. Tysabri Prescribing Information. https://www.tysabri.com/content/dam/commercial/tysabri/pat/en_us/pdf/tysabri_prescribing_information.pdf. Bloomgren, 2012, Risk of natalizumab-associated progressive multifocal leukoencephalopathy, N. Engl. J. Med., 366, 1870, 10.1056/NEJMoa1107829 Bomprezzi, 2014, Extended interval dosing of natalizumab: a two-center, 7-year experience, Ther. Adv. Neurol. Disord., 7, 227, 10.1177/1756285614540224 Campagnolo, 2016, Statistical analysis of PML incidences of natalizumab-treated patients from 2009 to 2016: outcomes after introduction of the Stratify JCV(R) DxSelect antibody assay, J. Neurovirol., 22, 880, 10.1007/s13365-016-0482-z Chisari, 2020, Clinical effectiveness of different natalizumab interval dosing schedules in a large Italian population of patients with multiple sclerosis, J. Neurol. Neurosurg. Psychiatry, 91, 1297, 10.1136/jnnp-2020-323472 De Mercanti, 2021, MRI activity and extended interval of Natalizumab dosing regimen: a multicentre Italian study, J. Neurol. Sci., 424, 10.1016/j.jns.2021.117385 Foley, 2022, Comparison of switching to 6-week dosing of natalizumab versus continuing with 4-week dosing in patients with relapsing-remitting multiple sclerosis (NOVA): a randomised, controlled, open-label, phase 3b trial, Lancet Neurol., 21, 608, 10.1016/S1474-4422(22)00143-0 Ho, 2017, Risk of natalizumab-associated progressive multifocal leukoencephalopathy in patients with multiple sclerosis: a retrospective analysis of data from four clinical studies, Lancet Neurol., 16, 925, 10.1016/S1474-4422(17)30282-X Kågström, 2021, Reduction of the risk of PML in natalizumab treated MS patients in Sweden: an effect of improved PML risk surveillance, Mult. Scler. Relat. Disord., 50, 10.1016/j.msard.2021.102842 McGuigan, 2016, Stratification and monitoring of natalizumab-associated progressive multifocal leukoencephalopathy risk: recommendations from an expert group, J. Neurol. Neurosurg. Psychiatry, 87, 117 Plavina, 2014, Anti-JC virus antibody levels in serum or plasma further define risk of natalizumab-associated progressive multifocal leukoencephalopathy, Ann. Neurol., 10.1002/ana.24286 Riancho, 2021, Does extended interval dosing natalizumab preserve effectiveness in multiple sclerosis? A 7 year-retrospective observational study, Front. Immunol., 12, 10.3389/fimmu.2021.614715 Ryerson, 2019, Risk of natalizumab-associated PML in patients with MS is reduced with extended interval dosing, Neurology, 93, e1452, 10.1212/WNL.0000000000008243 Ryerson, 2022, No difference in radiologic outcomes for natalizumab patients treated with extended interval dosing compared with standard interval dosing: real-world evidence from MS PATHS, Mult. Scler. Relat. Disord., 58, 10.1016/j.msard.2021.103480 van Kempen, 2020, Personalized extended interval dosing of natalizumab in MS: a prospective multicenter trial, Neurology, 95, e745, 10.1212/WNL.0000000000009995 Vukusic, 2020, Progressive multifocal leukoencephalopathy incidence and risk stratification among natalizumab users in France, JAMA Neurol., 77, 94, 10.1001/jamaneurol.2019.2670 Yamout, 2018, Efficacy and safety of natalizumab extended interval dosing, Mult. Scler. Relat. Disord., 24, 113, 10.1016/j.msard.2018.06.015 Zhovtis Ryerson, 2016, Extended interval dosing of natalizumab in multiple sclerosis, J. Neurol. Neurosurg. Psychiatry, 87, 885, 10.1136/jnnp-2015-312940