Karen Vossen Smirnakis

Serious Neurologic Adverse Events in Tofersen Clinical Trials for Amyotrophic Lateral Sclerosis

Alexandra Lovett, Sowmya Chary, Suma Babu, Gaëlle Bruneteau et autres

INTRODUCTION/AIMS: Tofersen is approved for the treatment of amyotrophic lateral sclerosis (ALS) due to superoxide dismutase 1 mutations (SOD1-ALS). Here we report serious neurologic adverse events (AEs) that occurred in the tofersen clinical trials in people with SOD1-ALS. METHODS: Serious neurologic AEs …

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Reduced Risk of Progressive Multifocal Leukoencephalopathy (PML) with Natalizumab Extended Interval Dosing (EID) Compared with Every-4-week (Q4W) Dosing: Updated Analysis of the TOUCH® Prescribing Program Database (P10-6.005)

Lana Zhovtis Ryerson, John F. Foley, Ilya Kister, Gary Cutter et autres

To update the assessment of PML risk with natalizumab EID in comparison with Q4W dosing using TOUCH data as of June 30, 2023.

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Progressive multifocal leukoencephalopathy with natalizumab extended or standard interval dosing in the United States and the rest of the world

Liesel D’silva, Kerry Robin McCarthy, Jennifer L. Lyons, Bernadette Cabigas et autres

BACKGROUND: Progressive multifocal leukoencephalopathy (PML), an important identified risk for natalizumab, has been described for standard interval dosing (SID; dosing interval every-4-weeks). Information on PML with natalizumab extended interval dosing (EID; dosing interval >every-4-weeks) in the US and the rest of the …

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Natalizumab Extended Interval Dosing (EID) is Associated with a Reduced Risk of Progressive Multifocal Leukoencephalopathy (PML) Compared with Every-4-Week (Q4W) Dosing: Updated Analysis of the TOUCH® Prescribing Program Database (P14-3.011)

Lana Zhovtis Ryerson, John F. Foley, Ilya Kister, Gary Cutter et autres

Objective: To update the assessment of PML risk with natalizumab EID in comparison with Q4W dosing using TOUCH data as of June 30, 2022. Background: Natalizumab treatment is associated with PML risk. Previous analyses of TOUCH data have demonstrated that natalizumab EID …

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Progressive multifocal leukoencephalopathy outcomes in patients with multiple sclerosis treated with dimethyl fumarate

Jennifer L. Lyons, Richard Hughes, Kerry Robin McCarthy, Nicholas J. Everage et autres

Background and objectives: Dimethyl fumarate (DMF), an oral disease-modifying therapy with an established benefit and well-described safety profile, is among the most commonly used therapies for relapsing forms of multiple sclerosis. As of 31 December 2021, >560,000 patients have been treated with …

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Natalizumab Extended Interval Dosing (EID) is Associated with a Reduced Risk of Progressive Multifocal Leukoencephalopathy (PML) Compared With Every-4-Week (Q4W) Dosing: Updated Analysis of the TOUCH® Prescribing Program Database (P13-4.010)

Lana Zhovtis Ryerson, John F. Foley, Ilya Kister, Gary Cutter et autres

To update the assessment of PML risk with natalizumab EID in comparison with Q4W dosing using TOUCH data as of June 30, 2021.

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Primary Results of NOVA: a Randomized Controlled Study of the Efficacy of 6 - Week Dosing of Natalizumab Versus Continued 4-Week Treatment for Multiple Sclerosis (S14.005)

John F. Foley, Gilles Louis Defer, Lana Zhovtis Ryerson, Jeffrey Allen Cohen et autres

Evaluate the efficacy of natalizumab Q6W in patients previously treated with natalizumab Q4W for ≥12 months compared with continuation of Q4W over 72 weeks.

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Considerations for the Real-World Management of ARIA From the Aducanumab Phase 3 Studies EMERGE and ENGAGE (P1-1.Virtual)

Richard E. Hughes, Patrick Burkett, Spyridon G. Chalkias, Kimberly Umans et autres

To describe the characteristics of amyloid-related imaging abnormalities (ARIA) that occurred in Phase 3 studies EMERGE (NCT02484547) and ENGAGE (NCT02477800) and to inform effective ARIA monitoring and management in real-world clinical practice.

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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

John F. Foley, Gilles Louis Defer, Lana Zhovtis Ryerson, Jeffrey Allen Cohen et autres

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Résultats primaires de NOVA : une étude contrôlée randomisée comparant l’administration de natalizumab toutes les 6 semaines versus une administration continue toutes les 4 semaines dans le traitement de la sclérose en plaques

John F. Foley, Gilles Louis Defer, Lana Zhvotis Ryerson, Jeffrey Allen Cohen et autres

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Primary Results of NOVA: A Randomized Controlled Study of the Efficacy of 6 Week Dosing of Natalizumab Versus Continued 4-Week Treatment for Multiple Sclerosis

John F. Foley, Gilles Louis Defer, Lana Zhovtis Ryerson, Jeffrey Allen Cohen et autres

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Considerations for the real‐world management of ARIA from the aducanumab phase 3 studies EMERGE and ENGAGE

Patrick Burkett, Spyros Chalkias, Kimberly Umans, Carmen Castrillo‐Viguera et autres

Abstract Background Amyloid‐related imaging abnormalities (ARIA), a spectrum of imaging findings detected on brain magnetic resonance imaging (MRI), are associated with the investigational use of amyloid‐targeting monoclonal antibodies, including aducanumab, in patients with Alzheimer’s disease (AD). EMERGE (NCT02484547) and ENGAGE (NCT02477800) were …

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