Publications by authors named "Natasha Penner"
Article Synopsis
- Lecanemab (Leqembi®) has been approved for early Alzheimer's disease treatment and shows effectiveness in patients with mild cognitive impairment and mild dementia when amyloid beta pathology is present.
- The pharmacokinetics (PK) of lecanemab were studied in a large group of subjects, revealing that body weight, sex, and Japanese ethnicity can influence its clearance and distribution, but age does not significantly affect its pharmacokinetics.
- The relationship between lecanemab exposure and ARIA-E (amyloid-related imaging abnormalities) was noted, with higher incidence in APOE4 carriers, whereas isolated ARIA-H occurrences were similar between groups receiving lecanemab and placebo.
Introduction: Diroximel fumarate (DRF) is a next-generation oral fumarate that is indicated in the USA for relapsing forms of multiple sclerosis (MS). A joint population pharmacokinetic model was developed for the major active metabolite (monomethyl fumarate, MMF) and the major inactive metabolite (2-hydroxyethyl succinimide, HES) of DRF.
Methods: MMF and HES data were included from 341 healthy volunteers and 48 patients with MS across 11 phase I and III studies in which DRF was administered as single or multiple doses.
Objectives: To examine levels of neurofilament light chain (NFL) in identical cerebrospinal fluid (CSF) and blood samples at two different facilities, and how differences affect interpretation of levels within and above the normal range.
Methods: CSF and plasma from patients with multiple sclerosis (MS) and healthy controls (HCs) were analysed by Simoa (Quanterix) for levels of NFL providing a total of 165 CSF samples (119 from MS) and 225 plasma samples (180 from MS).
Results: CSF and plasma concentrations highly correlated between NFL laboratory facilities (R: 0.
Dimethyl fumarate decreases neurofilament light chain in CSF and blood of treatment naïve relapsing MS patients.
J Neurol Neurosurg Psychiatry
December 2019
Objectives: In a prospective phase IV trial of the first-line oral treatment dimethyl fumarate (DMF), we examined dynamics of neurofilament light (NFL) chain in serum, plasma and cerebrospinal fluid (CSF) samples collected over 12 months from relapsing-remitting multiple sclerosis (RRMS) patients. NFL changes were related to disease activity.
Methods: We examined NFL levels by single-molecule array in 88 CSF, 348 plasma and 131 sera from treatment-naïve RRMS patients (n=52), healthy controls (n=23) and a placebo group matched by age, sex and NFL (n=52).
Introduction: Diroximel fumarate (DRF) is a novel oral fumarate in development for patients with relapsing forms of multiple sclerosis (MS). Clinical findings from the DRF development program suggest that rates of gastrointestinal (GI) treatment-emergent adverse events (TEAEs) and discontinuation due to GI TEAEs are low, based on clinical and real-world observations of other fumaric acid esters, including dimethyl fumarate (DMF). The incidence of GI TEAEs varies from 40 to 88% in clinical and real-world studies of DMF.
View Article and Find Full Text PDFBackground: No therapies have been formally approved by the Food and Drug Administration for use in pediatric multiple sclerosis, a rare disease.
Objective: We evaluated the safety, efficacy, and pharmacokinetics of dimethyl fumarate in pediatric patients with multiple sclerosis.
Methods: FOCUS, a phase 2, multicenter study of patients aged 10 to 17 years with relapsing-remitting multiple sclerosis, comprised an eight-week baseline and 24-week treatment period; during treatment, patients received dimethyl fumarate (120 mg twice daily on days one to seven; 240 mg twice a day thereafter).