6-Week Natalizumab Dosing Efficacious, MS Cognitive Perceptions, Glatiramer Acetate Depot Shines in Progressive MS


Neurology News Network for the week ending June 11, 2022. [WATCH TIME: 3 minutes]

WATCH TIME: 3 minutes

Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

Exploratory data from the phase 3b NOVA study (NCT03689972) showed no significant or clinically meaningful differences in patient-reported outcomes (PRO) or Clinical Global Impression (CGI) rating scores among those with relapsing-remitting multiple sclerosis (MS) treated with natalizumab 300 mg (Tysabri; Biogen) every 4 weeks (Q4W)—the approved regimen—or every 6 weeks. The randomized, controlled, open-label, rater-blinded study looked at several PROs, including the Treatment Satisfaction Questionnaire for Medication (TSMQ), Neurology Quality of Life (NQoL) fatigue questionnaire, Multiple Sclerosis Impact Scale (MSIS-29), and EuroQol 5 Dimensions (EQ-5D-5L) index score.Between the Q6W (n = 247) and Q4W (n = 242) dosing groups, there were no significant differences in least-squares mean change from baseline to week 72 in PROs. Similarly, the odds ratios (ORs) for CGI scores, specifically patient GCI-improvement physician GCI-improvement, and physician CGI-severity, were not meaningfully different between the dosing regimens.

New data presented at the 2022 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, June 1-4, in National Harbor, Maryland, identified several different factors for patients with multiple sclerosis (MS) and clinicians that drive the perception of self-reported cognitive impairment.In this study, patients with MS took a computerized multidomain cognitive screening battery and reported on several factors, including fatigue, as assessed by Modified Fatigue Impact Scale, depression, assessed using the Beck Depression Inventory-II, and quality of life, using a Likert scale. Physical disability was assessed by the patient’s clinician using the Expanded Disability Status Scale (EDSS), while perceived cognitive deficits among both groups were self-reported using Likert scale. Using hierarchical regression analyses in the cohort of 202 patients with MS, data reported that fatigue (<.001) and cognitive (<.05) scores significantly predicted patient-perceived cognitive deficits, but not depression (= .377) or physical disability (= .213). Clinician-perceived cognitive deficits differed from those with MS, mainly by cognitive scores (<.001), depression (<.001), physical disability (<.05), age (<.05), and self-reported quality of life (<.05); however, fatigue was not among the significant factors for these deficits.

One-year interim data from a phase 2 study of patients with progressive multiple sclerosis (MS) showed that treatment with glatiramer acetate depot (Mapi Pharma), an intramuscularly administered formulation of the approved treatment given every 4 weeks, was safe and effective based on the low rate of adverse events (AEs) and stable Expanded Disability Status Scale (EDSS) scores. The interim data included patients with progressive MS, aged 18 to 65 years with rapid disease progression, demonstrated by at least a 1 point increase per year on EDSS in the year prior to screening. At 1 year, treatment with glatiramer acetate depot was shown to be safe, with 88% of the AEs recorded mild in nature. Injection site reactions and asthenia made up the majority of AEs, with no unexpected AEs reported. Two serious AEs, one related and one unrelated to the study drug, were also reported.

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