MS Treatments Linked With PML, Neflamapimod Effectiveness Based on P-Tau181 Levels, Nerivio Safe in Pregnant Women

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

A large study presented at the 2023 American Neurological Association (ANA) Annual Meeting, held September 9-12 in Philadelphia, Pennsylvania, showed that nearly 100 treatments used for multiple sclerosis (MS), blood cancers, rheumatoid arthritis and other diseases may increase the risk of developing progressive multifocal leukoencephalopathy (PML). These findings highlight the importance of understanding the risk and options to help prevent future cases of this treatment-induced adverse event among patients. In analyzing the FDA Adverse Event Reporting System, researchers identified 81 treatments and an additional 18 therapies, not reported to the system but in the same class as PML linked treatments, that were associated with PML. The majority of the cautioned treatments were immunosuppressant disease-modifying therapies.

An additional prespecified analysis of the phase 2a AscenD-LB trial newly published in Neurology showed that patients with dementia with Lewy bodies (DLB) without elevated plasma phosphorylated tau at position 181 (ptau181) levels were more responsive to neflamapimod (EIP Pharma) compared to those with such elevation. These findings suggest an association between ptau181 levels at baseline and patient response to treatment, highlighting the significance of this biomarker in clinical trials. During the 16-week treatment period, improvements in all end points were higher among neflamapimod-treated patients who were below the 2.2 pg/mL of ptau181 cutoff at baseline, compared with those above it. Participants below the cutoff showed significant improvement compared with placebo in an Attention Composite measure, the Clinical Dementia Rating Scale Sum of Boxes, the Timed Up and Go, and International Shopping List Test-Recognition.

Findings from a recently published retrospective controlled survey-study assessing the Nerivio (Theranica) remote electrical neuromodulation (REN) device indicated that the treatment was safe to use among pregnant women with migraine, with no increased risk for adverse pregnancy outcomes. An online survey was sent to all females in the specified age range and within the REN device users’ database and to patients in participating headache clinics. At the conclusion of the analysis, findings showed no between-group statistical difference in the primary end point of gestational age between the REN and control groups. Similar to the primary end point, no statistically significant difference was observed between REN and controls on secondary end points of newborn weight, miscarriage rate, preterm birth rate, birth defect rate, stillbirths rate, rate of newborns meeting developmental milestones at 3 months postnatal, and the rate of participants who visited emergency room during their pregnancy

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