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New Study on COVID-19 Vaccinations in MS, FDA Lifts Hold on SRP-5051, Implantable Loop Recorder and Atrial Fibrillation

Neurology News Network for the week ending September 10, 2022. [WATCH TIME: 4 minutes]

WATCH TIME: 4 minutes

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

Through a new collaborative effort, a group of investigators will assess immune response to COVID-19 vaccinations in patients with multiple sclerosis (MS), with the goal to learn how the number and timing of vaccine doses effects antibody levels and duration in the disease.The research project is a substudy of the larger COVER-MS Project, and was announced in a new partnership between Accelerated Cure Project (ACP), Quest Diagnostics, and the National Multiple Sclerosis Society. Behind the project is ACP’s iConquerMS People-Powered Research Network, for which members will have input on research questions for the study. In total, the study will gather patient-reported survey data on 300 participants from the original 1600-person study. Previously, in early January 2022, initial findings from COVER-MS were published. All told, COVD-19 vaccine reactogenicity profiles and the associated factors were similar between patients with MS and the general population. In that retrospective analysis, investigators intended to generate real-world MS-specific vaccine safety information, particularly in the context of specific disease-modifying therapies.

The FDA has lifted its clinical hold on part B of the phase 2 MOMENTUM trial (NCT04004065) of SRP-5051, Sarepta Therapeutics’ investigational treatment for patients with Duchenne muscular dystrophy (DMD) who are amenable to exon 51 skipping.The hold was originally placed in June 2022, after a patient experienced a serious adverse event (SAE) of hypomagnesemia after treatment with high-dose SRP-5051. Specifically, the patient had grade 3 hypomagnesemia, grade 4 potassium deficiency, muscular cramps, and mild-to-moderate tingling of the extremities. At the time, the FDA requested information on all cases of hypomagnesemia, including a small number of nonserious grade 2 cases, and to assess the adequacy of the risk mitigation and safety monitoring plan.As a result of this lift, Sarepta will now need to adjust the global trial protocol to include expanded monitoring of urine biomarkers as part of the risk mitigation and safety monitoring plan.

Recently published post hoc findings from the LOOP randomized clinical trial showed that screening for atrial fibrillation (AF) using an implantable loop recorder (ILR) did not result in a significant decrease in ischemic or severe strokes compared with usual care. More than 1 in 3 strokes were classified as disabling or lethal, with a nonsignificant 31% reduction in this outcome by ILR screening. Among a cohort of 6004 individuals randomly assigned to either standard of care or ILR, 1027 participants were diagnosed with AF during follow-up, of whom 89% initiated anticoagulation, and 4.6% later discontinued the treatment. In total, 5.2% of the total cohort had stroke during follow-up, with a median modified Rankin Scale (mRS) score of 2 (IQR, 1-3) that was not different across the groups. The overall stroke rate was 1.02 per 100 person years. In total, 16% of the participants admitted with stroke had been diagnosed with AF before their event, and a further 5 patients were diagnosed with AF on the same day as the event. The median mRS score was 3 vs 2 for patients with and without AF diagnosis, respectively (<.001). Within the control group, the median mRS score was 4 (IQR, 2-6) vs 1 (IQR, 0-3) for patients with and without AF diagnosis, respectively (<.001), whereas there was no statistical difference within the ILR group.

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