Vyvgart Hytrulo Meets Primary End Point, Trial on Fibromyalgia-Type Long COVID Continues, Aspirin Increased Intracranial Bleeding in Elders


Neurology News Network for the week ending August 12, 2023. [WATCH TIME: 3 minutes]

WATCH TIME: 3 minutes

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

Vyvgart Hytrulo met its primary end point in the pivotal ADHERE study of adults with chronic inflammatory demyelinating polyneuropathy (CIDP), with treated patients showing significantly lower risk of relapse in comparison with placebo. The primary end point was measured once 88 total relapses or events were achieved in Stage B of the study and was based on the hazard ratio (HR) for the time to first adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) deterioration. All told, treatment with Vyvgart Hytrulo resulted in a 61% reduction in the risk of relapse relative to placebo (P =.000039) while maintaining a safety and tolerability profile that was consistent with previous studies. Considered the largest clinical trial of CIDP to date, the study consisted of a run-in period where current treatment was stopped followed by an open-label Stage A, after which responders to Vyvgart Hytrulo advanced to a randomized, placebo-controlled Stage B.

According to an announcement from Tonix Pharmaceuticals, the company has completed the clinical phase of its phase 2 proof-of-concept PREVAIL study (NCT05472090) assessing its investigational agent TNX-102 SL for the treatment of fibromyalgia-type long COVID. Topline results for the trial are expected to be announced in the third quarter of 2023. The study, which spans across 30 sites in the US, is a 14-week, double-blind, randomized, placebo-controlled trial that uses change from baseline in the weekly average of daily self-reported worst pain intensity scores as the primary end point. Patients included were between 18 and 65 years, had a polymerase chain reaction confirmed history of SARS-CoV-2 infection at least 3 months prior to enrollment, and had new onset or significant worsening of pain that coincides with a prior COVID-19 infection. Fibromyalgia syndrome is characterized by a chronic widespread musculoskeletal pain that frequently is accompanied by fatigue, sleep, cognitive and mood disturbances.

Among a cohort of older, healthy adults, findings from a secondary analysis of the ASPREE randomized, double-blind, placebo-controlled study showed no statistically significant benefit in preventing stroke with low-dose aspirin; however, aspirin significantly increased the overall risk of intracranial bleeding. Above all, these data support recommendations from the US Preventive Services Task Force (USPSTF) that low-dose aspirin should not be prescribed for primary prevention in healthy older adults. The trial featured 19114 older adults free of symptomatic cardiovascular disease who were randomly assigned to either daily 100-mg enteric-coated aspirin (n = 9525) or matching placebo (n = 9589). Recruitment took place between 2010 and 2014, and participants were followed up for a median of 4.7 (IQR, 3.6-5.7) years. The study’s primary outcome, disability-free survival, was previously reported, showing no difference between aspirin and placebo groups.

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