DTAS Leads to Improved Stroke Outcomes, FDA Approves Avalglucosidase Alfa, No Evidence of Suicidality in ASMs

Neurology News Network for the week ending August 14, 2021.

This week Neurology News Network covered a comparison study evaluating stroke outcomes using direct transfer to angiography suite vs direct transfer to computed tomography, the FDA approval of avalglucosidase alfa in patients with Pompe disease, and the lack of suicide increase from using antiseizure medications.

Welcome to this special edition of Neurology News Network. I’m Marco Meglio. Please excuse our appearance this week as a majority of the US workforce, including the NeurologyLive team, moves to working remote as we come together to help reduce the spread of the novel coronavirus.

For patients with acute ischemic stroke (AIS) caused by large vessel occlusion (LVO), direct transfer to angiography suite (DTAS) within 6 hours of symptom onset was safe and led to improved clinical outcomes compared with direct transfer to computed tomography (DTCT) suite. ANGIOCAT, a prospective, open clinical trial, included 174 patients who were randomized 1:1 to follow either DTAS (n = 89) or conventional workflow (n = 85) to assess the indication of endovascular treatment (EVT). Lead author Manuel Requena, MD, PhD, and colleagues used a shift analysis evaluating the distribution of 90-day 7-category modified Rankin Scale (mRS) scores from patients as the primary outcome of the study.At the end of the study period, findings showed an adjusted common OR of improvement of 1 point on the mRS scrore of 2.2 favoring DTAS over DTCT. Requena et al wrote, "the improvements in clinical outcomes shown in our study are substantial and are likely due to 2 major reasons: increasing the rate of EVT by avoiding overselection in treatment indication and reducing in-hospital workflow."

According to an announcement from Sanofi, the FDA has granted approval to avalglucosidase alfa-ngpt (Nexviazyme) for the treatment of late-onset Pompe disease in patients aged 1 year and older. The biologics license application for the long-term enzyme replacement therapy (ERT) was originally accepted for review by the agency in late 2020, after granting the agent breakthrough therapy and fast track designations.The therapy is administered as a monotherapy ERT every 2 weeks, with a recommended dose based on body weight—20 mg/kg for patients with late-onset Pompe disease weighing 30 kg or heavier, and 40 mg/kg for those patients under 30 kg—and is administered incrementally via intravenous infusion. It is expected to be available in the US in the coming weeks, according to Sanofi. The basis for the application was built on positive data from both the phase 3 COMET trial and the phase 2 mini-COMET trial, which showed improvements over standard of care.

A recently conducted meta-analysis of 5 antiseizure medications (ASMs) approved since 2008 showed no evidence of increased suicidality in patients with refractory epilepsy who don’t have a history of suicidality. Investigators concluded that the FDA-mandated suicidality class warning for these drugs is not warranted.The final analysis included 17 studies of 5 ASMs involving 5996 patients, including 4000 patients treated with ASMs and 1996 treated with placebo. In total, 12 patients (0.30%) treated with ASM had suicidal ideation, compared with 7 of 1996 patients (0.35%) treated with placebo (X2 = 0.108; = .74). Additionally, 3 patients who received active treatment and no patients treated with placebo attempted suicide. Notably, there were no completed suicides. Investigators not only concluded that the suicidality class warning is no longer warranted, but that “determination and labeling of suicidality risk should be based on evidence from randomized clinical trials and individualized for each new ASM.”

For more direct access to expert insight, head to NeurologyLive.com. This has been Neurology News Network. Thanks for watching.