Fingolimod Preserves MS Cognition, Ravulizumab ALS Trial Discontinued, ADVANCE Results Published


Neurology News Network for the week ending August 28, 2021.

This week Neurology News Network covered a long-term trial evaluating fingolimod's ability to preserve cognition in patients with multiple sclerosis, the discontinuation of Alexion Pharmaceuticals' phase 3 trial of ravulizumab in ALS, and the full results of ADVANCE, a pivotal study evaluating atogepant as a preventive treatment.

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.

Fingolimod (Gilenya; Novartis), an FDA-approved disease modifying therapy (DMT) for patients with multiple sclerosis (MS), demonstrated a high rate of treatment continuation at 5 years and statistically significantly decreased the rate of patients demonstrating impairment on several cognitive assessments in a recent study. Lead author Serkan Ozakbas, and colleagues conducted a multicenter, prospective study that followed 376 patients with relapsing-remitting MS who initiated fingolimod treatment from 2011 to 2014 for at least 5 years. When the study group was evaluated in 2019, the treatment showed positive long-term retention rates, indicated by 82.2% (n = 309) of patients who continued the therapy. Prior to initiation of treatment, patients had EDSS scores of 2.43. At the end of the second and fifth years, patients demonstrated scores of 2.39 and 2.28, respectively. Although there were no statistically significant differences between the evaluations, the EDSS scores did tend to decrease.

Alexion Pharmaceuticals announced that it is discontinuing its phase 3 trial of the ravulizumab (Ultomiris) in amyotrophic lateral sclerosis (ALS), CHAMPION-ALS (NCT04248465). The decision was reached based on a recommendation from the Independent Data Monitoring Committee’s prespecified interim analysis which suggested that the trial be discontinued because of a lack of efficacy.Those enrolled in the study—target enrollment was 350 adults with sporadic or familial ALS—will discontinue treatment with ravulizumab and complete necessary follow-up visits, with the remaining data planned to be used to inform ongoing research. Otherwise, no new safety data were collected, with the overall safety profile maintaining consistency to prior study of the long-acting C5 complement inhibitor. Study participants were randomized 2:1 to receive either ravulizumab or placebo every 8 weeks following an initial loading dose while remaining on their existing standard of care treatment for ALS. After 50 weeks, all patients were expected to enter the 2-year open-label extension phase of the study.

With a regulatory decision expected to come late in the third quarter of 2021, AbbVie has released full results of the phase 3 ADVANCE study in the New England Journal of Medicine, reinforcing atogepant as a potential option for the preventive treatment of episodic migraine. A total of 873 patients with episodic migraine were included in the efficacy analysis and were randomized 1:1:1:1 to receive a once-daily dose of oral atogepant (10 mg, 30 mg, or 60 mg) or placebo for 12 weeks. Investigators used change from baseline in the mean number of migraine days per month as the primary end point, and headache days per month, 50% reductions in 3-month average of migraine days per month, quality of life, and scores on the Activity Impairment in Migraine-Diary (AIM-D) as key secondary end points. Topline results previously announced in July 2020 showed that treatment with the agent met primary end point, with decreases in mean monthly headache days of 3.7, 3.9, and 4.2 days, respectively, in the 10 mg (n = 214), 30 mg (n = 223) and 60 mg (n = 222) atogepant groups compared with a 2.5-day decline in the placebo arm.

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