Efgartigimod Improves HR-Related Quality of Life, Traditional Approval for Lecanemab Pending, Satrlizumab Benefits NMOSD After Switching


Neurology News Network for the week ending March 11, 2023. [WATCH TIME: 3 minutes]

WATCH TIME: 3 minutes

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

Recently reported ancillary data from the phase 3 ADAPT study showed that treatment with efgartigimod (Vyvgart; Argenx) had a significant impact on health-related quality of life (HRQoL) in patients with myasthenia gravis, with positive effects seen as early as the first week of treatment in both cycles. Of the 167 patients enrolled, 129 (77.2%) were AChR antibody positive. Participants were randomly assigned 1:1 to either efgartigimod or placebo for a 28-week treatment period, consisting of up to 3, 8-week treatment cycles (TCs). Comparing the 2 arms, significantly greater improvements in HRQoL scores were seen in those on efgartigimod, even among patients who had poor HRQoL at baseline. Relative to placebo, there was a greater reduction in MG-QOL15r scores for AChR-Ab+ participants on efgartigimod (<.0001), with statistically significant differences maintained for up to 8 weeks in TC1 and TC2. Throughout the study, there was an observed trend in mean change in MG-QOL15r that was similar to that in total IgG level, by week.

The FDA has accepted Eisai’s supplemental biologics license application (sBLA) for the traditional approval of lecenamab (Leqembi), an antiamyloid therapy approved for patients with early Alzheimer disease (AD). The agency placed a PDUFA action date of July 6, 2023, for the decision. Approved under the accelerated approval pathway early January 2023, the sBLA is based on findings from the phase 3 confirmatory Clarity AD study, an 18-month study that further demonstrated lecanemab’s effect in early AD. Designed as a humanized IgG1 monoclonal antibody, lecanemab was originally greenlit on data from the phase 2, Study 201, which demonstrated the drug’s significant effect on reducing amyloid-ß in the brain. Under the accelerated approval, drug companies are still required to conduct phase 4 studies that confirm the anticipated clinical benefit of a therapy.

New data from an ongoing retrospective case series showed that patients with NMOSD, including those with concomitant autoimmune comorbidities, had a more beneficial response on satralizumab after switching from previous treatments. The cases provided valuable real-world data on responses of patients on satralizumab after previous treatment with biologics such as rituximab and conventional immunosuppressive therapies. Nine of the 10 patients included the analysis were relapse free after being treated with satralizumab, despite reports of confirmed or suspected relapses in some patients because of previous treatments. Notably, patients maintained disease control and few adverse events were reported, with leukopenia being the most common. There were no patients that discontinued the use of satralizumab permanently because of ineffectiveness or intolerance.

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