The division director of Neuromuscular Medicine & EMG at USF Health provided an overview of the open-label findings from ADAPT-SC, a phase 3 study assessing subcutaneous efgartigimod in patients with myasthenia gravis. [WATCH TIME: 3 minutes]
WATCH TIME: 3 minutes
"There was no new signal in terms of safety events. I think it’s [subcutaneous efgartigimod] a good option for patients who want to have the flexibility of having a subcutaneous injection at home or elsewhere."
Over the years, the treatment options for patients with generalized myasthenia gravis (gMG) has grown significantly. In addition to traditional immunosuppressants and cholinesterase inhibitors, patients now have medications like ziucoplan, nipocalimab, eculizumab, and efgartigimod at their disposal. Earlier this year, the FDA approved a subcutaneous formulation of efgartigimod (Vyvgart Hytrulo; Argenx) for patients with gMG who are antiacetylcholine receptor antibody positive, offering a different way of administering the agent.
The decision was based on the phase 3 ADAPT-SC study (NCT04735432), which evaluated the noninferiority of the pharmacodynamic profile effect of subcutaneous efgartigimod as compared with the previously approved intravenous (IV) administration. ADAPT-SC a trial that featured 110 individuals with gMG, met its primary end point of change in total immunoglobulin (IgG) reduction over a 29-day period. Months following the approval, investigators announced new interim results from the open-label extension of ADAPT-SC at the 2023 American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) meeting, held November 1-4, in Phoenix, Arizona.
Led by Tuan Vu, MD, results showed that in the first cycle of treatment, at week 4, there was a –4.0 score (SE, 0.25) reduction in the Myasthenia Gravis Activities of Daily Living total score from cycle baseline, with consistent and repeatable improvements observed by investigators in subsequent cycles. Vu, a professor in the department of neurology and division director of Neuromuscular Medicine & EMG, sat down with NeurologyLive® at the event to discuss the data in detail and the topline findings clinicians should focus in on.