The professor of neurology at Cedars-Sinai Medical Center talked about findings from the ADHERE trial assessing efgartigimod, a human IgG1 antibody Fc fragment, as a treatment for patients with chronic inflammatory demyelinating polyneuropathy. [WATCH TIME: 6 minutes]
WATCH TIME: 6 minutes
"This trial shows that immunoglobulin G plays a very important role in a significant number or probably a majority of patients with CIDP. So we're learning a little bit more about the pathogenesis of the disease based on the trial."
Efgartigimod (Vyvgart; Argenx), a human IgG1 antibody Fc fragment, blocks the neonatal Fc receptor (FcRn). By blocking the FcRn, recycling of immunoglobulin G (IgG) is decreased and pathogenic IgG autoantibody levels are reduced which may have a part in the pathogenesis of chronic inflammatory demyelinating polyneuropathy (CIDP). As of now, not every patient with CIDP achieves clinically meaningful benefits from current treatments, which can mean long-term safety risks, high costs, and burdensome care. The ongoing global phase 2 ADHERE trial (NCT04281472) is assessing subcutaneous (SC) efgartigimod PH20 as a treatment for CIDP.1
The trial is currently enrolling adult patients with CIDP who are treatment naive or are receiving standard treatments, which are then withdrawn prior to day 1 of the 12-week run-in period. Following an open-label phase of 1000 mg efgartigimod PH20 SC weekly (stage A), treatment responders enter a 48-week randomized phase of weekly treatment versus placebo (stage B). ADHERE plans to recruit up to 360 patients in stage A up until 88 events of clinical deterioration are observed in stage B. The primary objectives of the trial include investigating evidence of clinical improvement (stage A) and efficacy of efgartigimod PH20 SC compared with placebo based on time to occurrence of clinical deterioration (stage B).
The recent findings of ADHERE were presented at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) meeting, held November 1-4, in Phoenix, Arizona, by lead author Richard Lewis, MD, professor of neurology at Cedars-Sinai Medical Center, and colleagues. At the meeting, Lewis sat down in an interview with NeurologyLive® to discuss how efgartigimod differs from traditional treatments for CIDP, and why it is being considered a potential breakthrough therapy. He talked about the role IgG plays in CIDP, and how the trial could potentially uncover more about the disease's pathogenesis. In addition, Lewis spoke about the key advantages of subcutaneous efgartigimod over intravenous immunoglobulin for patients with CIDP, and how well it was tolerated in the trial.