Vyvgart Hytrulo Reduces Relapse Risk in Patients with Chronic Inflammatory Demyelinating Polyneuropathy

Analysis of topline data from the ADHERE (NCT04281472) clinical trial revealed that Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc; Argenx SE, Amsterdam, The Netherlands) treatment administered with the drug delivery technology Enhanze (rHuPH20; Halozyme Therapeutics, Inc., San Diego, CA) was associated with a decreased risk of relapses compared with placebo in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

ADHERE was a multicenter, randomized, double-blind, placebo-controlled clinical trial in 322 participants with CIDP. In the first part of the study, patients received Vyvgart Hytrulo, with the primary endpoint of the study being evidence of clinical improvement (ECI) per Inflammatory Neuropathy Cause and Treatment (INCAT) score, Inflammatory Rasch-built Overall Disability Scale (I-RODS), and mean grip strength. In the second stage of the study, participants were randomized to receive either Vyvgart Hytrulo or placebo, with the primary endpoint studied being hazard ratio (HR) for relapse as measured by time to first adjusted deterioration in INCAT score. Primary endpoints of the study were met, with Vyvgart Hytrulo demonstrating a 61% reduction in risk of relapse compared to placebo (HR, 0.39; 95% CI, 0.25-0.61; P=0.000039).

"We are delighted with the strong data in CIDP and what it can mean for patients living with this challenging condition," said Helen Torley, MB, ChB, MRCP, President and Chief Executive Officer of Halozyme Therapeutics.

Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc; Argenx SE, Amsterdam, Netherlands) received Food and Drug Administration (FDA) approval in June 2023 for the treatment of generalized myasthenia gravis (gMG) in adult patients as a subcutaneous injection.