Phase III ADVANCE-1 trial of HyQvia meets primary endpoint in chronic inflammatory demyelinating polyradiculoneuropathy

Topline data show that HyQvia reduced relapse of neuromuscular disability and impairment when used as a maintenance therapy for CIDP, supporting its potential as a facilitated subcutaneous immunoglobulin (fSCIG) solution that could allow for monthly infusion for many CIDP patients. Analyses from ADVANCE-1 are ongoing, and the company anticipates disclosing additional data in an upcoming medical forum.

The pivotal ADVANCE-1 clinical trial evaluated the efficacy, safety and tolerability of HyQvia in 132 adult patients with CIDP who had been on a stable dosing regimen of intravenous immunoglobulin (IVIG) therapy for at least three months prior to infusion. Analysis of the primary endpoint shows that HyQvia, when administered at the same dose and dosing interval as the patient’s previous IVIG, reduced CIDP relapse as compared to placebo [9.7% vs 31.4%, respectively; p-value = 0.0045], as measured by Inflammatory Neuropathy Cause and Treatment (INCAT). The majority of patients in the study received a four-week dosing regimen of HyQvia.

In topline analyses of ADVANCE-1, HyQvia showed a favorable safety profile, further supporting its use as a maintenance therapy for CIDP. Of the 62 patients treated with HyQvia, the majority of treatment-related adverse events were reported as mild or moderate. No new safety risks were reported with HyQvia. The safety profile of HyQvia in CIDP will be further supported by data from the ongoing ADVANCE-3 clinical trial, the longest extension study of its kind with up to six years of follow-up data on some participants.