Hyaluronidase-Facilitated Subcutaneous Immune Globulin Effective as Maintenance Therapy for CIDP: Pivotal Trial Results

Comprising recombinant human hyaluronidase and 10% human immune globulin (Gammagard Liquid), Takeda Pharmaceuticals’ facilitated subcutaneous immune globulin (fSCIG; HyQvia) enables self-infusion of a full therapeutic dose on a less frequent schedule than conventional 16% or 20% SCIG. The Phase III, double-blind, placebo-controlled ADVANCE-CIDP 1 trial was conducted at 54 sites in 21 countries to evaluate whether fSCIG could prevent relapse in patients with definite or probable chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) who had received stable intravenous immune globulin (IVIG) for ≥12 weeks before screening.

A total of 132 patients received fSCIG 10% (n = 62) or placebo (n = 70). fSCIG 10% was administered at the same dose (or matching placebo volume) and interval as pre-randomization IVIG. The primary outcome was patient proportion experiencing CIDP relapse (defined as a ≥1-point increase in adjusted INCAT score from pre-subcutaneous treatment baseline) in the modified intention-to-treat population.

CIDP relapse was reduced with fSCIG 10% versus placebo (9.7% versus 31.4%, respectively) for an absolute difference of -21.8% (p = 0.0045). The probability of relapse was higher with placebo versus fSCIG 10% over time (p = 0.002). Adverse events were more frequent with fSCIG 10% (79.0% of patients) than placebo (57.1%), but severe (1.6% vs. 8.6%) and serious adverse events (3.2% vs. 7.1%) were less common.

The study investigators concluded that “fSCIG 10% more effectively prevented CIDP relapse than placebo, supporting its potential use as maintenance CIDP treatment.”