To determine the effect of facilitated subcutaneous immunoglobulin (fSCIG; human immunoglobulin G 10% with recombinant human hyaluronidase) on patient-reported outcomes (PROs) in a Phase 3, randomized, placebo-controlled, double-blind, multicenter study (ADVANCE-CIDP 1; NCT02549170).

fSCIG is under investigation as a potential maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

Adults with CIDP who had received stable doses of intravenous immunoglobulin (IVIG) for ≥12 weeks were randomized to fSCIG or placebo (at same dose/interval as pre-randomization IVIG) for 6 months or until relapse/discontinuation. Rasch-built Overall Disability Scale (R-ODS), EuroQoL Visual Analog Scale (EQ-VAS), 36-Item Short Form health survey (SF-36), 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) and treatment preference were assessed.

Overall, 132 patients received fSCIG (n=62) or placebo (n=70). From baseline to end of therapy (EOT), least-squares mean changes in R-ODS centile score were −0.9 and −6.1 with fSCIG and placebo, respectively (P=0.03). Mean EQ-VAS and SF-36 scores generally indicated stable/improved health-related quality of life with fSCIG and stability/deterioration with placebo. Median TSQM-9 global satisfaction/effectiveness scores remained stable with fSCIG and decreased from baseline to EOT with placebo; convenience scores improved in both groups. Overall, 67% of the fSCIG group preferred fSCIG to pre-study IVIG at EOT and 83% stated that they would choose to continue study treatment.

fSCIG maintained the HRQoL that patients with CIDP previously experienced with IVIG and demonstrated favorable treatment satisfaction, preference, and convenience.