Background and Aims

HyQvia (facilitated subcutaneous immunoglobulin [fSCIG]) is a dual-vial unit of recombinant human hyaluronidase (rHuPH20) and 10% normal immunoglobulin (IgG) solution. In the registration study, fSCIG was effective, safe, and bioequivalent to intravenous IgG at the same administration intervals, with fewer systemic reactions. FIGARO will provide real-world data about fSCIG usage in routine administration.

Methods

In this multicenter, prospective, observational study in Europe under the auspices of ESID (NCT03054181), patients are eligible for documentation if they receive treatment for primary or secondary immunodeficiency disease and provide informed consent. Planned enrolment is 100 patients. The cut-off for this interim analysis was February 18, 2019.

Results

Patient characteristics (n=85) are shown in the Table. For most patients, average time between infusions was every 4 (68.3%) or every 3 (22.0%) weeks. Median dose of the last fSCIG infusion was 30g (interquartile range: 20–35g), median maximum infusion rate was 300 ml/hr, and thus, median volume infused was 300 ml; most patients used one application site (91.9%; most commonly abdomen) and an infusion pump (97.4%). The most recent fSCIG administration was most commonly given at home (80.5%), followed by doctor’s office (12.2%) and hospital (7.3%) by self-administration (84.0%) or by nurse/physician (16.0%). Technical problems occurred twice. In all cases, the full planned dose of fSCIG was administered.

Conclusions

fSCIG offers the flexibility of infusions performed at home by the patient or in the hospital. Dosing schedule allows variability; however, most infusions are administered every 4 weeks into 1 site. The study is recruiting, and patient observation continues.

Table 1