fSCIG (HyQvia®) is a recombinant human hyaluronidase (rHuPH20)-facilitated subcutaneous immunoglobulin 10% replacement therapy approved in the European Union for patients with primary immunodeficiency disease (PID). This study is acquiring additional data on the long-term safety of fSCIG and assessing the prescribed treatment regimens and administration in routine clinical practice.
This ongoing prospective, non-interventional, open-label, uncontrolled, multicenter study initiated in July 2014 in Europe, includes patients aged ≥18 years with PID currently receiving or prescribed fSCIG (EUPAS5812). The treatment regimens are prescribed at the discretion of the attending physician in accordance with standard clinical practice. Assessments of anti-rHuPH20 antibodies are performed on a voluntary basis.
As of January 10, 2019, out of 111 enrolled patients, 103 patients had received ≥1 dose of fSCIG and were included in the safety analysis population; the mean (SD) fSCIG exposure duration was 2.26 (1.19) years. Incidence of treatment emergent non-serious (non-infectious) adverse events/treatment emergent serious adverse events in the safety population (n=103) was 2.37/0.24 events per person-year; 553/57 events were observed in 83/28 patients. 2 of 78 patients with immunogenicity data developed positive binding antibodies (defined as titer ≥160) to rHuPH20. There were no neutralizing antibodies to rHuPH20. The average annualized per-patient rates for both hospitalizations and emergency room visits were <0.25. Most treatments were administered at home during the first (91.2%), second (93.2%), third (93.2%), and fourth year (85.2%).
This interim analysis of prospectively-collected data of fSCIG use suggests that fSCIG is well tolerated in a real-word study population.