Efficacy and safety of Hizentra® in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy

Abstract

A prospective, open-label, multicenter, single-arm, Phase III study evaluated the efficacy and safety of Hizentra(®), a 20% human IgG for subcutaneous administration, in 51 primary immunodeficiency patients over 40 weeks. Patients previously on intravenous or subcutaneous IgG were switched to weekly subcutaneous infusions of Hizentra(®) at doses equivalent to their previous treatment. IgG levels achieved with Hizentra(®) were similar to pre-study levels with subcutaneous, and higher by 17.7% than pre-study levels with intravenous IgG. No serious bacterial infections were reported in the efficacy period. The rate of all infections was 5.18/year/patient, the rates of days missed from work/school, and days spent in hospital were 8.00/year/patient and 3.48/year/patient, respectively. Local reactions (rate 0.060/infusion) were mostly mild (87.3%). No serious, Hizentra(®)-related adverse events were reported. Individual median infusion durations ranged between 1.14 and 1.27 h. Hizentra(®) maintained or improved serum IgG levels without dose increases and effectively protected patients against infections.

Subcutaneous immunoglobulin replacement therapy with Hizentra®, the first 20% SCIG preparation: a Practical approach

“…In the European Hizentra study, doses equivalent to previous IVIG doses were administered according to the clinical practice in Europe. 11 In contrast, the US Hizentra study aimed to achieve AUCs similar to that of previous IVIG treatment. 10 Therefore, Figure 6.…”

“…6,8 Hizentra was infused at a median infusion rate of 25.3 mL/hour in the recent European study, and rates as high as 35.0 mL/hour were used in 34.8% of patients. 11 In the US study, the median infusion rate was 39.1 mL/hour, with a maximum infusion rate of 50 mL/hour for all simultaneously used sites. 10 The high infusion rates, as well as the small volume required, led to a short duration of weekly infusions, with median values ranging from 1.14 to 1.27 hours 11 and from 1.6 to 2 hours.…”

ERS statement on the multidisciplinary respiratory management of ataxia telangiectasia

“…These findings suggest that the recognition of groups who may be at higher risk of lower pulmonary function may help to direct care and improve clinical outcomes in A-T. If Ig therapy is considered, most centres administer subcutaneous Ig, as is currently recommended for severe immundeficiencies [29][30][31].…”

Affinity Chromatography for Purification of IgG from Human Plasma

“…This trend is reflected by new IGSC products on the market or in the clinical stage (Jolles et al, 2011, Teschner et al, 2009). …”