A 10% ready-to-use intravenous human immunoglobulin offers potential economic advantages over a lyophilized product in the treatment of primary immunodeficiency

Abstract

SummaryIntravenous immunoglobulin (IVIg) replacement therapy is the standard of care for patients with primary humoral immunodeficiencies. This study evaluated differences in infusion time between a 10% IVIg ready-to-use solution and a 6% IVIg lyophilized product and addressed potential cost implications. After receiving in-hospital treatment with 6% IVIg lyophilized solution for at least 6 months, 14 patients with humoral immunodeficiency without anti-IgA antibodies received five successive infusions with 10% IVIg ready-to-use solution. Data on infusion times were collected during the last two infusions of each IVIg product when maximum infusion rates had been reached. The median infusion time was reduced from 104·4 min with the 6% IVIg lyophilized solution to 51·0 min with the 10% IVIg ready-to-use solution (51% reduction), with corresponding median maximum infusion rates of 4·1 ml/kg/h and 5·9 ml/kg/h, respectively. Median gammaglobulin (IgG) trough levels were 7·1 g/l for the 6% IVIg lyophilized solution and 7·9 g/l for the 10% IVIg ready-to-use solution. Fewer adverse events were observed after infusing with 10% IVIg ready-to-use solution compared with 6% IVIg lyophilized preparation. We conclude that the 10% IVIg ready-to-use solution was well tolerated by most patients and reduced the median infusion time by 51% compared with a 6% lyophilized preparation of IVIg. The reduced bed occupancy and nursing time associated with a reduced infusion time, together with the elimination of a reconstitution step, were estimated to provide a cost-saving of €59·42 per patient per infusion. Thus, this product has the potential to reduce overall costs of IVIg treatment. Reduced infusion time is also likely to improve patients' quality of life.

Controlled tetra-Fc sialylation of IVIg results in a drug candidate with consistent enhanced anti-inflammatory activity

“…At the current maximal dosing regimens, only partial and unsustained responses are obtained in many instances (2,4). In addition, the long infusion times (4-6 h) associated with the high volume of IVIg treatment consume significant resources at infusion centers (8) and negatively affect patient-reported outcomes, such as convenience and quality of life (10). Developing therapeutic alternatives that could leverage the broad biological activities of IVIg and simultaneously, provide more consistent and potent anti-inflammatory activity with minimal inconvenience would be highly valuable to clinicians and patients.…”

New liquid intravenous immunoglobulin (10 % IVIg) for treatment of multifocal motor neuropathy

“…Treatment with 10 % liquid IVIg may reduce infusion time [3]. The aim of our study was to evaluate efficacy, safety and tolerability of the 10 % liquid IVIg preparation in patients with MMN. A prospective open-label, noncontrolled study over 12 months was performed in 20 adult patients with a diagnosis of 'definite' or 'probable' MMN according to the criteria published previously [6].…”

Kiovig for primary immunodeficiency: Reduced infusion and decreased costs per infusion

“…Clinical data used to populate the model were derived from a study conducted in Groningen, the Netherlands [10]. The Dutch study enrolled 14 adult patients who had received in-hospital replacement therapy with a 6% intravenous immunoglobulin lyophilized solution for at least 6 months and were then switched to 10% Kiovig.…”