title: A 10% ready-to-use intravenous human immunoglobulin offers potential economic advantages over a lyophilized product in the treatment of primary immunodeficiency.
abstract: Intravenous 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 euros 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.
authors.affiliation: Department of Rheumatology and Clinical Immunology, University Medical Center Groningen, The Netherlands. c.g.m.kallenberg@int.umcg.nl
authors.forename: C G M
authors.initials: CG
authors.lastname: Kallenberg
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002626:Chemistry, Pharmaceutical; D003362:Cost-Benefit Analysis; D016527:Drug Costs / Q000706:statistics & numerical data; D005260:Female; D005612:Freeze Drying; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D007153:Immunologic Deficiency Syndromes / Q000191:economics / Q000276:immunology / Q000628:therapy*; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D013997:Time Factors
chemical_list: D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous