An open, prospective trial investigating the pharmacokinetics and safety, and the tolerability of escalating infusion rates of a 10% human normal immunoglobulin for intravenous infusion (IVIg), BT090, in patients with primary immunodeficiency disease. Issue 3 (7th May 2015)

• Record Type: Journal Article
• Authors: Kriván, G.; Königs, Ch.; Bernatowska, E.; Salama, A.; Wartenberg‐Demand, A.; Sonnenburg, C.; Linde, R.
• Is Part Of: Vox sanguinis. Volume 109:Issue 3(2015)
• Page Start: 248
• Page End: 256
• Publication Date: 2015-05-07
• Subjects: infusion rates -- intravenous immunoglobulin -- primary immunodeficiency disease; Blood -- Periodicals; Blood -- Transfusion -- Periodicals; Immunohematology -- Periodicals; Immunopathology -- Periodicals; 615.39
• DOI: 10.1111/vox.12275
• Languages: English
• ISSNs: 0042-9007

Abstract

Abstract : Background and Objectives: Pharmacokinetics, safety and tolerability of escalating infusion rates of BT090, a 10% intravenous immunoglobulin (IVIg), were studied in patients with primary immunodeficiency disease. Materials and Methods: In Part A, patients ( n = 30) received 3 infusions of BT090 at their pretrial dose and dosing interval; the infusion rate of BT090 was increased from 0·3 to 1·4 to 2·0 ml/kg/h for each infusion in each patient initially at 30‐min intervals. Pharmacokinetics was evaluated at the 3rd infusion ( n = 24). At the 4th infusion, infusion rates were to be gradually escalated from 0·3 to 1·4 to 4·0 to a maximum of 8·0 ml/kg/h initially at 30‐min intervals to establish the maximum tolerated infusion rate per patient. Results: The pharmacokinetic characteristics and safety profile of BT090 were comparable with those of other IVIgs, including Intratect ® . Escalation of infusion rates was well tolerated, allowing identification of individual patient's maximum tolerated infusion rate. At subsequent infusions, all patients tolerated their individually defined maximum infusion rate: 17 patients (68·0%) tolerated infusion rates of 6·0 or 8·0 ml/kg/h and four patients (16%) had maximum tolerated infusion rates of <4·0 ml/kg/h at subsequent infusions. Escalation of infusion rates shortened infusion time from a median of around 2·5 h to around 1·6 h. SAEs were reported in three patients, but none was related to BT090 treatment. Conclusions: Shortening infusion time may reduce overall healthcare spending, for example nursing time needed, and also minimize disruption of patients' daily routine, especially for those patients in work or school settings.