PURPOSE: The tolerability of L-proline-stabilized Privigen, a new 10% liquid immunoglobulin for intravenous administration, was assessed at high infusion rates in a Phase III, open-label, single-arm, multicenter study in 45 patients with primary immune deficiencies. PATIENTS AND METHODS: Maximum infusion rates were not assigned prospectively. For analysis, patients were grouped according to maximum infusion rate in a low infusion rate group (8 mg/kg/min) and high infusion rate group (12 mg/kg/min). RESULTS: Twenty-three patients, selected at the investigators' discretion for the high infusion rate group based on their good tolerability, tolerated Privigen at 12 mg/kg/min with no increase in temporally associated adverse events (AEs) above the level they had experienced at 8 mg/kg/min. The proportion of infusions with temporally associated AEs in these patients was 0.079 [97.5% confidence interval (CI) 0.114] compared to 0.211 (97.5% CI 0.267) in the low infusion rate group. The most frequent AE was headache. Thus, selected patients tolerate Privigen at high infusion rates.
PURPOSE: The tolerability of L-proline-stabilized Privigen, a new 10% liquid immunoglobulin for intravenous administration, was assessed at high infusion rates in a Phase III, open-label, single-arm, multicenter study in 45 patients with primary immune deficiencies. PATIENTS AND METHODS: Maximum infusion rates were not assigned prospectively. For analysis, patients were grouped according to maximum infusion rate in a low infusion rate group (8 mg/kg/min) and high infusion rate group (12 mg/kg/min). RESULTS: Twenty-three patients, selected at the investigators' discretion for the high infusion rate group based on their good tolerability, tolerated Privigen at 12 mg/kg/min with no increase in temporally associated adverse events (AEs) above the level they had experienced at 8 mg/kg/min. The proportion of infusions with temporally associated AEs in these patients was 0.079 [97.5% confidence interval (CI) 0.114] compared to 0.211 (97.5% CI 0.267) in the low infusion rate group. The most frequent AE was headache. Thus, selected patients tolerate Privigen at high infusion rates.
Authors: A J Ammann; R F Ashman; R H Buckley; W R Hardie; H J Krantmann; J Nelson; H Ochs; E R Stiehm; T Tiller; D W Wara; R Wedgwood Journal: Clin Immunol Immunopathol Date: 1982-01
Authors: Jordan S Orange; Elham M Hossny; Catherine R Weiler; Mark Ballow; Melvin Berger; Francisco A Bonilla; Rebecca Buckley; Javier Chinen; Yehia El-Gamal; Bruce D Mazer; Robert P Nelson; Dhavalkumar D Patel; Elizabeth Secord; Ricardo U Sorensen; Richard L Wasserman; Charlotte Cunningham-Rundles Journal: J Allergy Clin Immunol Date: 2006-04 Impact factor: 10.793
Authors: Melvin Berger; Charlotte Cunningham-Rundles; Francisco A Bonilla; Isaac Melamed; Johann Bichler; Othmar Zenker; Mark Ballow Journal: J Clin Immunol Date: 2007-05-04 Impact factor: 8.317
Authors: C Cunningham-Rundles; F P Siegal; E M Smithwick; A Lion-Boulé; S Cunningham-Rundles; J O'Malley; S Barandun; R A Good Journal: Ann Intern Med Date: 1984-10 Impact factor: 25.391
Authors: Richard L Wasserman; Isaac R Melamed; Mark R Stein; Stephen Jolles; Miranda Norton; James N Moy Journal: J Clin Immunol Date: 2017-03-18 Impact factor: 8.317
Authors: Melissa Wich; Stephanie Greim; Marta Ferreira-Gomes; Thomas Krüger; Olaf Kniemeyer; Axel A Brakhage; Ilse D Jacobsen; Bernhard Hube; Berit Jungnickel Journal: Virulence Date: 2021-12 Impact factor: 5.882
Authors: Laia Alsina; Andreas Mohr; Maria Montañés; Xènia Oliver; Esperanza Martín; Jaime Pons; Elizabeth Drewe; Jens Papke; Georg Günther; Ronnie Chee; Mark Gompels Journal: Pharmacol Res Perspect Date: 2017-10