Assuntos
Agamaglobulinemia/epidemiologia , Qualidade de Vida , Agamaglobulinemia/diagnóstico , Agamaglobulinemia/etiologia , Imunodeficiência de Variável Comum , Doenças Genéticas Ligadas ao Cromossomo X/diagnóstico , Doenças Genéticas Ligadas ao Cromossomo X/epidemiologia , Doenças Genéticas Ligadas ao Cromossomo X/etiologia , Humanos , Vigilância em Saúde Pública , Reprodutibilidade dos TestesRESUMO
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.
