Quantitative Evidence of Wear-Off Effect at the End of the Intravenous IgG (IVIG) Dosing Cycle in Primary Immunodeficiency

Journal of Clinical Immunology
Mikhail A RojavinJohn-Philip Lawo

Abstract

Intravenous IgG (IVIG) treatment wear-off is commonly experienced by patients, who report increased susceptibility to infection, and decreased quality of life towards the end of their 3- or 4-week dosing cycle, when serum IgG levels approach their trough. We quantified IVIG wear-off in terms of treatment efficacy and patient well-being. Data were collected from patients enrolled in three Phase III trials of Sandoglobulin NF Liquid or Privigen, treated every 3- or 4- weeks. Pooled analyses of raw patient data compared the rate of infection and other clinical outcomes during the course of the dosing cycle. Subjective symptoms of wear-off were quantified by comparing patient-reported overall well-being scores. The probability of a first infection in the final week of the IVIG cycle was 1.26 (95% confidence intervals [CI]: 0.76-2.11; p = 0.3621) and 1.55 (95% CI: 1.04-2.32; p = 0.0314) times higher than in the first week, for patients on a 3-week cycle and 4-week dosing cycles, respectively. Wear-off, as manifested by a decrease in overall well-being, was experienced in 10% of all cycles and reported at least once by 61% of the patients on a 3-week cycle, and 43% of those on a 4-week cycle. These findings confirm the existence of d...Continue Reading

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Mar 25, 2018·Journal of the Peripheral Nervous System : JPNS·Jeffrey A AllenRobert D Hadden
Sep 1, 2018·Clinical and Experimental Immunology·J HajjarJ Orange
Mar 23, 2019·BMC Health Services Research·Verónica PolicarpoSuzete Costa
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Clinical Trials Mentioned

NCT00168012
NCT00168025
NCT00322556

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