Author: Beigel, John H.; Tebas, Pablo; Elie-Turenne, Marie-Carmelle; Bajwa, Ednan; Bell, Todd E.; Cairns, Charles B.; Shoham, Shmuel; Deville, Jaime G.; Feucht, Eric; Feinberg, Judith; Luke, Thomas; Raviprakash, Kanakatte; Danko, Janine; O’Neil, Dorothy; Metcalf, Julia A.; King, Karen; Burgess, Timothy H.; Aga, Evgenia; Lane, H. Clifford; Hughes, Michael D.; Davey, Richard T.
Title: A Randomized Study of Immune Plasma for the Treatment of Severe Influenza Document date: 2017_5_15
ID: 2g22oqf2_35
Snippet: There was a demonstrable difference in geometric mean titers in the plasma treatment arm compared to non-treated participants in the first few days after plasma administration. The analysis of the pharmacokinetic/pharmacodynamic (PK/PD) relationship of this intervention, however, presents several challenges. The administered plasma is not discernable from the intrinsic immune response. Unlike small molecules, the baseline titer does not begin at .....
Document: There was a demonstrable difference in geometric mean titers in the plasma treatment arm compared to non-treated participants in the first few days after plasma administration. The analysis of the pharmacokinetic/pharmacodynamic (PK/PD) relationship of this intervention, however, presents several challenges. The administered plasma is not discernable from the intrinsic immune response. Unlike small molecules, the baseline titer does not begin at 0 due to both pre-existing immunity (prior infections and vaccinations) as well as any immune response occurring after the illness onset. By Day 28, the titer is higher in all participants regardless of treatment due to the adaptive immune response and remains elevated above baseline for months. Given the complexity of this type of analysis, the PK/PD is beyond the scope of this paper.
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