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Intravenous Immunoglobulin for Hypogammaglobulinemia after Lung Transplantation: A Randomized Crossover Trial

David J. Lederer; Nisha Philip; Debbie Rybak; Selim Arcasoy; Steven M. Kawut

Title:
Intravenous Immunoglobulin for Hypogammaglobulinemia after Lung Transplantation: A Randomized Crossover Trial
Author(s):
Lederer, David J.
Philip, Nisha
Rybak, Debbie
Arcasoy, Selim
Kawut, Steven M.
Date:
Department(s):
Medicine
Obstetrics and Gynecology
Volume:
9
Persistent URL:
Book/Journal Title:
PLOS ONE
Abstract:
Background We aimed to determine the effects of treatment with intravenous immunoglobulin on bacterial infections in patients with hypogammaglobulinemia (HGG) after lung transplantation. Methods We performed a randomized, double-blind, placebo-controlled two-period crossover trial of immune globulin intravenous (IVIG), 10% Purified (Gamunex, Bayer, Elkhart, IN) monthly in eleven adults who had undergone lung transplantation more than three months previously. We randomized study participants to three doses of IVIG (or 0.1% albumin solution (placebo)) given four weeks apart followed by a twelve week washout and then three doses of placebo (or IVIG). The primary outcome was the number of bacterial infections within each treatment period. Results IVIG had no effect on the number of bacterial infections during the treatment period (3 during IVIG and 1 during placebo; odds ratio 3.5, 95% confidence interval 0.4 to 27.6, p = 0.24). There were no effects on other infections, use of antibiotics, or lung function. IVIG significantly increased trough IgG levels at all time points (least square means, 765.3 mg/dl during IVIG and 486.3 mg/dl during placebo, p<0.001). Four serious adverse events (resulting in hospitalization) occurred during the treatment periods (3 during active treatment and 1 during the placebo period, p = 0.37). Chills, flushing, and nausea occurred during one infusion of IVIG. Conclusions Treatment with IVIG did not reduce the short-term risk of bacterial infection in patients with HGG after lung transplantation. The clinical efficacy of immunoglobulin supplementation in HGG related to lung transplantation over the long term or with recurrent infections is unknown.
Subject(s):
Infection
Lungs--Transplantation
Bacterial diseases
Immunology
Publisher DOI:
https://doi.org/10.1371/journal.pone.0103908
Item views
97
Metadata:
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Suggested Citation:
David J. Lederer, Nisha Philip, Debbie Rybak, Selim Arcasoy, Steven M. Kawut, , Intravenous Immunoglobulin for Hypogammaglobulinemia after Lung Transplantation: A Randomized Crossover Trial, Columbia University Academic Commons, .

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