Abstract
BackgroundWe aimed to determine the effects of treatment with intravenous immunoglobulin on bacterial infections in patients with hypogammaglobulinemia (HGG) after lung transplantation.MethodsWe 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.ResultsIVIG 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.ConclusionsTreatment 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.Trial RegistrationClinicaltrials.gov NCT00115778
Highlights
Potent immunosuppressive regimens, consisting of a calcineurin inhibitor, an anti-metabolite, and corticosteroids, predominantly target cell-mediated immunity to prevent lung allograft rejection after lung transplantation
Immunosuppressive therapy after solid organ transplantation may contribute to humoral immunodeficiency due to hypogammaglobulinemia (HGG). [6,7,8,9] A recent meta-analysis suggested that severe HGG after solid organ transplantation is associated with an increased risk of early infection and all-cause mortality
We previously found that 58% of lung transplant recipients had mild incident HGG and 15% had severe HGG, with most episodes occurring within the first year of transplantation
Summary
Potent immunosuppressive regimens, consisting of a calcineurin inhibitor, an anti-metabolite, and corticosteroids, predominantly target cell-mediated immunity to prevent lung allograft rejection after lung transplantation. Immunosuppressive therapy after solid organ transplantation may contribute to humoral immunodeficiency due to hypogammaglobulinemia (HGG). [6,7,8,9] A recent meta-analysis suggested that severe HGG after solid organ transplantation is associated with an increased risk of early infection and all-cause mortality. We have shown that the presence of HGG is associated with an increased risk of pneumonia, supporting the clinical importance of HGG in our lung transplant recipients. IVIG is FDA-approved for treatment of primary humoral immunodeficiency, Kawasaki syndrome, B-cell chronic lymphocytic leukemia, and bone marrow transplant recipients with recurrent infections, pediatric HIV infection, and idiopathic thrombocytopenic purpura. We aimed to determine the effects of treatment with intravenous immunoglobulin on bacterial infections in patients with hypogammaglobulinemia (HGG) after lung transplantation
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