title: Intravenous immunoglobulin for hypogammaglobulinemia after lung transplantation: a randomized crossover trial.
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.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT00115778.
authors.affiliation: Department of Medicine, College of Physicians and Surgeons, Columbia University, New York City, New York, United States of America; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York City, New York, United States of America.
authors.forename: David J
authors.initials: DJ
authors.lastname: Lederer
authors.affiliation: Department of Medicine, College of Physicians and Surgeons, Columbia University, New York City, New York, United States of America.
authors.forename: Nisha
authors.initials: N
authors.lastname: Philip
authors.affiliation: Department of Medicine, College of Physicians and Surgeons, Columbia University, New York City, New York, United States of America.
authors.forename: Debbie
authors.initials: D
authors.lastname: Rybak
authors.affiliation: Department of Medicine, College of Physicians and Surgeons, Columbia University, New York City, New York, United States of America.
authors.forename: Selim M
authors.initials: SM
authors.lastname: Arcasoy
authors.affiliation: Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, United States of America; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.
authors.forename: Steven M
authors.initials: SM
authors.lastname: Kawut
mesh_terms: D000328:Adult; D000361:Agammaglobulinemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology*; D000368:Aged; D016001:Confidence Intervals; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects / Q000627:therapeutic use*; D016018:Least-Squares Analysis; D016040:Lung Transplantation / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D010919:Placebos; D013147:Spirometry
chemical_list: D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous; D010919:Placebos
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