Intravenous immunoglobulin for hypogammaglobulinemia after lung transplantation: a randomized crossover trial

PLoS One. 2014 Aug 4;9(8):e103908. doi: 10.1371/journal.pone.0103908. eCollection 2014.

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.

Trial registration: Clinicaltrials.gov NCT00115778.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Agammaglobulinemia / blood
  • Agammaglobulinemia / drug therapy*
  • Agammaglobulinemia / etiology*
  • Aged
  • Confidence Intervals
  • Cross-Over Studies
  • Female
  • Humans
  • Immunoglobulin G / blood
  • Immunoglobulins, Intravenous / adverse effects
  • Immunoglobulins, Intravenous / therapeutic use*
  • Least-Squares Analysis
  • Lung Transplantation / adverse effects*
  • Male
  • Middle Aged
  • Placebos
  • Spirometry

Substances

  • Immunoglobulin G
  • Immunoglobulins, Intravenous
  • Placebos

Associated data

  • ClinicalTrials.gov/NCT00115778

Grants and funding

This study was funded by an investigator-initiated grant from Bayer Healthcare (now Talecris Pharmaceuticals). The manuscript was written by the authors, and the decision to submit the manuscript for publication was made solely by the authors. This manuscript was sent to the sponsor before submission for publication, however the sponsor had no right to delay or require any revisions to this manuscript. The sponsor had no role in the design of the study, data collection, analysis, interpretation of the data, or the decision to submit the manuscript.