High-Dose Weekly Intravenous Immunoglobulin to Prevent Infections in Patients Undergoing Autologous Bone Marrow Transplantation or Severe Myelosuppressive Therapy: A Study of the American Bone Marrow Transplant Group

15 June 1993 | Volume 118 Issue 12 | Pages 937-942

Objective: To determine whether intravenous immunoglobulin (IVIG) prevents severe infections during autologous bone marrow transplantation or equivalent high-dose myelosuppressive therapy.

Design: Randomized, stratified, nonblinded study.

Setting: Three tertiary care university hospitals.

Patients: One hundred seventy patients entered the study; 82 received IVIG and 88 were untreated controls. The study groups were similar for parameters capable of influencing the likelihood of infection.

Interventions: Intravenous immunoglobulin was given weekly at a dose of 500 mg/kg body weight from the initiation of cytotoxic therapy to the resolution of neutropenia.

Measurements: The development of bloodstream or other clinically proven infection, platelet use, and the development of alloimmunity to platelet transfusion.

Results: Clinical infection, bacteremia, and fungemia occurred in 43%, 35%, and 6% of the IVIG-treated patients and in 44%, 34%, and 9% of the control patients. Gram-positive bacteremia and gram-negative bacteremia occurred in 28% and 11% of the IVIG group and in 23% and 13% of the control group. Death due to infection occurred in 4.9% of IVIG recipients and in 2.3% of controls. None of these observations was statistically significant (P > 0.2). Survival to hospital discharge was achieved in 86.6% of the IVIG group and in 96.6% of the control group. The survival difference (10%; 95% CI, 1.7% to 18.3%; P = 0.02) was due to a higher incidence of regimen-related toxic death in the IVIG-treated group.

Conclusions: The use of IVIG did not prevent infection. Fewer deaths occurred among controls due to a higher incidence of fatal hepatic veno-occlusive disease in patients receiving IVIG.

Author and Article Information

From Vanderbilt University, Nashville, Tennessee; Baylor University Medical Center, Dallas, Texas; University of Louisville, Louisville, Kentucky; Washington University, St. Louis, Missouri.
Requests for Reprints: Steven N. Wolff, MD, Bone Marrow Transplant Program, 913 Oxford House, Vanderbilt University, Nashville, TN 37232-4535.
Acknowledgments: The authors thank the physicians, housestaff, fellows, and clinical nurse coordinators at each institution for their assistance in the management of the patients and thank Martin J. Blaser, MD, for critical review of the manuscript.
Grant Support: In part by Sandoz Research Institute.