Immunoglobulin in Patients with Stem-Cell Transplants

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The summary below is from the full report titled "Should Immunoglobulin Therapy Be Used in Allogeneic Stem-Cell Transplantation? A Randomized, Double-Blind, Dose Effect, Placebo-Controlled, Multicenter Trial." It is in the 1 July 2003 issue of Annals of Internal Medicine (volume 139, pages 8-18). The authors are C. Cordonnier, S. Chevret, M. Legrand, H. Rafi, N. Dhédin, B. Lehmann, F. Bassompierre, and E. Gluckman, for the GREFIG Study Group.

What is the problem and what is known about it so far?

Stem cells are immature blood cells that mature into red blood cells, white blood cells, and platelets. The mature cells carry oxygen to tissues, defend against infection, and prevent bleeding. Life-threatening problems result if patients do not produce stem cells or if powerful cancer treatments or immune body processes destroy stem cells. In either instance, doctors can replace stem cells and restore the body's ability to produce the blood cells that the patient needs. One method that doctors may use is allogeneic stem-cell transplantation (ASCT). In this type of transplantation, patients receive healthy stem cells from another person.

Patients who have ASCT are given powerful drugs that suppress the immune system. These drugs help prevent the body from rejecting the transplant and also prevent transplanted cells from harming the patient's existing cells (graft-versus-host disease). As a result, these patients have problems fighting infections. To help prevent the infections, doctors may give patients a drug that contains antibodies (immunoglobulin). Whether immunoglobulin actually benefits the patients, however, is not proven.

Why did the researchers do this particular study?

To find out whether immunoglobulin is better than placebo (dummy medicine) in preventing adverse results in patients who have ASCT.

Who was studied?

200 patients who had ASCT from 19 French transplantation centers.

How was the study done?

The researchers randomly assigned patients to receive either placebo or one of three dose levels of immunoglobulin. All treatments were given as solutions through a vein once a week. They were started the week before ASCT and were continued until 100 days after ASCT. Neither the researchers nor the patients knew which patients received which solution. The researchers followed patients closely for 180 days after ASCT to assess infections, inflammation between spaces of cells in the lung (interstitial pneumonia), and whether the transplanted cells were toxic for the patient (graft-versus-host disease). They then compared results among the groups.

What did the researchers find?

About 90% of the patients in each group had at least one infection. No major differences were seen between groups in total numbers of infections, interstitial pneumonia, graft-versus-host disease, and deaths. In addition, there was no clear evidence that higher doses of immunoglobulin worked better than lower doses. Patients given higher doses of immunoglobulin had side effects, such as fever and chills, more often than did other patients.

What were the limitations of the study?

The study had a limited ability to detect differences in graft-versus-host disease among groups. It could have missed a lower incidence of this problem in patients given higher doses of immunoglobulin.

What are the implications of the study?

Immunoglobulin does not prevent infections or graft-versus-host disease in people undergoing ASCT.