Intravenous Gammaglobulin (IVIG): A Novel Approach to Improve Transplant Rates and Outcomes in Highly HLA-Sensitized Patients

S. C. Jordan; A. A. Vo; A. Peng; M. Toyoda; D. Tyan

Disclosures

American Journal of Transplantation. 2006;6(3):459-466. 

In This Article

Complications and Cost of IVIG Therapy

Unlike the use in immunodeficiency, patients who are highly HLA-sensitized require higher doses (1-2 g/kg/dose) to achieve a beneficial outcome. The use of higher doses and concentrations of IVIG products results in higher rates of infusion-related complications that were, at first, not anticipated and were poorly understood. We have recently reviewed the complications associated with IVIG infusions in patients with normal renal function and those on dialysis.[25] Briefly, the safety of IVIG infusion (2 g/kg) doses given over a 4-h hemodialysis session, monthly 4 times versus placebo (0.1% albumin) in equivalent doses was studied in the IGO2 trial.[14] The results are shown in Table 1 . There were more than 300 infusions in each arm of the study using Gamimune N 10% versus placebo. Adverse events were similar in both arms of the study (24 IVIG vs. 23 placebo). The most common adverse event in the IVIG arm was headache (52% vs. 24%, p = 0.056). This usually abated with reduction in infusion rate and Tylenol®. Ten serious adverse events were noted, nine were in the placebo group. Thus, we concluded from this double-blind placebo-controlled trial that high-dose IVIG infusions during hemodialysis are safe.

IVIG is an expensive therapy and ultimately, insurers and hospitals question the use of this drug for desensitization. Is it cost-effective? Data do exist in this regard[5,14] Currently, a four dose course of IVIG for a 70 kg person at 2 g/kg would cost $25 000-$26 000. However, one must compare this to the cost of maintaining patients on dialysis, which is the only other option. In the IGO2 study,[14] the calculated cost savings was ~$300 000/patient transplanted versus those who remained on dialysis for the 5 years of the study. Data from USRDS (2001) and others also confirms that a considerable cost savings to Medicare is seen in patients transplanted versus those who remain on dialysis.[2,35]

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