Ten-Year Results Show Thymoglobulin Outperforms Lymphocyte Immune Globulin for Induction Therapy in Renal Transplant Recipients: Presented at ATC

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Title: Ten-Year Results Show Thymoglobulin Outperforms Lymphocyte Immune Globulin for Induction Therapy in Renal Transplant Recipients: Presented at ATC
URL: http://www.pslgroup.com/dg/2231FE.htm
Doctor's Guide
June 6, 2008

By Thomas S. May

TORONTO -- June 6, 2008 -- Ten-year results from a randomised, double-blind trial indicate that thymoglobulin 1.5 mg/kg is safer and more effective than lymphocyte immune globulin 15 mg/kg for induction immunosuppressive therapy in adult kidney transplant recipients.

The study was presented here in a poster session on June 1 at the 2008 American Transplant Congress (ATC).

Between May of 1996 and March of 1997, Karen Hardinger, PharmD, Department of Pharmacy, University of Missouri, Kansas City, Missouri, and colleagues randomised 72 patients in a 2:1 ratio to receive IV thymoglobulin 1.5 mg/kg or lymphocyte immune globulin 15 mg/kg intraoperatively and then daily for at least 6 days.

After 10 years of follow-up, the primary composite endpoint of patient and graft survival, and event-free survival was higher with thymoglobulin compared with lymphocyte immune globulin (48% vs 29%; P = .011). Patient survival (75% vs 67%) and graft survival (48% vs 50%) were similar, while acute rejection remained lower in the thymoglobulin group (13% vs 33%, P = .007).

The incidence of all types of cancer was numerically lower with thymoglobulin compared with lymphocyte immune globulin (8% vs 21%); however, this result was not statistically significant. There was no post-transplant lymphoproliferative disorder in the thymoglobulin arm and there were 2 cases in the lymphocyte immune globulin arm. There was no late cytomegalovirus disease in either group.

Mean serum creatinine levels were higher in the thymoglobulin arm (1.7 vs 1.2 mg/dL; P = .003), while estimated glomerular filtration rates were similar in the 2 groups (49 vs 65 mL/min; P = NS). Overall, there were 0.53 quality-adjusted life years gained with thymoglobulin compared with lymphocyte immune globulin (3.68 vs 3.15).

Dr. Hardinger concluded, "The data indicate that thymoglobulin is superior to [lymphocyte immune globulin], with regards to the triple composite endpoint and quality-adjusted life years, and it also appears to be safer, with fewer cases of post-transplant lymphoproliferative disorder and viral infection."

Funding for this study was provided by Genzyme Corporation.

[Presentation title: A Randomized, Double-Blinded Comparison of Thymoglobulin Versus Lymphocyte Immune Globulin for Induction Immunosuppressive Therapy in Adult Renal Transplant Recipients: 10 Year Results. Abstract 984]

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