Immunosuppressive Induction Therapy Using the Antithymocyteglobulin Grafalon: A Single-Center Non-Interventional...

Area of Science:

• Immunology
• Transplantation Medicine
• Clinical Pharmacology

Background:

• Controversy surrounds depleting antibody induction therapy in liver transplantation (LT).
• Rabbit antithymocyte globulin (ATG) (Thymoglobulin) has been a standard LT induction agent since 1984.
• Limited data exists on Grafalon (ATG-F) as an LT induction agent.

Purpose of the Study:

• To assess the safety and efficacy of Grafalon induction therapy in LT.
• To characterize the clinical effects of Grafalon in LT patients.
• To evaluate Grafalon's impact on rejection, infections, and survival.

Main Methods:

• Observational, non-interventional study of 80 deceased donor LT recipients.
• Grafalon administered as part of standard immunosuppression (March 2021-November 2022).
• Monitoring for leukocytopenia, thrombocytopenia, biopsy-proven acute rejection (BPAR), infections, and survival.

Main Results:

• Thrombocytopenia (64%) and leukocytopenia (31%) peaked postoperatively day 4; no severe leukocytopenia after week 1.
• Bacterial infections occurred in 28% (localized) and 21% (bacteremia).
• 12.5% BPAR rate and 90% one-year survival observed.

Conclusions:

• Grafalon demonstrates safety and efficacy as an induction agent in LT.
• Further research is needed on long-term Grafalon effects and comparative studies.
• Grafalon represents a viable option for LT induction therapy.