Induction therapy by anti-thymocyte globulin (rabbit) in renal transplantation: a 1-yr follow-up of safety and efficacy
Article first published online: 4 NOV 2003
Volume 17, Issue 6, pages 539–545, December 2003
How to Cite
Büchler, M., Ligny, B. H. d., Madec, C., Lebranchu, Y. and The French Thymoglobuline Pharmacovigilance Study Group (2003), Induction therapy by anti-thymocyte globulin (rabbit) in renal transplantation: a 1-yr follow-up of safety and efficacy. Clinical Transplantation, 17: 539–545. doi: 10.1046/j.1399-0012.2003.00102.x
- Issue published online: 4 NOV 2003
- Article first published online: 4 NOV 2003
- Accepted for publication 10 March 2003
- polyclonal antibodies;
- renal transplantation;
Abstract: Background: Two hundred and forty cadaveric renal transplant recipients given anti-thymocyte globulin (Thymoglobulin®) as induction immunotherapy were followed up prospectively to review safety and efficacy.
Methods: The median number of infusions was 10 [2–21] with a cumulative dose of 8.8 mg/kg [2.0–23.2 mg/kg]. During the fortnight following transplantation, 231 patients (96%) received a calcineurin inhibitor; all patients were given steroids and azathioprine or mycophenolate mofetil. At 1 yr, 60% of patients were on tripletherapy, 38% on bitherapy, and 2% on monotherapy; 20% had discontinued steroids.
Results: Tolerance was excellent with no cases of anaphylaxis. The commonest adverse event was fever (55%). Eighteen patients developed serum sickness on median day 11 [10–14]. Seven patients had thrombocytopenia; six patients had severe neutropenia. All of these adverse events recovered spontaneously. The overall incidence of delayed graft function was 24%.
At 1 yr patient and graft survival were 98 and 95%, respectively, and creatinine was 135 ± 43 μmol/L. Clinically suspected and biopsy-proven acute rejection were observed in 65 patients (27%) and 34 patients (14%), respectively. There were 62 non-cytomegalovirus (CMV) infections (two fatal) and 81 episodes of CMV infections. Eight malignancies were reported; two possibly related to immunosuppression.
Conclusions: These results demonstrate that anti-thymocyte globulin has a safety profile with good tolerability and excellent efficacy.