Induction therapy by anti-thymocyte globulin (rabbit) in renal transplantation: a 1-yr follow-up of safety and efficacy.
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 micromol/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.
Büchler
Matthias
M
Service Nephrologie et Immunologie Clinique, CHU Bretonneau,Tours, France.
Hurault de Ligny
Bruno
B
Madec
Corinne
C
Lebranchu
Yvon
Y
D000328:Adult; D000818:Animals; D000961:Antilymphocyte Serum / Q000009:adverse effects / Q000627:therapeutic use*; D002102:Cadaver; D015331:Cohort Studies; D003586:Cytomegalovirus Infections / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000453:epidemiology / Q000517:prevention & control*; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016030:Kidney Transplantation; D008297:Male; D011446:Prospective Studies; D011817:Rabbits; D013997:Time Factors
D000961:Antilymphocyte Serum; D007166:Immunosuppressive Agents