The long-term effects of prophylactic OKT3 monoclonal antibody in cadaver kidney transplantation--a single-center, prospective, randomized study.
We conducted a randomized, prospective study to determine the long-term effects of prophylactic OKT3 in cadaveric renal transplantation. In the first group of patients (n = 56) OKT3 (5 mg/day) was administered for the first 14 postoperative days in association with azathioprine (AZA) and low-dose steroids, cyclosporine (CsA) being introduced on day 11. The other group of patients (n = 52) received CsA from the first POD, together with AZA and steroids. Both protocols were identical from POD 14 on. The total number of infections was higher in OKT3 patients (124/1455 patient-months [P-M] vs. 68/1320 in CsA patients, P less than 0.001) without impact on patient survival (94.5% in OKT3 vs. 93% in CsA patients). OKT3 patients experienced a lower number of rejection episodes (61 per 1455 P-M of risk exposure vs. 81/1320 in CsA patients, P less than 0.05). In addition, the frequency of corticoresistant rejection episodes was lower in OKT3 patients (9 out of 61 vs. 24 out of 81 in CsA patients, P less than 0.05). This resulted in a trend toward improved overall graft survival (83% vs. 75%, P = 0.12) and in a significant increase in immunological graft survival (92% vs. 79%, P = 0.02) in OKT3 patients at 3 years. Taken together, these data suggest that prophylactic OKT3 therapy might have long-term beneficial effects in cadaveric renal transplantation.
Abramowicz
D
D
Department of Nephrology, Cliniques Universitaires de Bruxelles, Hospital Erasme, Belgium.
Goldman
M
M
De Pauw
L
L
Vanherweghem
J L
JL
Kinnaert
P
P
Vereerstraeten
P
P
D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use*; D002102:Cadaver; D005260:Female; D006084:Graft Rejection / Q000187:drug effects; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007114:Immunization; D016030:Kidney Transplantation / Q000009:adverse effects / Q000276:immunology* / Q000502:physiology; D008297:Male; D011446:Prospective Studies; D012514:Sarcoma, Kaposi / Q000209:etiology; D013997:Time Factors
D000911:Antibodies, Monoclonal