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OKT3 prophylaxis versus conventional drug therapy: single-center perspective, part of a multicenter trial
L Kahana1, J Narvarte, J Ackermann
1Department of Medicine, University of South Florida, Tampa.
Abstract:
As part of a collaborative study, Orthoclone OKT3 (Ortho Pharmaceutical Corporation, Raritan, NJ) monoclonal anti-T-cell antibody was used prophylactically for 14 days following cadaveric renal transplantation. Patients were randomized before treatment and compared with a control group treated with triple-drug immunosuppressant therapy consisting of cyclosporine, azathioprine, and prednisone. The OKT3 group (also treated with prednisone and azathioprine) had significantly fewer patients with acute rejection during the first year (27% v 60%), significantly delayed onset of acute rejection (median number of days to rejection, 56 v 10), and shortened duration of delayed initial graft function (median number of days on nonfunction, 5.5 v 9.0). OKT3 was safely administered intraoperatively. The study group included diabetics and patients over the age of 50 years. There was an increased incidence of benign fungal infection in patients treated with OKT3. The outcome data of both the prophylactic and control groups in this single-center trial was different from the multicenter experience in that patient and graft survival was 100% in both groups. The only difference in the immunosuppressive protocol was the use of 2 g intravenous methylprednisolone intraoperatively. The combination of intraoperative OKT3 with 2 g methylprednisolone may merit further study. It was concluded that OKT3 prophylaxis reduces the incidence of rejection episodes, delays the occurrence of rejection, and may reduce the duration of delayed initial graft function. It is not associated with an increase in serious infection and can be administered safely to a variety of cadaver transplant recipients.
Insights
Orthoclone OKT3 prophylaxis significantly reduced acute rejection episodes and delayed rejection onset in kidney transplant patients. This treatment also shortened delayed graft function duration without increasing serious infections.
Area of Science:
- Nephrology
- Immunology
- Transplantation Medicine
Background:
- Cadaveric renal transplantation requires effective immunosuppression to prevent rejection.
- Orthoclone OKT3 (monoclonal anti-T-cell antibody) is a potential prophylactic agent.
- Standard triple-drug therapy (cyclosporine, azathioprine, prednisone) is the control.
Purpose of the Study:
- To evaluate the efficacy and safety of prophylactic Orthoclone OKT3 in cadaveric renal transplant recipients.
- To compare OKT3 treatment with standard triple-drug immunosuppression.
- To assess the impact on acute rejection, graft function, and survival.
Main Methods:
- Randomized controlled trial comparing OKT3 prophylaxis (14 days) plus prednisone/azathioprine versus triple-drug therapy.
- Patients received OKT3 intraoperatively.
- Outcomes included acute rejection incidence, onset, delayed graft function, and patient/graft survival.
Main Results:
- Significantly lower acute rejection rates (27% vs. 60%) in the OKT3 group.
- Delayed onset of acute rejection (median 56 vs. 10 days) with OKT3.
- Shortened duration of delayed initial graft function (median 5.5 vs. 9.0 days) with OKT3.
- Increased incidence of benign fungal infections observed with OKT3.
Conclusions:
- Prophylactic Orthoclone OKT3 is effective in reducing acute rejection and delaying its onset post-renal transplant.
- OKT3 may improve early graft function and can be safely administered.
- Further investigation into intraoperative OKT3 combined with high-dose methylprednisolone is warranted.