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A randomized prospective trial of prophylactic immunosuppression with ATG-fresenius versus OKT3 after renal
H A Bock1, H Gallati, R M Zürcher
1Department of Internal Medicine, Kantonsspital Basel, Switzerland.
Abstract:
We carried out a randomized prospective trial to compare OKT3 (5 mg/d, 51 patients) with ATG-Fresenius (ATG-F, 4 mg/kg/d, 53 patients) for induction therapy after renal transplantation, concerning side effects, rejection, and infection incidence within a one year follow-up period. Concomitant immunosuppression included azathioprine/steroids from day 0 and cyclosporine A from day 4. OKT3 patients experienced significantly more and more-severe side effects, particularly pyrexia, headache, and pulmonary fluid overload. One-year graft survival was excellent in the ATG-F group (91%), but only 78% in the OKT3 group (P < 0.05) due to a series of rejections that occurred beyond day 100; patient survival (96% and 92%) was similar in both groups. OKT3-treated patients experienced more biopsy-proven rejections (0.6 +/- 0.1/pt.) than ATG-F patients (0.3 +/- 0.1, P < 0.05), and there was a similar, albeit not significant trend in clinical rejections (OKT3: 1.1 +/- 0.2/pt.; ATG-F: 0.8 +/- 0.1/pt.). Infections were more common in the OKT3 group (OKT3: 3.2 +/- 0.3, ATG-F: 2.0 +/- 0.2, P < 0.05), although this was entirely attributable to "minor" infections. On days 1 through 6, CD3 counts were more profoundly depressed with OKT3 therapy. Beyond day 10, however, CD3 counts were lower in the ATG-F group, as were CD2 counts, CD4 counts, and the CD4/CD8 ratio, suggesting a more prolonged immunosuppressive effect of ATG-F. Sensitization occurred more frequently with OKT3 (31%) than with ATG-F (10%), but was usually irrelevant, except in two patients (one in each group), whose grafts were lost because of immunization against OKT3 and ATG-F, respectively. In conclusion, a 7-day induction therapy with OKT3 does not improve outcome or diminish immunological graft loss when compared with ATG-F, but is associated with more rejections, infections, and side effects. ATG-F appears to be preferable for induction immunosuppression after renal transplantation.
Insights
OKT3 induction therapy after renal transplantation led to more side effects, rejections, and infections compared to ATG-Fresenius (ATG-F). ATG-F demonstrated superior one-year graft survival, making it a preferable choice for immunosuppression.
Area of Science:
- Nephrology
- Immunology
- Transplantation
Background:
- Induction therapy is crucial for preventing early rejection after renal transplantation.
- Optimizing immunosuppressive regimens balances efficacy with side effect profiles.
Purpose of the Study:
- To compare the efficacy and safety of OKT3 versus ATG-Fresenius (ATG-F) as induction therapy in renal transplant recipients.
- To evaluate differences in side effects, rejection rates, infection incidence, and graft survival over one year.
Main Methods:
- A randomized prospective trial involving 104 renal transplant patients.
- Patients received either OKT3 (5 mg/d) or ATG-F (4 mg/kg/d) for induction.
- Concomitant immunosuppression included azathioprine/steroids and cyclosporine A.
Main Results:
- OKT3 group experienced significantly more severe side effects (pyrexia, fluid overload) and infections.
- One-year graft survival was higher with ATG-F (91%) than OKT3 (78%, P < 0.05).
- OKT3 group had more biopsy-proven rejections and higher CD3 counts post-induction, suggesting less prolonged immunosuppression.
Conclusions:
- OKT3 induction therapy is associated with increased rejections, infections, and side effects compared to ATG-F.
- ATG-F appears to be a preferable agent for induction immunosuppression in renal transplantation, offering better graft survival.
- Both therapies showed similar patient survival rates.