BASILIXIMAB (SIMULECT???) REDUCES ACUTE REJECTIONS, CMV-INFECTIONS AND DURATION OF HOSPITAL STAY IN RENAL ALLOGRAFT PATIENTS

Abstract

709 Purpose: Basiliximab (Simulect™, SDZ CHI 621) is a chimeric mAb against the α-chain of the IL-2 receptor (CD25). Its efficacy and safety in renal transplantation was determined in a multicenter, randomised, double-blind, placebo controlled phase-III trial. Here we present the data of 41 consecutive patients treated at our institution. Methods: Fourty-one recipients of primary mismatched cadaveric kidney allografts were enrolled in this study between 4/95 and 1/96. Twenty-one patients received two 20-mg doses of basiliximab and twenty patients received placebo on day 0 and 4, respectively. Baseline immunosuppression consisted of the new CyA-microemulsion (Neoral™), target levels: 150-200 ng/ml, and low dose corticosteroids. Primary objective was the incidence of acute rejections during the first six month. Secondary objectives were the safety and tolerability of basiliximab, as well as patient and graft survival up to 12 month post-transplantation. Results: [1] No significant differences regarding sex, height, weight, cold ischemic time, initial non function, time on dialysis, or history of end-stage renal disease could be observed between both treatment groups. [2] Biopsy proven acute rejections were significantly reduced in the basiliximab treated group compared with the placebo group: 28,6 % versus 55%,(p<0.05). [3] No steroid resistant acute rejections were seen in the basiliximab group vs. five (25%) in the placebo group (p=0.02). [4] One CMV-infection (4%) was observed in the basiliximab treated group, compared with five CMV-infections (25%) in the placebo group (p=0.02). [5] The incidence of bacterial infections (mainly UTI) was slightly decreased in the basiliximab group. [6] Patient survival at 24 month was 100 % in both groups.[7] Two patients lost their graft in the basiliximab group (venous thrombosis of the graft) and one patient in the placebo group (anaemic infarction of the kidney). [8] No post-transplant lymphoproliferative disorders occurred up to 24 month. [9] Acute tolerability was excellent, with no signs of cytokine release syndrome. [10] The initial hospital stay was longer in the placebo group (35 days; range: 7-73) compared with the basiliximab group (25 days; range: 4-58). Conclusion: Basiliximab was well tolerated in kidney transplanted recipients. Prophylactic treatment with 40-mg of basiliximab significantly reduces the incidence and severity of acute rejections, the incidence of CMV-infections and the duration of hospital stay in renal allograft patients.