Randomized double-blind study of immunoprophylaxis with basiliekimab, a chimeric anti-interleukin-2 receptor monoclonal antibody, in combination with mycophenolate mofetil-containing triple therapy in renal transplantation

被引:107
作者
Lawen, JG
Davies, EA
Mourad, G
Oppenheimer, F
Molina, MG
Rostaing, L
Wilkinson, AH
Mulloy, LL
Bourbigot, BJ
Prestele, H
Korn, A
Girault, D
机构
[1] Novartis Pharma AG, Basel, Switzerland
[2] Hop La Cavale Blanche, Brest, France
[3] Med Coll Georgia, Augusta, GA 30912 USA
[4] Univ Calif Los Angeles, Sch Med, Los Angeles, CA USA
[5] Hop Rangueil, Toulouse, France
[6] Hosp Carlos Haya, Dept Nephrol, Malaga, Spain
[7] Hosp Clin Barcelona, Dept Nephrol, Barcelona, Spain
[8] Hop Lapeyronie, Montpellier, France
[9] Ohio State Univ, Med Ctr, Div Transplantat, Columbus, OH 43210 USA
[10] Queen Elizabeth 2 Hlth Sci Ctr, Halifax, NS, Canada
关键词
D O I
10.1097/00007890-200301150-00007
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Background. Acute rejection remains a major problem in renal transplantation. Immunoprophylaxis with basiliximab (Simulect) has achieved significant reductions in acute rejection episodes in renal allograft recipients receiving dual immunosuppression. This study explored the tolerability and cumulative benefit of combining basiliximab with triple-drug therapy-cyclosporine (USP Modified, Neoral), mycophenolate mofetil, and steroids. Methods. In a randomized, double-blind, placebo-controlled, multicenter study, 123 kidney transplant recipients received either basiliximab at 20 mg before transplantation (day 0) and 20 mg on day 4 (n=59), or placebo (n=64). All received triple-drug immunosuppression and were followed for 6 months. Results. Tolerability of basiliximab was equivalent to placebo, with no increase in serious adverse events, infection, malignancy, or post-transplant lymphoproliferative disorder. At 6 months, there were trends in favor of basiliximab over placebo in the incidences of first biopsy-confirmed acute rejection (15.3% vs. 26.6%, P=NS) and of acute rejection treated with antibody (5.1% vs. 15.6%, P=NS). Kaplan-Meier estimates at 4 weeks and 6 months were significantly in favor of basiliximab treatment for first acute rejection, biopsy-confirmed rejection, rejection episodes treated with antibody therapy, and treatment failure. Renal function improved more rapidly in the basiliximab group, with mean creatinine clearance at week 2 being 54.7 mL/min versus 43.2 mL/min for placebo (P=0.034). At 12 months, patient survival was 100% in both groups; graft survival was 94.9% with basiliximab and 92.2% with placebo. Conclusions. Basiliximab immunoprophylaxis is safe, well tolerated, and shows a trend toward reduction in number of acute rejection episodes in renal transplant patients receiving cyclosporine, mycophenolate mofetil, and steroids.
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页码:37 / 43
页数:7
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