Taking an interleukin-2 receptor monoclonal antibody in addition to other immunosuppressants following kidney transplantation led to a 32% reduction in the incidence of acute rejection in a study that involved 21 centers in Europe and Canada.
The randomized, double-blind, placebo-controlled phase III study was led by Dr. Björn Nashan of the CHIB 201 International Study Group.
"Prophylaxis with 40 mg basiliximab [Simulect] reduces the incidence of acute rejection episodes significantly, with no clinically relevant safety or tolerability concerns," the researchers reported on October 25 in The Lancet (1997;350:1193-1198).
All of the patients took steroids and the immunosuppressant Sandimmune throughout the study. In addition, about half of the patients received a 20-mg infusion of basiliximab on the day of the transplant and another 20-mg infusion four days later; the other half of the patients received a placebo.
Acute rejection occurred in 51 (30%) of the 171 patients receiving basiliximab and in 73 (44%) of the 166 patients receiving placebo.
The reduction in the incidence of acute rejection "was apparent immediately after transplantation," the investigators reported. A year after surgery, the incidence of rejection had grown to 38% in the basiliximab group and 55% in the placebo group.
An additional benefit of basiliximab was that, in the first month after surgery, patients who received the IL-2 receptor required significantly lower doses of steroid.
The study was supported by a grant from Novartis Pharma AG, maker of basiliximab and Sandimmune.
For Your Information:
Dr. Björn Nashan
Klinik fur Abdominal-und Transplantationschirurgie, Medizinische Hochschule Hannover
Carl-Neuberg-Strasse 1, 30625 Hannover, Germany
nashan@TX-Amb.MH-Hannover.de
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