The chimaeric monoclonal antibody basiliximab specifically binds the a subu
nit of the interleukin-2 (IL-2) receptor on activated T lymphocytes. Throug
h competitive antagonism of IL-2, basiliximab supplements standard immunosu
ppressive therapy after renal transplantation.
less than or equal to 24 hours after a single intravenous dose of basilixim
ab 2.5 to 25mg, approximate to 90% of available IL-2 receptors on T lymphoc
ytes were complexed with the drug. This level of basiliximab binding was ma
intained for 4 to 6 weeks when renal transplant patients received basilixim
ab 20mg 2 hours before and then 4 days after transplantation surgery.
In 2 large, well-designed trials, the percentage of patients with biopsy-co
nfirmed acute rejection episodes after renal transplantation was significan
tly lower with basiliximab 20mg (administered 2 hours before and then 4 day
s after transplantation surgery; 30 or 33%, respectively) than placebo (44
or 46%) at 6 months after surgery.
Basiliximab was well tolerated during clinical trials. The incidence of inf
ections (including active cytomegalovirus infection) and post-transplant ly
mphoproliferative disorders was similar with basiliximab and placebo. Cytok
ine release syndrome was not observed in patients who received basiliximab.