Clinical studies 

 

The efficacy of basiliximab in prophylaxis of organ rejection in de novo renal transplantation has been demonstrated in double-blind placebo-controlled studies. Results from two pivotal 12-month multicentre studies (722 patients in total) comparing basiliximab with placebo show that basiliximab, used concomitantly with ciclosporin for microemulsion and corticosteroids, significantly reduces the incidence of acute rejection episodes both within 6 (31% vs. 45%, p<0.001) and 12 (33% vs. 48%, p<0.001) months after transplantation. There was no significant difference between basiliximab and placebo-treated patients in graft survival after 6 and 12 months (at 12 months 32 graft losses on basiliximab (9%) and 37 graft losses on placebo (10%)). The incidence of acute rejection episode was substantially lower in patients receiving basiliximab and a triple drug immunosuppressive regimen.

 

Results from two multicentre double-blind studies comparing basiliximab with placebo (463 patients in total) show that basiliximab significantly reduces the incidence of acute rejection episodes within 6 months after transplantation when used concomitantly with ciclosporin for microemulsion, corticosteroids, and either azathioprine (21% vs. 35%) or mycophenolate mofetil (15% vs. 27%). Graft loss occurred in 6% of basiliximab-treated and 10% of placebo-treated patients by 6 months. The adverse event profile remained comparable between treatment groups.

 

In a pooled analysis of two five-year open-label extension studies (586 patients total) the combined graft and patient survival rates were not statistically different for the basiliximab and placebo groups. Extension studies also showed that patients who experienced an acute rejection episode during the first year after transplantation experienced more graft losses and deaths over the five-year follow-up period than patients who had no rejection. These events were not influenced by basiliximab.

 

Paediatric population  

 

The efficacy and safety of basiliximab were eva luated in two paediatric studies.

 

Basiliximab was used concomitantly with ciclosporin for microemulsion and steroids in an uncontrolled study in 41 paediatric de novo renal transplant recipients. Acute rejection occurred in 14.6% of patients by 6 months post-transplantation, and in 24.3% by 12 months. Overall the adverse event profile was consistent with general clinical experience in the paediatric renal transplantation population and with the profile in the controlled adult transplantation studies.