Reduction of the occurrence of acute cellular rejection among renal allograft recipients treated with basiliximab, a chimeric anti- XXXX -receptor monoclonal antibody. United States Simulect Renal Study Group.

@entity1 @entity230 @entity8 @entity205 @entity1011 @entity1199
BACKGROUND: A double-blind, placebo-controlled phase III study was performed to assess whether basiliximab, a chimeric anti- @entity1199 receptor monoclonal antibody, reduced the incidence of acute rejection episodes in renal allograft recipients. METHODS: A total of 348 @entity1 were randomized into two demographically matched, equally sized groups treated with either basiliximab or placebo. The dose of basiliximab-20-mg infusions on day 0 and day 4-was selected to block detection of @entity1199 receptor on 97% of peripheral blood lymphocytes for 30-45 days. All @entity1 received immunosuppressive therapy with @entity205 microemulsion (Neoral) and @entity230 . An intent-to-treat analysis of 1-year data assessed the incidence of posttransplant acute rejection episodes, @entity1 and graft survival rates, and the safety and tolerability of basiliximab. RESULTS: Among the eligible 346 @entity1 equally divided into the two treatment groups, basiliximab reduced the proportion of @entity1 who experienced biopsy-confirmed acute rejection episodes by 28%: 61 (35.3%) basiliximab vs. 85 (49.1%) placebo (P=0.009). Graft losses occurred in 9 (5.2%) basiliximab-treated and 12 (6.9%) placebo-treated @entity1 . Five (2.9%) deaths in the basiliximab group and seven (4.0%) in the placebo group occurred. Compared with placebo, a higher fraction of basiliximab @entity1 produced urine in the operating room, and a significantly lower fraction had @entity8 in the first month (serum @entity1011 > or =5 mg(dl) and between 1 and 12 months (serum @entity1011 > or =3 mg/dl). During the first 12 months, 94 (54%) basiliximab-treated @entity1 experienced serious adverse events, compared with 106 (61%) who received placebo. CONCLUSIONS: Prophylactic basiliximab therapy is well tolerated, has an adverse event profile comparable to placebo, and significantly reduces the number of acute rejection episodes in renal allograft @entity1 within the first year after transplantation.
