Immunoprophylaxis with simulect (Basiliximab) in pediatric kidney transplant recipients: results from routine clinical practice at 5 kidney transplant units

Simulect (basiliximab) was introduced in Spain in February 1999, being the first anti–interleukin-2 receptor monoclonal antibody used in our country for the prevention of acute rejection in kidney transplantation. The objective of this study was to assess the efficacy and safety of Simulect (basiliximab) in routine clinical practice in pediatric Spanish kidney transplantation units. In this prospective, observational study, we collected data related to demographics, parameters of efficacy, immunosuppressive therapy, and safety on kidney transplant patients treated with Simulect (basiliximab) using an on-line collection system. Fifty pediatric patients at 5 kidney transplant units with 12 months follow-up included recipient mean age of 10.00 years (DS 5.40). Twenty-nine (58.00%) were boys and 21 (42.00%) were girls. Cold ischemia time was 15 hours and 50 minutes (DS 9.70h). No patient presented with a PRA >50%. For prophylactic immunosuppression, 85.70% of patients received triple therapy with CNI (cyclosporine 48.97% or tacrolimus 36.73%), MMF (87.76%) or AZA (12.24%), and steroids. Acute rejection incidence at 12 months was 22%, including 3 steroid-resistant episodes (6%). One patient lost the graft (2%), 7 adverse events (AE) were reported (1 mild, 4 moderate, and 1 severe AE), of which none were attributed to the study drug. Simulect (basiliximab) treatment of pediatric patients who underwent kidney transplantations performed in routine clinical practice showed good prophylaxis against acute rejection with excellent safety.