Immunoprophylaxis with Simulect (basiliximab) in pediatric kidney transplant recipients: results from routine clinical practice at 5 kidney transplant units.
BACKGROUND
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.


METHODS
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.


RESULTS
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 9.70 h). 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.


CONCLUSIONS
Simulect (basiliximab) treatment of pediatric patients who underwent kidney transplantations performed in routine clinical practice showed good prophylaxis against acute rejection with excellent safety.
García Meseguer
C
C
Hospital La Paz Infantil, Madrid, Spain
Vila López
A
A
Luque de Pablos
A
A
Vallo Boado
A
A
Simon
J M
JM
D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D000077552:Basiliximab; D002648:Child; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology*; D008297:Male; D009862:Online Systems; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins; D012449:Safety; D013030:Spain; D013997:Time Factors; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab