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Initial data on basiliximab in critically ill children undergoing heart transplantation
Katrina A Ford1, Catherine M Cale, Philip G Rees
1Pharmacy Department, Great Ormond Street Hospital for Children, London, United Kingdom. fordk2@gosh.nhs.uk
Summary
Basiliximab is a safe and effective option for pediatric heart transplant patients with renal impairment, showing a low rejection rate. Further research is needed to confirm its efficacy, especially in patients on extracorporeal membrane oxygenation (ECMO).
Area of Science:
- Pediatric Cardiology
- Transplantation Immunology
- Nephrology
Background:
- Increasing number of pediatric heart transplant recipients require extracorporeal membrane oxygenation (ECMO), inotropic support, or have renal impairment.
- Basiliximab, an anti-CD25 monoclonal antibody, has not been previously studied in critically ill pediatric heart transplant recipients.
- Basiliximab offers potential benefits for patients with renal impairment due to its favorable profile.
Purpose of the Study:
- To evaluate the safety and efficacy of basiliximab in critically ill pediatric heart transplant recipients.
- To assess the impact of basiliximab on rejection rates and renal function in this vulnerable population.
- To explore the use of basiliximab in conjunction with modified calcineurin inhibitor regimens.
Main Methods:
- Basiliximab was administered to 29 pediatric heart transplant recipients (median age 7.8 years) on ECMO, with renal impairment, or on inotropes.
- Patients received standard basiliximab dosing (Day 0 and Day 4), with low-dose or withheld calcineurin inhibitors for renal impairment.
- CD25 levels were monitored using flow cytometry.
Main Results:
- A low incidence of severe acute rejection (4 episodes in 6 months) was observed.
- Glomerular filtration rate improved or returned to baseline in most patients within 1 month post-transplant.
- Basiliximab was well-tolerated with low infection rates and no reported adverse effects; CD25 was undetectable for 2-3 weeks post-administration.
Conclusions:
- Basiliximab is well-tolerated and associated with a low rejection rate in critically ill pediatric heart transplant recipients, particularly those with renal dysfunction.
- Modified calcineurin inhibitor protocols can be safely used with basiliximab in renal impairment.
- Further large-scale randomized trials are necessary to confirm these findings, especially regarding potential reduced efficacy in patients on post-transplant ECMO.