RESUMEN
UNLABELLED: rATG is used for HTx induction but is costly and associated with infection and PTLD. HYPOTHESIS: Tailoring rATG induction with CD3 monitoring results in less infection, reduced costs, and similar rejection. Retrospective review of HTx recipients receiving rATG induction. Control cases received "usual" rATG dosing (1.5 mg/kg/day typically × 5 days). Starting in October 2009, absolute CD3 monitoring (target <25 cells/mm(3) ) guided rATG dosing (study cases). Outcomes included first-year incidence of infection/rejection, direct costs of therapy, and incidence of PTLD/death. Study cases (n = 32) received fewer doses of rATG (median 4 vs. 5, p < 0.001) and less total rATG (median 3.2 vs. 7.4 mg/kg, p < 0.001) compared with controls (n = 17). There was no difference in incidence of infection, rejection, or patient survival during the first year post-HTx. There was one early death in both groups and one late case of PTLD in the control group. Drug savings were significant (median drug cost per patient $2718 vs. $4756, p < 0.001). CD3-tailored rATG induction in HTx recipients is associated with reduced drug costs and similar rates of rejection/infection. Longer follow-up will determine whether extended benefits are associated with this induction monitoring strategy.
Asunto(s)
Cardiomiopatías/terapia , Insuficiencia Cardíaca/terapia , Trasplante de Corazón/métodos , Síndrome del Corazón Izquierdo Hipoplásico/terapia , Terapia de Inmunosupresión/métodos , Monitorización Inmunológica/métodos , Adolescente , Suero Antilinfocítico/uso terapéutico , Complejo CD3/metabolismo , Cardiomiopatías/inmunología , Niño , Preescolar , Femenino , Estudios de Seguimiento , Rechazo de Injerto , Insuficiencia Cardíaca/inmunología , Humanos , Síndrome del Corazón Izquierdo Hipoplásico/inmunología , Inmunosupresores/uso terapéutico , Lactante , Recién Nacido , Masculino , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
INTRODUCTION: Real-world data with extended-release tacrolimus (ER-T) are lacking in the USA. This study examined clinical outcomes and healthcare resource utilization in kidney transplant patients receiving ER-T in clinical practice. METHODS: This was a retrospective, single-center analysis (February-June 2016) using data from Northwestern University's Enterprise Data Warehouse. Adult patients receiving a kidney transplant in the preceding 4 years, treated de novo or converted to ER-T from immediate-release tacrolimus (IR-T) within 10 days post-transplantation, and maintained on ER-T (at least 3 months) were included. Patients were matched for demographic and clinical characteristics with IR-T-treated control patients. Endpoints included clinical outcomes and healthcare resource utilization up to 1 year post-transplantation. RESULTS: A total of 19 ER-T-treated patients were matched with 55 IR-T-treated patients. No ER-T-treated patients experienced biopsy-confirmed acute rejection (BCAR) or graft failure versus 3 (5.5%) and 3 (5.5%) IR-T-treated patients, respectively. Mean estimated glomerular filtration rate (eGFR), the number of all-cause outpatient visits, readmissions, and all-cause hospitalization days were comparable between groups. Tacrolimus trough levels, days to target level (6-10 ng/mL), and number of required dose adjustments were also similar. CONCLUSION: Real-world clinical outcomes and healthcare resource utilization were similar with ER-T and IR-T. Larger studies will need to investigate the trend toward fewer BCAR events, and increased graft survival with ER-T. FUNDING: Astellas Pharma Global Development, Inc. Plain language summary available for this article.