Estudio primario

No clasificado

Immunoprophylaxis with basiliximab compared with antithymocyte globulin in renal transplant patients receiving MMF-containing triple therapy.

Año 2002
Revista American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons
Enlaces Pubmed , DOI

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Acute graft rejection remains a major problem in renal transplant recipients, and there is no consensus on the optimal immunosuppressive strategy. Immunoprophylaxis with Thymoglobulin or basiliximab has significantly reduced the incidence of acute rejection episodes and graft loss following kidney transplantation. This open, randomized, multicenter study investigated the efficacy and tolerability of basiliximab (20mg day 0-day 4) plus early cyclosporine from day 0 (n = 50) compared with Thymoglobulin plus delayed cyclosporine (n = 50) in adult kidney transplant patients. In addition, all patients received steroids and mycophenolate mofetil (MMF) at standard doses from day 0. Patient and graft survival rates at 12 months were 98 and 94% in the basiliximab group, respectively, compared with 100 and 96% in the Thymoglobulin' group. The incidences of biopsy-confirmed acute rejection (8.0% in each group) and treatment failure (14% in the basiliximab group vs. 8% in the Thymoglobulin group) were comparable in the two groups. There was a non-significant tendency to more dialysis (14 vs. 6%), and fewer cytomegalovirus (CMV) infections (p = 0.005) in the basiliximab group, but the percentage of clinical CMV was not different between the two groups (6 vs. 12%). Both strategies give excellent results, despite the differences in patterns, in nonhyperimmunized patients receiving their first cadaveric renal allograft.

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Estudio primario

No clasificado

Influence of basiliximab induction therapy on long term outcome after liver transplantation, a prospectively randomised trial.

Año 2007
Revista Annals of transplantation : quarterly of the Polish Transplantation Society
Enlaces Pubmed

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BACKGROUND:

In OLT induction therapy with interleukin-2-receptor antibodies is often applied as part of the standard immunosuppression protocol. It was the aim of this study to determine if Basilixirnab mduction therapy serves to reduce the incidence of acute rejection episodes and improves graft function and survival in the long term after OLT.

MATERIAL/METHODS:

We prospectively analysed 99 patients transplanted at our institution (1997-2000). Patients were randomised to two study groups: 51 patients received Basiliximab induction combined with Calcineurin inhibitors and steroids, 48 patients received CNIs and steroids only. Incidence and severity of rejection, graft and patient survival and intensity of long-term immunosuppression were analysed. Frequency of CNI and steroid induced adverse effects were recorded.

RESULTS:

In our patient collective we could not detect a significant impact of Basiliximab induction therapy on the fre queny of acute or chronic rejection. CNI levels were almost identical in both groups; graft and patient survival rates were not influenced by the application of induction therapy.

CONCLUSIONS:

In our patient collective induction therapy does not have a general positive influence on the post transplant course. A slight improvement in long term renal function could be detected for Basiliximab treated patients.

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Estudio primario

No clasificado

Steroid-free, tacrolimus-basiliximab immunosuppression in pediatric liver transplantation: clinical and pharmacoeconomic study in 50 children.

Año 2008
Revista Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society
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Corticosteroid-free immunosuppression (IS) may be potentially beneficial for transplanted patients, particularly children. The purpose of this study was to evaluate the efficacy and cost of such strategy in primary pediatric liver transplantation (LT). Fifty pediatric LT recipients were prospectively treated with a steroid-free, tacrolimus-basiliximab-based IS (group TB). A group of 34 children transplanted under a conventional tacrolimus-steroids regimen served as control series (group TS). Groups TB and TS were compared regarding patient and graft survival, rejection incidence, infectious complications, and growth, as well as cost of the transplant procedure. Patient and graft survivals at 3 years were 96% and 94% in group TB, versus 91% and 88% in group TS (P = 0.380 and P = 0.370, respectively). Rejection-free graft survival at 3 years was 72% in group TB, versus 41% in group TS (P = 0.007). Patients in group TB had significantly less viral infections than patients in group TS (P = 0.045). Height standard deviation score was significantly enhanced in children from group TB, when compared to group TS. Medical care costs were similar in both groups. Steroid avoidance together with basiliximab immunoprophylaxis was not harmful in terms of allograft acceptance, and even seemed to be beneficial in the long term.

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Estudio primario

No clasificado

Multicenter, randomized study of the effectiveness of basiliximab in avoiding addition of steroids to cyclosporine a monotherapy in renal transplant recipients.

Año 2005
Revista Transplantation
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BACKGROUND:

Steroid therapy is associated with an increased risk of cardiovascular events and well-documented adverse effects, but two thirds of patients initiated on monotherapy with cyclosporine A (CsA) microemulsion require addition of steroids.

METHODS:

In this 12-month randomized, double-blind, multicenter study, 108 renal transplant recipients were randomized and received basiliximab (n=52) or placebo (n=56) to assess whether basiliximab reduces the need for addition of steroids or other adjunctive immunosuppressive drugs to CsA monotherapy.

RESULTS:

The primary endpoint of the study (requirement for additional immunosuppression at 12 months posttransplant) occurred significantly less frequently with basiliximab (54%) than placebo (73%) (P=0.046). By the end of the study, 25% of basiliximab-treated patients were receiving maintenance steroids versus 61% of placebo-treated patients (P=0.0006). During the trial, 33% of basiliximab-treated patients received oral steroids at some time compared with 61% of placebo-treated patients (P=0.004). The proportion of patients experiencing biopsy-proven rejection was not significantly different between the basiliximab (29%) and placebo (43%) groups (P=0.16). Median serum creatinine at 12 months was 141 mumol/L with basiliximab and 164 mumol/L with placebo (not significant). One-year graft and patient survivals were 88% and 98% for basiliximab and 88% and 96% for placebo (not significant), respectively. Adverse events were similar in the basiliximab and placebo treatment groups.

CONCLUSIONS:

These findings demonstrate that the addition of basiliximab significantly reduces the need to modify the initial treatment regimen in patients scheduled to receive steroid-free CsA therapy, suggesting that basiliximab induction may be useful as a strategy in other steroid-avoidance regimens.

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Estudio primario

No clasificado

Sequential protocols using basiliximab versus antithymocyte globulins in renal-transplant patients receiving mycophenolate mofetil and steroids.

Año 2004
Revista Transplantation
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BACKGROUND:

Sequential anti-thymocyte globulins (ATG)/cyclosporine immunosuppression has two main advantages: delayed introduction of the nephrotoxic drug cyclosporine and prevention of acute rejection. Basiliximab, a recently developed chimeric monoclonal antibody that selectively depletes the minor subpopulation of activated T lymphocytes, has been shown to reduce the incidence of acute rejection when used with cyclosporine introduced on day 1.

METHODS:

This open, randomized, multicenter study was undertaken to compare the safety and efficacy of ATG versus basiliximab induction therapy (IT) with delayed introduction of cyclosporine for microemulsion (Neoral) in 105 low immunologic risk renal-transplant patients receiving mycophenolate mofetil and steroids.

RESULTS:

One-year patient and graft survival rates were 98.1% and 94.2%, respectively, in the basiliximab group (n = 52), and 98.1% and 96.2% in the ATG group (n = 53). The incidence of biopsy-confirmed acute rejection was comparable (basiliximab 9.6%, ATG 9.4%), as were key parameters of renal function, notably serum creatinine levels, time-to-nadir serum creatinine, and the number of patients requiring posttransplantation dialysis (basiliximab 28.8%, ATG 30.2%). However, significantly fewer patients in the basiliximab group experienced cytomegalovirus (CMV) infection, leukopenia, and thrombocytopenia, and this without any significant difference in any other key safety parameters (including the incidences of serum sickness, fever, lymphoma, and infections in general).

CONCLUSIONS:

Both ATG and basiliximab, when used for IT in a sequential protocol, are equally effective in terms of graft and patient survival as well as at preventing acute rejection. However, basiliximab is associated with a lower incidence of certain key adverse events, namely CMV infection, leukopenia, and thrombocytopenia.

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Estudio primario

No clasificado

Population pharmacokinetics and exposure-response relationships for basiliximab in kidney transplantation. The U.S. Simulect Renal Transplant Study Group.

Año 1999
Revista Transplantation
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BACKGROUND:

Basiliximab is an interleukin-2 receptor (CD25) chimeric monoclonal antibody used for acute rejection prophylaxis in renal transplants. In the context of a randomized, double-blind efficacy trial, its population pharmacokinetics and potential exposure-response relationships were explored in de novo kidney allograft recipients receiving 40 mg basiliximab (20 mg on days 0 and 4) in addition to baseline immunosuppressive therapy with cyclosporine microemulsion and corticosteroids.

METHODS:

Serial blood samples (8.2+/-1.3 per patient) were collected over 12 weeks after transplant from 169 basiliximab-treated patients, and empirical Bayes estimates of each patient's disposition parameters were derived. The duration of CD25 saturation was estimated as the time over which serum basiliximab concentrations exceeded 0.2 microg/ml. The relationships between pharmacokinetic parameters and demographic-clinical covariates were explored by regression methods and unpaired t-tests.

RESULTS:

Basiliximab clearance was 36.7+/-15.2 ml/hr, distribution volume 8.0+/-2.4 L, and half life 7.4+/-3.0 days. Patient weight (range, 44-131 kg) and age (range, 20-69 yrs) each contributed < or =6% to the variability in clearance and volume. Gender, ethnic group, and the presence of proteinuria had no clinically relevant influences on basiliximab disposition. Receptor-saturating basiliximab concentrations were maintained for 36+/-14 days (range, 12-91). There was no apparent relationship between the incidence or day of onset of acute rejection episodes during CD25 saturation and basiliximab concentration (range, 0.2-5.0 microg/ml). In patients who experienced a rejection episode after basiliximab was eliminated from serum (n=33), basiliximab had not been cleared faster than in their rejection-free peers (P=0.322) nor had CD25 been saturated for a shorter period of time (33+/-13 days vs. 37+/-14 days for rejection-free patients, P=0.162).

CONCLUSIONS:

There were no demographic or clinical subpopulations not adequately treated with the standard basiliximab dosing regimen. Over the range of CD25 suppression durations observed in this study, extended periods of receptor blockade did not seem to confer an immunoprophylactic advantage compared with shorter periods of receptor suppression.

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Estudio primario

No clasificado

Timoglobulina en dosis bajas vs. basiliximab en receptores de trasplante renal positivos para citomegalovirus: efectividad de una estrategia preventiva modificada

Traducción oficial
Año 2023
Revista Nefrología (Madrid)
Enlaces Virtual Health Library , DOI

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Antecedentes: Llevamos a cabo un estudio retrospectivo para determinar la reactivación y enfermedad por CMV en receptores de trasplante renal CMV seropositivos bajo diferentes esquemas de inducción. Métodos: Una estrategia preventiva modificada bajo inducción con basiliximab y timoglobulina en dosis bajas fue evaluada. Se llevó a cabo un seguimiento de la carga viral-reacción de cadena de la polimerasa-CMV; los valores mayores de 4000 copias/μl recibieron valganciclovir ajustado a la función renal. Resultados: Un total de 132 receptores de trasplante renal fueron incluidos; 84 y 48 recibieron inducción con basiliximab y timoglobulina respectivamente. Seguimiento hasta el mes 12 postrasplante. La reactivación asintomática de CMV fue significativamente mayor para timoglobulina (77,1% vs. 16,7%, p<0,001). La tasa de enfermedad por CMV fue similar en ambos grupos de tratamiento (3,6% vs. 2,1%, p=0,538). Ningún impacto en la función renal un año postrasplante fue encontrado entre los grupos a pesar de la diferencia significativa en reactivación asintomática de CMV (71±26ml/min vs. 74±19ml/min; p=0,475); igualmente, no encontramos diferencias en los hallazgos histológicos en biopsias por protocolo entre receptores con reactivación asintomática por CMV y aquellos sin reactivación. Conclusiones: La alta incidencia de reactivación asintomática por CMV en receptores seropositivos a pesar del uso de bajas dosis de timoglobulina sugiere que la profilaxis con valganciclovir es una estrategia apropiada en este grupo; sin embargo, una estrategia preventiva reduce significativamente la probabilidad de enfermedad por CMV en ambos grupos de tratamiento. El riesgo de rechazo y el impacto negativo en la función renal asociado a la reactivación asintomática por CMV no fue encontrado en nuestra experiencia.

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Estudio primario

No clasificado

Economic implications of the use of basiliximab in addition to triple immunosuppressive therapy in renal allograft recipients: a UK perspective.

Año 2003
Revista PharmacoEconomics
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OBJECTIVE:

To compare resource use and costs in renal transplant recipients treated with basiliximab or placebo plus triple immunosuppressive therapy.

DESIGN:

International randomised, double-blind, placebo-controlled trial; economic evaluation undertaken alongside the efficacy trial. The economic evaluation was performed from a UK National Health Service hospital perspective.

SETTING:

31 centres in 12 countries.

PARTICIPANTS:

345 renal transplant recipients were enrolled; 340 were randomised (basiliximab 168; placebo 172) and included in the intention-to-treat analysis.

INTERVENTION:

Treatment with placebo or basiliximab (20mg intravenous bolus) on day 0 and day 4 after transplantation.

MAIN OUTCOME MEASURES:

Resource utilisation in multiple categories and treatment costs for basiliximab and placebo-treated patients during the 6-month post-transplantation period.

RESULTS:

No statistically significant differences were found in any of the economically important categories of resource use or in the mean cost of treatment per person across the whole trial. The mean cost of treatment, including the cost of basiliximab, was pound 16 095 for basiliximab recipients and pound 15 864 (1997/1998 costs) for placebo recipients, a mean difference of pound 231 (95% CI.: - pound 1983 to pound 2446), which was not significant. Basiliximab treatment led to a significant reduction in acute rejection episodes (basiliximab 20.8%; placebo 34.9%; p = 0.005).

CONCLUSIONS:

Basiliximab therapy confers a significant clinical benefit to renal transplant recipients without increasing overall treatment costs.

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Estudio primario

No clasificado

Lower risk of infectious deaths in cardiac transplant patients receiving basiliximab versus anti-thymocyte globulin as induction therapy.

Año 2007
Revista The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation
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BACKGROUND:

Conventional antibody induction therapy is currently used in heart transplantation despite safety concerns. This 6-month, prospective, randomized, multicenter, open-label study examined whether basiliximab offers a tolerability benefit compared with anti-thymocyte globulin (ATG) while maintaining similar efficacy in de novo heart transplant recipients.

METHODS:

Adult heart transplant recipients were randomized to receive basiliximab (20 mg on Day 0 and Day 4) or ATG (2.5 mg/kg/day for 3 to 5 days) with cyclosporine, mycophenolate mofetil and steroids. The primary safety end-point was a composite of serum sickness, fever, cutaneous rash, anaphylaxis, infection, thrombocytopenia, leukopenia and post-transplant proliferative disease. Efficacy was assessed by a composite end-point of death, graft loss, acute rejection Grade > 1B, acute rejection associated with hemodynamic compromise or treated with antibody therapy, or loss to follow-up, whichever occurred first.

RESULTS:

Eighty patients were randomized and analyzed. By Month 6, the incidence of the composite safety end-point was significantly lower with basiliximab than with ATG (50.0% vs 78.6%, p = 0.01), and infectious death was less frequent in the basiliximab group (0 of 38 vs 6 of 42, p = 0.027). The composite efficacy end-point occurred in 24 patients (63.2%) in the basiliximab arm vs 28 patients (66.7%, p = not significant [NS]) receiving ATG. Acute rejection episodes of Grade > or = 1B were reported with similar frequency (50% with basiliximab vs 45.2% with ATG, p = NS); 7 patients (18.4%) in the basiliximab group and 3 (7.1%) in the ATG group had rejection Grade > or = 3A.

CONCLUSIONS:

These results suggest that basiliximab offers improved tolerability with similar efficacy compared with current polyclonal antibody induction therapy in de novo heart transplant patients.

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Estudio primario

No clasificado

The beneficial effect of high-dose mizoribine combined with cyclosporine, basiliximab, and corticosteroids on CMV infection in renal transplant recipients.

Año 2013
Revista Clinical and experimental nephrology
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BACKGROUND:

Mizoribine (MZR) has been developed as an immunosuppressive agent, but has a less potent immunosuppressive effect up to 3 mg/kg/day MZR. Therefore, we investigated whether high-dose MZR, at 6 mg/kg/day, would be effective and safe for kidney transplant patients in conjunction with cyclosporine (CsA), basiliximab, and corticosteroids.

METHODS:

A total of 40 living related patients were administered MZR (6 mg/kg/day), CsA (7 mg/kg/day), prednisolone (maintenance dose 10 mg/day), and basiliximab (20 mg/body). A control group (n = 38) treated with CsA, mycophenolate mofetil (MMF, 25 mg/kg/day), basiliximab, and corticosteroids was also employed in this study.

RESULTS:

The 2-year graft survival rates for the MZR and MMF groups were 100 and 94.7 %, respectively. The rejection rate in the MZR group (25 %) was not significantly higher than that in the MMF group (16 %). Serum creatinine level was not significant between the two groups. The number of patients who developed cytomegalovirus (CMV) disease was 0 (0 %) in the MZR group and 7 (18.4 %) in the MMF group (P < 0.05). The number of patients treated with ganciclovir was 3 (7.5 %) and 11 (28.9 %) (P < 0.05), respectively.

CONCLUSIONS:

The combination of high-dose MZR with CsA, basiliximab, and corticosteroids can establish not only satisfactory immunosuppression but also a low rate of CMV infection in vivo.

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