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A multicenter, double blind, placebo controlled study of basiliximab (simulect) in combination with triple therapy including azathioprine for the prevention of acute rejection episodes in renal allograft patients

Año 1999
Revista Transplantation
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Estudio primario

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1-year follow-up of two steroid-free immunosuppressive regimens—Basiliximab/Tacrolimus and tacrolimus/MMF—In comparison to tacrolimus/MMF/steroids after renal transplantation

Año 2004
Autores Kramer BK , Kruger B , Hoffmann U , et al.
Revista J Am Soc Nephrol
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Estudio primario

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1‐year‐follow‐up of two steroid‐free immunosuppressive regimens ‐ basiliximab/tacrolimus and tacrolimus/MMR ‐ in comparison to tacrolimus/MMF/steroids after renal transplantation

Año 2004
Revista Journal of the American Society of Nephrology
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Estudio primario

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IL-2 receptor antagonist [basiliximab] is associated with rapid fibrosis progression in patients with recurrent hepatitis c after liver transplantation using serial biopsy specimens

Año 2010
Revista Int. J. Organ Transplant. Med.
Enlaces Virtual Health Library

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Recurrence of hepatitis C virus [HCV] infection following orthotopic liver transplantation [OLT] is universal. There is paucity of data on the safety and efficacy of interleukin [IL]-2 receptor antagonist [IL-2RA] when added to the standard immunosuppression regimen in OLT recipients with recurrent HCV infection. To evaluate the efficacy of IL-2RA [Basiliximab] in preventing acute cellular rejection [ACR] in patients with recurrent HCV infection after OLT and to assess the impact of IL-2RA in promoting fibrosis progression in post-OLT recurrent HCV infection. Using an electronic pathology database, we identified all OLT/HCV patients with at least 2 post-OLT liver biopsies [1998-2006]. Standard immunosuppression consisted of steroids and calcineurin inhibitor with and without mycophenolate mofetil. All patients who were transplanted after May 2004 received IL- 2RA induction therapy. The Ludwig-Batts system was used to stage all biopsies [593 biopsies from 124 patients]. The first biopsy that showed post-OLT fibrosis or the last follow-up biopsy was used for time- to-progression analysis. Univariate and multivariate Cox proportional hazards regression analyses were performed to identify factors associated with the progression of fibrosis. ACR was significantly [p<0.001] lower in patients who received IL-2RA [20 of 70, 29%] compared to those who did not [33 of 54, 61%]. The median [25%ile, 75%ile] follow-up was 12.1 [6.1, 23.9] months during which 61% of patients had progression of fibrosis. Univariate analysis revealed that a higher HCV RNA load at 4 months post-OLT [p=0.002], cytomegalovirus [CMV] infection [p<0.001], use of steroid therapy for ACR [p=0.043], and use of IL-2RA [p<0.001] were associated with higher hazards for the pro- gression of fibrosis. Viral load at 4 months post-OLT was significantly [p=0.025] higher in patients who had IL-2RA therapy [median [25%ile, 75%ile]: 2.9 [1.0, 5.0] _10[6] vs. 1.4 [1.0, 2.3] _10[6]]. In multivariate analysis, patients who received IL-2RA therapy were 3.1 [95% CI.: 1.8-5.3] times more likely to develop fi- brosis than those who did not treated with IL-2RA. Steroid therapy for ACR remained significantly [Hazard Ratio=2.9, p=0.002] associated with the progression of fibrosis. IL-2RA [Basiliximab] decreases the rate of ACR. However, it may be associated with more rapid histological progression of the disease in post-OLT recurrent HCV

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IL-2 Receptor Antagonist (Basiliximab) Is Associated with Rapid Fibrosis Progression in Patients with Recurrent Hepatitis C after Liver Transplantation Using Serial Biopsy Specimens.

Año 2010
Revista International journal of organ transplantation medicine
Enlaces PMC , Pubmed

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BACKGROUND:

Recurrence of hepatitis C virus (HCV) infection following orthotopic liver transplantation (OLT) is universal. There is paucity of data on the safety and efficacy of interleukin (IL)-2 receptor antagonist (IL-2RA) when added to the standard immunosuppression regimen in OLT recipients with recurrent HCV infection.

OBJECTIVES:

To evaluate the efficacy of IL-2RA (Basiliximab) in preventing acute cellular rejection (ACR) in patients with recurrent HCV infection after OLT and to assess the impact of IL-2RA in promoting fibrosis progression in post-OLT recurrent HCV infection.

METHODS:

Using an electronic pathology database, we identified all OLT/HCV patients with at least 2 post-OLT liver biopsies (1998-2006). Standard immunosuppression consisted of steroids and calcineurin inhibitor with and without mycophenolate mofetil. All patients who were transplanted after May 2004 received IL-2RA induction therapy. The Ludwig-Batts system was used to stage all biopsies (593 biopsies from 124 patients). The first biopsy that showed post-OLT fibrosis or the last follow-up biopsy was used for time-to-progression analysis. Univariate and multivariate Cox proportional hazards regression analyses were performed to identify factors associated with the progression of fibrosis.

RESULTS:

ACR was significantly (p<0.001) lower in patients who received IL-2RA (20 of 70, 29%) compared to those who did not (33 of 54, 61%). The median (25%ile, 75%ile) follow-up was 12.1 (6.1, 23.9) months during which 61% of patients had progression of fibrosis. Univariate analysis revealed that a higher HCV RNA load at 4 months post-OLT (p=0.002), cytomegalovirus (CMV) infection (p<0.001), use of steroid therapy for ACR (p=0.043), and use of IL-2RA (p<0.001) were associated with higher hazards for the progression of fibrosis. Viral load at 4 months post-OLT was significantly (p=0.025) higher in patients who had IL-2RA therapy (median [25%ile, 75%ile]: 2.9 [1.0, 5.0] ×10(6) vs. 1.4 [1.0, 2.3] ×10(6)). In multivariate analysis, patients who received IL-2RA therapy were 3.1 (95% CI.: 1.8-5.3) times more likely to develop fibrosis than those who did not treated with IL-2RA. Steroid therapy for ACR remained significantly (Hazard Ratio=2.9, p=0.002) associated with the progression of fibrosis.

CONCLUSION:

IL-2RA (Basiliximab) decreases the rate of ACR. However, it may be associated with more rapid histological progression of the disease in post-OLT recurrent HCV.

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Efficacy and security of low toxicity immunosuppressive regimen using basiliximab, mycophenolate mofetil, neoral or tacrolimus and corticosteroids versus full doses of neoral, thymoglobulin, azathioprine and corticosteroids

Año 2007
Autores Hernandez, Domingo
Registro de estudios ISRCTN registry
Enlaces ISRCTN , DOI

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Mesenchymal stromal cells plus basiliximab improve the response of steroid-refractory acute graft-versus-host disease as a second-line therapy: a multicentre, randomized, controlled trial

Año 2024
Revista BMC medicine
Enlaces PMC , Pubmed , DOI

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BACKGROUND:

For patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD), effective second-line regimens are urgently needed. Mesenchymal stromal cells (MSCs) have been used as salvage regimens for SR-aGVHD in the past. However, clinical trials and an overall understanding of the molecular mechanisms of MSCs combined with basiliximab for SR-aGVHD are limited, especially in haploidentical haemopoietic stem cell transplantation (HID HSCT).

METHODS:

The primary endpoint of this multicentre, randomized, controlled trial was the 4-week complete response (CR) rate of SR-aGVHD. A total of 130 patients with SR-aGVHD were assigned in a 1:1 randomization schedule to the MSC group (receiving basiliximab plus MSCs) or control group (receiving basiliximab alone) (NCT04738981).

RESULTS:

Most enrolled patients (96.2%) received HID HSCT. The 4-week CR rate of SR-aGVHD in the MSC group was obviously better than that in the control group (83.1% vs. 55.4%, P = 0.001). However, for the overall response rates at week 4, the two groups were comparable. More patients in the control group used ≥ 6 doses of basiliximab (4.6% vs. 20%, P = 0.008). We collected blood samples from 19 consecutive patients and evaluated MSC-derived immunosuppressive cytokines, including HO1, GAL1, GAL9, TNFIA6, PGE2, PDL1, TGF-β and HGF. Compared to the levels before MSC infusion, the HO1 (P = 0.0072) and TGF-β (P = 0.0243) levels increased significantly 1 day after MSC infusion. At 7 days after MSC infusion, the levels of HO1, GAL1, TNFIA6 and TGF-β tended to increase; however, the differences were not statistically significant. Although the 52-week cumulative incidence of cGVHD in the MSC group was comparable to that in the control group, fewer patients in the MSC group developed cGVHD involving ≥3 organs (14.3% vs. 43.6%, P = 0.006). MSCs were well tolerated, no infusion-related adverse events (AEs) occurred and other AEs were also comparable between the two groups. However, patients with malignant haematological diseases in the MSC group had a higher 52-week disease-free survival rate than those in the control group (84.8% vs. 65.9%, P = 0.031).

CONCLUSIONS:

For SR-aGVHD after allo-HSCT, especially HID HSCT, the combination of MSCs and basiliximab as the second-line therapy led to significantly better 4-week CR rates than basiliximab alone. The addition of MSCs not only did not increase toxicity but also provided a survival benefit.

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Estudio primario

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12 month results of a multicenter, randomized trial comparing three induction agents (alemtuzumab, thymoglobulin and basiliximab) with tacrolimus, mycophenolate mofetil and a rapid steroid withdrawal in renal transplantation

Año 2008
Revista Transplantation
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Estudio primario

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Basiliximab (Simulect) is safe and effective in combination with neoral, steroids and cellcept for the prevention of acute rejection episodes in renal transplantation. Interim results of a double blind, randomized clinical trial

Año 1999
Revista American Society of Nephrology
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Estudio primario

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Two corticosteroid-free regimens-tacrolimus monotherapy after basiliximab administration and tacrolimus/mycophenolate mofetil-in comparison with a standard triple regimen in renal transplantation: results of the Atlas study

Año 2005
Enlaces DOI

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BACKGROUND:

The side effects associated with corticosteroids have led to efforts to minimize their use in renal transplant patients. In this study we compared two corticosteroid‐free tacrolimus‐based regimens with a standard triple therapy.

METHODS:

This was a 6‐month, phase III, open‐label, parallel‐group, multicenter study. The total analysis set comprised 451 patients, randomized (1:1:1) to receive tacrolimus (Tac) monotherapy following basiliximab (Bas) administration (n=153), Tac/mycophenolate mofetil (MMF) (n=151), or, Tac/MMF/corticosteroids triple therapy as a control (n=147).

RESULTS:

The study was completed by 91.2% (triple therapy), 94.7% (Tac/MMF), and 82.4% (Bas/Tac) of patients. Patient baseline characteristics were similar in all groups. The incidences of biopsy‐proven acute rejection were 8.2% (triple therapy), 30.5% (Tac/MMF), and 26.1% (Bas/Tac), p<0.001 (multiple test for comparison with triple therapy); Bas/Tac vs. Tac/MMF, p=ns. The incidences of corticosteroid‐resistant acute rejection were 2.0%, 4.0%, and 5.2%, p=ns. Graft survival (95.9%, 96.7%, and 94.7%, p=ns) and patient survival (100%, 99.3%, and 99.3%, p=ns) were similar in all groups. Median serum creatinine at month 6 was 123.0 micromol/L (triple therapy), 134.7 micromol/L (Tac/MMF) and 135.8 micromol/L (Bas/Tac). The overall safety profiles were similar; differences (p<0.05) were reported for anaemia (24.5% vs. 12.6% vs. 14.5%), diarrhoea (12.9% vs. 17.9% vs. 5.9%), and leukopenia (7.5% vs. 18.5% vs. 5.9%) for the triple therapy, Tac/MMF, and Bas/Tac group, respectively. The incidences of new‐onset diabetes mellitus were 4.6%, 7.1%, and 1.4%, respectively.

CONCLUSION:

Corticosteroid‐free immunosuppression was feasible with the Bas/Tac and the Tac/MMF regimens. Both corticosteroid‐free regimens were equally effective in preventing acute rejection, with the Bas/Tac therapy offering some safety benefits.

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