Steroid-free regimen with daclizumab, mycophenolate mofetil, and tacrolimus in liver transplant recipients

Figueras, Joan; Bernardos, Á.; Prieto, M.; Gómez, Martín; Rimola, Antoni; Urbina, J. Ortiz de; Cuervas-Mons, Valentín; Mata, Manuel de la; Domínguez-Granados, Rosa

doi:10.1016/s0041-1345(02)02951-2

Cited by 14 publications

(10 citation statements)

References 11 publications

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“…The type and incidence of adverse events in these 15 patients were similar to those found in the whole series included in the multicenter trial (12).…”

Section: Resultssupporting

confidence: 73%

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Sequential Determination of Pharmacokinetics and Pharmacodynamics of Mycophenolic Acid in Liver Transplant Patients Treated with Mycophenolate Mofetil

et al. 2006

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“…The type and incidence of adverse events in these 15 patients were similar to those found in the whole series included in the multicenter trial (12).…”

Section: Resultssupporting

confidence: 73%

“…The trial was approved by the Ethics Committee of our center and all patients gave their informed consent to participate. The results of this trial have been published elsewhere (12).…”

Section: Methodsmentioning

confidence: 99%

Sequential Determination of Pharmacokinetics and Pharmacodynamics of Mycophenolic Acid in Liver Transplant Patients Treated with Mycophenolate Mofetil

et al. 2006

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“…The efficacy and safety of DZM has been demonstrated in a large number of kidney [8-28], kidney-pancreas [29,30], liver [31-36], and lung clinical trials [37,38]. There have been few studies involving DZM in cardiac transplantation [39-45], despite the observation that almost 50% of patients undergoing cardiac transplantation receive anti-body-based induction therapy [1].…”

Section: Discussionmentioning

confidence: 99%

A randomized controlled trial of daclizumab versus anti-thymocyte globulin induction for heart transplantation

et al. 2014

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BackgroundThe purpose of this study was to test the efficacy and safety of daclizumab (DZM) versus anti-thymocyte globulin (ATG) as a component of induction therapy in heart transplant recipients.MethodsThirty heart transplant patients were randomized to receive either ATG or DZM during induction therapy. Patients in the DZM group received an initial dose of 2 mg/kg intravenous (IV) at the time of transplant and 1 mg/kg IV on postoperative day 4.DiscussionRecipient, donor, and intraoperative variables did not differ significantly between groups. The cost of induction therapy, total drug cost, and hospital ward costs were significantly less for the DZM group. Average absolute lymphocyte and platelet counts were significantly higher in the DZM group. There were no significant differences in the incidence of rejection, infection, malignancy, or steroid-induced diabetes. One year survival was excellent in both groups (87%, P = 0.1). Daclizumab is a safe component of induction therapy in heart transplantation.

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“…However, the use of daclizumab in liver transplant patients has increased over the last few years 6–9. In both kidney and liver recipients, daclizumab used as an induction agent has been shown to be effective in reducing the rate of acute rejection,3, 7, 14 has recently been successfully utilized as part of immunosuppression protocols aimed at rapid withdrawal of corticosteroids,10, 11, 17, 18 and has been used with reduced and delayed doses of tacrolimus in kidney‐sparing protocols 8, 18…”

Section: Discussionmentioning

confidence: 99%

“…Daclizumab half‐life was 99 hours, total body clearance was 57 mL/hr, and no significant decrease in CD3+, CD4+, or CD8+ lymphocytes was found. Most clinical trials of daclizumab in liver transplantation have used either a single‐dose regimen of 1–2 mg/kg within 24 hours posttransplant, or a 2‐dose regimen of 1–2 mg/kg administered within 24 hours posttransplant and on day 7–14 posttransplant 7–11. These 2‐dose regimens proved to be effective treatment, providing effective prevention of acute rejection, allowing for minimization of calcineurin inhibitors, and enabling early steroid withdrawal, which may positively affect the rate of recurrence of hepatitis C 8, 10, 12…”

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confidence: 99%

A novel three-dose regimen of daclizumab in liver transplant recipients with hepatitis C: A pharmacokinetic and pharmacodynamic study

et al. 2006

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This study evaluated the pharmacokinetics and pharmacodynamics of a novel 3-dose regimen of daclizumab in de novo hepatitis C liver transplant recipients. In 30 of 156 recipients receiving daclizumab, mycophenolate mofetil, tacrolimus, and no steroids (Arm 3 of Hep C 3 Liver Study), daclizumab (2, 2, and 1 mg/kg, respectively) was given on days 1, 3, and 8 posttransplant, respectively, with trough, peak (C max ), and CD25 saturation (CD sat ) measured sequentially. Mean daclizumab C max was 50.3 g/mL on day 1, and mean trough levels were 21.8, 25.7, and 9.9 g/mL on days 3, 8, and 30, respectively. A significant decline in CD sat (mean, 15.7% to 4.7%) was observed on day 1 and was sustained throughout the study (2.8% on day 30). Daclizumab concentration Ն5 g/mL was the level where most of the effect on CD sat was noticed. Elevated baseline CD sat was observed in African Americans, patients weighing Յ75 kg, and patients Ͻ60 years of age. After 365 days, 2 patients had experienced 3 rejections, 10 patients had recurrent hepatitis C, 4 patients died, and 2 grafts were lost. In conclusion, this novel 3-dose regimen is effective in rapidly achieving high therapeutic concentration of daclizumab and a significant decline in CD sat lasting over 30 days. Daclizumab (Zenapax, Roche Laboratories, Basel, Switzerland) is a highly specific humanized anti-interleukin 2 receptor (IL-2R) monoclonal antibody approved for induction therapy in renal transplant patients. Daclizumab specifically binds to the CD25 subunit of activated lymphocytes and specifically interferes with IL-2 signaling and receptors by inhibiting binding and phosphorylation of the IL-2R beta and gamma chains. Due to its high affinity for the CD25 subunit, daclizumab is an effective IL-2 inhibitor suppressing T-cell activity in the cellular immune response to allograft rejection.

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Steroid-free regimen with daclizumab, mycophenolate mofetil, and tacrolimus in liver transplant recipients

Cited by 14 publications

References 11 publications

Sequential Determination of Pharmacokinetics and Pharmacodynamics of Mycophenolic Acid in Liver Transplant Patients Treated with Mycophenolate Mofetil

Sequential Determination of Pharmacokinetics and Pharmacodynamics of Mycophenolic Acid in Liver Transplant Patients Treated with Mycophenolate Mofetil

A randomized controlled trial of daclizumab versus anti-thymocyte globulin induction for heart transplantation

A novel three-dose regimen of daclizumab in liver transplant recipients with hepatitis C: A pharmacokinetic and pharmacodynamic study

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