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Basiliximab

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Barry D Kahan – 1st expert on this subject based on the ideXlab platform

  • the selective use of Basiliximab versus thymoglobulin in combination with sirolimus for cadaveric renal transplant recipients at low risk versus high risk for delayed graft function
    Transplantation, 2004
    Co-Authors: Richard J Knight, R H Kerman, L Schoenberg, Hemangshu Podder, Charles T Van Buren, Stephen M Katz, Barry D Kahan

    Abstract:

    Background. We previously reported that the use of Basiliximab together with sirolimus permits a window of recovery from delayed graft function before the introduction of reduced-dose cyclosporine. The present study reviews our experience with the substitution of thymoglobulin for Basiliximab as induction therapy for recipients at increased risk for early acute rejection episodes. Methods. We retrospectively reviewed 145 cadaveric renal allograft recipients who received either Basiliximab (n = 115) or thymoglobulin (n = 30) in combination with sirolimus and prednisone, followed by delayed introduction of reduced doses of cyclosporine. Recipients were stratified as high immune responders if they were African American, a retransplant recipient, or a recipient with a panel-reactive antibody greater than 50%. All other recipients were considered low immune responders. Results. Basiliximab-treated high immune responders exhibited a higher incidence of acute rejection episodes (26%) than either Basiliximab-treated low immune responders (10%, P=0.04) or thymoglobulin-treated high immune responders (3%, P=0.01). The median time to initiation of cyclosporine was 12 days; cyclosporine was initiated when the serum creatinine level was 2.5 mg/dL or less. Patients with early return of renal function displayed a lower incidence of acute rejection episodes than those with later recovery of function (P=0.003). High immune responders treated with Basiliximab expressed a higher mean serum creatinine level at 3 months (P<0.01), 6 months (P=0.02) and 12 months (P=0.01) than either low immune responders treated with Basiliximab or high immune responders treated with thymoglobulin. Conclusion. A strategy combining sirolimus with Basiliximab for low-immunologic risk recipients and thymoglobulin for high-risk recipients leads to prompt recovery of renal function with a low risk of acute rejection episodes.

  • population pharmacokinetics and exposure response relationships for Basiliximab in kidney transplantation
    Transplantation, 1999
    Co-Authors: John M. Kovarik, Barry D Kahan, P R Rajagopalan, William M Bennett, Laura L Mulloy, C Gerbeau, M Hall

    Abstract:

    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.

  • reduction of the occurrence of acute cellular rejection among renal allograft recipients treated with Basiliximab a chimeric anti interleukin 2 receptor monoclonal antibody united states simulect renal study group
    Transplantation, 1999
    Co-Authors: Barry D Kahan, P R Rajagopalan, Michael Hall

    Abstract:

    Background. A double-blind, placebo-controlled phase III study was performed to assess whether Basiliximab, a chimeric anti-interleukin-2 receptor monoclonal antibody, reduced the incidence of acute rejection episodes in renal allograft recipients. Methods. A total of 348 patients were randomized into two demographically matched, equally sized groups treated with either Basiliximab or placebo. The dose of Basiliximab-20-mg infusions on day 0 and day 4-was selected to block detection of interleukin-2 receptor on 97% of peripheral blood lymphocytes for 30-45 days. All patients received immunosuppressive therapy with cyclosporine microemulsion (Neoral®) and steroids. An intent-to-treat analysis of 1-year data assessed the incidence of posttransplant acute rejection episodes, patient and graft survival rates, and the safety and tolerability of Basiliximab. Results. Among the eligible 346 patients equally divided into the two treatment groups, Basiliximab reduced the proportion of patients who experienced biopsy-confirmed acute rejection episodes by 28%: 61 (35.3%) Basiliximab vs. 85 (49.1%) placebo (P=0.009). Graft losses occurred in 9 (5.2%) Basiliximab-treated and 12 (6.9%) placebo-treated patients. Five (2.9%) deaths in the Basiliximab group and seven (4.0%) in the placebo group occurred. Compared with placebo, a higher fraction of Basiliximab patients produced urine in the operating room, and a significantly lower fraction had renal dysfunction in the first month (serum creatinine 3 mg/dl). During the first 12 months, 94 (54%) Basiliximab-treated patients experienced serious adverse events, compared with 106 (61%) who received placebo. Conclusions. Prophylactic Basiliximab therapy is well tolerated, has an adverse event profile comparable to placebo, and significantly reduces the number of acute rejection episodes in renal allograft patients within the first year after transplantation.

Michael Hall – 2nd expert on this subject based on the ideXlab platform

  • reduction of the occurrence of acute cellular rejection among renal allograft recipients treated with Basiliximab a chimeric anti interleukin 2 receptor monoclonal antibody united states simulect renal study group
    Transplantation, 1999
    Co-Authors: Barry D Kahan, P R Rajagopalan, Michael Hall

    Abstract:

    Background. A double-blind, placebo-controlled phase III study was performed to assess whether Basiliximab, a chimeric anti-interleukin-2 receptor monoclonal antibody, reduced the incidence of acute rejection episodes in renal allograft recipients. Methods. A total of 348 patients were randomized into two demographically matched, equally sized groups treated with either Basiliximab or placebo. The dose of Basiliximab-20-mg infusions on day 0 and day 4-was selected to block detection of interleukin-2 receptor on 97% of peripheral blood lymphocytes for 30-45 days. All patients received immunosuppressive therapy with cyclosporine microemulsion (Neoral®) and steroids. An intent-to-treat analysis of 1-year data assessed the incidence of posttransplant acute rejection episodes, patient and graft survival rates, and the safety and tolerability of Basiliximab. Results. Among the eligible 346 patients equally divided into the two treatment groups, Basiliximab reduced the proportion of patients who experienced biopsy-confirmed acute rejection episodes by 28%: 61 (35.3%) Basiliximab vs. 85 (49.1%) placebo (P=0.009). Graft losses occurred in 9 (5.2%) Basiliximab-treated and 12 (6.9%) placebo-treated patients. Five (2.9%) deaths in the Basiliximab group and seven (4.0%) in the placebo group occurred. Compared with placebo, a higher fraction of Basiliximab patients produced urine in the operating room, and a significantly lower fraction had renal dysfunction in the first month (serum creatinine 3 mg/dl). During the first 12 months, 94 (54%) Basiliximab-treated patients experienced serious adverse events, compared with 106 (61%) who received placebo. Conclusions. Prophylactic Basiliximab therapy is well tolerated, has an adverse event profile comparable to placebo, and significantly reduces the number of acute rejection episodes in renal allograft patients within the first year after transplantation.

  • reduction of the occurrence of acute cellular rejection among renal allograft recipients treated with Basiliximab a chimeric anti interleukin 2 receptor monoclonal antibody united states simulect renal study group
    Transplantation, 1999
    Co-Authors: Barry D Kahan, P R Rajagopalan, Michael Hall

    Abstract:

    BACKGROUND: A double-blind, placebo-controlled phase III study was performed to assess whether Basiliximab, a chimeric anti-interleukin-2 receptor monoclonal antibody, reduced the incidence of acute rejection episodes in renal allograft recipients. METHODS: A total of 348 patients were randomized into two demographically matched, equally sized groups treated with either Basiliximab or placebo. The dose of Basiliximab-20-mg infusions on day 0 and day 4-was selected to block detection of interleukin-2 receptor on 97% of peripheral blood lymphocytes for 30-45 days. All patients received immunosuppressive therapy with cyclosporine microemulsion (Neoral) and steroids. An intent-to-treat analysis of 1-year data assessed the incidence of posttransplant acute rejection episodes, patient and graft survival rates, and the safety and tolerability of Basiliximab. RESULTS: Among the eligible 346 patients equally divided into the two treatment groups, Basiliximab reduced the proportion of patients who experienced biopsy-confirmed acute rejection episodes by 28%: 61 (35.3%) Basiliximab vs. 85 (49.1%) placebo (P=0.009). Graft losses occurred in 9 (5.2%) Basiliximab-treated and 12 (6.9%) placebo-treated patients. Five (2.9%) deaths in the Basiliximab group and seven (4.0%) in the placebo group occurred. Compared with placebo, a higher fraction of Basiliximab patients produced urine in the operating room, and a significantly lower fraction had renal dysfunction in the first month (serum creatinine > or =5 mg(dl) and between 1 and 12 months (serum creatinine > or =3 mg/dl). During the first 12 months, 94 (54%) Basiliximab-treated patients experienced serious adverse events, compared with 106 (61%) who received placebo. CONCLUSIONS: Prophylactic Basiliximab therapy is well tolerated, has an adverse event profile comparable to placebo, and significantly reduces the number of acute rejection episodes in renal allograft patients within the first year after transplantation.

P R Rajagopalan – 3rd expert on this subject based on the ideXlab platform

  • population pharmacokinetics and exposure response relationships for Basiliximab in kidney transplantation
    Transplantation, 1999
    Co-Authors: John M. Kovarik, Barry D Kahan, P R Rajagopalan, William M Bennett, Laura L Mulloy, C Gerbeau, M Hall

    Abstract:

    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.

  • reduction of the occurrence of acute cellular rejection among renal allograft recipients treated with Basiliximab a chimeric anti interleukin 2 receptor monoclonal antibody united states simulect renal study group
    Transplantation, 1999
    Co-Authors: Barry D Kahan, P R Rajagopalan, Michael Hall

    Abstract:

    Background. A double-blind, placebo-controlled phase III study was performed to assess whether Basiliximab, a chimeric anti-interleukin-2 receptor monoclonal antibody, reduced the incidence of acute rejection episodes in renal allograft recipients. Methods. A total of 348 patients were randomized into two demographically matched, equally sized groups treated with either Basiliximab or placebo. The dose of Basiliximab-20-mg infusions on day 0 and day 4-was selected to block detection of interleukin-2 receptor on 97% of peripheral blood lymphocytes for 30-45 days. All patients received immunosuppressive therapy with cyclosporine microemulsion (Neoral®) and steroids. An intent-to-treat analysis of 1-year data assessed the incidence of posttransplant acute rejection episodes, patient and graft survival rates, and the safety and tolerability of Basiliximab. Results. Among the eligible 346 patients equally divided into the two treatment groups, Basiliximab reduced the proportion of patients who experienced biopsy-confirmed acute rejection episodes by 28%: 61 (35.3%) Basiliximab vs. 85 (49.1%) placebo (P=0.009). Graft losses occurred in 9 (5.2%) Basiliximab-treated and 12 (6.9%) placebo-treated patients. Five (2.9%) deaths in the Basiliximab group and seven (4.0%) in the placebo group occurred. Compared with placebo, a higher fraction of Basiliximab patients produced urine in the operating room, and a significantly lower fraction had renal dysfunction in the first month (serum creatinine 3 mg/dl). During the first 12 months, 94 (54%) Basiliximab-treated patients experienced serious adverse events, compared with 106 (61%) who received placebo. Conclusions. Prophylactic Basiliximab therapy is well tolerated, has an adverse event profile comparable to placebo, and significantly reduces the number of acute rejection episodes in renal allograft patients within the first year after transplantation.

  • reduction of the occurrence of acute cellular rejection among renal allograft recipients treated with Basiliximab a chimeric anti interleukin 2 receptor monoclonal antibody united states simulect renal study group
    Transplantation, 1999
    Co-Authors: Barry D Kahan, P R Rajagopalan, Michael Hall

    Abstract:

    BACKGROUND: A double-blind, placebo-controlled phase III study was performed to assess whether Basiliximab, a chimeric anti-interleukin-2 receptor monoclonal antibody, reduced the incidence of acute rejection episodes in renal allograft recipients. METHODS: A total of 348 patients were randomized into two demographically matched, equally sized groups treated with either Basiliximab or placebo. The dose of Basiliximab-20-mg infusions on day 0 and day 4-was selected to block detection of interleukin-2 receptor on 97% of peripheral blood lymphocytes for 30-45 days. All patients received immunosuppressive therapy with cyclosporine microemulsion (Neoral) and steroids. An intent-to-treat analysis of 1-year data assessed the incidence of posttransplant acute rejection episodes, patient and graft survival rates, and the safety and tolerability of Basiliximab. RESULTS: Among the eligible 346 patients equally divided into the two treatment groups, Basiliximab reduced the proportion of patients who experienced biopsy-confirmed acute rejection episodes by 28%: 61 (35.3%) Basiliximab vs. 85 (49.1%) placebo (P=0.009). Graft losses occurred in 9 (5.2%) Basiliximab-treated and 12 (6.9%) placebo-treated patients. Five (2.9%) deaths in the Basiliximab group and seven (4.0%) in the placebo group occurred. Compared with placebo, a higher fraction of Basiliximab patients produced urine in the operating room, and a significantly lower fraction had renal dysfunction in the first month (serum creatinine > or =5 mg(dl) and between 1 and 12 months (serum creatinine > or =3 mg/dl). During the first 12 months, 94 (54%) Basiliximab-treated patients experienced serious adverse events, compared with 106 (61%) who received placebo. CONCLUSIONS: Prophylactic Basiliximab therapy is well tolerated, has an adverse event profile comparable to placebo, and significantly reduces the number of acute rejection episodes in renal allograft patients within the first year after transplantation.