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PubMed2004

Efficacy and safety of basiliximab with a tacrolimus-based regimen in liver transplant recipients.

BACKGROUND: Induction with monoclonal antibodies for prevention of acute cellular rejection (ACR) may avoid many of the adverse events associated with polyclonal antibodies. Basiliximab, a chimeric monoclonal antibody directed against the alpha-chain of the interleukin 2 receptor (CD25), has been extensively evaluated as an induction therapy for kidney transplant recipients, more frequently in combination with a cyclosporine-based regimen. In this study, we assessed the efficacy and safety of basiliximab in combination with a tacrolimus-based regimen after liver transplantation. METHODS: Fifty consecutive liver transplants (47 cadaveric donors; 3 living donors) were analyzed. All patients received two 20-mg doses of basiliximab (days 0 and 4 after transplantation) followed by tacrolimus (0.15 mg/kg/day; 10-15 ng/mL target trough levels) and a tapered dose regimen of steroids. Follow-up ranged from 404 to 1,364 days after transplantation (mean 799.89 days, SD+/-257.37; median 796 days). RESULTS: A total of 88% of patients remained rejection-free during follow-up with an actuarial rejection-free probability of 75% within 3 months. The actuarial patient survival rate at 3 years was 88%, and the graft survival rate was 75%. Twelve (24%) patients experienced one episode of sepsis, requiring temporary reduction of immunosuppressive therapy. There were no immediate side effects associated with basiliximab and no evidence of cytomegalovirus infection or posttransplant lymphoproliferative disorder. CONCLUSIONS: Basiliximab in combination with a tacrolimus-based immunosuppressive regimen is effective in reducing episodes of ACR and increasing ACR-free survival after liver transplantation. In addition, basiliximab does not increase the incidence of adverse effects or infections.

Adolescent↗
PubMed2006

Basiliximab for the treatment of steroid-resistant ulcerative colitis: further experience in moderate and severe disease.

BACKGROUND: Preliminary data have suggested that interleukin-2 receptor blockade with basiliximab may increase steroid sensitivity. We have previously reported a small case series demonstrating the potential of basiliximab as a novel agent for the treatment of steroid-resistant ulcerative colitis. AIM: To report further experience of the efficacy and safety of treatment with the interleukin-2 receptor blocking monoclonal antibody basiliximab, in addition to steroids, for the treatment of severe and moderate steroid-resistant ulcerative colitis. METHODS: Twenty patients were enrolled - 13 patients with moderate steroid-resistant ulcerative colitis (Ulcerative Colitis Symptom Score: >or=6) and seven patients with severe steroid-resistant ulcerative colitis. All were given a single dose of 40 mg basiliximab plus standard steroid therapy in an open-label, uncontrolled trial. Primary end point was clinical remission within 8 weeks (Ulcerative Colitis Symptom Score: <or=2). RESULTS: Within 8 weeks, 10 of 20 (50%) patients achieved clinical remission (seven of 13 moderate, and three of seven severe). At 24 weeks, 13 of 20 (65%) patients were in clinical remission. Five patients required colectomy (four severe, one moderate ulcerative colitis) and one required rescue ciclosporin (moderate ulcerative colitis). Two patients developed herpes zoster, but treatment was generally well tolerated. CONCLUSIONS: Basiliximab appears to promote prolonged remission after a single treatment. Taken in combination with previously reported data, basiliximab shows particular promise in moderate steroid-resistant ulcerative colitis.

Adolescent↗
PubMed2005

Long-term evaluation of basiliximab induction therapy in live donor kidney transplantation: a five-year prospective randomized study.

BACKGROUND/AIMS: The long-term evaluation of basiliximab induction therapy has not been addressed yet. We aim to evaluate its long-term effects in living related donor kidney transplantation. METHODS: 100 adult recipients with their first kidney allograft were randomized into two treatment groups--one group received basiliximab and the second served as a control. All patients received a maintenance triple immunosuppressive therapy (steroids, cyclosporine microemulsion and azathioprine) and were closely followed for 5 years. RESULTS: Basiliximab significantly reduced the proportion of patients who experienced an acute rejection in the first year (18/50) when compared to the control group (31/50) and in 5 years (27/50) when compared to (36/50) the controls. The cumulative steroid dose used throughout the study was significantly lower in the basiliximab group. The overall incidence of post-transplant complications was comparable between the two treatment groups. There was no significant difference in patients and graft survival; 5-year patient and graft survival were 100 and 86% for basiliximab, and 96 and 88% for the control group respectively. CONCLUSION: Although routine basiliximab induction significantly reduces the incidence of acute rejection, its beneficial long-term effects on graft function and patient and graft survival are not yet evident.

Acute Disease↗
PubMedDate not supplied

Basiliximab reduces the incidence of acute cellular rejection in live-related-donor kidney transplantation: a three-year prospective randomized trial.

BACKGROUND: The aim of this work was to investigate the benefit of basiliximab induction therapy in living-related-donor kidney transplantation. METHODS: One hundred adult recipients of a first kidney allograft were randomized into two treatment groups, one to receive basiliximab and the second as a control. All patients received maintenance triple immunosuppressive therapy (steroids, cyclosporine microemulsion and azathioprine). The patients were followed up for a minimum of three years. The end points for evaluation included the incidence of acute rejection episodes, severity of rejection, cumulative steroid dose, patients' and graft survival. RESULTS: Basiliximab significantly reduced the proportion of patients who experienced an acute rejection in the first year (18/50) compared to the control group (31/50). At three years there were 26 acute rejections in the basiliximab group and 36 in control group. The cumulative steroid dose at three and 12 months was significantly lower in the basiliximab group. The overall incidence of post-transplant complications was comparable in the two groups. CONCLUSIONS: Prophylactic basiliximab is well tolerated and significantly reduces the incidence of acute rejection episodes in living-related-donor kidney transplantation.

Acute Disease↗
PubMed1997

Disposition of basiliximab, an interleukin-2 receptor monoclonal antibody, in recipients of mismatched cadaver renal allografts.

BACKGROUND: Basiliximab is an interleukin-2 receptor (IL-2R; CD25) chimeric monoclonal antibody for immunoprophylaxis against acute rejection in renal transplantation. Its pharmacokinetics were characterized in a multicenter open-label, prospective dose-escalation study to identify a single-dose regimen providing IL-2R-saturating serum concentrations in the critical first posttransplant month. METHODS: Thirty-two recipients of primary, mismatched cadaver kidneys were enrolled: 20 men and 12 women, who were 47+/-11 years old and weighed 65+/-12 kg. The immunosuppression regimen consisted of steroids and azathioprine from day 0 and cyclosporine from day 10. Basiliximab was infused over 30 min as a single dose preoperatively. RESULTS: Thirty patients were evaluable for basiliximab pharmacokinetics: 24 received 40 mg and 6 received 60 mg. Basiliximab was well tolerated without evidence of cytokine-release syndrome, hypersensitivity reactions, or anti-idiotype antibody response. Peak concentration and area under the concentration curve increased proportionally with dose. Postinfusion concentrations declined in a biphasic manner with a terminal half-life of 6.5+/-2.1 days. Weak, widely dispersed correlations were noted between body weight versus distribution volume (r=0.29) and versus clearance (r=0.45), suggesting no clinical relevance for weight-adjusted dosing. There were no apparent gender-related differences in basiliximab disposition. Previous phase II data indicated that serum concentrations in excess of 0.2 microg/ml are sufficient to saturate IL-2R epitopes on circulating T lymphocytes. Concentrations were above this threshold for 26+/-8 days (range 16 to 46) at the 40-mg dose level and for 32+/-11 days (range 22 to 51) at the 60-mg dose level. CONCLUSIONS: Total basiliximab doses of 40-60 mg were well tolerated, nonimmunogenic, and estimated to provide immunoprophylaxis to cover the first posttransplant month.

Adult↗
PubMed2002

[Immune suppression by combination therapy with basiliximab and cyclosporin in high risk keratoplasty. A pilot study].

BACKGROUND: The risk of postoperative immune reaction/transplant rejection is increased in the presence of distinct risk factors. In these situations, the use of established immunosuppressive agents (steroids, cyclosporin) is indicated. However, immune reactions can occur despite this therapy. Basiliximab is a monoclonal antibody with a high specific binding affinity to the IL-2 receptor of activated T-cells. After renal transplantation, the combination therapy with basiliximab and cyclosporin reduces the risk of acute rejection by 30% against placebo. The aim of this study was to investigate the effect of complementary immune suppression with the IL-2 synthesis inhibitor cyclosporin and the IL-2 receptor antagonist basiliximab on the incidence of transplant rejection after high-risk keratoplasty. PATIENTS AND METHODS: In an open pilot study, seven patients with high-risk keratoplasty were treated with basiliximab perioperatively and cyclosporin postoperatively. All patients had penetrating keratoplasty with a non-HLA-matched corneal graft. RESULTS: Seven patients were operated on from 12/98 through 12/99 with a corneal transplant diameter between 7.1 and 9.5 mm. Risk factors included extensive corneal neovascularization in all patients (indications for surgery: 4 cases with corneal scars after herpetic disease, 2 cases with conditions after alkali burns, 1 case with corneal ulceration after thermal burn). During the follow-up of 14-25 months, no immune reaction has occurred, and all transplants are clear. The mean visual acuity increased from 0.04 to 0.41 postoperatively. DISCUSSION: The preliminary data on a combination therapy with basiliximab and cyclosporin are promising. For further evaluation a prospective multicenter study is planned.

Adult↗
PubMed2002

The economics of basiliximab (Simulect) in preventing acute rejection in renal transplantation.

An economic evaluation was undertaken alongside a multicentre international trial of basiliximab. Resource usage within the trial was assessed, and the cost implications of using basiliximab evaluated. Recipients of a primary cadaveric kidney transplant were recruited into a double-blind trial and received either placebo ( n=186) or basiliximab ( n=190). Clinical outcomes and resource usage were monitored in the 12 months following transplantation. Local unit costs were obtained, and global analysis was undertaken using health sector purchasing-power parity rates. No statistically significant differences were found in the mean cost of treatment per patient. The mean cost of treatment was US$47,940 for basiliximab patients and US$46,280 for placebo patients, a mean difference of US$1,660 (95% confidence interval (CI): -US$4,150, US$7,360; P=0.58). Basiliximab produces clinical benefit in terms of preventing episodes of acute rejection, whilst the difference in the total resource usage and cost of treatment is not statistically significant.

Analysis of Variance↗
PubMed2002

Safety and efficacy of an alternative basiliximab (Simulect) regimen after renal transplantation: administration of a single 40-mg dose on the first postoperative day in patients receiving triple therapy with azathioprine.

This was a multi-center, open-label, randomized, dose-comparative study on 202 renal transplantation patients. We evaluated for the first time an alternative dosing regimen for basiliximab, consisting of a single 40-mg intravenous dose on day 1 post-transplantation plus triple therapy, in comparison with the conventional two-dose regimen (2 h before transplantation and on day 4) plus triple therapy. At 6 months, the incidence of acute rejection was low: 22.5% of patients in the basiliximab 2 x 20-mg group and 20.0% of patients in the basiliximab 1 x 40-mg group experienced an acute rejection episode ( P = 0.628) (biopsy-proven rejection: 19.6% and 17.0%, P = 0.585). There was no statistically significant difference in any of the secondary efficacy parameters. The incidence of graft loss by 12 months was 4.9% and 6.0% in the 2 x 20-mg and 1 x 40-mg group, respectively ( P = 0.73). No differences were observed between the dosage groups with regards to safety assessments (adverse events (AEs), infections, vital signs, laboratory safety evaluations, and physical examinations). The data reveal that basiliximab can be safely and effectively administered as a single 40-mg dose on day 1 after renal transplantation as a therapeutic option to the established 2 x 20-mg dosing regimen. This alternative dosing regimen may be of significant convenience under circumstances when a first dose of basiliximab was not given prior to transplantation. Both regimens can conveniently be used during the initial hospitalization of the patient.

Acute Disease↗
PubMed2003

Basiliximab widens the therapeutic window for AUC-monitored neoral therapy early after kidney transplantation.

Early adequate cyclosporine exposure has been shown to predict low acute rejection. Recently basiliximab induction has been added to immunosuppressive regimens to further reduce rejection. The aim of this study was to determine the importance of achieving the early cyclosporine therapeutic threshold with basiliximab induction. A retrospective analysis of first cadaver and nonidentical living donor transplant recipients treated with or without basiliximab induction was performed. All patients (n = 170) received neoral, mycophenolate mofetil, and prednisone. The cyclosporine absorption profile was measured on day 3. Adequate cyclosporine exposure was defined as area under the curve (AUC) 0-4: >4400 microg x h/L at day 3. The primary outcome was acute rejection (AR) within the first 6 month. In the no basiliximab (control) group, AR occurred in 22% (17/78) of recipients and was strongly associated with low cyclosporine exposure on day 3. AR occurred in 39% (9/23) with cyclosporine AUC0-4 < 4400 microg x h/L compared with 15% (8/55) with AUC0-4 > 4400 microg x h/L (P =.016). In the basiliximab group, AR occurred in only 9% (8/92) of recipients and did not correlate with cyclosporine exposure. AR occurred in 8% (2/24) with cyclosporine AUC0-4 < 4400 microg x h/L compared with 9% (6/68) with AUC0-4 > 4400 microg x h/L (P =.94). Achieving cyclosporine therapeutic targets by day 3 may not be required when anti-IL2 induction is used.

Antibodies, Monoclonal↗
PubMedDate not supplied

Basiliximab in a triple-drug regimen with tacrolimus and steroids in liver transplantation.

BACKGROUND: Basiliximab, a chimeric monoclonal antibody (mAb) directed against the alpha chain of the interleukin-2 (IL-2) receptor (CD25), has been extensively evaluated as induction therapy for kidney transplant recipients, more frequently in combination with a cyclosporine-based regimen. In this study, we assessed the efficacy and safety of basiliximab in combination with tacrolimus and steroids following liver transplantation. METHODS: One hundred fifty-two liver transplant recipients (141 cadaveric donors and 11 living donors [LRLT]) in the last 4 years were treated with 2 20-mg doses of basiliximab (days 0 and 4 posttransplantation) followed by tacrolimus (0.15 mg/kg/d; 10-15 ng/mL target trough levels) and steroids (500 mg intravenous [IV] bolus at the reperfusion followed by 20 mg orally daily and weaning off in 1 or 2 months). Follow-up ranged from 104 to 1630 days after transplantation (mean, 665 days; SD +/- 442.65; median, 509 days). RESULTS: Eighty-five percent of patients remained rejection-free during follow-up with an actuarial rejection-free probability of 78% within 3 months. Nineteen patients had 22 episodes of biopsy-proven acute cellular rejection (ACR). Actuarial patient and graft survival rates at 3 years were 86.7% and 75.8%, respectively. Twenty-seven patients (20.6%) experienced 1 episode of sepsis, requiring temporary reduction of immunosuppressive therapy. There was no evidence of CMV infections or side effects related to basiliximab. We observed 2 de novo malignancies, 1 recurrence from an ileal carcinoid tumor and 1 pulmonary recurrence of hepatocellular carcinoma (HCC) in 1 recipient of LRLT. CONCLUSIONS: Basiliximab in association with tacrolimus and steroids is effective prophylaxis of ACR in liver transplant recipients and does not increase the incidence of infections or adverse effects.

Antibodies, Monoclonal↗
PubMed2001

First experience with basiliximab in pediatric liver graft recipients.

Several studies have shown a significant reduction of acute cellular graft rejection in adult liver and kidney graft recipients treated with monoclonal anti-interleukin-2 (IL-2)-receptor antibodies. The mechanism was inhibition of activated T-helper cells by blocking the alpha-chain (CD25) of the IL-2 receptor. The pilot study described here evaluated the use of basiliximab in pediatric liver transplantation (LTx), which is the first report on its use in children. Fifty-two liver-transplanted children were analyzed in this study. A matched-pair historical control group (n = 26) received cyclosporin A (CsA) and prednisolone, and patients in the basiliximab group (n = 26) were treated with low-dose CsA and basiliximab (after reperfusion and on day 4 post-transplant). The incidences were compared of acute graft rejections, infectious complications, and the adverse effects of immunosuppressive medication within the first 6 months post-transplant. The incidence of acute rejection was significantly higher in the control group (61.5% vs. 11.5%, p = 0.0004). The frequency of infectious complications was similar (46.1% vs. 53.8%). Patients in the basiliximab group showed less arterial hypertension; however, the differences were not statistically significant (30.7% vs. 7.7%, p = 0.07). Nephrotoxicity, hepatotoxicity or neurotoxicity were only seen in the control group (7.7%; 3.8%; 3.8%, respectively). Hence, the use of basiliximab in combination with CsA and steroids in pediatric liver transplant recipients is safe and reduces the incidence of acute graft rejection. Further studies are needed to confirm our preliminary results and to analyze long-term effects on post-transplant lymphoproliferative disease, chronic rejection, and patient survival.

Antibodies, Monoclonal↗
PubMed2002

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

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.

Adult↗
PubMed2003

Basiliximab (anti-CD25) in combination with steroids may be an effective new treatment for steroid-resistant ulcerative colitis.

BACKGROUND: Steroid resistance represents a major clinical problem in the treatment of ulcerative colitis. In vitro, interleukin-2 renders lymphocytes steroid resistant. AIM: To explore the therapeutic potential of interleukin-2 receptor blockade in steroid-resistant ulcerative colitis with both in vitro measures and a pilot in vivo study. METHODS: Ten patients with steroid-resistant ulcerative colitis received a single bolus of 40 mg of intravenous basiliximab plus steroid treatment in an open-label, uncontrolled, 24-week study. The outcome was assessed using the Ulcerative Colitis Symptom Score, rectal biopsy and Inflammatory Bowel Disease Questionnaire. Lymphocyte steroid sensitivity was measured in vitro in 39 subjects in the presence or absence of basiliximab. RESULTS: Nine of the 10 patients achieved clinical remission within 8 weeks. At 24 weeks, seven patients were in clinical remission. Marked improvement in the Ulcerative Colitis Symptom Score was seen by 1 week (P = 0.004) and on rectal biopsy and Inflammatory Bowel Disease Questionnaire by 2 weeks (both P < 0.05). Improvements persisted to 24 weeks (Ulcerative Colitis Symptom Score, Inflammatory Bowel Disease Questionnaire, both P < 0.005). Eight of the nine responders relapsed (median, 9 weeks), but remission was re-achieved with further corticosteroids and the addition of azathioprine. At 24 weeks, seven patients were in full clinical remission, five off all steroid therapy. In vitro measurement of lymphocyte steroid sensitivity demonstrated steroid resistance in 22% of subjects. All were rendered steroid sensitive in the presence of basiliximab. CONCLUSIONS: Basiliximab appears to be effective at inducing remission in steroid-resistant ulcerative colitis. In vitro, basiliximab also produced a dramatic increase in lymphocyte steroid sensitivity in healthy subjects. Confirmation in randomized controlled studies is required.

Adult↗
PubMed2005

Long-term results of basiliximab induction immunosuppression in pediatric liver transplant recipients.

It has been shown that an induction therapy with the monoclonal anti-interleukin-2 receptor antibody basiliximab (Simulect) is capable to reduce the incidence of acute graft rejection in adult and pediatric liver transplantation (Ltx). However, data on long-term results using basiliximab in children post-Ltx are still pending. Therefore, the objective of our study was to report on the long-term results of basiliximab induction therapy in pediatric liver transplant recipients. A total of 54 children received two single doses of basiliximab in addition to cyclosporine and prednisolone following Ltx. We analyzed the incidence of acute and chronic graft rejection that of post-transplant lymphoproliferative disease (PTLD), and patient and graft survival. The follow-up was 22-46 months. The historical control group (matched controls) consisted of 54 patients treated with a cyclosporine and prednisolone dual therapy. Patient survival was 53 of 54 in the treatment group and 51 of 54 in the controls. One patient was retransplanted in the treatment group vs. three patients in the control group. The incidence of acute graft rejection was 16.6% compared with 53.7% in the control group (p < 0.001), that of chronic rejection was comparable in both groups (one of 54 vs. one of 54). The incidence of steroid resistant rejection was four of 54 vs. six of 54 that of PTLD were one of 54 vs. zero of 54. There were no adverse effects observed, which could be related to the antibody treatment. We conclude that basiliximab provides safe and effective induction immunosuppression in pediatric liver graft recipients. Short- and even long-term results are excellent.

Antibodies, Monoclonal↗
PubMed2005

Efficacy and safety of basiliximab in kidney transplantation.

The efficacy and safety of basiliximab, in combination with different maintenance regimens, are extensively addressed in the available literature. Basiliximab reduces the incidence of acute rejection, allows a safe reduction of steroid dosage, and is associated with economic savings, although there is substantially no proof that basiliximab prolongs either patient or graft survival. Initial basiliximab administration entails a low-risk and is associated with fewer adverse events than T cell depleting agents. However, life-threatening reactions were reported following re-exposure to basiliximab in recipients who lost graft function early after transplantation and, therefore, discontinued all immunosuppressive agents.

Antibodies, Monoclonal↗
PubMed2005

Alemtuzumab induction and prednisone-free maintenance immunotherapy in kidney transplantation: comparison with basiliximab induction--long-term results.

This study examined alemtuzumab (anti-CD 52, Campath-1H) and basiliximab (anti-CD 25, Simulect) as induction immunosuppression in kidney transplantation. We used a single-center, nonrandomized, retrospective, sequential study design to evaluate outcomes in kidney transplant recipients given either alemtuzumab (n = 123) or basiliximab (n = 155) induction in combination with a prednisone-free maintenance protocol using tacrolimus and mycophenolate mofetil. Kaplan-Meier analyses of long-term patient and graft survivals and rejection rates were determined according to induction agent, donor source and recipient ethnicity. Secondary endpoints included the quality of renal allograft function and the etiology of infectious complications. Overall long-term patient and graft survival rates did not significantly differ between patients treated with alemtuzumab and basiliximab. A lower rate of early (<3 months) rejection was observed in the alemtuzumab (4.1%) versus the basiliximab (11.6%) group, but the rates for both groups were equivalent at 1 year. Patient and kidney survival and rejection rates were nearly identical between Caucasians and African Americans that received alemtuzumab. Quality of renal function and incidence of infectious complications were similar in the two groups. Alemtuzumab induction therapy was similar in efficacy to basiliximab in a prednisone-free maintenance immunosuppressive protocol for an ethnically diverse population of kidney transplant recipients.

Adolescent↗
PubMed2005

The renal-sparing efficacy of basiliximab in adult living donor liver transplantation.

The purpose of this study is to find out whether basiliximab administration will improve postoperative renal function by delaying the start of tacrolimus and decreasing of dosage requirement for tacrolimus in adult living donor liver transplantation (LDLT). Forty-five adult LDLT recipients were enrolled in the study. The induction group (n = 27) was given basiliximab 20 mg on days 0 and 4; tacrolimus administration was delayed until renal function improved. The control group (n = 18) did not receive basiliximab; tacrolimus was given on the first postoperative day. Trough levels of tacrolimus in the induction and control groups were aimed to be maintained at 5-10 ng/ml and 10-15 ng/ml during the first week after transplant, respectively. The median follow-up was 22 months (range 10-34 months). The preoperative conditions were poorer in the induction group (Child C, 56% vs. 33%, P = 0.01; UNOS 2a, 15% vs. 0%, P = 0.02). The intraoperative blood loss was also higher in the induction group than in the control group (median 2,180 ml vs. 495 ml, P < 0.01). The median delay in tacrolimus administration in the induction group was 36 hours (range 24-108 hours). Serum creatinine levels at second and third postoperative months were significantly lower in the induction group. The creatinine clearance rate in the induction group was higher at the third month posttransplant (median 72 vs. 57 ml/minute, P = 0.04). The incidence of renal insufficiency was significantly lower in the induction group at the third month posttransplant (26% vs. 67%, P < 0.01). Blood cholesterol level at the sixth month posttransplant was lower in the induction group (median 152 vs. 196 mg/dl P = 0.03). The incidences of acute cellular rejection, bacteremia, and cytomegalovirus (CMV) infection were similar in both groups. In conclusion, for pretransplant critical patients with more intraoperative blood loss, basiliximab induction could prevent early renal dysfunction by delaying the start of tacrolimus and reducing the dose requirement of tacrolimus without increasing graft rejection and infection. Furthermore, it also improved renal function as well as lowered cholesterol levels within 6 months after transplantation.

Adult↗
PubMed2005

Use of basiliximab and cyclosporine in heart transplant patients with pre-operative renal dysfunction.

BACKGROUND: The combined use of basiliximab and cyclosporine in heart transplantation is under investigation. In this study we sought to evaluate the safety and efficacy of basiliximab and delayed initiation of cyclosporine in patients with renal dysfunction undergoing heart transplantation. METHODS: Seven patients (Group A) with renal dysfunction (creatinine > or =200 micromol/liter) received induction therapy with basiliximab. Seven patients (Group B) with renal dysfunction comprised the control group and received induction therapy with rabbit anti-thymocyte serum. Cyclosporine was initiated 5 days post-transplant in Group A and within 5 days post-transplant in Group B. RESULTS: All patients were alive at the end of the 6-month follow-up. In Group A, mean pre-transplant creatinine was 243 +/- 48 micromol/liter, at 1 week post-transplant was 180 +/- 39 micromol/liter (p = 0.02), at 1 month was 166 +/- 57 micromol/liter (p = 0.019), at 3 months was 182 +/- 25 micromol/liter (p = 0.01) and at 6 months was 179 +/- 45 micromol/liter (p = 0.024). In Group B, mean pre-transplant creatinine was 242 +/- 41 micromol/liter, at 1 week was 140 +/- 35 micromol/liter (p = 0.0003), at 1 month was 143 +/- 38 mumol/liter (p = 0.0005), at 3 months was 138 +/- 37 micromol/liter (p = 0.0003) and at 6 months was 154 +/- 30 micromol/liter (p = 0.0006). There were no differences in renal dysfunction between both groups at 1 week (p = 0.069), 1 month (p = 0.39) or 6 months (p = 0.24) post-HT. Fewer episodes of cellular rejection were identified in Group B within the 6-month follow-up period. CONCLUSIONS: The use of induction therapy either with basiliximab or rabbit anti-thymocyte serum in patients with pre-operative renal dysfunction confers renal protection early and up to 6 months post-transplant. Delayed initiation of cyclosporine might be considered to provide additional renal protection.

Adult↗