BACKGROUND: Basiliximab is a chimeric monoclonal directed against the alpha-chain of the interleukin-2 receptor. International studies have shown that it is highly effective in preventing acute rejection in patients receiving Neoral, and causes no measurable incremental toxicity, but its economic value remains unknown. METHODS: This study employed an economic model to examine the potential economic benefit of basiliximab. Parameter estimates were derived from a randomized, prospective, double-blind study conducted in 21 renal transplant centers in seven countries in which 380 adult primary allograft recipients were randomized within center to receive basiliximab (20 mg i.v.) on days 0 and 4 or placebo in addition to dual immunosuppression with Neoral and steroids. Key clinical events included primary hospitalization, immunosuppressive drug use, patient and graft survival, graft rejection, treatment of rejection, dialysis, and repeat hospitalization. Health resources were valued via a comprehensive electronic cost dictionary, based upon a detailed economic evaluation of renal transplantation in Canada. Medication costs were calculated from hospital pharmacy acquisition costs; basiliximab was assessed a zero cost. RESULTS: The average estimated cost per patient for the first year after transplant was $55,393 (Canadian dollars) for placebo and $50,839 for basiliximab, rising to $141,690 and $130,592, respectively, after 5 years. A principal component of the cost in both groups was accrued during the initial transplant hospitalization ($14,663 for standard therapy and $14,099 for basiliximab). An additional $15,852 and $14,130 was attributable to continued care, graft loss, and dialysis in the two groups, whereas follow-up hospitalization consumed an additional $15,538 for placebo and $13,916 for basiliximab. The mean incremental cost of dialysis was $5,397 for placebo compared with $3,821 for basiliximab, whereas incremental costs of graft loss were $2,548 compared with $2,295 in the two treatment groups. The principal costs associated with repeat admission to the transplant ward and the general ward were marginally higher for placebo ($7,395 vs. $6,300 and $5,986 vs. $4,625). Treatment of acute rejection and maintenance immunosuppressive drug use were associated with only limited savings as a result of basiliximab (savings <$200 each). Sensitivity analysis indicated that the most influential parameters affecting the savings as a result of using basiliximab were a reduction in the duration of initial and repeat hospitalization followed by the reduced risks of acute rejection and graft loss. CONCLUSIONS: Before accounting for the cost of the therapy itself, basiliximab produces an estimated economic saving of $4,554 during the first year after transplant, of which $3,344 is attributable to the reduced costs of graft dysfunction, including graft loss and dialysis ($1,722) and follow-up hospitalizations ($1,622). When marketed, basiliximab is expected to cost approximately $3,000 per course (two doses of 20 mg), resulting in a net first-year saving of $1,554. Under these circumstances, basiliximab can be considered a dominant therapy in renal transplantation.

BACKGROUND: Basiliximab is a high-affinity chimeric monoclonal antibody directed against the alpha-chain of the interleukin (IL)-2 receptor. Individual studies have shown that it is highly effective in preventing acute rejection and causes no measurable incremental toxicity. However, incorporation of basiliximab immunoprophylaxis into routine practice depends upon the demonstration of benefit across treatment regimens and quantitation of the treatment effect. METHODS: This study employed a meta-analysis to examine the clinical benefit of basiliximab. Parameter estimates were derived from four randomised prospective double-blind studies conducted in 93 renal transplant centres in 18 countries. A total of 1185 adult primary allograft recipients were randomised within the centres to receive either basiliximab 20mg intravenously on days 0 and 4 or placebo, in addition to double or triple immunosuppression consisting of cyclosporin-microemulsion (Neoral((R))The use of tradenames is for product identification purposes only and does not imply endorsement.), corticosteroids, and azathioprine or mycophenolate mofetil. Key clinical events included patient and graft survival, graft rejection and complications. Analysis was performed using a variable model; odds ratios and the numbers needed to treat (NNT) to benefit or to harm one patient were calculated for each principal outcome at 6 or 12 months post-transplant. RESULTS: Basiliximab reduced the relative risk (RR) and absolute risk (AR) of clinical and biopsy-proven acute graft rejection across all treatment regimens. The overall RR of clinical acute graft rejection was decreased by 35% in patients receiving basiliximab. AR was reduced by 15.6% (pooled incidence: 28.8% vs 44.4%, p < 0.0001), and the NNT for efficacy was six. The reduction in RR of biopsy-proven rejection was similar (32%) with an absolute risk reduction (ARR) of 11.7% (pooled incidence: 25.1% vs 36.8%, p < 0.0001) and NNT of nine over 6 months. There was a concomitant reduction in the risk of graft loss which did not reach statistical significance (p = 0.14). The RR of graft loss was reduced by 26% with an AR reduction of 2.3% (pooled incidence: 6.4% vs 8.7%) and an NNT of 42 over 6 months. The risk of death was unchanged. CONCLUSIONS: Immunoprophylaxis with basiliximab produces a significant reduction in the RR and AR of clinical and biopsy-proven acute graft rejection with a trend towards a concomitant reduction in the risk of graft loss. The magnitude of protection provided by basiliximab, the fact that it is observed across treatment regimens and the safety of this therapy are arguments for its routine use in renal transplantation.

OBJECTIVE: To compare efficacy and safety of basiliximab versus antithymocyte globulin (ATG) for induction therapy in kidney transplantation. METHODS: A literature search of the MEDLINE, EMBASE, CBMdisc, and Cochrane databases was used to identify randomized controlled trials that compared basiliximab and ATG for induction therapy in kidney transplantation. Inclusion criteria comprised: prospective randomized controlled clinical trials, follow-up time >or=12 months, randomized comparisons of ATG versus basiliximab as induction therapy in kidney transplantation. Meta-analytical techniques were applied to identify differences in outcomes between the two agents. RESULTS: A total of six studies involving 853 patients were identified. No differences between ATG and basiliximab were seen in terms of biopsy-proven rejection (relative risk [RR] 1.15, 95% confidence interval [CI] 0.88-1.52, P = .31), delayed graft function (RR 1.02, 95% CI 0.69-1.51, P = .93), graft loss (RR 1.15, 95% CI 0.73-1.80, P = .55), and patient death (RR 1.22, 95% CI 0.65-2.30, P = .54). But basiliximab had a lower incidence of infection (RR 0.87, 95% CI 0.78-0.97, P = .02) and neoplasm (RR 0.29, 95% CI 0.09-0.97, P = .04). CONCLUSIONS: Basiliximab is as effective as ATG for induction therapy in kidney transplantation, whereas basiliximab has a lower incidence of infection. Basiliximab may be a safer and preferable option for induction therapy in kidney transplantation.

BACKGROUND: Interleukin-2 receptor antagonists (IL-2RAs) have been extensively used in kidney transplant patients to prevent the occurrence of acute rejection. The efficacy and safety of basiliximab and daclizumab, the 2 most commonly used IL-2RAs in clinics, have been compared in a number of randomized controlled trials, but no definite conclusions have been drawn. OBJECTIVE: This meta-analysis aimed to compare the efficacy and safety of basiliximab and daclizumab in kidney transplant patients. METHODS: We performed keyword searches in Pubmed, Embase, and the Cochrane library. In total, 6 randomized controlled trials with 509 patients were included in this meta-analysis. Data collected included patient survival, graft survival, acute rejection, infection, and cytomegalovirus infection. The outcome measure was the relative risk of basiliximab versus daclizumab. RESULTS: Therapy with basiliximab and daclizumab resulted in similar outcomes regarding acute rejection (6-month 95% confidence interval [CI], 0.09-1.14; 12-month 95% CI, 0.53-1.91), patient survival (95% CI, 0.97-1.04), graft survival (95% CI, 0.98-1.08), infection (95% CI, 0.66-1.01), and cytomegalovirus infection (95% CI, 0.45-1.14) within the follow-up period. There were no significant differences in safety and efficacy between the 2 drugs. CONCLUSIONS: The safety and efficacy of daclizumab and basiliximab are similar in kidney transplant recipients.

BACKGROUND: The benefits of the application of basiliximab induction therapy in liver transplantation are not clear. The present meta-analysis was to evaluate the pros and cons of basiliximab use in liver transplantation. DATA SOURCES: We searched the associated publications in English from July 1998 to December 2015 in the following databases: MEDLINE, PubMed, Ovid, EMBASE, Web of Science and Cochrane Library. RESULTS: Basiliximab significantly decreased the incidence of de novo diabetes mellitus after liver transplantation (RR=0.56; 95% CI: 0.34-0.91; P=0.02). Subgroup analysis showed that basiliximab in combination with steroids-free immunosuppressant significantly decreased the incidence of biopsy-proven acute rejection (RR=0.62; 95% CI: 0.39-0.97; P=0.04) and new-onset hypertension (RR=0.62; 95% CI: 0.42-0.93; P=0.02). CONCLUSIONS: Basiliximab may be effective in reducing de novo diabetes mellitus. What is more, basiliximab in combination with steroids-free immunosuppressant shows statistical benefit to reduce biopsy-proven acute rejection and de novo hypertension.

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BACKGROUND: Optimal immunosuppression is essential to maintain kidney allograft viability but minimizing toxicity is also fundamental. OBJECTIVE: This article compares immunosuppressants, corticosteroids, cyclosporine, tacrolimus, and basiliximab, which are used in the treatment regimens for renal transplantation. The analyses evaluated their effectiveness to prevent acute rejection episodes and to reduce the appearance of other complications, mainly infectious disease complications. METHODS: Ninety-five patients were analysed during the first year after primary renal transplantation. These patients were included in a random way in 3 different groups according to the immunosuppressant drug therapy: Group I (35 patients) received corticosteroids + CsA; Group II (35 patients) received corticosteroids + CsA + Basiliximab; Group III (25 patients) received corticosteroids + Tacrolimus + Basiliximab. RESULTS: Among the 95 patients, 9 presented with an acute rejection episode in Group I. None in Group II, and one in group III. With reference to the infectious disease complications, the incidence of oral herpes was one case in Group I, 4 cases in Group II, and 2 cases in group III. CONCLUSIONS: Treatment with Basiliximab produced a significantly lower incidence of acute rejection cases and an increase in infectious disease complications, such as lip herpes.

The immunosuppressant basiliximab--a chimeric monoclonal antibody specific to the interleukin-2 receptor on activated T-lymphocytes--significantly reduces the incidence of acute cellular rejection following renal transplantation. Screening for exposure-response relationships was performed within a randomized, blinded, placebo-controlled efficacy trial in which patients received 40 mg basiliximab (20 mg on days 0 and 4) by intravenous infusion in addition to cyclosporine and corticosteroids. In a subset of patients, serum samples were collected pre-transplant and once in weeks 2, 3 and 4 for determination of basiliximab concentrations. A population pharmacostatistical model was used to derive individual empirical Bayes estimates of each patient's pharmacokinetic parameters. Biopsy-confirmed acute rejection episodes were recorded to month 6 post-transplant. Forty basiliximab-treated patients were evaluated, 30 men and 10 women, aged 48 +/- 12 yr (range, 24-73) and weighing 72.4 +/- 12.9 kg (range, 52.5-107.5). The basiliximab distribution volume was 7.5 +/- 1.7 L, the half-life 7.5 +/- 2.5 d and the clearance 33 +/- 12 mL/h. There was no clinically relevant influence of weight, age, or gender on basiliximab disposition. Receptor-saturating serum basiliximab concentrations (> 0.2 microgram/mL) were maintained for 41 +/- 23 d. Twenty-five patients remained rejection-free over the 6-month observation period, while a total of 26 biopsy-confirmed acute rejection episodes occurred in the remaining 14 patients. Of these episodes, 12 occurred during receptor blockade. No apparent relationship to basiliximab concentration on the day of onset was observed range, 0.1-9.0 microgram/mL) nor did the time of suppression offset represent a period of increased risk for rejection episodes. Fourteen rejection episodes occurred after basiliximab had cleared from the serum. The durations of receptor suppression preceding these events did not differ compared with those in patients who remained rejection-free: 32 +/- 11 versus 45 +/- 26 d, respectively (p = 0.1269). Given the durations of receptor saturation achieved with the chosen basiliximab regimen, this screen for exposure-response relationships did not identify the duration of receptor saturation in peripheral blood as a predictive factor for acute rejection episodes. Further exploration for exposure-effect relationships in a larger population is warranted.

BACKGROUND: Induction therapy reduces the frequency of acute rejection and delayed graft function after transplantation. A rabbit antithymocyte polyclonal antibody or basiliximab, an interleukin-2 receptor monoclonal antibody, is most commonly used for induction. METHODS: In this prospective, randomized, international study, we compared short courses of antithymocyte globulin and basiliximab in patients at high risk for acute rejection or delayed graft function who received a renal transplant from a deceased donor. Patients taking cyclosporine, mycophenolate mofetil, and prednisone were randomly assigned to receive either rabbit antithymocyte globulin (1.5 mg per kilogram of body weight daily, 141 patients) during transplantation (day 0) and on days 1 through 4 or basiliximab (20 mg, 137 patients) on days 0 and 4. The primary end point was a composite of acute rejection, delayed graft function, graft loss, and death. RESULTS: At 12 months, the incidence of the composite end point was similar in the two groups (P=0.34). The antithymocyte globulin group, as compared with the basiliximab group, had lower incidences of acute rejection (15.6% vs. 25.5%, P=0.02) and of acute rejection that required treatment with antibody (1.4% vs. 8.0%, P=0.005). The antithymocyte globulin group and the basiliximab group had similar incidences of graft loss (9.2% and 10.2%, respectively), delayed graft function (40.4% and 44.5%), and death (4.3% and 4.4%). Though the incidences of all adverse events, serious adverse events, and cancers were also similar between the two groups, patients receiving antithymocyte globulin had a greater incidence of infection (85.8% vs. 75.2%, P=0.03) but a lower incidence of cytomegalovirus disease (7.8% vs. 17.5%, P=0.02). CONCLUSIONS: Among patients at high risk for acute rejection or delayed graft function who received a renal transplant from a deceased donor, induction therapy consisting of a 5-day course of antithymocyte globulin, as compared with basiliximab, reduced the incidence and severity of acute rejection but not the incidence of delayed graft function. Patient and graft survival were similar in the two groups. (ClinicalTrials.gov number, NCT00235300 [ClinicalTrials.gov].).

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