Effect of basiliximab use on the risk of postoperative infection and death after heart transplantation: An observational study.

Heart transplantation (HT) has become the preferred treatment for end-stage heart disease, but postoperative complications such as infection still threaten the prognosis of HT patients. Basiliximab can help minimize immune rejection. However, there is a lack of relevant information to compare the prognosis of different immunosuppression regimens. This study aimed to investigate the risk factors associated with death and infection after HT surgery. We also provide some insightful information on the administration of basiliximab to improve the prognosis of HT patients. In total, 70 patients were included in this retrospective observational study. All participants underwent primary HT and were administered immunosuppressive agents postoperatively. Of these, 38 received additional basiliximab. There was a 6-month follow-up period after HT during which clinical outcomes were monitored. Logistic regression and cox-proportional hazard regression analyses were performed to determine the relationship between basiliximab use and the clinical outcomes of HT. Logistic regression analysis revealed that basiliximab use (odds ratio [OR] = 0.07, P = .014) was an independent risk factor for death after HT. d-Dimer (OR = 9.05, P = .002) and basiliximab use (OR = 0.15, P = .004) were independent risk factors for death after HT. Moreover, patients treated with basiliximab had shorter hospital lengths of stay (23.58 ±â€…13.89 vs 39.41 ±â€…24.43, P = .001) and intensive care unit lengths of stay (4.76 ±â€…2.85 vs 11.25 ±â€…5.79, P < .001). Furthermore, patients administered basiliximab had lower rates of death (1 [5.4%] vs 9 [28.1%], P = .007) and infection (6 [15.8%] vs 19 [59.4%], P < .001). The postoperative survival rate (hazard ratio 0.08, 95% confidence interval 0.01-0.65, P = .018) and survival against infection (hazard ratio 0.24, 95% confidence interval 0.09-0.64, P = .004) were significantly higher among patients receiving basiliximab treatment than among those not receiving treatment. Our study showed that basiliximab use was closely associated with the rate of postoperative death and infection after HT. HT patients with additional basiliximab administration as immunosuppressive treatment had a better clinical prognosis.

The Impact of Basiliximab on Clinical Treg Detection through the Interference with CD25 Binding Site.

OBJECTIVE: Basiliximab (BXM) is commercial monoclonal antibody inhibitor of interleukin 2 receptor, which is widely used in the transplantation therapy for preventing acute rejection. However, we found BXM would interfere with the detection of Treg through flow cytometry in clinical practice. This study aimed to explore the interference caused by BXM in the clinical detection of Treg. METHODS: We compared the effects of BXM on two CD25 antibodies with different clone site, which are commonly used for Treg measurement. RESULTS: The result suggested CD25 (2A3) was inhibited by BXM, while CD25 (M-A251) was not affected. Moreover, we found 2A3/M-A251 Treg Ratio could reflect Treg cell activity and BXM blood concentration to some extent. CONCLUSION: BXM can effectively inhibit the binding of CD25 (2A3) antibody to its receptor on T cells membrane, which should be noted during Treg clinical detection.

Basiliximab Does Not Impair Airway Mucociliary Clearance of Rats.

Previous studies have shown that immunosuppressive drugs impair the airway mucociliary clearance of rats. However, considering the high specificity of basiliximab (BSX) and the absence of studies reporting its side effects, our aim was to investigate whether BSX, associated or not with triple therapy, impairs the mucociliary system. Forty rats were divided into 4 groups: Control, BSX, Triple, and BSX + Triple. After 15 days of treatment, animals were euthanized and the ciliary beating frequency (CBF), mucociliary transport velocity (MCTV), neutral and acid mucin production, Muc5ac and Muc5b gene expression, inflammatory cell number, and interleukin (IL)-6 concentration were analyzed. CBF and MCTV were lower in Triple and BSX + Triple groups (p < 0.05). Neutral mucin percentage was higher in Triple group (p < 0.05), and acid mucin percentage was higher in Triple and BSX + Triple groups (p < 0.05). The Muc5ac and Muc5b gene expression was higher in Triple and BSX + Triple groups (p < 0.05). Animals from Triple and BSX + Triple groups presented fewer mononuclear cells (p < 0.05). The number of polymorphonuclear cells was higher in the Triple group (p < 0.05). In the analysis of inflammatory cells in the blood, there was a decrease in lymphocytes and an increase in neutrophils in the Triple and BSX + Triple groups (p < 0.05). The concentration of IL-6 significantly increased in the animals of the Triple and BSX + Triple groups (p < 0.05). BSX did not change the mucociliary apparatus of rats.

Prognostic factors and long-term follow-up of basiliximab for steroid-refractory acute graft-versus-host disease: Updated experience from a large-scale study.

Acute graft-vs-host disease (aGVHD) is one of the most important causes of early mortality after allogeneic hematopoietic stem cell transplantation (allo-HSCT), particularly for those with steroid-refractory (SR)-aGVHD. We aimed to identify the prognostic factors and long-term clinical outcomes of basiliximab treatment for SR-aGVHD. Basiliximab was administered on days 1, 3, and 8, and repeated weekly until aGVHD was less than grade II, or patients showed no response after four doses. Out of 1498 patients receiving allo-HSCT, 230 patients with SR-aGVHD were enrolled. Grade III to IV aGVHD before basiliximab treatment significantly and independently predicted a poorer response to basiliximab in multivariate analysis. And, the cumulative incidence of overall response at 14 days, 28 days, and 56 days after treatment was 41.4% vs 23.1% (P = .023), 70.2% vs 43.6% (P = .002), and 80.1% vs 66.7% (P = .013), respectively. This was for those with grade II and grade III to IV aGVHD. Patients receiving more than four doses of basiliximab had higher rates of infections. The 4-year cumulative incidence of total and severe chronic GVHD after basiliximab treatment was 44.8% (95% CI 38.3%-51.3%) and 2.2% (95% CI 0.3%-4.1%), respectively. The 4-year cumulative incidence of relapse, non-relapse mortality, disease-free survival, and overall survival after basiliximab treatment was 11.3% (95% CI 7.2%-15.4%), 30.0% (95% CI 24.1%-35.9%), 58.7% (95% CI 52.3%-65.1%), and 61.7% (95% CI 55.4%-68.0%), respectively. Comorbidities before allo-HSCT and refined Minnesota aGVHD risk score at diagnosis had significant influences on long-term survival. Thus, basiliximab was a safe and effective treatment for patients with SR-aGVHD.

Comparison of 10-year graft failure rates after induction with basiliximab or anti-thymocyte globulin in pediatric heart transplant recipients-The influence of race.

BACKGROUND/OBJECTIVE: The impact of induction therapy in pediatric heart transplantation has been uncertain. Given the risk of poor outcomes in black pediatric heart transplant recipients, we evaluated the effect on graft survival of ATG and BAS induction in black and non-black pediatric recipients. METHODS: This was a retrospective analysis of pediatric candidates (aged ≤18 years) who underwent heart transplantation from 2000 to 2016 identified from the UNOS database. Primary outcome was 10-year graft survival. RESULTS: This study included 654 patients receiving BAS, 2385 patients receiving ATG, and 2425 receiving no induction. Ten-year survival was similar for the following groups: non-black BAS (57%), non-black ATG (66%), and black ATG (51%). The black BAS group had a 10-year graft survival of 39% which was inferior on pairwise comparison to the other groups (all P values < 0.001). On multivariate analysis, ATG was associated with decreased risk of graft failure when compared to no induction (HR 0.86, 95% CI 0.76-0.97, P = 0.011) and had an association approaching statistical significance when compared to BAS induction (0.84, 0.7-1.01, P = 0.069). This association was seen in black recipients in whom ATG was strongly associated with decreased risk of graft failure when compared to either no induction (0.65, 0.5-0.83, P = 0.001) or BAS (0.64, 0.46-0.89, P = 0.008) but was not seen in non-black recipients. CONCLUSIONS: Black pediatric heart transplant recipients who received ATG induction had an improved long-term graft survival compared to those who received BAS induction or no induction.

Review of the Clinical Pharmacokinetics and Pharmacodynamics of Alemtuzumab and Its Use in Kidney Transplantation.

Alemtuzumab is a humanized monoclonal antibody against CD52 and causes depletion of T and B lymphocytes, monocytes, and NK cells. Alemtuzumab is registered for the treatment of multiple sclerosis (MS) and is also used in chronic lymphocytic leukemia (CLL). Alemtuzumab is used off-label in kidney transplantation as induction and anti-rejection therapy. The objective of this review is to present a review of the pharmacokinetics, pharmacodynamics, and use of alemtuzumab in kidney transplantation. A systematic literature search was conducted using Ovid Medline, Embase, and Cochrane Central Register of controlled trials. No pharmacokinetic or dose-finding studies of alemtuzumab have been performed in kidney transplantation. Although such studies were conducted in patients with CLL and MS, these findings cannot be directly extrapolated to transplant recipients, because CLL patients have a much higher load of CD52-positive cells and, therefore, target-mediated clearance will differ between these two indications. Alemtuzumab used as induction therapy in kidney transplantation results in a lower incidence of acute rejection compared to basiliximab therapy and comparable results as compared with rabbit anti-thymocyte globulin (rATG). Alemtuzumab used as anti-rejection therapy results in a comparable graft survival rate compared with rATG, although infusion-related side effects appear to be less. There is a need for pharmacokinetic and dose-finding studies of alemtuzumab in kidney transplant recipients to establish the optimal balance between efficacy and toxicity. Furthermore, randomized controlled trials with sufficient follow-up are necessary to provide further evidence for the treatment of severe kidney transplant rejection.