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Background: Induction therapy with basiliximab is recommended in kidney transplant (KT) recipients with a low immunological risk (LIR) profile. Whether basiliximab is associated with a decreased risk of acute rejection (AR) and graft loss is controversial. Methods: In our institution, LIR patients (absence of anti-HLA antibodies before KT) are inducted with basiliximab in case of living-donor KT, while deceased-donor KT recipients receive no induction. Maintenance immunosuppression is similar, including a combination of tacrolimus (Tac), mycophenolate (MPA) and steroids. In this single-center retrospective study, we included all adult LIR patients who underwent KT between 1 January 2015 and 31 December 2022. Results: Of the 471 patients included, 354 received no induction and 117 received basiliximab. The median (IQR) number of HLA A-B-DR mismatches was 3 (2–3) and 2 (2–4) in the no induction group and the basiliximab group, respectively. The cumulative incidences in the no induction group vs. the basiliximab group of acute rejection and graft loss over 5 years post-KT were similar at 8.9% vs. 7.8% (p = 0.8) and 8.5% vs. 4.2% (p = 0.063), respectively. In multivariable Cox regression analysis, delayed graft function emerged as an independent risk factor for acute rejection (hazard ratio [HR] 2.75, 95% confidence interval [CI] 1.23–6.13, p = 0.014) and graft loss (HR 9.32, CI 4.10–21.1, p < 0.001). Conclusions: Basiliximab did not provide any advantage in terms of rate of acute rejection and graft survival within 5 years post KT compared with a strategy without induction therapy in patients with a low immunological risk profile receiving triple maintenance immunosuppression Tac/MPA/steroids. [ABSTRACT FROM AUTHOR]

Background: Basiliximab is a high‐cost induction agent typically given as two doses in liver transplant recipients. This study evaluated renal outcomes in live‐donor liver transplant recipients (LDLTRs) with stable renal function at the time of transplant receiving one versus two doses of basiliximab. Methods: We retrospectively identified 231 adult LDLTR with a serum creatinine (SCr) <1.5 mg/dL on post‐transplant Day 5. The primary endpoint was a change in SCr from post‐transplant Days 5 to 30 between the groups. Secondary endpoints included incidence of acute kidney injury (AKI), liver rejection, and culture‐positive infections within 3 and 6 months of transplant. Basiliximab‐related cost savings were also evaluated. Results: Median change in SCr from post‐transplant Days 5 to 30 was no different between the single‐dose or two‐dose groups (0.1 [IQR: −0.1–0.3] vs. 0.2 [IQR: −0.1–0.4], p = 0.08). Incidence of AKI was 56.9% in the two‐dose group versus 39.0% in the single‐dose group (p = 0.01). There was no difference in bacterial (p = 0.40), fungal (p = 0.59), or viral (p = 0.78) infections. Acute cellular rejection through 6 months post‐transplant was noted in 9.7% of patients receiving two doses and 6.3% in the single‐dose arm (p = 0.42). Basiliximab‐related cost savings in the single‐dose arm was ∼$697 863.72 over 159 transplants. Conclusions: Single‐dose basiliximab appears to be safe and effective in place of two doses in LDLTR with stable renal function on post‐transplant Day 5. Utilization of a single basiliximab dose significantly reduced medication‐related costs. [ABSTRACT FROM AUTHOR]

Background Individualizing induction therapy based on immunological risk is crucial for optimizing outcomes in kidney transplantation. Methods A retrospective analysis included 157 first live-donor non-sensitized kidney transplant recipients (KTRs). Within this cohort, 96 individuals exhibited low human leukocyte antigen (HLA) matching (5–6 HLA mismatches). The low HLA match subgroup was categorized into 52 KTRs receiving basiliximab alone and 44 recipients treated with a combined single ATG dose of 1.5 mg/kg and basiliximab. The primary endpoint was early acute cellular rejection (ACR) within 6 months post-transplant while secondary outcomes encompassed infection rates, renal allograft function, length of stay (LOS) and readmissions post-transplant. Results The incidence of early ACR was decreased for low HLA match KTRs, who received ATG–basiliximab, when compared with low HLA-matched KTRs who received basiliximab alone (9.1% vs 23.9%, P  = .067). Age was a predictor for rejection, and subgroup analysis showed consistent rejection reduction across age groups. No significant differences were observed in admission for transplant LOS or in peri-operative complications, nor in infections rate including BK and cytomegalovirus viremia, allograft function and number of readmissions post-transplant up to 6 months post-transplant. Conclusion In non-sensitized first live-donor KTRs with low HLA matching, a dual ATG–basiliximab induction approach significantly reduced early ACR without compromising safety. [ABSTRACT FROM AUTHOR]

Background: Delayed graft function (DGF) is a common early complication after kidney transplantation (KT) and is associated with various long‐term adverse outcomes. Despite numerous studies on hemodynamic management, the optimal hemodynamic goals during KT remain unclear. In this retrospective study, we aimed to investigate if three mean artery pressure (MAP) thresholds (≤75, 80, and 85 mmHg) that were commonly used in clinical practice were associated with DGF in adult patients undergoing KT. Methods: We extracted de‐identified data on adult patients who underwent deceased donor KT from our Discovery Data Repository. DGF was defined as the requirement for dialysis within the first 7 days after transplantation. Three MAP thresholds (≤75, 80, and 85 mmHg) and the duration of pressure below the three thresholds were recorded. Multivariable logistic analysis was used to identify risk factors for DGF. Results: We included 2301 adult KT patients. The mean age was 52.5±12.9 years and 59% were male. DGF occurred in 1066 patients (46.3%). Patients frequently experienced MAP ≤75, 80, and 85 mmHg (approximately 70%, 80%, and 90% of patients experienced 10 min of MAP ≤75, 80, and 85 mmHg, respectively). Patients with DGF spent significantly longer durations below the three MAP thresholds during surgery compared with those without DGF. Further analysis revealed that the minimal time spent on MAP ≤75, 80, and 85 mmHg that were significantly associated with DGF were 6, 23, and 37 min, respectively. After adjusting for non‐hemodynamic risk factors (age, basiliximab administration, and urine output), prolonged exposure to the three MAP thresholds remained significant predictors for DGF (for MAP ≤75 mmHg, OR 1.257, 95% CI 1.017–1.554, p = 0.034; MAP ≤80 mmHg, OR 1.220, 95% CI 1.018–1.463, p = 0.031; MAP ≤85 mmHg, OR 1.253, 95% CI 1.048–1.498, p = 0.013). Conclusion: Prolonged exposure to the three common MAP thresholds (≤75, 80, and 85 mmHg) occurred frequently during adult deceased donor KT and was associated with DGF. [ABSTRACT FROM AUTHOR]

Background: Steroid-resistant (SR) lower gastrointestinal (LGI) tract graft-versus-host disease (GVHD) is the predominant cause of morbidity and mortality from GVHD after allogeneic hematopoietic stem cell transplantation (allo-HSCT). The role of vedolizumab in the treatment of SR-LGI acute GVHD (aGVHD) remains uncertain. We aimed to assess the efficacy and safety of vedolizumab combined with basiliximab as second-line therapy for SRLGI-aGVHD. Methods: This study aimed to explore the efficacy of vedolizumab combined with basiliximab for SR-LGI-aGVHD. The primary endpoint was the overall response (OR) on day 28. Secondary and safety endpoints included durable OR at day 56, overall survival (OS), chronic GVHD (cGVHD), non-relapse mortality (NRM), failure-free survival (FFS), and adverse events. Results: Twenty-eight patients with SR-LGI-aGVHD were included. The median time to start of combination therapy after SR-LGI-aGVHD diagnosis was 7 (range, 4-16) days. The overall response rate (ORR) at 28 days was 75.0% (95% CI: 54.8%-88.6%), and 18 achieved a complete response (CR) (64.3%, 95% CI: 44.1%-80.7%). The durable OR at day 56 was 64.3% (95% CI: 44.1%-80.7%). The 100-day, 6-month, and 12-month OS rates for the entire cohort of patients were 60.7% (95% CI: 45.1%-81.8%), 60.7% (95% CI: 45.1%-81.8%), and 47.6% (95% CI: 31.4%-72.1%), respectively. The median failure-free survival was 276 days; (95% CI: 50-not evaluable) 12-month NRM was 42.9% (95% CI: 24.1%-60.3%). The 1-year cumulative incidence of cGVHD was 35.7%. Within 180 days after study treatments, the most common grade 3 and 4 adverse events were infections. Nine (32.1%) patients developed cytomegalovirus (CMV) reactivation complicated with bacterial infections (25.0%, CMV infection; 7.1%, CMV viremia). Epstein-Barr virus (EBV) reactivation occurred in five patients (17.9%, 95% CI: 6.8%-37.6%). Only three patients (10.7%, 95% CI: 2.8%-29.4%) in our study developed pseudomembranous colitis. Conclusions: Vedolizumab plus basiliximab demonstrated efficacy in severe SRLGI-aGVHD and was well-tolerated. Vedolizumab plus basiliximab may be considered a potential treatment option for patients with LGI-aGVHD. [ABSTRACT FROM AUTHOR]

Background: Patients undergoing heart transplants are at risk of rejection which can have significant morbidity and mortality. Induction immunosuppression at the time of transplant reduces the early risk and has additional benefits. The induction agent of choice within our program was changed from rabbit antithymocyte‐globulin (rATG) to basiliximab, so it was necessary to evaluate whether this had any impact on patient outcomes. Objectives: Our primary objective was to describe rejection, infection, and other outcomes in adult heart transplant patients at the University of Alberta Hospital in Edmonton, Canada. Methods: This study was a nonrandomized, retrospective cohort study. Results: Sixty‐three patients were included with median ages 50 years versus 54 years. More female patients received rATG (20% vs. 42.4%). The most common indication for transplant in both cohorts was ICM (63.3% vs. 57.6%). Patients who received rATG had significantly higher PRA (0% vs. 43%, p <.001). Acute rejection episodes were similar between basiliximab and rATG at 3 months (16.7% vs. 15.1%; p = 1.0) and 6‐months (30.0% vs. 18.1%; p =.376). Infections were not statistically different with basiliximab compared to rATG at 3‐months, 43.3% vs. 63.6% and at 6‐months 60.0% vs. 66.7%). There were no fatalities in either group. Conclusions: Our study did not demonstrate differences in rejection with basiliximab compared to rATG. Mortality did not differ, but basiliximab‐treated patients had fewer infections and infection‐related hospitalizations than those treated with rATG. Larger studies with longer durations are needed to more completely describe the differences in rejection and infectious outcomes. [ABSTRACT FROM AUTHOR]

Background: We hypothesized that alemtuzumab use is safe in pediatric kidney transplant recipients (KTRs) with equivalent long‐term outcomes compared to other induction agents. Methods: Using pediatric kidney transplant recipient data in the UNOS database between January 1, 2000, and June 30, 2022, multivariate logistic regression, multivariable Cox regression, and survival analyses were utilized to estimate the likelihoods of 1st‐year and all‐time hospitalizations, acute rejection, CMV infection, delayed graft function (DGF), graft loss, and patient mortality among recipients of three common induction regimens (ATG, alemtuzumab, and basiliximab). Results: There were no differences in acute rejection or graft failure among induction or maintenance regimens. Basiliximab was associated with lower odds of DGF in deceased donor recipients (OR 0.77 [0.60–0.99], p =.04). Mortality was increased in patients treated with steroid‐containing maintenance (HR 1.3 [1.005–1.7] p =.045). Alemtuzumab induction correlated with less risk of CMV infection than ATG (OR 0.76 [0.59–0.99], p =.039). Steroid‐containing maintenance conferred lower rate of PTLD compared to steroid‐free maintenance (HR 0.59 [0.4–0.8] p =.001). Alemtuzumab was associated with less risk of hospitalization within 1 year (OR 0.79 [0.67–0.95] p =.012) and 5 years (HR 0.54 [0.46–0.65] p <.001) of transplantation. Steroid maintenance also decreased 5 years hospitalization risk (HR 0.78 [0.69–0.89] p <.001). Conclusions: Pediatric KTRs may be safely treated with alemtuzumab induction without increased risk of acute rejection, DGF, graft loss, or patient mortality. The decreased risk of CMV infections and lower hospitalization rates compared to other agents make alemtuzumab an attractive choice for induction in pediatric KTRs, especially in those who cannot tolerate ATG. [ABSTRACT FROM AUTHOR]

Immune checkpoint inhibitors (ICIs) targeting programmed cell death-1 (PD-1) and its corresponding ligand PD-L1 are being increasingly used for a wide variety of cancers, including refractory sarcomas. Autoimmune hepatitis is a known side effect of ICIs, and is typically managed with broad, non-specific immunosuppression. Here, we report a case of severe autoimmune hepatitis occurring after anti-PD-1 therapy with nivolumab in a patient with osteosarcoma. Following prolonged unsuccessful treatment with intravenous immunoglobulin, steroids, everolimus, tacrolimus, mycophenolate, and anti-thymoglobulin, the patient was eventually treated with the anti-CD25 monoclonal antibody basiliximab. This resulted in prompt, sustained resolution of her hepatitis without significant side effects. Our case demonstrates that basiliximab may be an effective therapy for steroid-refractory severe ICI-associated hepatitis.

Introduction: Induction therapy (IT) utility in heart transplantation (HT) remains contested. Commissioned by a clinical‐practice guidelines panel to evaluate the effectiveness and safety of IT in adult HT patients, we conducted this systematic review and network meta‐analysis (NMA). Methods: We searched for studies from January 2000 to October 2022, reporting on the use of any IT agent in adult HT patients. Based on patient‐important outcomes, we performed frequentist NMAs separately for RCTs and observational studies with adjusted analyses, and assessed the certainty of evidence using the GRADE framework. Results: From 5156 publications identified, we included 7 RCTs and 12 observational studies, and report on two contemporarily‐used IT agents—basiliximab and rATG. The RCTs provide only very low certainty evidence and was uninformative of the effect of the two agents versus no IT or one another. With low certainty in the evidence from observational studies, basiliximab may increase 30‐day (OR 1.13; 95% CI 1.06–1.20) and 1‐year (OR 1.11; 95% CI 1.02–1.22) mortality compared to no IT. With low certainty from observational studies, rATG may decrease 5‐year cardiac allograft vasculopathy (OR.82; 95% CI.74–.90) compared to no IT, as well as 30‐day (OR.85; 95% CI.80–.92), 1‐year (OR.87; 95% CI.79–.96), and overall (HR.84; 95% CI.76–.93) mortality compared to basiliximab. Conclusion: With low and very low certainty in the synthetized evidence, these NMAs suggest possible superiority of rATG compared to basiliximab, but do not provide compelling evidence for the routine use of these agents in HT recipients. [ABSTRACT FROM AUTHOR]

Background: The role of induction in low-risk, living-donor kidney transplants being treated with tacrolimus, mycophenolate mofetil, and prednisolone is debatable. Materials and Methods: This was a retrospective study that consisted of patients undergoing living kidney transplantation between February 2010 and June 2021 with a related haplomatch donor, with maintenance immunosuppression of tacrolimus, mycophenolate mofetil, and prednisolone. High-risk transplants, such as second or more transplants, immunologically incompatible transplants, and steroid-free transplants, were excluded. Patients were divided into three groups: no induction, basiliximab induction, and thymoglobulin induction, and the outcomes of all three were compared. Results: A total of 350 transplants were performed. There was a significant difference in the recipient sex distribution (P = 0.0373) and the number of preemptive transplants (P = 0.0272) between the groups. Other parameters were comparable. Biopsy-proven acute rejection (BPAR) was significantly less frequent in the thymoglobulin group than in the no-induction (5.3% vs. 17.5%; P = 0.0051) or basiliximab (5.3% vs. 18.8%; P = 0.0054) group. This persisted even after we performed multivariate regression analysis (thymoglobulin vs. no-induction group, P = 0.0146; thymoglobulin vs. basiliximab group, P = 0.0237). There was no difference in BPAR between the basiliximab and no-induction groups. There were no differences in other outcomes between the groups. Conclusion: In a low-risk haplomatch, related, living-donor kidney transplant on tacrolimus, mycophenolate mofetil, and prednisolone, BPAR was significantly lower with thymoglobulin as opposed to no induction or basiliximab induction with a similar short-term patient and death-censored graft survival and infection rates. Basiliximab did not provide any benefit over no induction. [ABSTRACT FROM AUTHOR]

Background: This study aimed to compare the efficacy and safety of basiliximab (BAS) versus a single dose of anti‐thymocyte globulin (r‐ATG) induction therapy in pediatric kidney transplant recipients (KTRs). Methods: This single‐center retrospective comparative cohort study included all pediatric KTRs from May 2013 to April 2018 and followed up to 12 months. In the first period, all recipients received BAS, while from May 2016, a single 3 mg/kg dose of r‐ATG was instituted. Maintenance therapy consisted of a calcineurin inhibitor plus prednisone plus azathioprine or mycophenolate. Results: A total of 227 patients were included (BAS, n = 113; r‐ATG, n = 114). The main combination of immunosuppressive drugs was tacrolimus, prednisone, and azathioprine in both groups (87% vs. 88%, p =.718). Patients receiving r‐ATG showed superior survival‐free of the composite endpoint (acute rejection, graft loss, or death; 76% vs. 61%, p =.003; HR 2.08, 1.29–3.34, p =.003) and lower incidence of biopsy‐proven acute rejection (10% vs. 21%, p =.015). There was no difference in the overall incidence of CMV infection (33% vs. 37%, p =.457), PTLD (1% vs. 3%, p =.309), 30‐day hospital readmissions (24% vs. 23%, p =.847), and kidney function at 12 months (86 ± 29 vs. 84 ± 30 mL/min/1.73m2, p =.614). Conclusions: These data suggest that induction therapy with a single 3 mg/kg dose of r‐ATG is associated with higher efficacy for preventing acute rejection and similar safety profile compared to BAS. [ABSTRACT FROM AUTHOR]

Liver transplantation (LT) is a technically complex operation and usually performed on ill patients. A major postoperative morbidity is incisional hernia, occurring in 9.5%-32.4% of cases. There are mixed results in transplant studies regarding potential risk factors. Additionally, the literature is lacking in the relationship between specific immunosuppressive induction agents administered during LT and postoperative incisional hernia. A single center, retrospective cohort study of patients who underwent primary LT between 4/2011-1/2018 was conducted. Clinical variables including demographics and comorbidities were reviewed. The primary end point was the development of an incisional hernia following LT. Sub analysis was performed for secondary end points to determine potential risk factors, including immunosuppressive induction agent. Overall, 418 patients met inclusion criteria. At 5 y post-LT, there were 66/271 (24.4%) and 53/147 (36.1%) patients diagnosed with an incisional hernia in the methylprednisolone and basiliximab groups, respectively. After propensity score matching, there was no difference in incisional hernia development between induction agents, P = 0.19. For patients with body mass index ≥30 and postoperative seroma of the abdominal wall, the hazard ratios were 2.67 (95% CI = 1.7, 4.3) and 2.03 (95% CI = 1.1, 3.9), respectively. Incisional hernia rate after LT was 28.5% at 5 y. Our analysis found that immunosuppressive induction agent at LT was not associated with the development of postoperative incisional hernia. However, preoperative obesity (body mass index ≥30) and postoperative seroma of the abdominal wall were potential risk factors. Further studies are needed to delineate if these risk factors remain across institutions and in alternative settings. • Incisional hernia after LT may occur in nearly one third of patients. • Hernia after LT may present later, with one third being diagnosed at 2-5 y. • Immunosuppressive induction agent was not a risk factor for hernia after LT. • Obesity (body mass index ≥30) was a risk factor for developing an incisional hernia after LT. • Seroma of the abdominal wall was a risk factor for developing a hernia after LT. [ABSTRACT FROM AUTHOR]

Background/Objectives: Potent immunosuppression lowers the incidence of acute graft rejection but increases the risk of infections. In order to decrease either infectious complications or acute rejection, it is necessary to identify risk groups of patients profiting from personalized induction immunosuppressive treatment. The aim of our analysis was to find whether there were higher incidences of infectious complications after kidney transplantation (KT) in groups with different induction immunosuppressive treatment and also to find independent risk factors for recurrent infections. Materials: We retrospectively evaluated all patients with induction treatment with basiliximab after kidney transplantation from 2014 to 2019 at our center relative to age- and sex-matched controls of patients with thymoglobulin induction immunosuppression. Results: Our study consisted of two groups: basiliximab (39) and thymoglobulin (39). In the thymoglobulin group we observed an increased incidence of recurrent infection in every observed interval; however, acute rejection was seen more often in the basiliximab group. A history of respiratory diseases and thrombocytopenia were identified as independent risk factors for recurrent bacterial infections from the first to sixth month after KT. Decreased eGFR from the first month, infections caused by multi-drug-resistant bacteria, and severe infections (reflected by the need for hospitalization) were identified as independent risk factors for recurrent bacterial infections from the first to the twelfth month after KT. Conclusions: We found that in the group of patients with thymoglobulin induction immunosuppressive treatment, infectious complications occurred significantly more often during the entire monitored period with decreased incidence of acute humoral and cellular rejection occurred more often. [ABSTRACT FROM AUTHOR]

Intestinal steroid refractory acute graft-versus-host disease (SR-aGVHD) is the major cause of mortality in allogeneic hematopoietic stem cell transplantation (allo-HSCT). This retrospective cohort study aimed to identify the relationship between different steroid decreasing velocity and therapeutic response in patients with intestinal SR-aGVHD receiving basiliximab treatment, and also aimed to propose a reasonable steroid decreasing regimen for these patients. The median time for steroid dose decreasing to the 50% of initial dose and decreasing to the low-dose steroid for patients achieving ORR was 5 days and 12 days, respectively, which was both shorter than patients without achieving ORR. The ORR, NRM and survival in rapid and medium steroid decreasing group were all better than slow group. The cumulative incidence of ORR at any time was 90.4%, 78.1% and 62.3%, respectively, in rapid, medium, and slow group. The cumulative incidence of NRM at 1 year after basiliximab treatment was 18.7% (95% CI 11.3%-26.1%), 22.8% (95% CI 14.2%-31.4%) and 32.8% (95% CI 24.1%-41.5%), respectively, in rapid, medium, and slow group. The probability of OS at 1year after basiliximab treatment was 76.9% (95% CI 68.9%-84.9%), 72.7% (95% CI 63.7%-81.7%), and 62.3% (95% CI 53.5%-71.1%), respectively, in rapid, medium, and slow group. Hence, it was helpful to decrease steroid to the 50% of initial dose ≤ 5 days and to the low-dose steroid ≤ 12 days after basiliximab treatment for intestinal SR-aGVHD patients, which may also be the reasonable steroid decrease protocol for these patients. [ABSTRACT FROM AUTHOR]

Background: The use of induction immunosuppression for heart transplantation (HT) is debated given the uncertain benefit and potential risks of infection and malignancy. Methods: This is a retrospective single‐center analysis of 475 consecutive HT recipients from 2003 to 2020 grouped by use of induction with basiliximab group (BG) and the no basiliximab group (NBG). Subgroup analysis by era compared pre‐2016 standard‐basiliximab (BX) induction and 2016–2020 with selective‐BX use as part of a calcineurin‐inhibitor‐sparing regimen. Results: When adjusted for confounders (sex, age, PRA, eGFR), the BG was less likely to have acute cellular rejection (ACR) (OR.42, p <.001), but had more antibody mediated rejection (AMR) (OR 11.7, p <.001) and more cardiac allograft vasculopathy (CAV) (OR 3.8, p =.04). There was no difference between BG and NBG in the incidence of malignancies or infections. When stratified by era (pre‐2016 vs. 2016–2020), ACR remained less common in the BG than the NBG (36% vs. 50%, p =.045) groups, while AMR remained more common (9.7 vs. 0% p =.005). There was no significant difference in conditional survival comparing pre‐and post‐2016 NBG (HR 2.20 (95% CI.75–6.43); however, both pre‐2016 BG and post‐2016 BG have significantly higher mortality (HR 2.37 [95% CI 1.02–5.50) and HR 2.69 (95% CI 1.08–6.71), p =.045 and.03, respectively]. Conclusion: Basiliximab reduces the incidence of ACR but increases the risk of AMR, CAV, and may be associated with increased mortality. Mechanistic studies are needed to describe a potential T‐cell‐escape mechanism with enhanced humoral immunity. [ABSTRACT FROM AUTHOR]

Background: The use of induction therapy (IT) agents in the early post‐heart transplant period remains controversial. The following recommendations aim to provide guidance on the use of IT agents, including Basiliximab and Thymoglobulin, as part of routine care in heart transplantation (HTx). Methods: We recruited an international, multidisciplinary panel of 15 stakeholders, including patient partners, transplant cardiologists and surgeons, nurse practitioners, pharmacists, and methodologists. We commissioned a systematic review on benefits and harms of IT on patient‐important outcomes, and another on patients' values and preferences to inform our recommendations. We used the GRADE framework to summarize our findings, rate certainty in the evidence, and develop recommendations. The panel considered the balance between benefits and harms, certainty in the evidence, and patient's values and preferences, to make recommendations for or against the routine post‐operative use of Thymoglobulin or Basiliximab. Results: The panel made recommendations on three major clinical problems in HTx: (1) We suggest against the routine post‐operative use of Basiliximab compared to no IT, (2) we suggest against the routine use of Thymoglobulin compared to no IT, and (3) for those patients for whom IT is deemed desirable, we suggest for the use of Thymoglobulin as compared to Basiliximab. Conclusion: This report highlights gaps in current knowledge and provides directions for clinical research in the future to better understand the clinical utility of IT agents in the early post heart transplant period, leading to improved management and care. [ABSTRACT FROM AUTHOR]

The efficacy and safety of early steroid withdrawal (ESW) in Black renal transplant recipients (RTR) remains uncertain, especially when combined with non‐lymphocyte depleting induction. This study compared patient and graft outcomes of older Black and Non‐Black RTR who received basiliximab induction followed by ESW. Included subjects in this single center, retrospective study were first‐time deceased and living donor RTR aged over 65 years who received basiliximab induction therapy and ESW. Black RTR and Non‐Black deceased donor RTR received an oral prednisone taper starting POD3 which was discontinued by POD21 per protocol. Of 139 patients (55 Black and 84 Non‐Black), the Black patient group included a higher percentage of deceased donors and hepatitis C positive donors, and more frequently underwent renal replacement therapy prior to transplant. One Black and zero Non‐Black RTR experienced graft loss within 3 years (p = 1.0). Patient survival was similar at 1 year (93% vs. 97%, p =.16) and 3 years (91% vs. 96%, p =.17). Rejection‐free survival and biopsy‐proven rejection did not differ at 1 or 3 years. Median eGFR and change in eGFR also did not differ between groups. Black patients were maintained on significantly higher median mycophenolate doses from 6 months post‐transplant to the end of the study period (p =.03 and.048). In older Black RTR, basiliximab induction followed by ESW produced comparable patient, graft, and rejection‐free survival compared to Non‐Black RTR over 3 years post‐transplant. [ABSTRACT FROM AUTHOR]

High donor‐derived cell‐free DNA (dd‐cfDNA) levels indicate transplant allograft injury and can identify graft rejection in kidney transplant recipients. Here, we evaluated the use of dd‐cfDNA in pediatric kidney transplant rejection monitoring and treatment. Methods: Forty‐two pediatric kidney transplant patients were enrolled between February 2020 and August 2021. Dd‐cfDNA was tested before and after biopsy/rejection treatment. There was a total of 61 allograft biopsies (44 for‐cause, 17 surveillance). Results: Graft rejection was found in 35/61 biopsies. Rejection was more common in basiliximab induction compared to rATG (77.1% vs. 22.9%, p =.0121). Median dd‐cfDNA was higher in those with rejection (1.2% [0.34–3.12] vs. 0.24% [0.08–0.78], p <.0001). Dd‐cfDNA was highest in biopsies with AMR and mixed AMR/TCMR. In addition, dd‐cfDNA in basiliximab induction was higher compared to rATG (0.92% [0.27–1.8] vs. 0.26% [0.08–2], p =.0437). Median change in dd‐cfDNA after rejection treatment was −0.57% (−1.67 to 0.05). Median time to dd‐cfDNA <1% post‐rejection treatment was 8.5 days (3.0–19.5). Dd‐cfDNA in AMR was higher compared to TCMR or mixed rejection, and levels remained higher in AMR after treatment. In surveillance biopsies, 4/17 had rejection. Median dd‐cfDNA was not different in those with versus without rejection (0.48% vs. 0.28%, p =.2342). Those without rejection all had dd‐cfDNA <1%. In those with rejection, only one patient had dd‐cfDNA >1%, and all had TCMR. Conclusions: Our findings support dd‐cfDNA as a useful indicator of graft rejection and response to treatment. Additional studies are needed to determine the role of dd‐cfDNA in graft health surveillance. [ABSTRACT FROM AUTHOR]

To compare the safety and efficacy of once-daily tacrolimus (ODT) versus twice-daily tacrolimus (BDT) in adult live donor liver transplantation (LDLT). In this open-labelled randomized trial, 174 adult patients undergoing LDLT were randomized into ODT or BDT, combined with basiliximab induction and mycophenolate mofetil (steroid-free regimen). Tacrolimus was started at a total dose of 1 mg and the trough level was aimed at 3–7 ng/ml. The primary endpoint was eGFR at 1,3- and 6 months post-transplant, using CKD- EPI equation. Secondary endpoints included biopsy-proven acute rejection (BPAR), metabolic complications, post-operative bilio-vascular complications and patient survival. There was no statistically significant difference in eGFR between the two groups at 6 months (ODT –96 ± 19, BDT –91 ± 21, p value-0.164). BPAR was comparable (18/84 in ODT, 19/88 in BDT, p value-0.981). For a similar dosage of tacrolimus, the median trough tacrolimus levels attained were significantly lower for ODT than BDT during the first-month post-transplant (p value-0.001). Metabolic complications due to immunosuppression, post-operative bilio-vascular complications and patient survival was similar between the two groups at 6 months. Once-daily tacrolimus has similar renal safety and efficacy as twice-daily tacrolimus when used in combination with basiliximab induction and mycophenolate in adult LDLT. [ABSTRACT FROM AUTHOR]

Introduction: IgA nephropathy (IgAN) can cause end‐stage kidney disease (ESKD). This study assesses the impact of induction and maintenance immunosuppression on IgAN recurrence, graft survival, and mortality in living and deceased donor kidney transplants (LDKT and DDKT). Methods: Retrospective analysis of the UNOS database in adults with ESKD secondary to IgAN who received kidney transplants between January 2000 and June 30, 2022. Patients with thymoglobulin (ATG), alemtuzumab, or basiliximab/daclizumab induction with calcineurin inhibitor (CNI) and mycophenolate mofetil (MMF) with or without prednisone maintenance were analyzed. Multivariate logistic regression was performed to identify factors correlated with IgA recurrence. Multivariable Cox regression analyses were performed for clinically suspected risk factors. Kaplan Meir Analysis was utilized for overall graft survival. Results: Compared to ATG with steroid maintenance, alemtuzumab with steroid increased the odds of IgAN recurrence in DDKTs (OR 1.90, p <.010, 95% CI [1.169–3.101]). Alemtuzumab with and without steroid increased the odds of recurrence by 52% (p =.036) and 56% (p =.005), respectively, in LDKTs. ATG without steroids was associated with less risk of IgAN recurrence (HR.665, p =.044, 95% CI [.447–.989]), graft failure (HR.758, p =.002, 95% CI [.633–.907]), and death (HR.619, p <.001, 95% CI [.490–.783]) in DDKTs. Recurrence was strongly associated with risks of graft failure in DDKTs and LDKTs and death in LDKTs. Conclusion: In patients with IgAN requiring a kidney transplant, Alemtuzumab induction correlates with increased IgAN recurrence. Relapse significantly affects graft survival and mortality. ATG without steroids is associated with the least graft loss and mortality. [ABSTRACT FROM AUTHOR]

Background We previously reported excellent efficacy and improved safety aspects of rapid steroid withdrawal (RSWD) in the randomized controlled 1-year "Harmony" trial with 587 predominantly deceased-donor kidney transplant recipients randomized either to basiliximab or rabbit antithymocyte globulin induction therapy and compared with standard immunosuppressive therapy consisting of basiliximab, low tacrolimus once daily, mycophenolate mofetil and corticosteroids. Methods The 5-year post-trial follow-up (FU) data were obtained in an observational manner at a 3- and a 5-year visit only for those Harmony patients who consented to participate and covered clinical events that occurred from the second year onwards. Results Biopsy-proven acute rejection and death-censored graft loss rates remained low and independent of RSWD. Rapid steroid withdrawal was an independent positive factor for patient survival (adjusted hazard ratio 0.554, 95% confidence interval 0.314–0.976; P  = .041). The reduced incidence of post-transplantation diabetes mellitus in RSWD patients during the original 1-year study period was not compensated by later incidences during FU. Incidences of other important outcome parameters such as opportunistic infections, malignancies, cardiovascular morbidity/risk factors, donor-specific antibody formation or kidney function did not differ during FU period. Conclusions With all the limitations of a post-trial FU study, the Harmony FU data confirm excellent efficacy and beneficial safety aspects of RSWD under modern immunosuppressive therapy over the course of 5 years after kidney transplantation in an immunologically low-risk, elderly population of Caucasian kidney transplant recipients. Trial registration: Clinical trial registration number: Investigator Initiated Trial (NCT 00724022, FU study DRKS00005786) [ABSTRACT FROM AUTHOR]

Purpose: Blood group B kidney transplant candidates have lower transplantation rates and longer waiting times compared to other blood groups. Kidney transplantation from blood group A2-to-B has offered a solution for these patients. This study aimed to investigate the impact of Basiliximab and Alemtuzumab induction therapies on kidney function and de novo donor-specific antibodies (DSA) in blood type A2-to-B kidney transplant recipients within the first 12 months of post-transplant. Methods: A retrospective analysis was conducted on 110 consecutive A2-to-B kidney transplant recipients between January 2015 and December 2022. Of these, 46 (41.8%) received Basiliximab, while 64 (58.2%) received Alemtuzumab as induction therapy. Demographics and comorbidities data were collected and compared between the two groups. Serum samples collected at 4- and 12-month intervals post-transplant were used to assess the presence of de novo DSA. Kidney allograft function was evaluated by monitoring serum creatinine levels and assessing Creatinine Clearance based on 24-h urine collection at various time points. Results: During the follow-up period, 20.00% of patients who received Alemtuzumab developed de novo DSA, whereas none of the patients induced with Basiliximab developed de novo DSA (p 0.038). Recipients who received Basiliximab were older (mean age 72.00) and received higher Kidney Donor Profile Index (KDPI) kidneys (mean - 75) compared to those induced with Alemtuzumab (mean age -- 58.00, mean KDPI = 49) (p < 0.001), with no significant difference observed in the last follow-up creatinine clearance or creatinine levels between the two groups (p 0.28). Conclusion: The use of Basiliximab as induction immunosuppression in A2-to-B kidney transplant recipients is associated with a lower incidence of de novo HLA DSA formation without significant differences in overall renal function compared to Alemtuzumab. [ABSTRACT FROM AUTHOR]

The study aimed to determine the influence of induction therapy on the acute cellular rejection (ACR) index in adult heart transplant recipients during the one-year observation. The study population consisted of 256 consecutive adult patients (pts), aged 51.5 (±11.9) years, 199 (77%) men treated with orthotopic heart transplantation (OHT) in the period between 2015 and 2020 in a single high-volume heart transplant center. The endomyocardial biopsies (EMBs) were performed according to the protocol consisting of 7 protocolary EMBs for up to 3 months and 10 EMBs for up to one year after OHT. The rejection index (ACRI) was calculated as the number of scheduled EMBs with the ACR > 2 divided by the total number of protocolary EMBs. The study population was divided into two groups according to the application of basiliximab. The total number of pts. who received basiliximab was 10 (3.9%). The main indications for the usage of the induction therapy were heart retransplantation, mechanical circulatory support (MCS), severe renal insufficiency (eGFR <30 mL/min/1.73 m2), and a panel of reactive antibody (PRA) > 10%. In the group with induction, the mean age was 49 (±14) years; 3 (30%) patients had the MCS prior to OHT. and 3 (30%) patients had heart retransplantation. Four (40%) patients had diabetes mellitus, and 4 (40%) patients had severe renal insufficiency. As maintenance therapy during the observation period, tacrolimus was given to 10 (100%) patients, everolimus to 2 (20%) patients, and MPA to 9 (90%) patients. In the group with no induction, the mean age was 51.8 (±12) years, MCS was used in 56 (23%) patients, 2 (0.8%) patients were retransplanted; 10 (4%) patients had eGFR <30 mL/min/1.73 m2 and 58 (24%) patients had diabetes. Tacrolimus was administered to 243 (99%) patients, cyclosporine to 3 (1%), everolimus to 40 (16%), and mycophenolate to 245 (99.6%) heart recipients. The median one-year ACRI was 0.0, IQR:0.0-0.08 in the group with induction vs. 0.077, IQR: 0.0-0.154 with no induction; p 0.11. ACRI up to three months was significantly higher in the entire cohort in comparison to up to one year (P < 0.01). The multivariate analysis showed that only everolimus implementation and younger age at the time of transplant influenced patients' mortality rate (P < 0.01). Significant graft rejections (> 2R ISHLT) are most common in the first three months after OHT. Patients who are initially at high risk of significant cellular rejection may benefit from induction therapy. [ABSTRACT FROM AUTHOR]

The aim of this study is to assess the outcomes of different induction therapies among mild to moderate immunological risk kidney transplants in the era tacrolimus and mycophenolate-derivate based maintenance. This was a retrospective cohort study using data from the United States Organ Procurement and Transplantation Network among mild to moderate immunological risk living-donor KTRs, defined as having first transplant and panel reactive antibodies less than 20% but with two HLA-DR mismatches. KTRs were divided into two groups based on induction therapy with either thymoglobulin or basiliximab. Instrumental variable regression models were used to assess the effect of induction therapy on acute rejection episodes, serum creatinine levels and graft survival. Of the entire cohort, 788 patients received basiliximab while 1727 patients received thymoglobulin induction. There were no significant differences between basiliximab versus thymoglobulin induction in acute rejection episodes at one-year post-transplant (coefficient= −0.229, p value =.106), serum creatinine levels at one-year post-transplant (coefficient= −0.024, p value =.128) or death-censored graft survival (coefficient: − <0.001, p value =.201). This study showed no significant difference in acute rejection episodes or graft survival when using thymoglobulin or basiliximab in mild to moderate immunological risk living donor KTRs, maintained on tacrolimus and mycophenolate-based immunosuppressive regimen. [ABSTRACT FROM AUTHOR]