What guidelines or literature exists describing the use of basiliximab for solid organ transplant groups such as lung, liver, kidney, heart, and intestine transplants?

Comment by InpharmD Researcher

There is a moderate amount of literature supporting the use of basiliximab for solid organ transplantation. Across the various types of solid organ transplant groups, basiliximab has been associated with reduced rates of acute rejection and the ability to delay or minimize calcineurin inhibitor and steroid use, potentially leading to fewer renal and metabolic complications. However, its efficacy and impact regarding infection and mortality remain uncertain, with evidence showing it has no clear advantage over another common induction agent, anti-thymocyte globulin (ATG). Some guidelines do not recommend routine use of basiliximab in simultaneous liver-kidney or ABO-incompatible transplants (AASLD), and others suggest using a lymphocyte-depleting agent, over first-line interleukin-2 receptor antagonist (IL2-RA) therapy, for patients at high immunologic risk (KDIGO), underscoring the importance of basing treatment decisions on individual patient factors.

Background

A 2025 systematic review analyzed the use of single versus double doses of basiliximab in adult solid organ transplant recipients, extracting data from three eligible studies (1 liver and 2 kidney studies). The review specifically focused on assessing efficacy, safety, and potential cost-savings associated with a single-dose basiliximab regimen. The included studies, encompassing observational and randomized controlled trials, consistently demonstrated that single-dose basiliximab regimens provided comparable outcomes to the traditional double-dose regimen in terms of acute cellular rejection rates, which ranged from 4.3% to 12.3%, and graft loss rates between 0% and 2.9%. Patient survival rates were high, ranging from 95.6% to 100%. Notably, there were no major differences in infection rates or hospital readmissions between the two groups. Economically, the single-dose regimen offered substantial cost savings, with per-patient savings ranging from approximately $2100 to $4400, and institutional savings reaching up to US$697,864. These findings suggest that a single dose of basiliximab can be an effective and economical alternative to the standard dosing protocol, maintaining therapeutic efficacy and safety while significantly reducing drug-related expenses. [1]

Lung:

A 2022 retrospective analysis examined induction therapy trends and outcomes in lung transplantation across the United States, utilizing data from the United Network for Organ Sharing database between 2006 and 2018. The study identified 22,025 first-time, adult lung-only transplant recipients, categorizing them into cohorts based on the induction therapy received: no induction, basiliximab, alemtuzumab, and anti-thymocyte globulin. Most patients, 50.15%, received basiliximab, while 36.34% received no induction therapy, and smaller percentages received alemtuzumab (7.06%) or anti-thymocyte globulin (6.45%). A propensity score matching was employed to form a subset for in-depth analysis, specifically comparing the outcomes of basiliximab and no induction therapy, resulting in a matched cohort of 15,560 patients, providing a robust comparison of outcomes. The results of this analysis demonstrated that basiliximab was associated with improved long-term survival and a lower risk of acute rejection and renal failure compared to those who received no induction therapy. Specifically, multivariable Cox regression analyses showed that treatment with basiliximab was linked to a 16% reduction in long-term mortality (p<0.001). Additionally, the study reported that basiliximab was associated with a 38% lower risk of acute rejection requiring treatment after discharge and a 25% lower risk of renal failure requiring hemodialysis after discharge. Furthermore, the use of basiliximab correlated with a significant decrease in 90-day mortality and hospital length of stay, highlighting the potential of basiliximab to enhance post-transplant outcomes with cost-effectiveness considerations also favoring its use. [2]

Liver:

Practice guidelines published in 2025 by the AASLD/AST on adult liver transplantation, highlighted basiliximab as the only commercially available interleukin-2 receptor antagonist (IL2-RA) currently used for induction immunosuppression. Basiliximab works by selectively inhibiting T-lymphocyte proliferation and has been shown to reduce acute rejection when used with or without corticosteroids. One guideline recommendation notes that in adult liver transplant recipients with renal dysfunction, basiliximab induction may be used to delay calcineurin inhibitor (CNI) initiation, thereby improving renal recovery (Weak, Level 2). However, routine use of basiliximab is not recommended in simultaneous liver-kidney or ABO-incompatible transplants due to insufficient evidence (Strong, Level 5). Evidence from RCTs and registry analyses indicates that basiliximab improves renal outcomes by allowing delayed or reduced tacrolimus dosing, lowers the risk of biopsy-proven acute rejection, and may reduce new-onset diabetes and hypertension in living donor liver transplantation. [3]

Specific to use as induction immunosuppression in liver transplantation, a 2017 meta-analysis analyzed data from six randomized controlled trials (RCTs) to evaluate the efficacy and safety of basiliximab induction. A total of 887 participants, 446 treated with basiliximab-based regimens and 441 with standard steroid-based induction therapies, were included in the analysis. The analysis examined biopsy-proven acute rejection (BPAR) rates, graft survival, mortality, de novo hypertension and diabetes mellitus, overall infection, cytomegalovirus infection, and recurrence of hepatitis C virus (HCV) or hepatocellular carcinoma (HCC). Data from all six studies indicated no significant difference in therapeutic effect between basiliximab and basiliximab-sparing groups on BPAR within 1 year (relative risk [RR] 0.89; 95% confidence interval [CI] 0.75 to 1.06; p= 0.19). However, when combined with steroid-free immunosuppressive regimens, basiliximab significantly reduced the incidence of acute rejection by 38% within the first year post-transplantation (RR 0.62; 95% CI 0.39 to 0.97; p= 0.04) compared to steroids. Additionally, basiliximab regimens were associated with a decrease in risk of de novo hypertension (RR 0.62; 95% CI 0.42 to 0.93; p= 0.02) and risk of new-onset diabetes mellitus (RR 0.56; 95% CI 0.34 to 0.91; p= 0.02). No statistical differences were observed in graft survival, mortality, overall infection, or the recurrence of HCV or HCC. These findings underscore the potential of basiliximab to enhance transplant outcomes by mitigating BPAR and metabolic complications while avoiding heightened risks of infection or malignancy, particularly within steroid-sparing protocols. Nonetheless, limitations such as the heterogeneity of immunosuppressive regimens and small trial numbers highlight the need for further large-scale, multicentric RCTs. [4]

Although again not for maintenance immunosuppression, a 2024 retrospective cohort analysis evaluated the safety, efficacy, and cost implications of single-dose versus two-dose basiliximab for induction immunosuppression in 231 live-donor liver transplant recipients with stable renal function. Patients who received two doses of basiliximab on post-transplant Days 1 and 5 were compared to those who received a single dose on post-transplant Day 1, following a change in protocol. Despite a higher incidence of acute kidney injury in the two-dose cohort (56.9% vs 39.0%; p= 0.01), there were no significant differences in the primary outcome of SCr change (median Day 5 to Day 30, 0.2 mg/dL; interquartile range [IQR] -0.1 to 0.4 vs 0.1 mg/dL; IQR -0.1 to 0.3; p= 0.08). Both cohorts demonstrated similar rates of acute cellular rejection within six months (9.7% vs 6.3%; p= 0.42) and no differences in bacterial, viral, or fungal infection rates. Single-dose basiliximab reduced calcineurin inhibitor initiation time by one day (median 3 vs 4 days; p<0.001) and significantly decreased the need for subsequent calcineurin inhibitor regimen changes (45.8% vs 25.2%; p= 0.002). The single-dose regimen yielded cost savings of approximately $697,863 over 159 transplants without compromising safety or efficacy outcomes. These findings indicate that single-dose basiliximab provides a cost-effective and clinically comparable alternative to the standard two-dose protocol in appropriately selected patients. [5]

Kidney:

Guidelines published by the Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group in 2009 recommend IL2-RAs (including basiliximab) to be the preferred first-line induction therapy in most kidney transplant patients (Grade 1, Quality of evidence B [moderate]). The panel recommends use of immunosuppressive medications before, or at the time of kidney transplantation and including induction therapy with a biologic agent as part of the initial immunosuppressive regimen (Grade 1, quality of evidence A [high]). For patients at high immunologic risk, the panel suggests using a lymphocyte-depleting agent, rather than an IL2-RA. [6]

A 2008 review described the role of basiliximab in renal transplantation. While traditional triple therapy consisting of corticosteroids, calcineurin inhibitors (CNIs), and antiproliferative agents has improved short-term graft survival, its use has also been limited by nephrotoxicity, infection risk, and metabolic effects. Consequently, basiliximab was introduced and has been increasingly used to mitigate the toxicities associated with standard immunosuppression. Data have shown that basiliximab reduces acute rejection and delayed graft function, lowers steroid requirements, and is well tolerated among patients with various comorbidities such as diabetes, HIV, and in the elderly. Particularly in the setting of high-risk or delayed CNI-based induction treatment, the early use of basixilimab has maintained effective immunosuppression. On the other hand, the long-term benefits of basiliximab remain unclear, especially concerning graft and patient survival, which have been similar to those seen with a placebo or other induction agents. [7]

Heart:

A 2013 Cochrane systematic review and meta-analysis evaluated the benefits, harms, feasibility, and tolerability of immunosuppressive T-cell antibody induction in heart transplant recipients. A total of 22 randomized controlled trials (N= 1,427 heart transplant recipients) were included, of which 4 trials studied basiliximab. Comparisons were made for outcomes of mortality, infection, cytomegalovirus infection, post-transplantation lymphoproliferative disorder, cancer, adverse events, chronic allograft vasculopathy, renal function, hypertension, diabetes mellitus, and hyperlipidemia, none of which were significantly different between groups. Use of interleukin 2 receptor antagonist induction (IL-2 RA) was associated with less frequent acute rejection when compared to no induction (93/284 [33%] vs 132/292 [45%]; RR 0.73; 95% Cl 0.59 to 0.90) when applying a fixed-effect model but not the random-effects model. However, acute rejection occurred more often with IL-2 RA induction compared to polyclonal antibody induction (24/90 [27%] vs 10/95 [11%]; RR 2.43; 95% CI 1.01 to 5.86). [8]

The Pediatric Cardiac Intensive Care Society 2014 guidelines’ discussion of basiliximab use in cardiac care is limited to study results. When basiliximab is used prior to donor heart reperfusion, pediatric patients exhibited greater freedom from severe acute cellular rejection compared to using basiliximab postoperatively. [9]

References:

[1] Provenzani A, Lape BA, Harp AM, Weisbrod V, Piazza L. Current evidence and insights on single vs double dose of basiliximab in adult solid organ transplant recipients: A systematic review. Br J Clin Pharmacol. Published online June 30, 2025. doi:10.1002/bcp.70151
[2] Shagabayeva L, Osho AA, Moonsamy P, et al. Induction therapy in lung transplantation: A contemporary analysis of trends and outcomes. Clin Transplant. 2022;36(11):e14782. doi:10.1111/ctr.14782
[3] Te HS, Agopian VG, Demetris AJ, et al. AASLD AST Practice Guideline on Adult Liver Transplantation: Diagnosis and management of Graft-Related complications. Liver Transpl. Published online August 22, 2025. doi:10.1097/LVT.0000000000000715
[4] Zhang GQ, Zhang CS, Sun N, Lv W, Chen BM, Zhang JL. Basiliximab application on liver recipients: a meta-analysis of randomized controlled trials. Hepatobiliary Pancreat Dis Int. 2017;16(2):139-146. doi:10.1016/s1499-3872(16)60183-2
[5] Herrmann BN, Moore CA, Johnson HJ, Humar A, Shimko KA. Evaluation of Single Versus Two-Dose Basiliximab Induction Therapy in Live-Donor Liver Transplant. Clin Transplant. 2024;38(10):e70006. doi:10.1111/ctr.70006
[6] Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009;9 Suppl 3:S1-S155. doi:10.1111/j.1600-6143.2009.02834.x
[7] Salis P, Caccamo C, Verzaro R, Gruttadauria S, Artero M. The role of basiliximab in the evolving renal transplantation immunosuppression protocol. Biologics. 2008;2(2):175-188. doi:10.2147/btt.s1437
[8] Penninga L, Møller CH, Gustafsson F, Gluud C, Steinbrüchel DA. Immunosuppressive T-cell antibody induction for heart transplant recipients. Cochrane Database Syst Rev. 2013;(12):CD008842. Published 2013 Dec 2. doi:10.1002/14651858.CD008842.pub2
[9] Singh RK, Humlicek T, Jeewa A, Fester K. Pediatric Cardiac Intensive Care Society 2014 Consensus Statement: Pharmacotherapies in Cardiac Critical Care Immune Therapy. Pediatr Crit Care Med. 2016;17(3 Suppl 1):S69-S76. doi:10.1097/PCC.0000000000000626
Literature Review

A search of the published medical literature revealed 17 studies investigating the researchable question:

What guidelines or literature exists describing the use of basiliximab for solid organ transplant groups such as lung, liver, kidney, heart, and intestine transplants?

Level of evidence

C - Multiple studies with limitations or conflicting results  Read more→


Please see Tables 1-17 for your response.

Basiliximab induction immunosuppression and lung transplant outcomes: Propensity analysis in a multicenter cohort
Design

Multicenter cohort study using propensity-based statistical methods

N= 768
Objective To determine the relationship between basiliximab induction and development of acute rejection, chronic lung allograft dysfunction, and other clinically relevant outcomes in lung transplant recipients
Study Groups

Basiliximab induction (n= 368)

No induction (n= 400)
Inclusion Criteria Newly transplanted adult lung recipients at 5 North American centers from December 17, 2015 to August 14, 2018
Exclusion Criteria Patients who received antithymocyte globulin induction immunosuppression
Methods

Propensity-based statistical methods applied to prospectively collected longitudinal data. Treatment effects estimated using outcome-specific propensity score regression models, weighted by outcome-specific overlap weights, and stratified by center strata. Basiliximab induction was administered within 24 hours of transplantation at 3 centers, while 2 centers rarely used it. All centers used perioperative intravenous steroids and calcineurin-based posttransplant maintenance immunosuppression regimens.
Duration Data collected from December 17, 2015 to August 14, 2018
Outcome Measures

Primary: Development of acute rejection, chronic lung allograft dysfunction(CLAD)

Secondary: Development of class II donor specific antibodies, infections, mortality, graft loss
Baseline Characteristics   Basiliximab induction (n= 368) No induction (n= 400)
Age, years 57.2 (13.9) 56.2 (14.4)
Female 39% (302) 42% (84)
White race 89% (683) 92% (184)
BMI 24.8 (4.2) 24.4 (4.3)
B or O blood group 56% (431) 54% (108)
UNOS lung disease = COPD 27% (207) 36% (71)
CAD 24% (181) 18% (36)
LAS ≥ 70 9% (66) 3% (5)
PRA sensitization 45% (329) 71% (141)
Hospitalized at time of transplant 14% (108) 10% (20)
PGD Grade 3 at 48 or 72 h post-transplant 16% (126) 17% (34)
Bilateral transplant 74% (571) 78% (156)
Donor lung(s) on EVLP 11% (83) 34% (68)
ECMO/bypass used during transplant 52% (395) 47% (94)
Concurrent cardiac surgery 9% (68) 2% (3)
ECMO required posttransplant 12% (89) 8% (15)
Ischemic time, hours 7.5 (3.6) 11.1 (4.0)
Results  

Difference in hazard ratio risk (95% CI) at 1 year)

 p-value for hazard ratio
Definite CLAD

1.9 (-2.5 to 6.2)

 0.71
Death -1.9 (-7.0 to 3.2) 0.49
Graft loss

1.3 (-5.2 to 7.7)

 0.40
Any grade AR

-11.1 (-19.9 to -2.2)

 0.015
Grade ≥A2 AR

-7.8 (-15.5 to -0.2)

 0.097
Lymphocytic bronchiolitis

4.4 (-5.2 to 13.9)

 0.60
Acute lung injury

-22.7 (-31.5 to -13.9)

 0.001
Organizing pneumonia

-19.2 (-30.6 to -7.8)

 0.028
CMV infection

-2.1 (-8.0 to 3.8)

 0.36
Aspergillus infection

-6.5 (-16.2 to 3.3)

 0.66
Death due to infection

0.9 (-1.2 to 3.0)

 0.60
Class I DSA

-4.4 (-11.2 to 2.5)

 0.366
Class II DSA

-14.3 (-24.9 to -3.7)

 0.034

BMI=body mass index; CAD=coronary artery disease; CI=confidence interval; CLAD=chronic lung allograft dysfunction; CMV=cytomegalovirus; COPD=chronic obstructive pulmonary disease; CTOT=Clinical Trials in
Organ Transplantation; DSA = donor specific antibodies; EBV=Epstein-Barr Virus; ECMO=extracorporeal membrane oxygenation; EVLP=ex vivo lung perfusion; HLA=human leukocyte antigen; LAS=lung allocation score; GD = primary graft dysfunction; PRA=panel reactive antibody; PTLC=predicted total lung capacity; UCLA=University of California, Los Angeles; UNOS=United Network for Organ Sharing.
Adverse Events No significant association between basiliximab and increased risk of select infections or infection-related death
Study Author Conclusions Basiliximab induction immunosuppression is associated with a significant reduction in early posttransplant cellular and humoral immune events and lung injury histologies but not chronic lung allograft dysfunction or mortality.
Critique The study's strengths include its use of prospectively collected data and robust statistical methods to minimize confounding. However, limitations include the inability to address unmeasured confounders and the lack of central adjudication for histology. The study's findings may not be generalizable due to the relative homogeneity of practice patterns across the centers involved.

 

References:

Rim JG, Hellkamp AS, Neely ML, et al. Basiliximab induction immunosuppression and lung transplant outcomes: Propensity analysis in a multicenter cohort. J Heart Lung Transplant. 2025;44(6):950-960. doi:10.1016/j.healun.2024.11.033

 

Basiliximab for early perioperative transplant-associated thrombotic microangiopathy after lung transplantation: a case report

Design

 Case report

Case presentation

A 58-year-old Asian woman who underwent a bilateral lung transplant developed transplant-associated thrombotic microangiopathy (TA-TMA) postoperatively. On POD 6, she presented with thrombocytopenia (platelet count of 46,000/mm3), followed by fever, hemolytic anemia (hemoglobin 7.9 g/dL, LDH 7577 U/L, low haptoglobin), and renal dysfunction (creatinine rising from a baseline of 0.37 to 0.98 mg/dL by POD 7). A blood smear confirmed the presence of schistocytes. The tacrolimus was suspected as the causal agent because its blood concentration had been above the target range of 13-16 ng/mL.

Tacrolimus was immediately discontinued on POD 8, and the patient was given basiliximab. Plasma exchange was initiated and repeated five times, confirming a normal ADAMTS13 level. Despite daily platelet transfusions, her platelet count dropped to 9,000/mm3. Due to escalating renal dysfunction and oliguria, continuous hemodiafiltration (CHDF) was started on POD 10. Following the cessation of tacrolimus, her platelet count recovered to 49,000/mm3 by POD 14. Cyclosporine was then initiated as an alternative immunosuppressant. Renal function gradually improved, allowing for CHDF to be switched to intermittent hemodialysis and eventually discontinued. The patient was discharged on POD 161, with her creatinine level having recovered to 0.81 mg/dL. She had no further episodes of TMA over the next three years.

Study Author Conclusions

 Switching from calcineurin inhibitors using basiliximab may be an option for treating thrombotic microangiopathy without increasing the risk of acute rejection 
References:

Ijiri N, Sato M, Konoeda C, Nagayama K, Nakajima J. Basiliximab for early perioperative transplant-associated thrombotic microangiopathy after lung transplantation: a case report. Surg Case Rep. 2022;8(1):187. Published 2022 Sep 29. doi:10.1186/s40792-022-01539-x

Improved Treatment Response With Basiliximab Immunoprophylaxis After Liver Transplantation: Results From a Double-Blind Randomized Placebo-Controlled Trial
Design

Double-blind, randomized, placebo-controlled trial

N= 381
Objective To evaluate the efficacy of basiliximab in the prevention of acute rejection episodes during the first 6 months after liver transplantation in patients receiving a primary cadaveric liver transplant
Study Groups

Basiliximab (n= 188)

Placebo (n= 193)
Inclusion Criteria Men and women aged 20 to 72 years undergoing a first cadaveric liver transplantation with a blood-group–identical or blood-group–compatible graft
Exclusion Criteria Second or subsequent liver transplantation, multiple organ transplantation, history of malignancy, fulminant liver failure, severe active infection requiring systemic antibiotics, treatment with an investigational drug in the preceding month, serological positivity for HIV, continuing drug abuse or mental dysfunction, myocardial infarction within 6 months before transplantation, or serum creatinine level greater than 176.8 µmol/L
Methods Patients were randomized to receive either basiliximab (40 mg) or placebo as two 20-mg bolus injections on days 0 and 4, in addition to cyclosporine and steroids. Biopsy-confirmed acute rejection and its composite endpoint, including death or graft loss, were assessed at 6 and 12 months. Safety and tolerability were monitored over 12 months
Duration August 1997 to June 1998
Outcome Measures

Primary: Biopsy-confirmed acute rejection, death, or graft loss

Secondary: Problem-free transplant (including HCV recurrence), safety and tolerability, patient and graft survival rates
Baseline Characteristics   Placebo (n= 193) Basiliximab (n= 188)
Mean age (yr) - Patient 50.2 (20-72) 49.0 (20-68)
Mean age (yr) - Donor 39.4 (9-84) 41.2 (8-78)
Men 117 (60.6%) 124 (66.0%)
Mean cold ischemia (h) 8.8 8.9
HCV-positive 69 (35.8%) 64 (34.0%)
Results   Placebo (n= 193) Basiliximab (n= 188) P-value
Biopsy-confirmed rejection at 6 months 84 (43.5%) 66 (35.1%) 0.105
Biopsy-confirmed rejection, death, or graft loss at 6 months 102 (52.8%) 83 (44.1%) 0.091
Problem-free transplant at 12 months 30.1% 39.7% 0.035
Adverse Events The incidence of infection and other adverse events was similar across the two treatment groups. Serious adverse events, infections, and drug-related events were reported more frequently in the HCV-positive cohorts of both treatment groups
Study Author Conclusions Immunoprophylaxis with 40 mg of basiliximab, in combination with cyclosporine and steroids, reduces the incidence of acute rejection episodes with no clinically relevant safety or tolerability concerns. The influence of HCV recurrence on efficacy results can be accounted for in future trials by using the concept of problem-free transplant, incorporating recurrence as a component of treatment failure.
Critique The study was well-designed as a double-blind, randomized, placebo-controlled trial, providing robust evidence for the efficacy of basiliximab in reducing acute rejection episodes. However, the inclusion of a high number of HCV-positive patients may have diluted the overall efficacy results, and the retrospective definition of 'problem-free transplant' as an endpoint could introduce bias. Additionally, the study's findings may not be generalizable to populations with different baseline characteristics or treatment protocols.
References:

Neuhaus P, Clavien PA, Kittur D, et al. Improved treatment response with basiliximab immunoprophylaxis after liver transplantation: results from a double-blind randomized placebo-controlled trial. Liver Transpl. 2002;8(2):132-142. doi:10.1053/jlts.2002.30302

Influence of Basiliximab induction therapy on long term outcome after liver transplantation, a prospectively randomised trial
Design

Prospectively randomized trial

N= 99
Objective To determine if Basiliximab induction therapy reduces the incidence of acute rejection episodes and improves graft function and survival in the long term after orthotopic liver transplantation (OLT)
Study Groups

Basiliximab induction + CNIs and steroids (n= 51)

CNIs and steroids only (n= 48)
Inclusion Criteria Patients transplanted at the institution between 1997 and 2000
Exclusion Criteria Not specified
Methods Patients were randomized into two groups: one received basiliximab induction (Day 0 and Day 4, 20 mg each) combined with tacrolimus and steroids, and the other received tacrolimus and steroids only. 
Duration 1997 to 2000
Outcome Measures

Primary: Incidence of acute and chronic rejection

Secondary: Graft and patient survival, intensity of long-term immunosuppression, frequency of CNI and steroid-induced adverse effects
Baseline Characteristics    Characteristic Basiliximab induction + CNIs and steroids (n= 51)  CNIs and steroids only (n= 48)
Age, years (mean) 49.4  49.6
Female 24 21
Surgery time, min 286 289
Results No significant difference noted in graft and patient survival between the groups. No significant difference noted in frequency of acute or chronic rejection. CNI levels were comparable in both groups, and graft and patient survival rates were not influenced by induction therapy. 
Adverse Events N/A
Study Author Conclusions Induction therapy does not have a general positive influence on the post-transplant course. A slight improvement in long-term renal function was detected for basiliximab treated patients.
Critique The study's prospective randomized design is a strength, providing a high level of evidence. However, the lack of significant findings regarding the primary outcomes may limit its impact. The study does not specify exclusion criteria, which could affect the generalizability of the results. Additionally, the study does not provide detailed adverse event data, which is a limitation in assessing the safety profile of basiliximab induction therapy.
References:

Schmeding M, Sauer IM, Kiessling A, et al. Influence of basiliximab induction therapy on long term outcome after liver transplantation, a prospectively randomised trial. Ann Transplant. 2007;12(3):15-21.

Basiliximab Versus Steroids in Double Therapy Immunosuppression in Liver Transplantation: A Prospective Randomized Clinical Trial
Design

Prospective randomized-controlled clinical trial

N= 47
Objective To compare basiliximab with steroids in a cyclosporin A-based immunosuppression regimen in primary liver transplantation
Study Groups

Basiliximab group (n= 26)

Steroids group (n= 21)
Inclusion Criteria Adult recipients of primary liver transplantation with an identical or compatible blood-group graft
Exclusion Criteria Second or subsequent liver transplantation, history of malignancy within the last 5 years, severe active infections requiring systemic antibiotic treatment, use of experimental drugs, pregnancy, fertile women not using effective contraception, fulminant liver failure, positive HIV serology, recent myocardial infarction, high serum creatinine, renal dialysis before transplantation
Methods Patients were randomly assigned to receive either basiliximab or steroids. Cyclosporin A was administered at an initial dose of 10 mg/kg/day, adjusted to target C2 levels. Basiliximab was given as a 20 mg dose on day 0 and day 4. Steroids were tapered from 200 mg of intravenous hydrocortisone to oral prednisolone, reduced over 90 days.
Duration November 2002 to November 2005
Outcome Measures

Primary: Acute cellular rejection (ACR) rate, patient and graft survival
Baseline Characteristics   Basiliximab (n= 26) Steroids (n= 21)
Median age (range), years 50.5 (34.2–63.7) 53.7 (30.2–64.7)
Recipient sex ratio (M:F) 23:3 18:3
Donor age (range), years 47.7 (16.4–77.0) 47.3 (19.8–77.0)
Primary liver disease - HCV 11 9
Primary liver disease - HBV 10 10
Results   Basiliximab (n= 26) Steroids (n= 21) p-value
ACR rate 15.4% 28.6% > 0.05
Cumulative survival at 36 months 84.3% 61.0% 0.094
Graft survival at 36 months 80.7% 57% 0.073
Adverse Events The incidence of infection and other adverse events was similar between the two treatment groups
Study Author Conclusions Basiliximab may represent a valid alternative to steroids in the induction of immunosuppression in liver transplantation. Further studies in a larger cohort are needed.
Critique The study provides valuable insights into the potential of basiliximab as an alternative to steroids in liver transplantation. However, the small sample size limits the statistical power and generalizability of the findings. Further research with larger cohorts is necessary to confirm these results.
References:

Lupo L, Panzera P, Tandoi F, et al. Basiliximab versus steroids in double therapy Immunosuppression in liver transplantation: a prospective randomized clinical trial. Transplantation. 2008;86(7):925-931. doi:10.1097/tp.0b013e318186b8a3

 

Randomized trial of steroid free immunosuppression with basiliximab induction in adult live donor liver transplantation (LDLT)
Design

Prospective, open-labelled, investigator-initiated, intention to treat randomized trial

N=104
Objective To evaluate the efficacy of steroid-free immunosuppression with basiliximab induction following live donor liver transplantation (LDLT)
Study Groups

Steroid-free arm (SF-arm) (n=52)

Steroid arm (S-arm) (n=52)
Inclusion Criteria Adults between 18 and 70 years old, recipients of primary liver allografts from a living donor
Exclusion Criteria Multi-organ transplants, ABO-incompatible grafts, recent/present corticosteroid therapy, intolerance to study medications, history of chronic kidney disease/current renal impairment
Methods Patients in the SF-arm received basiliximab 20 mg intravenously within 12 hours after reperfusion and on postoperative day 4, with tacrolimus and azathioprine maintenance. S-arm patients received tapering dose IV methylprednisolone for 4 days followed by oral steroids, with tacrolimus and azathioprine. Tacrolimus was titrated to achieve a trough level of 3–7 ng/mL. Azathioprine was started if WBC >4000/mcL and platelets >50,000/mcL, and gradually withdrawn over 3–6 months.
Duration May 2016 to February 2018
Outcome Measures

Primary: Incidence of metabolic complications (NODAT, NOSHT, dyslipidemia) within 6 months

Secondary: Biopsy-proven acute rejection (BPAR) within six months, patient and graft survival at 6 months
Baseline Characteristics   SF – Arm (n=52) S – Arm (n=52) p-value
Age (yrs) 48.10 ± 10.74 47.79 ± 8.5 0.872
MELD Score 23.94 ± 6.52 23.35 ± 6.04 0.630
GRWR 0.97 ± 0.21 0.96 ± 0.24 0.868
BMI 26.33 ± 3.91 26.04 ± 3.93 0.905
Male: Female 43 (48.3%): 9 (60%) 46(51.7%):6(40%) 0.402
Co-morbidities - Diabetes 19 (52.8%) 17 (47.2%) 0.680
Co-morbidities - Hypertension 8 (44.4%) 10 (55.6%) 0.604
Results   SF-arm S-arm P-value
NODAT at 3 months 9/32 (28.1%) 20/31 (64.5%) 0.004
NOSHT at 3 months 3/42 (7.1%) 10/36 (27.8%) 0.033
NODAT at 6 months 5/32 (15.6%) 16/31 (51.6%) 0.006
NOSHT at 6 months 2/42 (4.8%) 10/36 (27.8%) 0.013
Hypertriglyceridemia at 6 months 4/50 (8.0%) 12/45 (26.7%) 0.031
Renal dysfunction at 6 months (eGFR < 90 mL/min) 27 (54%) 14 (31.1%) 0.025
BPAR 10 (19.2%) 11 (21.2%) 0.807
Overall Infections 13 (25%) 18 (34.6%) 0.284
Urinary sepsis 2 (3.8%) 8 (15.4%) 0.046
Adverse Events Higher incidence of renal dysfunction in SF-arm at 6 months (eGFR < 90 mL/min)
Study Author Conclusions Following LDLT, basiliximab induction with tacrolimus and azathioprine maintenance resulted in significantly lower metabolic complications compared to the triple-drug regimen of steroid, tacrolimus, and azathioprine.
Critique The study was well-designed with a randomized controlled trial approach, providing robust evidence for the efficacy of steroid-free immunosuppression in reducing metabolic complications. However, the study's follow-up period was relatively short at 6 months, which may not capture long-term outcomes. Additionally, the study was conducted in a single center, which may limit the generalizability of the findings to other populations or settings. The cost-effectiveness analysis was a strength, highlighting the potential economic benefits of the steroid-free regimen despite the high cost of basiliximab.
References:

Kathirvel M, Mallick S, Sethi P, et al. Randomized trial of steroid free immunosuppression with basiliximab induction in adult live donor liver transplantation (LDLT). HPB (Oxford). 2021;23(5):666-674. doi:10.1016/j.hpb.2020.09.012

 

Efficacy and safety of basiliximab as initial immunosuppression in liver transplantation: A single center study

Design

Randomized controlled trial

N= 89

Objective

To evaluate the effectiveness and safety of basiliximab induction in liver transplantation

Study Groups

Standard triple immunosuppression (n= 47)

Basiliximab (n= 42)

Inclusion Criteria

Adult patients (age ≥ 18 years) who underwent living donor liver transplantation (LDLT) at a university hospital in Egypt

Exclusion Criteria

N/A

Methods

Patients were randomized into one of two treatment groups. Patients in the standard triple immunosuppression (IS) group were given a regimen of steroid, tacrolimus (TAC) and mycophenolate mofetil (MMF). Those in the basiliximab induction group received a regimen of basiliximab (20 mg IV intraoperatively followed by second dose on post-operative day 4), low-dose steroids and MMF with introduction of small dose of CNI on day 3 to 6. 

Duration

6 months

Outcome Measures

Primary: Patient mortality in first 6 months after liver transplant

Secondary: Incidence of acute rejection, renal impairment

Baseline Characteristics

  

Standard triple immunosuppression (n= 47)

Basiliximab (n= 42)

  

Age, years

 46.56 ± 7.94  46.90 ± 7.92   

Weight, kg

 78.30 ± 12.83 82.79 ± 12.77  

Female

6 (12.76%) 4 (9.52%)  
Preoperative GFR

83.19 ± 13.15

 86.64 ± 19.32   

Preoperative creatinine

 0.8 ± 0.34 1.4 ± 0.9  

Results

Endpoint

Standard triple immunosuppression (n= 47)

Basiliximab (n= 42)

p-Value

Mortality at 12 months

 83% 82% 0.74

Acute rejection

 17% 9.5%  0.15

Renal impairment

 19.14% 7.1% 0.04

Adverse Events

 No significant differences noted for incidence of infection. No significant major or serious adverse effects occurred; basiliximab was well tolerated. 

Study Author Conclusions

Basiliximab-induced IS protocol is a safe regimen that reduces medium-term renal dysfunction and achieves similar survival without increasing the acute rejection or infection rate in liver transplantation recipients.

InpharmD Researcher Critique

A relatively small sample size was included, making it more difficult to identify differences that may occur at a lower incidence rate. 



References:

Hashim M, Alsebaey A, Ragab A, Soliman HE, Waked I. Efficacy and safety of basiliximab as initial immunosuppression in liver transplantation: A single center study. Ann Hepatol. 2020;19(5):541-545. doi:10.5604/01.3001.0012.2246

 

Treatment of Graft-Versus-Host Disease After Liver Transplantation with Basiliximab Followed by Bowel Resection

Design

 Case reports

Case presentation 1

A 45-year-old male with a history of alcohol-related cirrhosis and alpha-1 antitrypsin deficiency received an orthotopic liver transplant from a 33-year-old female donor. His initial post-operative recovery was uncomplicated until day 5, when a seizure attributed to tacrolimus neurotoxicity prompted a switch to cyclosporine. On day 24, he presented with fever, a widespread rash, oral lesions, and diarrhea. Investigations, including skin biopsy and genetic testing, confirmed a diagnosis of graft-versus-host disease (GVHD), evidenced by donor lymphocyte macro-chimerism and the presence of donor-derived cells in the skin. After failing to respond to intravenous steroids, he was successfully treated with two doses of Basiliximab, which resolved the skin and oral symptoms. However, he subsequently developed severe intestinal GVHD that required a right hemicolectomy on day 72, the histology of which also confirmed GVHD. Following this, he recovered and was discharged, though he experienced an episode of acute rejection seven months post-transplant that was treated with steroids. At 36 months, the patient was alive and well with normal liver function.

Case presentation 2

A 56-year-old male with hepatitis C and alcohol-related cirrhosis received a liver transplant. His initial recovery was uncomplicated until day 31, when he developed a rash, erythema of the palms and soles, and diarrhea. A skin biopsy and the presence of donor lymphocytes in his blood (8% chimerism) confirmed a diagnosis of graft-versus-host disease (GVHD). He was treated with steroids and Basiliximab, which resolved the rash. However, his gastrointestinal symptoms persisted, leading to a diagnosis of refractory intestinal GVHD. Despite aggressive treatment, including high-dose steroids and total parenteral nutrition, he remained malnourished. He was readmitted on day 205 with a small-bowel obstruction caused by an ileal stricture, which was surgically resected; the histology was consistent with GVHD. Although he recovered from surgery, he later died of liver failure from recurrent hepatitis C nine months post-transplant.

Study Author Conclusions

 The combination of immunological and surgical treatment for GVHD following solid organ transplantation has not previously been described.

 

References:

S. Sudhindran, Taylor A, Luc Delriviere, et al. Treatment of Graft-Versus-Host Disease After Liver Transplantation with Basiliximab Followed by Bowel Resection. American Journal of Transplantation. 2003;3(8):1024-1029. doi:https://doi.org/10.1034/j.1600-6143.2003.00108.x

 

Basiliximab Versus No Induction Therapy in Kidney Transplant Recipients With a Low Immunological Risk Profile Receiving Tacrolimus/Mycophenolate/Steroids Maintenance Immunosuppression

Design

Single-center, retrospective study

N= 471

Objective

To compare the 1- and 5-year risk of acute graft rejection, graft survival, and patient survival between interleukin 2 receptor antagonist (IL2-RA) induction versus no induction in kidney transplant recipients with a low immunological risk profile receiving tacrolimus (Tac), mycophenolate (MPA), and steroid maintenance immunosuppressive therapy

Study Groups

Basiliximab (n= 117)

No induction (n= 354)

Inclusion Criteria

Patient >18 years with a low immunological risk profile, defined as a historic virtual panel reactive antibody (vPRA) at 0%

Exclusion Criteria

Patients with a history of vPRA > 0%, underwent an ABO-incompatible kidney transplant (ABOi-KT) or multiorgan transplantation, received specific peritransplant management (e.g., plasma exchanges to prevent focal segmental glomerulosclerosis recurrence or prophylactic eculizumab in moderate and high-risk atypical hemolytic and uremic syndrome)

Methods

Living-donor KT recipients were given basiliximab (20 mg at day 0 and day 4), followed by maintenance Tac (trough level range of 9–13 ng/mL in month 1, 7–9 ng/mL in months 2 to 3, and 5–7 ng/mL thereafter), MPA (500 mg twice daily), and methylprednisolone (500 mg on day 0 and then 16 mg/day from day 1 with reduction of 4 mg every two weeks to reach a daily dose of 4 mg/day for lifelong continuation). Deceased-donor KT recipients did not receive induction therapy.

All patients received prophylaxis with co-trimoxazole (3 times a week) and valganciclovir (except in Cytomegalovirus [CMV] D-/R-) for 6 months. Routine monitoring included human leucocytes antigen (HLA) antibody levels and BK virus screening.

Duration

January 1, 2015 to December 31, 2022

Outcome Measures

Risk of acute graft rejection (biopsy-proven acute rejection; BPAR), graft loss, patient survival

Baseline Characteristics

  

Basiliximab (n= 117)

No Induction (n= 354)

 p-Value

Age, years

 48 (34-55)  56 (46-64) < 0.001

Female

44 (38%) 86 (24%) 0.005

Kidney disease (congenital or hereditary nephropathy)

 37 (32%) 102 (29%) 0.2

Diabetes

 11 (9.4%)  56 (16%) -

Vintage dialysis, months

 15 (8-23) 40 (23-60) < 0.001

Dialysis mode

Hemodialysis

Peritoneal dialysis

Preemptive

 

67 (57%)

9 (7.7%)

41 (35%)

 

307 (87%)

26 (7.3%)

21 (5.9%)

 -

Prior cardiovascular events

 15 (13%) 101 (29%) < 0.001

Prior diabetes

 16 (14%) 91 (26%) 0.007

Prior neoplasia

 8 (6.8%) 45 (13%) 0.081

Prior organ transplantation (non-kidney)

 6 (5.1%) 10 (2.8%) 0.2

Number of kidney transplantations

1

2

3

 

110 (94%)

5 (4.3%)

2 (1.7%)

 

339 (96%)

15 (4.2%)

0

 -

Maintenance therapy (Tac/MPA/steroids)

116 (99%)

352 (99%)

 0.6

Number of HLA mismatchs

2 (2-4)

3 (2-3)

 0.6

Cold ischemia, hours

3 (2-3)

10 (7-14)

 <0.001

CMV status

Low-risk

Intermediate risk

High-risk

 

14 (12%)

80 (68%)

23 (20%)

 

95 (27%)

180 (51%)

79 (22%)

 0.001

Abbreviations: CMV = cytomegalovirus; IQR = interquartile range; Tac = tacrolimus; MPA = mycophenolate.

Results

Endpoint

Basiliximab (n= 117)

No Induction (n= 354)

p-Value

BPAR at 1 year

 8 (6.8%) 26 (7.5%) 0.7

BPAR at 5 years

 9 (7.8%)  29 (8.9%)  0.8

Graft loss

 4.2% 8.5% 0.063

There was no significant difference between groups in terms of patient survival.

Abbreviations: BPAR = Biopsy-proven acute rejection.

Adverse Events

Not disclosed.

Study Author Conclusions

Induction therapy with basiliximab has no benefit regarding the risk of acute rejection at one year and mid-term follow-up, or graft loss within 5 years post KT compared to a strategy without induction therapy in patients with a low immunological risk profile who receive Tac/MPA/steroids maintenance therapy.

InpharmD Researcher Critique

The study's retrospective nature may introduce bias, and the donor characteristics (living vs. deceased) could have influenced the results. The definition of low-immunological-risk profile as vPRA 0% may not be universally applicable, and the study's findings may not be generalizable to all settings. Further prospective studies are needed to confirm these results.



References:

Lacave F, de Terwangne C, Darius T, et al. Basiliximab vs. No Induction Therapy in Kidney Transplant Recipients with a Low Immunological Risk Profile Receiving Tacrolimus/Mycophenolate/Steroids Maintenance Immunosuppression. J Clin Med. 2024;13(20):6151. Published 2024 Oct 16. doi:10.3390/jcm13206151
Basiliximab Induction in Living Donor Kidney Transplant with Tacrolimus‑Based Triple Immunosuppression
Design

Prospective observational study

N= 260
Objective To compare the incidence of acute rejection with basiliximab induction versus no induction in first kidney recipients of living donors with tacrolimus and mycophenolate mofetil-based triple immunosuppression at 6 months
Study Groups

Basiliximab group (n= 202)

No induction group (n= 58)
Inclusion Criteria

Prospective living donor adult kidney transplant recipients admitted from November 1, 2014, to November 30, 2015, for transplant surgery at a tertiary care multi super-specialty hospital
Exclusion Criteria

Receiving cyclosporine/azathioprine-based or steroid-free protocol, ABO incompatible transplant, second or subsequent transplant, recent or historic crossmatch positive, deceased donor kidney transplants, and patients who received rabbit ATG induction
Methods

Patients opting for basiliximab induction received two doses of 20 mg each on day 0 and day 4. All patients were started on tacrolimus at 0.1 mg/kg/day in two divided doses and mycophenolate mofetil at 1000/720 mg twice daily one day prior to surgery. All patients also received one dose of intravenous methylprednisolone 500 mg perioperatively. Tacrolimus trough levels were monitored and maintained at 8–12 ng/ml during the first 3 months, 6–8 ng/ml over the next 3 months, and 4–6 ng/ml thereafter. Mycophenolate mofetil was tapered to 720/1000 mg/day after 3 months. Prednisolone was tapered to 5–7.5 mg/day by the end of 3 months.
Duration Patients were enrolled over a period of 12 months starting November 1, 2014, and followed for a minimum of 6 months posttransplant
Outcome Measures

Primary: Biopsy-proven acute rejection at 6 months

Secondary: Incidence of infections, other adverse events, graft and patient survival at the end of follow-up
Baseline Characteristics   IL2-RA group (n=202) No induction group (n=58)
Age (mean±SD) 40.5 ± 12.7 36.9 ± 12.01
Males 167 (82.7%) 49 (84.5%)
HCV positive 11 (5.4%) 3 (5.2%)
HBsAg positive 2 (1.0%) 4 (6.9%)
HLA mismatch (mean) 3.80 ± 1.50 2.81 ± 1.53
Results   IL2-RA group (n=202) No induction group (n=58) p-Value
Acute rejection (AR) 42 (20.8%) 10 (17.2%) 0.551
Acute cellular rejection (ACR) 38 (91.5%) 10 (100%) 0.444
Acute AMR 4 (9.5%) 0 0.226
Steroid resistant rejection 6 (14.28%) 0 --
Adverse Events There was no difference in adverse events between the groups. The overall incidence of infection was similar in both groups. The most common infections were urinary tract infections. One patient in the IL-2RA group developed posttransplant lymphoproliferative disorder
Study Author Conclusions

This study suggests that there is no advantage of using basiliximab induction in reducing acute rejection in first kidney recipients of living donors in tacrolimus-based triple immunosuppression.
Critique

The study was not a randomized trial, which might have led to selection bias, as more patients in the no induction group had better-matched kidneys. There were fewer patients in the no induction group compared to the IL-2 group. The study did not use panel reactive antibodies to define immunological risks.

 

References:

Bansal SB, Deepak Pathania, Sethi SK, et al. Basiliximab induction in living donor kidney transplant with tacrolimus-based triple immunosuppression. Indian Journal of Transplantation. 2019;13(2):104-104. doi:https://doi.org/10.4103/ijot.ijot_81_18

 

Low-Dose Basiliximab Induction Therapy in Heart Transplantation

Design

Single-cohort, prospective study

N= 17

Objective

To determine efficacy and safety outcomes of low-dose basiliximab induction post-transplant

Study Groups

All patients (n= 17)

Inclusion Criteria

Patients ≥15 years undergoing orthotopic heart transplant at King Chulalongkorn Memorial Hospital

Exclusion Criteria

Patients with post-operative renal failure requiring prolonged basiliximab therapy (greater than 2 doses) due to delay in calcineurin inhibitor (CNI) treatment

Methods

Patients received two 10 mg doses of intravenous (IV) basiliximab on day 0 and day 4 post-transplant in addition to adjunctive (mycophenolate sodium and methylprednisolone) 6 hours prior to transplant and maintenance immunosuppression (mycophenolate sodium, cyclosporine or tacrolimus, and steroids) post-transplant. Infection prophylaxis included trimethoprim-sulfamethoxazole and fluconazole.

Duration

April 2014 to April 2016

Outcome Measures

Primary: All-cause mortality, primary graft failure, acute cellular rejection with International Society for Heart and Lung Transplantation (ISHLT) grade ≥ 2R

Secondary: Treated infection

Baseline Characteristics

  

All patients (n= 17) 

Age, years

 42 ± 14

Female

3 (18%)   

Weight, kg

 54 ± 10

Pre-transplant diagnosis

Ischemic cardiomyopathy

Non-ischemic cardiomyopathy

Valvular cardiomyopathy

Peripartum cardiomyopathy

Hypertrophic cardiomyopathy

Arrhythmogenic RV dysplasia

Congenital heart disease

 

6 (35%)

4 (24%)

1 (6%)

1 (6%)

1 (6%)

1 (6%)

3 (18%)

Co-morbidities

Hypertension

Diabetes

Prior cardiac surgery

 

3 (18%)

3 (18%)

1 (6%)

Left ventricular ejection fraction

26 ± 16

Pre-transplant hemodynamics

Mean pulmonary arterial pressure, mmHg

Transpulmonary gradient, mmHg

PVR, WU

 

30 ± 9

7.4 ± 4.6

3.6 ± 2.0

Cardiac output, L/min

 3.2 ± 2.7

Panel Reactive Antibody (PRA) > 10%

Class I

Class II

 

1 (6%)

1 (6%)

Serum blood urea nitrogen, mg/dL

 29.4 ± 15.5

Serum creatinine, mg/dL

 1.2 ± 0.4

Cold ischemic time, minutes

 228 ± 78

Maintenance Immunosuppression

 Month 1 Month 6 (post-transplant)

Cyclosporine

Cyclosporine prescribed

Dose, mg/kg/day

C0 level, ng/mL

 

70%

4.2 ± 1.0

226 ± 96*

 

75 %

3.6 ± 0.9

250 ± 44**

Tacrolimus

Tacrolimus prescribed

Dose, mg/kg/day

Trough level, ng/mL

 

30%

0.09 ± 0.06

8.7 ± 4.7*

 

25%

0.07 ± 0.03

11.8 ± 1.8**

Mycophenolate sodium

Mycophenolate sodium prescribed

Daily dose, mg/kg

 

100%

22 ± 5

 

100%

20 ± 5

Everolimus

Everolimus prescribed

Trough level, ng/mL

 

6%

6.6 ± 1.2

 

0%

N/A

Prednisolone

Prednisolone prescribed

Dose, mg/kg/day

 

100%

0.3 ± 0.1

 

56%

0.1 ± 0.1

* Mean drug level of post-heart transplant day 8-30

** Mean drug level of post-heart transplant month 1-6

Abbreviations: MAP = Mean pulmonary arterial pressure. PVR = Pulmonary vascular resistance. RV = Right ventricular.

Results

Endpoint

All patients (n= 17)

All-cause mortality

 1 (6%)

Primary graft failure

 0

Acute cellular rejection

 2 (12%)

Adverse Events

At the 2-week post-transplant assessment, no adverse drug reactions were observed. By the 1-year mark, a total of four (25%) treated infections and six (35%) asymptomatic CMV infections were noted. Notably, no cases of CMV disease, malignancy, or post-transplant lymphoproliferative disorder were detected during the follow-up period.

Study Author Conclusions

Low-dose basiliximab induction with two 10 mg doses of basiliximab IV on day 0 and day 4 after heart transplant in low-risk patients was well tolerated and resulted in favorable efficacy and safety outcomes. Additionally, CNI initiation in a low-risk population could be safely delayed using the strategy of modified low-dose post-operative basiliximab. This strategy also appears to allow subsequent early corticosteroid wean, although with the concomitant maintenance of higher CNI levels and higher dosing of mycophenolate.

InpharmD Researcher Critique

This is a single-center study with a small number of participants, which limits the generalizability of the findings. The study lacks a control group for comparison. Further randomized controlled studies are needed to confirm these findings.



References:

Kittipibul V, Tantrachoti P, Ongcharit P, et al. Low-dose basiliximab induction therapy in heart transplantation. Clin Transplant. 2017;31(12):10.1111/ctr.13132. doi:10.1111/ctr.13132

Clinical Outcomes of Intestinal Transplant Recipients Receiving Maintenance Basiliximab, Sublingual Tacrolimus and Prednisone: A Case Series
Design

Retrospective case series

N= 5
Objective

To describe 1-year clinical outcomes of intestinal transplant recipients receiving a novel immunosuppression regimen consisting of monthly basiliximab, sublingual tacrolimus, and prednisone
Study Groups

All patients (n= 5)
Inclusion Criteria

Patients who underwent isolated intestinal transplantation and were followed for at least 1-year post-transplant
Exclusion Criteria

Not specified
Methods

Retrospective analysis of electronic health records. Patients received methylprednisolone intraoperatively, rabbit anti-thymocyte globulin post-operatively, sublingual tacrolimus starting on post-operative day 0, and basiliximab initiated within 7 days post-transplant. Tacrolimus trough levels were monitored, and steroids were tapered to a prednisone equivalence of 10 mg by post-operative day 5. Mycophenolate mofetil was used for up to 1 month
Duration

January 01, 2020, to January 31, 2022
Outcome Measures

1-year clinical outcomes, including graft survival and rejection rates; tacrolimus trough levels; infection rates; adverse events
Baseline Characteristics

 

 All patients (n= 5)

Age, years, median (IQR)

 20.1 (17.4 to 28.8)

Male

 2 (40.0%)

Race

African American

Caucasian

Hispanic

 

2 (40.0%)

2 (40.0%)

1 (20.0%)

Height, cm, median (IQR)

 160 (152 to 183)

Weight, kg, median (IQR)

 53.7 (50.3 to 64.0)

BMI, kg/m2, median (IQR)

 20.9 (19.1 to 22.4)

Cause of intestinal failure

Short gut syndrome

Desmoid tumor

Neuronal intestinal dysplasia

 

2 (40.0%)

2 (40.0%)

1 (20.0%)

Retransplant

 1 (20.0%)

Positive T and/or B cell Flow crossmatch

 1 (20.0%)

HLA (A-B-DR) mismatch, median (IQR)

 5 (4 to 5)

Peak Panel Reactive Antibody, median (IQR)

Class I

Class II

 

43% (0 to 88)

0 (0 to 71)

Cytomegalovirus, high risk

 1 (20.0%)

Epstein-Barr Virus recipient IgG seronegative

 1 (20.0)%

Abbreviations: IQR, interquartile range; BMI, body mass index
Results

 

 All patients (n= 5)

Biopsy-proven rejection

 3 (60.0%)

Time to first rejection, days, median (IQR)

 26 (14 to 30)

Rejection treatment

MP

MP + IFX

MP + IFX + BZ + VDZ

 

1 (33.3%)

1 (33.3%)

1 (33.3%)

Infection

Bacteremia

Fungemia

 

 

1 (20.0%)

1 (20.0%)

Initiation of hypoglycemic agent

 1 (20.0%)

The study reported that tacrolimus trough levels remained consistently within the therapeutic range over the first post-transplant year, with median levels of 10.4 ng/mL at month 1, 10.2 ng/mL at month 3, 8.4 ng/mL at month 6, and 8.8 ng/mL at month 12.

Despite achieving target levels, the cohort demonstrated high intra-patient variability (median CV% 42), suggesting potential challenges in maintaining stable tacrolimus exposure in intestinal transplant recipients.

Abbreviations: MP, methylprednisolone; IFX, infliximab; BZ, bortezomib; VDZ, vedolizumab
Adverse Events

Three patients (60.0%) experienced biopsy-proven rejection, which resolved after optimization of immunosuppression. Two patients had infectious complications related to central line for TPN. One patient developed diabetes mellitus requiring insulin therapy.
Study Author Conclusions

The combination of monthly basiliximab, sublingual tacrolimus, and prednisone is an effective novel maintenance immunosuppression in intestinal transplantation. A larger and more extended study duration would be necessary to thoroughly assess the safety and sustained benefits of the novel maintenance immunosuppression regimen.
Critique

The study provides valuable preliminary insights into a novel immunosuppression regimen for intestinal transplantation, showing favorable outcomes at 1-year. However, the small sample size and short follow-up period limit the generalizability and ability to assess long-term outcomes. A larger study with a longer duration is needed to confirm these findings and evaluate the regimen's sustained safety and efficacy.

 

References:

Di Cocco P, Martinino A, Bencini G, et al. Clinical outcomes of intestinal transplant recipients receiving maintenance basiliximab, sublingual tacrolimus and prednisone: A case series. Hum Immunol. 2024;85(3):110787. doi:10.1016/j.humimm.2024.110787

 

Induction With Anti-thymocyte Globulin in Heart Transplantation Is Associated With Better Long-term Survival Compared With Basiliximab

Design

Retrospective analysis

N= 9,324

Objective

To assess the association between basiliximab (BAS) vs. anti-thymocyte globulin (ATG) induction and long-term survival after heart transplantation

Study Groups

BAS (n= 3,810)

ATG (n= 6,144)

Inclusion Criteria

Adult heart recipients who were treated with ATG or BAS as induction therapy

Exclusion Criteria

Pediatric patients (recipients aged < 18 years), heart recipients who did not receive ATG or BAS, lack of information on the cause of death or vital status

Methods

All the necessary data were pulled from the International Society for Heart and Lung Transplantation Registry. The study did not fully detail information on induction therapy for both ATG and BAS such as administered regimens.

Duration

January 1, 2000 to June 31, 2011

Follow-up: up to 10 years

Outcome Measures

All-cause mortality (censoring those who died of trauma or unknown cause of death and those alive at last follow-up) and deaths related to graft failure, cardiovascular causes, infection, or malignancy

Baseline Characteristics

  

BAS (n= 3,810)

ATG (n= 6,144)

 p-Value

Age, median (IQR) years

 55 (45–61) 54 (45–61) 0.027

Female

755 (23.7%) 1,392 (22.7%) 0.243

Weight, kg

 81.2 ± 17.8 79.2 ± 17.1 < 0.001

Diagnosis

Coronary artery disease

Cardiomyopathy

Congenital

Retransplant due to graft failure

Heart valve disease

Miscellaneous

 

1,404 (44.2%)

1,473 (46.3%)

83 (2.6%)

84 (2.6%)

69 (2.2%)

1 (0.03%)

 

2,447 (39.8%)

3,023 (49.2%)

166 (2.7%)

161 (2.6%)

163 (2.7%)

37 (0.6%)

 0.001

Blood group

A

AB

B

O

 

1,359 (42.7%)

166 (5.2%)

412 (13.0%)

1,243 (39.1%)

 

2,661 (43.3%)

323 (5.3%)

767 (12.5%)

2,393 (39.0%)

 0.909

Pre-transplant management

Antiarrhythmics

Inotropic support

Dialysis

 

977 (35.3%)

1,173 (39.5%)

109 (3.6%)

 

1,497 (33.5%)

1,874 (42.6%)

263 (5.7%)

 

0.123

0.008

< 0.001

Implantable defibrillator

1,849 (74.4%) 2,575 (65.6%) < 0.001

Comorbidities

Diabetes (insulin-treated)

Hypertension

 

776 (25.4%)

1,323 (46.0%)

 

1,100 (22.8%)

1,871 (40.8%)

 

0.008

< 0.001

Medical condition at transplant

Home

Hospital

Intensive care unit

 

1,742 (56.6%)

473 (15.4%)

861 (28.0%)

 

2,607 (56.0%)

864 (18.6%)

1,184 (25.4%)

 0.001

Ventricular assist device

 735 (26.5%) 1,220 (32.1%) < 0.001

Creatinine most recent, μmol/liter

 118.8 ± 63.7 122.8 ± 71.4 0.011

Pulmonary vascular resistance (PVR), wood units

 2.5 ± 1.6 2.4 ± 1.8 0.003

Previous blood transfusion

 819 (58.8%) 1,450 (55.6%) 0.049

Previous transplant

 88 (2.8%) 217 (3.7%)  0.018

Panel-reactive antibodies (PRA)

Class I

Class II

 

6.1 ± 17

3.7 ± 14

 

7.5 ± 19

6.6 ± 19

 < 0.001

Results

Endpoint

BAS (n= 3,810)

ATG (n= 6,144)

p-Value

Survival

1-year

5-year

10-year

 

90%

77%

64%

 

91%

82%

67%

 

0.858

0.005

0.007 

BAS was associated with a higher risk of death related to graft failure (HR, 1.53; 95% CI, 1.21–1.94; p< 0.001), cardiovascular events (HR, 1.35; 95% CI, 1.05–1.73; p= 0.018), and infection (HR, 1.34; 95% CI, 1.05–1.73; p= 0.021) but not to malignancy (HR, 0.89; 95% CI, 0.60–1.31; p= 0.547).

Abbreviations: CI = confidence interval. HR = Hazard ratio.

Adverse Events

See results.

Study Author Conclusions

In the International Society for Heart and Lung Transplantation Registry experience, use of ATG rather than BAS as induction therapy appears to be associated with better long-term survival. A prospective study is necessary to confirm these findings.

InpharmD Researcher Critique

The study is subject to the limitations inherent to a retrospective analysis (e.g., multi-institutional database, variations in adverse events reporting, data analyzed at different time points, missing values). Despite a number of measures taken to control inherent bias in this retrospective review, residual confounders secondary to unmeasured variables cannot be ruled out. It is unlikely that BAS or ATG regimens are standardized across different institutions, making it challenging to draw definitive conclusions.



References:

Ansari D, Lund LH, Stehlik J, et al. Induction with anti-thymocyte globulin in heart transplantation is associated with better long-term survival compared with basiliximab. J Heart Lung Transplant. 2015;34(10):1283-1291. doi:10.1016/j.healun.2015.04.001

Comparison of basiliximab vs antithymocyte globulin for induction in pediatric heart transplant recipients: An analysis of the International Society for Heart and Lung Transplantation database

Design

Retrospective database review

N= 3,065

Objective

To compare the two most commonly utilized classes of induction agents, interleukin-2 (IL-2) receptor antibodies (basiliximab), and anti-thymocyte globulin (ATG), in the pediatric heart transplant population utilizing propensity scores to reduce bias in the analysis

Study Groups

Total cohort

Basiliximab (n= 707)

ATG (n= 2,358)

Matched cohort

Basiliximab (n= 677)

ATG (n= 677)

Inclusion Criteria

Aged < 18 years; heart transplants with induction therapy documentation

Exclusion Criteria

Part of multiorgan transplantation; did not receive either basiliximab or ATG (rabbit or equine antithymocyte antibodies); received both basiliximab and ATG

Methods

Pediatric patients receiving heart transplants within the specified review period and induced with basiliximab or ATG were identified from the International Society for Heart and Lung Transplantation database and were included in the study. A proportion of patients were matched by propensity score matching to compare end-points between basiliximab and ATG matched cohorts. 

Duration

Review period: January 1, 2000, to June 30, 2015

Outcome Measures

Primary end-point: graft survival 

Secondary end-points: overall graft loss (defined as patient death from any cause or transplantation), graft loss in the first post-transplant year, graft loss after conditional 1-year graft survival, infection prior to discharge, cardiac allograft vasculopathy (CAV), rejection prior to discharge, admitted for rejection, and discharged on steroid maintenance

Baseline Characteristics

  

Basiliximab (n= 677)

ATG (n= 677)

  

Age, years

 7 5  

Weight, kg

 23.6 18  

Female

49.8% 50.2%  

Cardiac diagnosis

Cardiomyopathy

Congenital heart disease

Retransplant

Other

 

56.7%

36.2%

4.0%

3.1%

 

53.2%

40.0%

4.3%

2.5%

  

Support at transplant

Extracorporeal membrane oxygenation

Ventricular assist device

Inotropes

Ventilator

Dialysis

 

7.3%

12.3%

77.0%

21.1%

4.0%

 

10.3%

9.9%

70.3%

21.9%

3.1% 

  

Panel reactive antibody, %

 11.5 11.9  

Bilirubin, mg/dL

 0.6 0.6  

Ischemic time, hours

 3.5  3.5  

Follow-up duration, years

 3.9 3.6  

Results

Endpoint

Total Cohort (N= 3,065)*

Matched cohort (n= 1,354)*

  

Overall graft loss, hazard/odds ratio (95% confidence interval [CI])

p-value

1.18 (0.99 to 1.4)

0.06

1.24 (1.0 to 1.5)

0.06

  

Graft loss in the first post-transplant year, hazard/odds ratio (95% CI)

p-value

1.2 (0.89 to 1.7) 

0.22

1.1 (0.81 to 1.5)

0.60

  

Graft loss after conditional 1-year graft survival, hazard/odds ratio (95% CI)

p-value

1.35 (1.1 to 1.7) 

< 0.01

1.48 (1.1 to 2.0)

< 0.01

  

 

Basiliximab (n= 677)

ATG (n= 677)

p-value

Graft survival

1-year

5-year

10-year

 

91.1%

74.2%

53.0%

 

90.6%

79.0%

63.0%

 0.05
Infection prior to discharge

21.1%

23.2%

 0.03

CAV

 15.8% 9.9% 0.04

Rejection prior to discharge

 103 (17.5%) 78 (13.3%) 0.04

Admitted for rejection

 27.5% 117.7% < 0.01

Discharged on steroid maintenance

 90% 60% < 0.01

*All hazard ratios/odds ratios are reported as the basiliximab cohort compared to the ATG cohort

Adverse Events

Not disclosed

Study Author Conclusions

In a large, international registry-based analysis, ATG appears to have improved long-term survival benefit as evidenced by the conditional 1-year survival analysis. The use of ATG induction is associated with decreased risk of rejection prior to hospital discharge although at the expense of a small increased chance of infection prior to discharge with ATG compared to basiliximab.

InpharmD Researcher Critique

The study is limited by its retrospective nature which increases the probability of reporting bias. The doses of induction regimens used were also not specified in the study. Further, despite propensity score matching, some baseline characteristics were still significantly different. 

 

References:

Butts RJ, Dipchand AI, Sutcliffe D, et al. Comparison of basiliximab vs antithymocyte globulin for induction in pediatric heart transplant recipients: An analysis of the International Society for Heart and Lung Transplantation database. Pediatr Transplant. 2018;22(4):e13190. doi:10.1111/petr.13190

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

Design

Retrospective study

N= 3,039

Objective

 To evaluate the effect on graft survival of anti-thymocyte globulin (ATG) and basiliximab (BAS) induction in black and non-black pediatric recipients

Study Groups

ATG (n= 2,385)

BAS (n= 654)

Inclusion Criteria

 Age 18 years or younger, underwent heart transplant from 2000 to 2016 and received either ATG or BAS induction

Exclusion Criteria

 Multi-organ transplant, cardiac re-transplantation, received any other induction agent

Methods

Patient data collected from the United Network for Organ Sharing (UNOS) database were included for analysis up to 10 years. Patients in the ATG group received either ATGAM or thyroglobulin as induction. Patients in the BAS group received basiliximab as induction. Specific dosing and timing of administration were not available.

Duration

Data collection period 2000 to 2016

Follow-up: up to 10 years (cut-off date: March 31, 2017)

Outcome Measures

Primary: 10-year graft survival

Secondary: Univariate and multivariate analysis of different parameters to predict graft failure at 10 years

Baseline Characteristics

  

ATG (n= 2385)

BAS (n= 654)

 p-value

Age, years

 5.9 7.1 < 0.01 
Male 54%

52%

  

Race

White

Black

Hispanic

Other

 

55%

18%

19%

8%

 

49%

27%

18%

5%

 < 0.01 

Transplant years

2010

2010

 0.12

Maintenance steroid after transplant

58%

94%

 < 0.01

Results

Endpoint

ATG (n= 2385)

BAS (n= 654)

p-value

10-year graft survival

Blacks

Non-Blacks

 

51%

66%

 

39%*

57%

  
 

Hazard ratio (HR)

 95% confidence interval (CI) p-value

Univariate analysis

Age, years

Black

ATG

BAS

Maintenance steroid

 

1.01

1.49

0.82

0.92

1.18

 

1.0 to 1.02

1.33 to 1.67

0.73 to 1.09

0.78 to 1.09

1.03 to 1.36

 

0.009

< 0.001

< 0.001

0.349

0.015

Multivariate analysis: entire cohort

ATG vs no induction

ATG vs BAS

Multivariate analysis: Black

ATG vs no induction

ATG vs BAS

Multivariate analysis: non-Black

ATG vs no induction

ATG vs BAS

 

0.86

0.84

 

0.65

0.64

 

0.92

0.94

 

0.76 to 0.97

0.7 to 1.01

 

0.5 to 0.83

0.46 to 0.89

 

0.8 to 1.05

0.75 to 1.19

 

0.011

0.069

 

0.001

0.008

 

0.212

0.622

Hazard ratio > 1 indicates increased risk of graft failure

*The Black BAS group observed significantly lower 10-year graft survival rates compared to the other treatment group (all p-Values < 0.001)

Study Author Conclusions

 Black pediatric heart transplant recipients who received ATG induction had improved long-term graft survival compared to those who received BAS induction or no induction.

InpharmD Researcher Critique

ONUS is a public registry funded by the United States which may contain inaccurate or incomplete data collection. The dosing and timing of basiliximab administration are not reported. Maintenance steroid use may be influenced by the choice of induction agent (higher with basiliximab use). The univariate analysis regarding steroid use in basiliximab patients remains suspect as a result.

 

References:

Carlo WF, Bryant R 3rd, Zafar F. Comparison of 10-year graft failure rates after induction with basiliximab or anti-thymocyte globulin in pediatric heart transplant recipients-The influence of race. Pediatr Transplant. 2019 May;23(3):e13366. doi: 10.1111/petr.13366. Epub 2019 Feb 8. PMID: 30735604.

Comparison of Basiliximab and Anti-Thymocyte Globulin as Induction Therapy in Pediatric Heart Transplantation: A Survival Analysis

Design

Retrospective database review

N= 2,275

Objective

To determine whether any differences could be observed between basiliximab and anti-thymocyte globulin (ATG), with respect to long-term mortality, in a population of pediatric cardiac transplant recipients

Study Groups

Basiliximab (n= 699)

ATG (n= 1,612)

Inclusion Criteria

Orthotopic cardiac transplant recipients under the age of 18 years, received induction therapy with either basiliximab or ATG

Exclusion Criteria

Missing values in basiliximab or ATG treatment

Methods

Deidentified patients from the United Network for Organ Sharing (UNOS) research database were extracted. Patients received induction therapy with either basiliximab or ATG.

Duration

Transplanted between January 3, 2001 and September 30, 2013

Outcome Measures

Primary: all-cause cumulative mortality

Secondary: mortality attributable to graft failure, cardiovascular causes, infection, or malignancy

Baseline Characteristics

  

Basiliximab (n= 699)

ATG (n= 1,612)

p-value

Age, years

 8.6 ± 6.3 6.1 ± 6.2 < 0.001

Female

51.9% 46.9% 0.026

Weight, kg

 30.8 ± 22.0 24.8± 23.0 < 0.001

Height, cm

 121.0 ± 39.7 105.6 ± 42.9 < 0.001

Maintenance immunosuppression therapy

Cyclosporine

Tacrolimus

Mycophenolate mofetil

Steroids

Azathioprine

Rapamycin


19.1%

83.4%

93.9%

95.1%

6.7%

0.9%


32.1%

69.9%

85.0%

60.6%

22.4%

5.2%


< 0.001

< 0.001

< 0.001

< 0.001

< 0.001

< 0.001

Results

Endpoint

Basiliximab (n= 699)

ATG (n= 1,612)

p-value

Estimated survival after transplant

30 days

1 year

5 years

10 years

97%

90%

68%

49%

96%

89%

76%

65%

0.545

0.727

< 0.001

< 0.001

Patients treated with basiliximab had an increased mortality risk of 27% (hazard ratio 1.27; 95% confidence interval 1.02 to 1.57; p< 0.03) compared to patients treated with ATG.

Basiliximab was associated with a higher risk of death due to graft failure (p= 0.013), but not death due to cardiovascular event (p= 0.444), infection (p= 0.095), or malignancy (p= 0.0392).

Adverse Events

Not disclosed

Study Author Conclusions

In pediatric heart transplant patients, the use of basiliximab for induction therapy was associated with an increased risk of mortality, when compared with those receiving anti‐thymocyte globulin.

InpharmD Researcher Critique

This study is limited by its retrospective design and the inherent limitations of using a public registry database, in which the completeness and accuracy of the information cannot be readily verified. While patients were not randomized to their respective treatments, significant differences in baseline characteristics may have confounded results.

 

 

References:

Ansari D, Höglund P, Andersson B, Nilsson J. Comparison of Basiliximab and Anti-Thymocyte Globulin as Induction Therapy in Pediatric Heart Transplantation: A Survival Analysis. J Am Heart Assoc. 2015;5(1):e002790. Published 2015 Dec 31. doi:10.1161/JAHA.115.002790

Influence of Induction Therapy Using Basiliximab With Delayed Tacrolimus Administration in Heart Transplant Recipients ― Comparison With Standard Tacrolimus-Based Triple Immunosuppression

Design

Retrospective cohort study

N= 86

Objective

To elucidate the influence of induction therapy using basiliximab along with delayed tacrolimus (Tac) initiation on the outcomes of high-risk heart transplant recipients

Study Groups

Induction group (n= 46)

No-induction group (n= 40)

Inclusion Criteria

Consecutive heart transplant recipients 

Exclusion Criteria

Aged < 16 years, received cyclosporine as the primary immunosuppressive drug immediately after transplantations, treated with
muromomab-monoclonal CD3 antibodies 

Methods

At the study center, induction therapy with basiliximab was based on clinical necessity and patient factors, including (1) pre-transplant impaired renal function (low estimated glomerular filtration rate [eGFR] defined as < 60mL/min/1.73 m2) or history of renal dysfunction regardless of eGFR level immediately prior to HTx; (2) sensitization for anti-human leukocyte antigen (HLA) antibody; (3) recipient related risk factors; and (4) donor-related risk factors. Basiliximab 20 mg was administered intravenously (IV) < 3 h after weaning a patient from cardiopulmonary bypass and on Day 4 after the transplant. 

In patients receiving standard triple immunosuppressive therapy (no induction), Tac is generally initiated at a dose of 1 mg/day on the first or second postoperative day to achieve an initial blood concentration range of 9–12 ng/mL within a week. In the induction group, patients received Tac 1 mg/day, 3 or 4 days after the transplantation, when postoperative renal dysfunction had resolved. Dosage of Tac was gradually increased to achieve an initial target concentration of 9–12 ng/mL within 1 month, especially in those with renal dysfunction. Follow-up biopsies were performed regularly or when ACR or AMR was suspected. Univariable and multivariable cox regression models were analyzed to identify risk factors associated with cumulative incidence of ACR ≥ 1R within 6 months post-transplant. 

Duration

From May 1999 to March 2018

Follow-up: 4.3 ± 2.9 years

Outcome Measures

Cumulative incidence of acute cellular rejection (ACR) Grade ≥ 1R (based on International Society of Heart and Lung Transplantation [ISHLT] guidelines) and ISHLT-classified antibody-mediated rejection (AMR) of pathological AMR (pAMR) ≥ 1; infection, defined by treatment with antiviral, antibacterial, or antifungal agents; changes in renal function up to 6 months 

Baseline Characteristics

  

Induction group (n= 46)

No-induction group (n= 40)

 p-value 

Recipient age, year

 41.2 38.7 Not significant (NS) 

Male

 69.6% 85.0% NS

Cytomegalovirus (CMV) mismatch (Donor+/Recipients−)

 19.6% 25.0% NS

Primary indication for heart transplant

Dilated cardiomyopathy

Hypertrophic cardiomyopathy

Ischemic cardiomyopathy

 

65.2%

14.3%

6.5%

 

62.5%

10.0%

10.0%

 NS 

Left ventricular assist device (LVAD) support 

 93.5% 97.5% NS 

Sensitization for anti-HLA antibodies

Class 1

Class 2

 

26.1%

8.7%

 

12.5%

0

 NS 
Estimated glomerular filtration rate, mL/min/1.73 m2 88.0 116.7 NS 

Trough level of Tac, ng/dL (interquartile range)

1 week post-transplant

2 week post-transplant

3 week post-transplant

4 week post-transplant

 

5.9 (3.3 to 8.0)　　

8.7 (7.1 to 10.8)

8.7 (7.6 to 10.9)

10.1 (9.1 to 11.8)

 

7.6 (5.8 to 10.0)

10.7 (9.3 to 12.5)　　

9.9 (8.9 to 10.9)

10.8 (9.3 to 12.3)　　

 

0.008

< 0.001

0.022

0.179 

Results

Endpoint

Induction group (n= 46)

No-induction group (n= 40)

p-value

All cumulative rejections at 6 months post-transplant 

 35 (76.1%) 32 (80.0%) 0.796

ACR ≥1R

3 weeks post-transplant

6 weeks post-transplant

 

9 (19.6%)

33 (71.7%)

 

9 (22.5%)

31 (77.5%)

 

0.795

0.624

AMR ≥ pAMR1 

3 weeks post-transplant

6 weeks post-transplant

 

4 (8.7%)

4 (8.7%)

 

2 (5.0%)

3 (7.5%)

 

0.681

0.999

All infectious diseases 

CMV infections

Non-CMV infections

Bacterial or fungal infections

19 (41.3%)

12 (26.1%)

10 (21.7%)

9 (21.7%)

11 (27.5%)

8 (20.0%)

3 (7.5%)

1 (2.5%)

0.257

0.612

0.078

0.017

Presence of BK virus in the urine samples within 1-year post-transplant

 14 (30.4%) 16 (40.0%) 0.374

Induction therapy with basiliximab was not associated with a significantly lower incidence of ACR ≥ 1R (p= 0.093). 

Multivariable Cox proportional hazard models showed that induction therapy using basiliximab was independently associated with a higher incidence of bacterial or fungal infections (hazard ratio 10.61, 95% confidence interval 1.28 to 88.2, p= 0.029).

Adverse Events

In the Induction group, bacterial cholangitis occurred in 3 recipients, whereas mediastinitis, cellulitis, urinary tract infection, catheter infection, clostridium difficile colitis, and fungal spondylitis each affected 1 recipient. In the No-induction group, 1 recipient was treated for surgical site (LVAD removal site) Candida albicans infection. 

Study Author Conclusions

These results suggest that basiliximab-based induction therapy with delayed Tac initiation may suppress mild acute cellular rejection and improve renal function in recipients with renal dysfunction, resulting in its non-inferior outcome, even in high-risk patients, when applied to the appropriate recipients. However, it should be carefully considered in recipients at a high risk of bacterial and fungal infections.

InpharmD Researcher Critique

The study was limited by its observational nature and small sample size, affecting the robustness of the findings. A study conducted in Japan may not reflect current practice in the US. 

 

References:

Watanabe T, Yanase M, Seguchi O, et al. Influence of Induction Therapy Using Basiliximab With Delayed Tacrolimus Administration in Heart Transplant Recipients　- Comparison With Standard Tacrolimus-Based Triple Immunosuppression. Circ J. 2020;84(12):2212-2223. doi:10.1253/circj.CJ-20-0164